chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result Positive; covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood, pressure. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; BUDESONIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Apr2022, outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of 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: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: one of them has a lump of medication that wouldn't dissolve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as 0.5ml (Lot number: FJ2602, Expiration Date: Jun2023) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "one of them has a lump of medication that wouldn't dissolve".  Additional information: This was a product complaint issue. Practice manager calling on behalf of the facility from  Primary Care. She has called about Prevnar 20 and says they got a shipment in and one of them has a lump of medication that would not dissolve so they do not feel safe giving to a patient, so they would like to see if they can get a replacement or refund for this one. Caller says she needs to put her glasses on when retrieving product to provide NDC/LOT/EXP from it, but does not clarify this statement. She says that the Prevnar 20 has a white lump that she guesses is the powder, and they were shaking and shaking it and could not get it to dissolve, and it has been at room temp for a while now. She says all the other doses seem fine so far, it is just this one. Packaging sealed and intact was done.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pain in extremity
Clinical narrative: Her arm was sore/arms still hurt; Not able to taste or smell anything/no smell and taste; Not able to taste or smell anything/no smell and taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 87-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: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Her arm was sore/arms still hurt"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Not able to taste or smell anything/no smell and taste".  Additional information: Her 4th dose on 05Apr2022, since then not able to. Her arm was sore and not able to taste or smell anything. Not experienced this with any of the prior 3 shots, just this one. Her Insurance agent heard that the vaccine had caused a lost sense of taste and smell. Thought he had heard it somewhere. Informed caller that a sore arm or injection site pain had been reported as a side effect, however no data available on the loss of taste and smell associated with the vaccine. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. She got her third vaccine and her arms still hurt from the shot and have no smell and taste. 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: Lymphadenopathy
Clinical narrative: swollen lymph nodes/ swollen lymph node under the arm intermittently and on the left side of her neck; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "swollen lymph nodes/ swollen lymph node under the arm intermittently and on the left side of her neck".  Additional information: Patient wanted to know if there was any information about getting another dose of the vaccine after experiencing swollen lymph nodes as an adverse event of the vaccine. She had to travel on 09July because her son was getting married. She wanted to know if there were reports of her adverse event being that long.  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: Dehydration, Lethargy, Pain, Rheumatoid arthritis, Vomiting
Clinical narrative: Rheumatoid arthritis flare up; reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with Humira; Lethargic; Pain; reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with Humira; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362258-00.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2021 (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of administration: Intramuscular), for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; PAIN (non-serious), outcome "not recovered"; VOMITING (non-serious), DEHYDRATION (non-serious), outcome "unknown" and all described as "reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with Humira". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "lethargic" and "pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with humira" related to BNT162b2.  Clinical informationSolicited report from the USA by a consumer of an adult female with events of Non-serious lethargic, pain, Rheumatoid arthritis flares and reaction to second dose of covid vaccine/vomiting resulted in dehydration with Humira (Adalimumab).Causality for Humira (Adalimumab). The reporters causality for the events of Lethargic, pain, Dose of covid vaccine/vomiting resulted in dehydration unknown vaccine/vomiting resulted in dehydration unknown onset was not rheumatoid arthritis flares, reaction to second onset and reaction to second dose of covid provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Iron deficiency
