chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: drug ineffective; positive for COVID-19; congested nose; body aches; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (COMIRNATY), on 01Mar2022 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247, Expiration Date: May2021) and on 29Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for seasonal allergy; TYLENOL taken for seasonal allergy; CLARITIN [LORATADINE] taken for seasonal allergy; NASACORT taken for seasonal allergy.  The following information was reported: PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 14Apr2022, outcome "unknown", described as "congested nose"; OROPHARYNGEAL PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "sore throat"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Additional information: Patient reported that I tested myself using the At Home test and was positive for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: drug ineffective; positive for COVID-19; congested nose; body aches; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (COMIRNATY), on 01Mar2022 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247, Expiration Date: May2021) and on 29Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for seasonal allergy; TYLENOL taken for seasonal allergy; CLARITIN [LORATADINE] taken for seasonal allergy; NASACORT taken for seasonal allergy.  The following information was reported: PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 14Apr2022, outcome "unknown", described as "congested nose"; OROPHARYNGEAL PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "sore throat"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Additional information: Patient reported that I tested myself using the At Home test and was positive for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: He died on 21Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 31Mar2021 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, medically significant) with onset 21Jun2021, outcome "fatal", described as "He died on 21Jun2021". The patient date of death was 21Jun2021. Reported cause of death: "He died on 21Jun2021".  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: He died on 21Jun2021
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: that in the third she didn't but she did spend 2 weeks on bed; 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.  A 72-year-old female patient received BNT162b2 (COMIRNATY), 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 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "that in the third she didn't but she did spend 2 weeks on bed".  Additional information: Call was transferred from agent, #, Report #. Call was previously transferred from Support. Caller on the line was a 72 years old female that already had 3 doses of the Pfizer COVID-19 Vaccine but got sick after and ended up in the emergency room. Caller wanted to know if the ingredients could have caused this. Caller added that when she got the first 2 doses she ended up in the Emergency Room, and that in the third she did not but she did spend 2 weeks on bed. Caller added that she was concerned about the possible allergies because she was the only one that got a bad reaction in her family from taking the Pfizer COVID-19 Vaccine. Caller also said that before getting COVID-19, her blood was on normal levels and that during her disease, her blood oxygen dropped to 88. She wanted to get another booster to avoid "end being another statistic", stating even that she prefers to feel sick for a week or two with the vaccine than getting COVID-19. While transfer was being made, caller told agent that her Doctor prescribed her Doxycycline Hyclate once she was diagnosed with COVID-19. Caller stated reading about the possibility of patients with her age getting the monoclonal shot instead of Pfizer's.: agent stated caller wanted to know if Pfizer pays emergency rooms visits related to the Pfizer COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200579860 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: she took her 4th shot from Pfizer for Covid and she okay and it is working good/potential unexpected benefit ("feel good") recognized after the call; 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.  A female patient received BNT162b2 (BNT162B2), on 13Apr2022 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 13Apr2022, outcome "unknown", described as "she took her 4th shot from Pfizer for Covid and she okay and it is working good/potential unexpected benefit ("feel good") recognized after the call".  Additional Information: Question: Customer Verbatim: She want to know about the medicine Suntinibe 50 mg (name) a friend in (country) have cancer and they said that Pfizer give a dose free she wants to know about. Outbound Callback Attempt 14Apr2022 at 11:53 AM ET: Reached the customer and she clarified her question. She stated she has a friend in (country) that has cancer and Pfizer is giving one bottle of this medicine for free. The friend has not received any medication she just "knows" Pfizer will give one bottle of this medication for free and she wants to know if she can get it. She wanted information on how her friend can get this product. Her friend said another country does not have this medication or it is not in stock, she cannot get it. she wanted to know if she could get this product and bring it to (country) for a friend. she got her 4 shots of the COVID vacine and feel good Thank you." She also stated over the phone that she trusts Pfizer. Additional Details: Outbound Callback Attempt 14Apr2022 at 11:53 AM ET: Reached the customer and she added that yesterday she took her 4th shot from Pfizer for Covid and she okay and it is working good. E-transmitting as potential AE for potential unexpected benefit ("feel good") recognized after the call. she stated, thank you so much for you prompt answer [call back], I am so happy for that.she got her 4 shots of the COVID vaccine and feel good Thank you." She also stated over the phone that she trusts Pfizer. Additional Details: Outbound Callback Attempt 14Apr2022 at 11:53 AM ET: Reached the customer and she added that yesterday she took her 4th shot from Pfizer for Covid and she okay and it is working good. E-transmitting as potential AE for potential unexpected benefit ("feel good") recognized after the call. she stated, thank you so much for you prompt answer [call back], I am so happy for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Pruritus, Vaccination site discolouration
