chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Eye movement disorder, Moaning, Unresponsive to stimuli
Clinical narrative: bilateral eye deviation to the left; moaning; Muscle tightness; Staring; Unresponsive to stimuli; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2204963-1. The original narrative from the sender is as below:  Infant received routine vaccines at 6 week well check. Within 12 hours of vaccination, had one episode where baby moaned then turned head to the left, become very tight, accompanied by bilateral eye deviation to the left, staring off unresponsive to sound or movement. No generalized convulsion. Episode lasted 1-1.5 minutes. No repeat episodes.  Current illness included Hyperbilirubinemia requiring phototherapy.  Medications at time of vaccination included Polyvisol with Iron oral drops.  Lab data none, history none and allergies none.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Unevaluable event
Clinical narrative: its been a year since I contacted your reporting adverse program with my issues and along with the medical professionals dont seem to hear me; 64 year old patient; This case was retrieved during the monitoring on 11-Apr-2022 with the following reference number: 2070121-1. The original narrative from the sender is as follows.  It's been a year since I contacted your reporting adverse program with my issues and along with the medical professionals don't seem to hear me.
Sex: F
Vaccine: DTPPVHBHPB, HEP
Symptoms: Peripheral swelling
Clinical narrative: Swollen leg; This case was retrieved during the monitoring on 11-Apr-2022 with the following reference number: 2183036-1. The original narrative from the sender is not available
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Dyspnoea, Hypotonia, Lethargy
Clinical narrative: He was having trouble breathing.; Tone went limp; Was lethargic; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2180696-1. The original narrative from the sender is as below:  While sleeping the night after the vaccines, mom woke to him gasping. He was having trouble breathing. Tone went limp. Was lethargic. Responded after mother provided stimulation. Similar issues occurred after 4 mo vaccinations.  Lab data included none this time. After 4mo vaccinations, he was evaluated by neuro and seizures were ruled out.  Current illness included mild viral URI the week prior.  Adverse Events After Prior Vaccinations included similar issue after 4 mo vaccinations.  Medications At Time Of Vaccination included Peanut allergy supplementation.  No allergies. No medical history.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B; This case was retrieved during monitoring on 11-APR-2022 with the following reference number: 2194500-1. The original narrative is as below.  Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B. Vaccine made Hep B #4
Sex: F
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, Injection site erythema
Clinical narrative: EXTRA DOSE ADMINISTERED; This case was retrieved during the monitoring on 11-Apr-2022 with the following reference number: 2189860-1. The original narrative from the sender is as follows:  Two Hib containing vaccine were given to patient on the same day. Vaxelis (DTaP+Hib+IPV+HepB) and PedvaxHib were administered on 02/12/2022 by on-call MA. Vaxelis was given in left thigh and Hib in right thigh.  Adverse events after prior vaccinations included redness on Right thigh injection site.
Sex: M
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Crying, Discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Overall uncomfortable after the administration of VAXELIS; Warm to touch; 3.5 cm of redness induration and also warm to touch; Red spot at the VAXELIS injection site; Crying more than usual; Significant fever; This non-serious spontaneous safety report with agency reference #02151156 was received via partner on 20-APR-2022 and forwarded to agency on 21-APR-2022, from a Health Care Professional.  The reporter did not assess the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever'.  It was reported that the PCV 13 Vaccine was administered the same day (on the opposite thigh) as VAXELIS. It was considered as co-suspect given that the patient experienced  'crying more than usual', and 'significant fever'. Nonetheless, PCV 13 was concomitant for the other reported adverse events.  Further information is expected.   Significant follow-up was received via fax by agency on 12-MAY-2022, from a Health Care Professional.  The reporter confirmed that the events were not serious. First dose of Vaxelis was administered on 12-NOV-2021. Second dose was administered on12-JAN-2022.  End date and outcome of events were provided.  The patient was treated with analgesic for pain, and cool or warm compresses.  The reporter assessed the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever' as related.  This case is maintained as non-serious.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Pyrexia
Clinical narrative: Overall uncomfortable after the administration of VAXELIS; Warm to touch; 3.5 cm of redness induration and also warm to touch; Red spot at the VAXELIS injection site; Crying more than usual; Significant fever; This non-serious spontaneous safety report with agency reference #02151156 was received via partner on 20-APR-2022 and forwarded to agency on 21-APR-2022, from a Health Care Professional.  The reporter did not assess the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever'.  It was reported that the PCV 13 Vaccine was administered the same day (on the opposite thigh) as VAXELIS. It was considered as co-suspect given that the patient experienced  'crying more than usual', and 'significant fever'. Nonetheless, PCV 13 was concomitant for the other reported adverse events.  Further information is expected.   Significant follow-up was received via fax by agency on 12-MAY-2022, from a Health Care Professional.  The reporter confirmed that the events were not serious. First dose of Vaxelis was administered on 12-NOV-2021. Second dose was administered on12-JAN-2022.  End date and outcome of events were provided.  The patient was treated with analgesic for pain, and cool or warm compresses.  The reporter assessed the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever' as related.  This case is maintained as non-serious.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VAXELIS was administered to a patient after his 5th birthday; This non-serious spontaneous safety Report with reference number 2022SA161948, was received by Sanofi, on 03-May-2022 and forwarded on 05-May-2022 from a HCP.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported off-label event, "VAXELIS was administered to a patient after his 5th birthday".  No further information is expected because HCP does not want to be contacted