Clinical narrative: iron deficiency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), in 2020 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: IRON DEFICIENCY (non-serious) with onset 2020, outcome "unknown".  Additional information: Reporter states that her daughter got the booster dose of the Pfizer-BioNTech COVID-19 Vaccine and she's been dealing with an inability to process iron. My daughter has some kind of iron deficiency problem. Serious iron processing incapacity. I'd like to know where can I go within Pfizer, who would know of patients receiving the vaccine who end up with a serious iron processing incapacity. Now my daughter needs iron infusions every three weeks. This changes people's lives. This is too important. My daughter was too weak, it was hard for her to even try to stand up. "There have been 5 cases of this same thing happening in the withheld area. withheld Clinic has 6 physicians assigned to this particular issue. Iron processing deficiency. My daughter's internist said this was real. They made her an endoscopy, but the results aren't in yet. She was referred to hematology and they say her blood cells have an oval shape. I have to call everyday to the withheld Clinic to see if they have an opening. I happen to be buying a dress for my daughter's birthday an another person, someone on the queue, mentioned that they had the same problem two years ago after receiving the vaccine. Up to this day they still need frequent iron infusions. It exists and it's widespread. Two people who don't know each other, different ages, from different parts of the country. Caller would like to know if Pfizer is aware that certain people who receive the Pfizer-BioNTech COVID-19 Vaccine are coming down with an iron deficiency problem.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Paraesthesia
Clinical narrative: her feet she can't walk on them; hands have a terrible sensation and tingling; pain; This is a spontaneous report received from a 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "her feet she can't walk on them"; PARAESTHESIA (non-serious), outcome "unknown", described as "hands have a terrible sensation and tingling"; PAIN (non-serious), outcome "unknown". Therapeutic measures were taken as a result of pain.  Additional information: It was reported that, can she be told what poison went into the vaccine. The only reason she is saying that is because half of her body and her feet. Ever since she got the vaccine her feet she can't walk on them. Her hands have a terrible sensation and tingling. Her right arm and her right breast and her right side goes totally. They had to prescribe Gabapentin and Lorazepam for the pain she is enduring. It all started when she got the vaccine. She was the healthiest 70 years old that had been seen. Not everyone got a fever and an ache. Who is in charge. She is one of the people having severe side effect. She wants to know if other people called in with more severe reactions. She is getting an attorney after this call. She was a professional dancer. She can't get on her feet anymore. She is so opposed to you people. She was so pro vaccine. Now she feels bad because she has told a lot of people to take the vaccine and a couple people have died in the last few weeks. She is not sure if it is related to the vaccine because she moved from that place. This should not be given to children.  It was given before it was approved.  she will say that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: he is breaking out in rash; it's itchy; This is a spontaneous report received from a contactable reporter consumer or other non HCP. The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "he is breaking out in rash"; PRURITUS (non-serious), outcome "unknown", described as "it's itchy".  Additional information:-Reporter stated, that his son got the Pfizer shot yesterday. he was 11-years-old and he was breaking out in rash and it's itchy. NDC number of Covid-19 vaccine was unknown. Number of Covid-19 vaccine was unknown. Expiry Date of Covid-19 vaccine was unknown. Reason for no lot number of Covid-19 vaccine: Complainant hung up abruptly/transfer incomplete. Reporter was informed about the role of Pfizer Drug Safety. Reporter asking that is there something they can give him to stop this rash and itching on him. Reporter was informed about the  Information Department and was provided with the telephone# option 3, timings as  8 am to 9 pm, monday to friday, as per. When requested to probe further : Reporter stated, "I am going to call this other number and press 3 because I need to find out if there is something to reverse this rash and itch. Reporter hung up the call abruptly. Reporter was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  comment that reporter type could not be probed hence, captured as consumer or other non HCP by default. Outcome of reaction/event at the time of last observation was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Under right arm in arm pit: noticeable swelling; Under right arm in arm pit: pain; Under right arm in arm pit: tenderness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:30 as dose 1, single (Lot number: Fj4989) at the age of 44 years, in right arm for covid-19 immunization at Pharmacy or Drug Store. The patient's relevant medical history included: "High bp" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; VALTREX; LISINOPRIL; PROZAC. Prior vaccinations within 4 weeks was reported as none.  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 19Apr2022 at 06:00, outcome "recovering", described as "Under right arm in arm pit: noticeable swelling"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2022 at 06:00, outcome "recovering", described as "Under right arm in arm pit: pain"; TENDERNESS (non-serious) with onset 19Apr2022 at 06:00, outcome "recovering", described as "Under right arm in arm pit: tenderness". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, tenderness. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 Since the vaccination. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain, Rhinorrhoea
Clinical narrative: cough; runny nose; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 36-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 36-year-old, for Covid-19 Immunization.  The following information was reported: PAIN (non-serious) with onset 19Apr2022, outcome "recovering", described as "body aches"; COUGH (non-serious) with onset 19Apr2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 19Apr2022, outcome "recovering", described as "runny nose". It was unknown if therapeutic measures were taken as a result of cough, rhinorrhea, pain. No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Menstruation after receiving first dose lasted 2.5 weeks, typically only lasts 4-5 days max; next menstruation was OVER 3 weeks LATE.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  An 11-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2022 at 09:15 as dose 1, single (Lot number: FK5618) at the age of 11 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN [LORATADINE]. Vaccination history included: Flu shot (known allergies Flu Shot), for Immunisation, reaction(s): "allergies: Flu Shot".  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 04Mar2022, outcome "unknown", described as "Menstruation after receiving first dose lasted 2.5 weeks, typically only lasts 4-5 days max"; MENSTRUATION DELAYED (non-serious) with onset 04Mar2022, outcome "unknown", described as "next menstruation was OVER 3 weeks LATE.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation delayed. Additional Information: No other vaccine in four weeks. Other medications in two weeks- Claritin. No COVID prior to the vaccination. Adverse event- Menstruation after receiving first dose lasted 2.5 weeks, typically only lasts 4-5 days max. Then after that period, next menstruation was over 3 weeks late. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Androgenetic alopecia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Androgenetic Alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 09:15 as dose 2, single (Lot number: ER8737) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing), notes: Hashimoto's Disease; "Bi-Polar II" (unspecified if ongoing), notes: Bi-Polar II; "Migraine Headaches" (unspecified if ongoing), notes: Migraine Headaches. The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "allergies:Doxycycline", notes: known allergies Doxycycline. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 16Mar2021, when the patient was 36-year-old, for Covid-19 immunization. The following information was reported: ANDROGENETIC ALOPECIA (non-serious) with onset 01Sep2021, outcome "not recovered". The event "androgenetic alopecia" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of androgenetic alopecia.  Additional Information: No other vaccine in four weeks. Other medications in two weeks: Yes (Not enough space in this field to list). Ae treatment: Spironolactone, Minoxidil, Ketoconazole. No covid prior vaccination. If covid tested post vaccination: Yes.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Oropharyngeal pain
Clinical narrative: GF is positive after international travel together, PCR-19Apr inconclusive; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Lot no.: EL3247), administration date: 27Jan2021, when the patient was 30-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, Lot no.: EL3247), administration date: 17Feb2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 19Apr2022, outcome "recovering", described as "Sore throat"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "GF is positive after international travel together, PCR-19Apr inconclusive". It was unknown if therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Unknown if covid prior vaccination and unknown if tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: Nerve pain shooting up and down the arm; painful tingly and numb sensation; painful tingly and numb sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 2, single (Lot number: EW0173) at the age of 38 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: EW0171, Manufacturer: Pfizer), administration date: 24Apr2021, when the patient was 38-year-old, for Covid-19 immunization.  The following information was reported: NEURALGIA (non-serious) with onset 19May2021, outcome "unknown", described as "Nerve pain shooting up and down the arm"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 19May2021, outcome "recovered" (Jul2021) and all described as "painful tingly and numb sensation". The events "nerve pain shooting up and down the arm" and "painful tingly and numb sensation" required physician office visit.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. If covid tested post vaccination Unknown. Nerve pain shooting up and down the arm where the vaccine was administered. A painful tingly and numb sensation that lasted for two months after receiving the second dose.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: I lost the hearing in my left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) 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 (Dose 1(manufacturer unknown)), for Covid-19 immunization; Covid-19 vaccine (Dose 2(manufacturer unknown)), for Covid-19 immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "I lost the hearing in my left ear". The event "i lost the hearing in my left ear" required physician office visit. 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, Cough, Drug ineffective, Investigation, Pyrexia