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Body temperature increased
Clinical narrative: 6 month old patient who received VAXELIS at 2 months and PENTACEL at 4 months/ Requesting information on whether VAXELIS can be given now for the 6 month/3rd dose; patient has a temperature today; This non-serious spontaneous safety report with reference number # 22022SA164823 / 01090895 was received by a partner on 05-May-2022 and forwarded on 09-May-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event, "patient has a temperature today" was not provided by the reporter. The causal relationship between Vaxelis and the reported event,"6-month-old patient who received VAXELIS at 2 months and PENTACEL at 4 months/ Requesting information on whether VAXELIS can be given now for the 6 month/3rd dose" was assessed as not applicable due to the nature of the event.  No further information is expected since the reporter did not give consent to follow-up.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: During temperature excursion call, customer reports that improperly stored VAXELIS was administered to unknown patient; This spontaneous non-serious safety report was received by partner (Ref: 02169914) on 20-May-2022 and forwarded on 23-May-2022 from a consumer.  Due to the nature of the event, the causality between the event and the product is not applicable.  This case is non-valid due to no patient identifiers.  Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 03-Jun-2022 from a consumer, with reference number: 02169906 (interaction number) and forwarded on 06-Jun-2022. The case was maintained as non-serious.  The case is now considered valid as patient identifiers (initials and age) were provided.  It was reported that there was no adverse event.  Due to the nature of the event, the causality between "During temperature excursion call, customer reports that improperly stored VAXELIS was administered to unknown patient" and Vaxelis is not applicable.  No further information is expected.
Age: 0.33
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Feeling abnormal, Pyrexia, Sluggishness
Clinical narrative: Patient received Vaxelis at 4 month wellness visit/ Patient developed fever and seemed little "off or sluggish" after the vaccination; Patient received Vaxelis at 4 month wellness visit/ Patient developed fever and seemed little "off or sluggish" after the vaccination; This non-serious spontaneous safety report was received by a partner on 25-May-2022 and forwarded on 27-May-2022, from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "the patient developed fever and the patient seemed little "off or sluggish" after the vaccination".   Further information is expected.  NON-SIGNIFICANT Follow-up information, with reference number 02174082, was received by a partner on 06-JUN-2022 and forwarded on 07-JUN-2022, from a physician. The case is maintain as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "the patient developed fever and the patient seemed little "off or sluggish" after the vaccination".  No further information is expected as all the follow-up attempts have been completed and the physician could not identify the patient.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Vaccination site mass
Clinical narrative: Subcutaneous nodule; This non-serious spontaneous Safety Report, with reference number 02162368, was received by on 09-May-2022 and forwarded on 10-May-2022, from a health care provider.  This case was considered non-valid due to no patient identifiers provided.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "6 of 10 patients (unknown by reporter), who received VAXELIS developed a knot/lump at the vaccination site".  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION, with reference number 02162368 (Interaction # 02162362), was received by on 27-May-2022 and forwarded on 01-Jun-2022 from a Health Professional.  The case is maintained as non-serious and became valid since the reporter provided one patient ID.  The reporter assessed the updated event "Subcutaneous nodule" as not related to Vaxelis.  Further information is expected.  Linked case: MCM-003552 (same reporter).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: brain fog; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog". Additional Information: She has experienced "brain fog" since receiving Pfizer covid-19 vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: My wife has a breakthrough case; My wife has a breakthrough case; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My wife has a breakthrough case". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for COVID-19". This report is from a contactable consumer communicated to a Pfizer colleague. This colleague received the information: "my brother about one of his friends. He reported to my brother that he received 2 doses of the Pfizer vaccine, the second one approximately 6 months ago. Within past several days he experienced fever, relatively mild symptoms including loss of taste and smell, and tested positive for COVID-19. I have no more details, but colleague has agreed that it is ok to reach him to obtain any additional information. On 28Sep2021 colleague confirms awareness date as 27Sep2021, but did not have contact info until this morning 28Sep2021.  The patient underwent the following laboratory tests and procedures: Body temperature increased: (unspecified date) Unknown results; SARS-CoV-2 test: (2021) Positive, notes: tested positive for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (01Nov2021): Follow-up attempts completed. No further information expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the reported events cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Lip infection, Oral herpes