Clinical narrative: then tested Ag positive 21Apr2022; sick for 2 weeks URI sx (symptoms) but tested neg covid , then 18Apr partner with cold symptoms, then 4/20 he had more cough then fever through the night and then tested Ag positive 4/21/22; sick for 2 weeks URI sx (symptoms); fever; more cough; This is a spontaneous report received from a non-contactable reporter (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3247), as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported:COUGH (non-serious) with onset 20Apr2021, outcome "unknown", described as "more cough"; PYREXIA (non-serious) with onset 20Apr2022, outcome "unknown", described as "fever"; RESPIRATORY SYMPTOM (non-serious) with onset 20Apr2022, outcome "unknown", described as "sick for 2 weeks URI sx (symptoms)"; COVID-19 (medically significant) with onset 20Apr2022, outcome "unknown", described as "sick for 2 weeks URI sx (symptoms) but tested neg covid , then 18Apr partner with cold symptoms, then 4/20 he had more cough then fever through the night and then tested Ag positive 4/21/22"; DRUG INEFFECTIVE (medically significant) with onset 20Apr2022, outcome "unknown", described as "then tested Ag positive 21Apr2022". The patient underwent the following laboratory tests and procedures: URI: (Apr2022) Negative, notes: sick for 2 weeks URI sx (symptoms) but tested neg; SARS-CoV-2 test: (21Apr2022) Positive, notes: Home Ag. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, respiratory symptom, cough, pyrexia.  Additional information: It was reported that the patient was sick for 2 weeks with URI symptoms but tested negative for COVID. On 18Apr2022, patient's partner had cold symptoms. On 20Apr2022, the patient had more cough then fever through the night and then tested Ag positive on 21Apr2022. Facility type vaccine: Workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, COVID-19  and the use of suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202200610046 Same patient and drug, different event separated in time
Sex: M
Vaccine: COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test
Clinical narrative: then tested Ag positive 21Apr2022; sick for 2 weeks URI sx (symptoms) but tested neg covid , then 18Apr partner with cold symptoms, then 4/20 he had more cough then fever through the night and then tested Ag positive 4/21/22; sick for 2 weeks URI sx (symptoms); fever; more cough; This is a spontaneous report received from a non-contactable reporter (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3247), as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported:COUGH (non-serious) with onset 20Apr2021, outcome "unknown", described as "more cough"; PYREXIA (non-serious) with onset 20Apr2022, outcome "unknown", described as "fever"; RESPIRATORY SYMPTOM (non-serious) with onset 20Apr2022, outcome "unknown", described as "sick for 2 weeks URI sx (symptoms)"; COVID-19 (medically significant) with onset 20Apr2022, outcome "unknown", described as "sick for 2 weeks URI sx (symptoms) but tested neg covid , then 18Apr partner with cold symptoms, then 4/20 he had more cough then fever through the night and then tested Ag positive 4/21/22"; DRUG INEFFECTIVE (medically significant) with onset 20Apr2022, outcome "unknown", described as "then tested Ag positive 21Apr2022". The patient underwent the following laboratory tests and procedures: URI: (Apr2022) Negative, notes: sick for 2 weeks URI sx (symptoms) but tested neg; SARS-CoV-2 test: (21Apr2022) Positive, notes: Home Ag. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, respiratory symptom, cough, pyrexia.  Additional information: It was reported that the patient was sick for 2 weeks with URI symptoms but tested negative for COVID. On 18Apr2022, patient's partner had cold symptoms. On 20Apr2022, the patient had more cough then fever through the night and then tested Ag positive on 21Apr2022. Facility type vaccine: Workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, COVID-19  and the use of suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202200610046 Same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Caller states she wound up with a lighter spot than her complexion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, She never had a problem with her first and second shots.) for Covid-19 immunisation, Bnt162b2 (DOSE 1, SINGLE, She never had a problem with her first and second shots.) for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Caller states she wound up with a lighter spot than her complexion".  