Clinical narrative: lip infection from believed cold sore; lip infection from believed cold sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LIP INFECTION (non-serious), ORAL HERPES (non-serious), outcome "unknown" and all described as "lip infection from believed cold sore". Therapeutic measures were taken as a result of lip infection, oral herpes. Clinical course was as follows: A Pfizer employee reported, "Friend was chatting about vacation activity. Vacationers came across a person who I think said were vaccinated and may or may not have covid (did not say definite). One of vaccinated people on vacation got a lip infection from believed cold sore. Is on round 3 of antibiotics." Upon a follow-up, this reporter stated, "The person with lip infection is adult male. Beyond this I have no further details."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Past drug history included: Ivig, notes: IVIG. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. Facility type was reported as vaccine Pharmacy or Drug Store. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown". The event "guillain-barre syndrome" required physician office visit.  The patient had developed Guillain-Barre syndrome sometime after her 2nd dose of the Pfizer- BioNTech COVID-19 vaccine this spring. She also received other vaccinations around that time period. The patient has multiple sclerosis (MS) and has received Intravenous immunoglobulin (IVIG) infusions. It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Malaise, Product use issue
Clinical narrative: after receiving both covid and flu vaccination; not feeling well; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "after receiving both covid and flu vaccination"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Additional information: the patient experienced general not feeling well after receiving both COVID and flu vaccination The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: sore leg after covid and flu vaccinations; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore leg after covid and flu vaccinations". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: burning at injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). An 11-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection".  Additional Information: The patient experienced burning at injection after receiving covid and flu vaccinations. Event took place after use of product.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  A 9-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: The patient experienced a sore arm day after injection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast pain, Breast swelling, Chills
Clinical narrative: body pain especially in back and knees; body pain especially in back and knees; body pain especially in back and knees; arm pain; chills; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization complete, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arm pain"; PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Nov2021, outcome "unknown" and all described as "body pain especially in back and knees"; CHILLS (non-serious) with onset Nov2021, outcome "unknown"; BREAST SWELLING (non-serious), BREAST PAIN (non-serious), LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset Nov2021, outcome "unknown" and all described as "swelling and pain in breast and lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Description of Event: 34 year old female, heavy weight received booster abs experienced body pain especially in back and knees within first 24 hrs of shot, along with the arm pain and chills. Within 36hrs of shot, developed swelling and pain in breast and lymph nodes on same side where received shot  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pain in extremity, Weight
Clinical narrative: body pain especially in back and knees; body pain especially in back and knees; body pain especially in back and knees; arm pain; chills; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization complete, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arm pain"; PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Nov2021, outcome "unknown" and all described as "body pain especially in back and knees"; CHILLS (non-serious) with onset Nov2021, outcome "unknown"; BREAST SWELLING (non-serious), BREAST PAIN (non-serious), LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset Nov2021, outcome "unknown" and all described as "swelling and pain in breast and lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Description of Event: 34 year old female, heavy weight received booster abs experienced body pain especially in back and knees within first 24 hrs of shot, along with the arm pain and chills. Within 36hrs of shot, developed swelling and pain in breast and lymph nodes on same side where received shot  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: not feeling well after receiving COVID vaccine; The initial case was missing the following minimum criteria: ICH-Reporter with No First-hand knowledge. Upon an updated that Pfizer colleague reported for a patients AE even the information did not come from the individual who experienced effects and has First-hand knowledge , this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via Pfizer colleague.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well after receiving COVID vaccine". It was unknown if therapeutic measures were taken as a result of malaise.        Additional information: None  Follow-up attempts are not possible, information about lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired; This is a spontaneous report received from non-contactable reporter (Consumer). An adult male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: Unknown) intramuscular for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Prev dose lot unknown reason= Not available/provided to reporter at the time of report completion), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Prev dose lot unknown reason= Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. It was unknown if the patient had covid prior to vaccination. It was unknown if the patient had covid test post vaccination.  The following information was reported: FATIGUE (non-serious) with onset 08Dec2021, outcome "recovering", described as "Feeling tired". It was unknown if therapeutic measures were taken as a result of fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test positive for COVID; test positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 84-year-old male patient received BNT162B2, in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Dec2021, outcome "unknown" and all described as "test positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2021) Positive, notes: tested positive 2 days ago. Additional information: Pfizer colleague stated, "I am a Pfizer colleague and someone a friend of mine told me about his parents. Pfizer colleague further stated, The two people that I am reporting on are husband and wife. The woman is 81, the man is 84 and they are married. Who I spoke to is their son, who is a friend and colleague of mine. He was the one who told me both his parents had preexisting condition, that they had to be vaccinated and they tested positive for COVID. They believe they tested positive two days ago and I asked what symptoms they have and they said fever, headache, fatigue, congestion and chills and they have not received any treatment. The time frame for their vaccination occurred the first dose in March and the second dose in April. I believe that they had the Pfizer vaccine. They had not had a chance to get the booster. During November, when family members were together, one of the siblings was not vaccinated. The son had a theory that perhaps his parents who had been vaccinated but did not have a chance to get booster shot, were exposed during an intimate family gathering because of someone who was not vaccinated".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test positive for COVID; test positive for COVID; This Initial case was previously missing the following minimum criteria: reporter has no first hand knowledge. Upon receipt of reporter has First-hand knowledge, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via Pfizer colleague.  An 81-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Dec2021, outcome "unknown" and all described as "test positive for COVID"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Congestion"; CHILLS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2021) Positive, notes: they did test positive for COVID. Therapeutic measures were not taken as a result of pyrexia, headache, fatigue, nasal congestion, chills. Additional Information: Pfizer colleague stated, "I am a Pfizer colleague and someone a friend of mine told me about his parents. Pfizer colleague further stated, The two people that I am reporting on are husband and wife. The woman is 81, the man is 84 and they are married. Who I spoke to is their son, who is a friend and colleague of mine. He was the one who told me both his parents had preexisting condition, that they had to be vaccinated and they tested positive for COVID. They believe they tested positive two days ago and I asked what symptoms they have and they said fever, headache, fatigue, congestion and chills and they have not received any treatment. The time frame for their vaccination occurred the first dose in March and the second dose in April. I believe that they had the Pfizer vaccine. They had not had a chance to get the booster. During Holiday, when family members were together, one of the siblings was not vaccinated. The son had a theory that perhaps his parents who had been vaccinated but did not have a chance to get booster shot, were exposed during an intimate family gathering because of someone who was not vaccinated".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: three of their team members have Covid, and they all got it from different people; three of their team members have Covid, and they all got it from different people; This is a spontaneous report received from non-contactable reporter (HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Exposure to COVID-19" (ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "three of their team members have Covid, and they all got it from different people". Additional information: adverse event: Friend who works partly remote and partly at hospital says that three of their team members have Covid, and they all got it from different people. Though I do not know them personally, there is a high chance they are all vaccinated to some extent, though manufacturer and dosage is unknown.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown) to the reported events COVID-19 and drug ineffective cannot be excluded.   However, the vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be re-assessed should additional information becomes available.,Linked Report(s) : US-PFIZER INC-202200028597 same reporter/drug/AE, different patients;US-PFIZER INC-202200028596 same reporter/drug/AE, different patients;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent; three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Exposure to COVID-19" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent". Adverse event: Friend who works partly remote and partly at hospital says that three of their team members have Covid, and they all got it from different people. Though I do not know them personally, there is a high chance they are all vaccinated to some extent, though manufacturer and dosage is unknown.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported events Drug ineffective  and COVID-19.,Linked Report(s) : US-PFIZER INC-202200027172 same reporter/drug/AE, different patients;US-PFIZER INC-202200028597 same reporter/drug/AE, different patients;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent; three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  An adult patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "exposure to COVID-19" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent". Adverse event: Friend who works partly remote and partly at hospital says that three of their team members have Covid, and they all got it from different people. Though I do not know them personally, there is a high chance they are all vaccinated to some extent, though manufacturer and dosage is unknown.