Additional information: Caller would like to know the difference between two of the Pfizer covid vaccines (Purple and Grey top). She says that when she asked the nurse who was administering it to her she gave her a vague and uninformative response about the way it is diluted. Transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Caller refused to provide further demographics as she states she already gave this information. I normally take the PFIZER with the purple cap. they gave me an injection with a grey top. Caller stated she wound up with a lighter spot than her complexion (she is Ethnicity withheld). She never had a problem with her first and second shots. Caller states a lady was telling her she was transferring her to someone that would answer her question . However, nobody ever came back. She just left me on hold. So she hung up and called us back. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, SARS-CoV-2 test
Clinical narrative: felt weak; I was standing at the window and fell into it".; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received BNT162b2 (COMIRNATY), on 06Apr2021 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: BNT162b2 (Dose 1, The first shot didn't bother me. It was on 16Mar2021), administration date: 16Mar2021, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "felt weak"; FALL (non-serious), outcome "unknown", described as "I was standing at the window and fell into it".". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Clinical course: It was reported that about the third day or so patient began noticing some symptoms that lasted a long time. She couldn't get up and felt weak. Was really weak. Standing at the window and fell into it. She couldn't get back, holding onto and didn't have anyone here to help her. Finally, she got back on her feet. She should have called, but she didn't. And now it's been a year and she is unable to get the COVID shot to protect her. She wants to know should go and get the shot and see what it does or should I get an alternative. She doesn't know what her antibodies are, she don't want COVID. She was starting to get out more and going to be exposed. She wants to be protected. Patient states that, given that we only have a vaccine to prevent the disease and an antiviral to treat it, she will take her chances and go get the vaccine.   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: Illness, Pustule
Clinical narrative: Reaction where they broke out in pustules; Got sick; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 2, single (Lot number: ER8737) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 01, Lot number: EN6207, Manufacturer: Pfizer), administration date: 16Mar2021, for Covid-19 immunization. The following information was reported: PUSTULE (non-serious), outcome "unknown", described as "Reaction where they broke out in pustules"; ILLNESS (non-serious), outcome "unknown", described as "Got sick".  Additional information: Expiry Date and NDC number of Pfizer Covid Shot was Not Provided. This Nurse was also the patient who called about Pfizer Covid Shot. When caller got their second dose of Pfizer Covid Shot they had a reaction where they broke out in pustules and got sick but got over those events. Caller did not had any reaction to the first dose. Caller wanted to be protected from COVID and wants to get another dose of Pfizer Covid Shot but is scared to. Wanted to find out what to do next, what they should do next about getting additional dose. Caller asked if there was a pill now instead of a shot. How long will the immunity from those prior 2 doses last. Reporter Fax/Email was Unknown.   No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered
Clinical narrative: they did not give him the booster but gave him the 2nd vaccine instead; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 3, (booster), single (Lot number: FK9895) at the age of 12 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, lot: 30155BA), administration date: 26Oct2021, when the patient was 12-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, They did not put the lot on his card for that dose), administration date: 19Nov2021, when the patient was 12-year-old, for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 14Apr2022, outcome "unknown", described as "they did not give him the booster but gave him the 2nd vaccine instead"; HEADACHE (non-serious) with onset Apr2022, outcome "unknown".  Additional information: Reporter stated that it is really upsetting that there was a confusion on the Pfizer BioNTech Covid-19 Vaccine ad-ministered to her grandson who "received the second shot instead of the booster". Reporter also stated that now her grandson is even more upset and will not go back to his doctor's office since he didn't really want to get the vaccine. Prior Vaccinations (within 4 weeks): None. States she took her grandson to get the booster shot on 14Apr2022 and they did not give him the booster but gave him the 2nd vaccine instead and thought he was supposed to get the 2nd dose that day but they were there for him to get the booster dose; states they made an error and she does not know what they did now and she is really concerned they made the mistake and does not know what they were giving him but he did have his vaccine card with him; reporter asks if all three doses of the vaccine are the same. Reporter states she is upset that they did this and now won't be going back there and they made this mistake and they said it was ok and to her this was not a little mistake. States the patient had the 1st dose of the Pfizer Vaccine on 26Oct2021 with lot 30155BA, his 2nd dose of the vaccine on 19Nov2021 and they did not put the lot on his card for that dose and the third dose on 14Apr2022 and the lot is FK9895 for that dose. States the patient just got a really bad headache after the vaccine and she gave him Tylenol and he laid down and she gave him a lot of fluids. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: arm is hurting, like there is a bruise; arm is hurting, like there is a bruise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2022 as dose 3 (booster), single (Lot number: FJ4991) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, LOT- EW0187), administration date: 23May2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, LOT- EW0180), administration date: 06Jun2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), CONTUSION (non-serious) all with onset 20Mar2022, outcome "not recovered" and all described as "arm is hurting, like there is a bruise".  Additional information: No other products reported. No investigations reported. Reporter stated he was listening to the radio right now and stated he was getting a reaction to the Pfizer Covid shot. Stated he got had shot on 17Mar2022 and his arm was still like it was bruised, clarified there was no bruise but it felt like a bruise, started about 3 days after the shot, stated it was his left arm. Stated that it was his third dose.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: The patient is afraid of getting the booster in her arm because she feels like she had more swelling after the initial 2 shots; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "The patient is afraid of getting the booster in her arm because she feels like she had more swelling after the initial 2 shots". 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: Death
Clinical narrative: died after the third booster dose with a mRNA vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "dementia" (unspecified if ongoing), notes: Caller says he believes the contact mentioned her mom had dementia or Alzheimer's; "Alzheimer's" (unspecified if ongoing), notes: Caller says he believes the contact mentioned her mom had dementia or Alzheimer's. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant) with onset Apr2022, outcome "fatal", described as "died after the third booster dose with a mRNA vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Reporter said that the contact said her mom died after the third booster dose with a mRNA vaccine that she got with another vaccine, which he thinks was the flu vaccine. unspecified flu vaccine NDC/LOT/EXP: not provided as reporter was unsure if this was product patient had gotten. He said he waited to call in the adverse event since the reporter said she would let him know which vaccines it was if she could find out, and had said the mRNA vaccine could be Moderna. It was reported that date of patient death is unknown.  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: died after the third booster dose with a mRNA vaccine
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: splitting headache or bad headache; fever running at 100F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (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 (Dose 1, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 21Apr2022, outcome "not recovered", described as "fever running at 100F"; HEADACHE (non-serious) with onset 21Apr2022, outcome "not recovered", described as "splitting headache or bad headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that "Yesterday, he received the Pfizer BioNTech COVID-19 vaccine second booster dose" and "now has fever running at 100F and a splitting headache, or bad headache". Caller asked if this had been reported with the vaccine or if it is normal. Headache and fever had been reported as possible side effects with the vaccine" and from CDC: "COVID-19 vaccination helps protect people from getting COVID-19. The patient received the Pfizer COVID 19 Vaccine second dose yesterday, 20Apr2022, and now has a fever which is running at 100 degrees Fahrenheit. Caller is also reporting a splitting headache or bad headache. Caller stated he just wanted to report he had the fever and the headache.  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: Neuropathy peripheral
Clinical narrative: peripheraly neuropathy got worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (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 series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "peripheraly neuropathy got worse".  Clinical information: Caller stated that she had peripheral neuropathy for three years and it was much more since the booster. Had first booster and not second. She was reconsidering not getting the second because it was not reversible. She was already suffering, and she suspects it was from all the vaccines and the problem has become compoundable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.