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective and Covid-19 are assessed as related to "COVID-19 Vaccine - Manufacturer Unknown". Limited information does not allow a medically meaningful assessment. Details regarding the vaccine dosing schedule and event onset date are not reported. The case will be re-evaluated upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202200028596 same reporter/drug/AE, different patients;US-PFIZER INC-202200027172 same reporter/drug/AE, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Death, Diarrhoea, Drug ineffective, Gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: He did have positive PCR test result; He did have positive PCR test result; His symptoms were gastrointestinal issues including excessive diarrhea; His symptoms were gastrointestinal issues including excessive diarrhea; vomiting; passed away on Saturday, 09Jan; The initial case was missing the following minimum criteria: ICH-Reporter with No First-hand knowledge. Upon an updated that Pfizer colleague reported for a patients AE even the information did not come from the individual who experienced effects and has First-hand knowledge , this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 09Jan2022, outcome "fatal", described as "passed away on Saturday, 09Jan"; DRUG INEFFECTIVE (death, medically significant), SARS-COV-2 TEST POSITIVE (death, medically significant), outcome "fatal" and all described as "He did have positive PCR test result"; GASTROINTESTINAL DISORDER (death), DIARRHOEA (death), outcome "fatal" and all described as "His symptoms were gastrointestinal issues including excessive diarrhea"; VOMITING (death), outcome "fatal". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient date of death was 09Jan2022. Reported cause of death: "passed away on Saturday, 09Jan", "He did have positive PCR test result", "His symptoms were gastrointestinal issues including excessive diarrhea", "vomiting". It was not reported if an autopsy was performed. Additional information:  I am not aware which vaccine he received and have not reached out to ask. I completed my reporting training and will enter the information into the system.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: passed away on Saturday, 09Jan; He did have positive PCR test result; His symptoms were gastrointestinal issues including excessive diarrhea; vomiting; His symptoms were gastrointestinal issues including excessive diarrhea; He did have positive PCR t
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: He did have positive PCR test result; He did have positive PCR test result; His symptoms were gastrointestinal issues including excessive diarrhea; His symptoms were gastrointestinal issues including excessive diarrhea; vomiting; passed away on Saturday, 09Jan; The initial case was missing the following minimum criteria: ICH-Reporter with No First-hand knowledge. Upon an updated that Pfizer colleague reported for a patients AE even the information did not come from the individual who experienced effects and has First-hand knowledge , this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 09Jan2022, outcome "fatal", described as "passed away on Saturday, 09Jan"; DRUG INEFFECTIVE (death, medically significant), SARS-COV-2 TEST POSITIVE (death, medically significant), outcome "fatal" and all described as "He did have positive PCR test result"; GASTROINTESTINAL DISORDER (death), DIARRHOEA (death), outcome "fatal" and all described as "His symptoms were gastrointestinal issues including excessive diarrhea"; VOMITING (death), outcome "fatal". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient date of death was 09Jan2022. Reported cause of death: "passed away on Saturday, 09Jan", "He did have positive PCR test result", "His symptoms were gastrointestinal issues including excessive diarrhea", "vomiting". It was not reported if an autopsy was performed. Additional information:  I am not aware which vaccine he received and have not reached out to ask. I completed my reporting training and will enter the information into the system.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: passed away on Saturday, 09Jan; He did have positive PCR test result; His symptoms were gastrointestinal issues including excessive diarrhea; vomiting; His symptoms were gastrointestinal issues including excessive diarrhea; He did have positive PCR t
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Seeing new sleep doctor to improve this; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non Health Care Professional). An adult patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "believe POTS amongst others" (unspecified if ongoing), notes: believe POTS amongst others. The patient's concomitant medications were not reported. The following information was reported: SLEEP DISORDER (non-serious), outcome "unknown", described as "Seeing new sleep doctor to improve this".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Pfizer colleague was speaking with someone who had to quit job because standing too long was impacting their health, this person also seeing new sleep doctor to improve this. Vaccination time frame reported as probably early-mid 2020 (not 100% sure which vaccine and vaccination time frame) for full vaccination. Patient has several health issues: believe may have POTS (Postural orthostatic tachycardia syndrome) along with other disorders. Likely the above is related to already ongoing disorders. Unsure when exactly quit job and started seeing new doctor, but probably recent. On 12Jan2022 it was reported that individual was fully vaccinated likely around early-mid 2021 (Not 2020). On 27Jan2022 a consumer reported in response to Non-HCP letter sent via email follow up activity reporter mobile number and Institution.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: experienced swelling, soreness and redness at the site of injection; experienced swelling, soreness and redness at the site of injection; experienced swelling, soreness and redness at the site of injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A 35-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2022 at 15:00 as dose number unknown (booster), single (Lot number: FL 3197) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE # and MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), INJECTION SITE ERYTHEMA (non-serious) all with onset 15Jan2022, outcome "unknown" and all described as "experienced swelling, soreness and redness at the site of injection". Description of Event: 35-year-old female patient received booster Pfizer-BioNTech Covid-19 vaccine around 3pm Friday 14Jan2022. The day after she experienced swelling, soreness and redness at the site of injection. No fever and site was not warm to the touch.