Clinical narrative: the arm had turned red/covid arm; that below the injection site a red dot appeared which ressembled that of a bullseye; her arm had turned red below the injection site/ The redness and issue is occurring in her left arm as well; She was in front of the mirror, and saw it. It was hot and a little itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 at 14:15 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tick bite" (unspecified if ongoing); "Rash" (unspecified if ongoing), notes: rash reaction not penicillin 1967, amoxicillin, and shell fish (iodine reaction) none of them anaphylactic all a rash.; "anaphylactic" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (First Vaccine, Lot number:EL9262), administration date: 26Jan2021, when the patient was 67-year-old, for COVID-19 Immunization; BNT162b2 (Second vaccine , lot number: EL9266), administration date: 16Feb2021, when the patient was 67-year-old, for COVID-19 Immunization; BNT162b2 (First booster , lot number: FF2590), administration date: 18Oct2021, when the patient was 67-year-old, for COVID-19 Immunization; Shingles vaccine (She did get her Shingles vaccine in Dec2021 or Jan2022); Tick antivenom (Her last tick bite was in Jan2022), administration date: Jan2022. The following information was reported: PRURITUS (non-serious) with onset 13Apr2022, outcome "recovering", described as "She was in front of the mirror, and saw it. It was hot and a little itchy"; ERYTHEMA (non-serious) with onset 13Apr2022, outcome "recovering", described as "her arm had turned red below the injection site/ The redness and issue is occurring in her left arm as well"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 13Apr2022, outcome "unknown", described as "that below the injection site a red dot appeared which ressembled that of a bullseye"; LIMB DISCOMFORT (non-serious) with onset 13Apr2022, outcome "recovering", described as "the arm had turned red/covid arm".  Additional information: Prior Vaccinations (within 4 weeks) patients Medical History (including any illness at time of vaccination) other relevant medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: never had anaphylactic shock, rash reaction not penicillin 1967, amoxicillin, and shell fish (iodine reaction) none of them anaphylactic all a rash. NDC/lot/expiration-no. over a decade ago. Some multiple but decade ago.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills; fever; nausea; vomiting; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; PYREXIA (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; NAUSEA (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; VOMITING (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, nausea, vomiting, headache.  Additional information: No other vaccine in four weeks. Other medications in two weeks included inhalers. No covid prior vaccination. No covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills; fever; nausea; vomiting; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; PYREXIA (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; NAUSEA (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; VOMITING (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, nausea, vomiting, headache.  Additional information: No other vaccine in four weeks. Other medications in two weeks included inhalers. No covid prior vaccination. No covid tested post 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
Symptoms: Feeling abnormal, Mass, Pityriasis rosea, Pruritus
Clinical narrative: Pityriasis rosea on stomach and back and arm; She had tiny spots on her stomach that have spread and gotten bigger.; itchy; looks awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 37-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 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 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: PITYRIASIS ROSEA (non-serious), outcome "unknown", described as "Pityriasis rosea on stomach and back and arm"; MASS (non-serious), outcome "unknown", described as "She had tiny spots on her stomach that have spread and gotten bigger."; PRURITUS (non-serious), outcome "unknown", described as "itchy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "looks awful".  Additional information: The reporter stated that in the last few weeks the patient (daughter) got a condition of Pityriasis rosea on stomach and back and arm. It's itchy and looks awful. She's had 3 doses of the Pfizer covid 19 vaccine - booster dose was on 14Feb or Feb15. The condition started a few weeks ago. She had tiny spots on her stomach that have spread and gotten bigger. Daughter was 37 years old. There are studies that connect people with this condition who received the mRNA vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: she was sick for about 5 days a few weeks ago.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2021-102695.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 28Oct2021 (Batch/Lot number: unknown) at 12 mg. The patient's relevant medical history included: "C22 Liver Cancer" (unspecified if ongoing). The patient's 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: ILLNESS (non-serious), outcome "unknown", described as "she was sick for about 5 days a few weeks ago.". The action taken for lenvatinib mesilate was unknown.  Additional information: Patient advised she was sick for about 5 days a few weeks ago. Her illness coincided with getting her COVID booster shot. She believe this issue was caused by the COVID booster shot and not Lenvima. PI reviewed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Myalgia
Clinical narrative: Her back began to hurt.; Headache; fever ~101.5; chills; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 11:00 as dose 4 (booster) single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1), for COVID-19 Immunization; Bnt162b2 (dose:2), for COVID-19 Immunization; Bnt162b2 (dose:3), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022); BACK PAIN (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "Her back began to hurt."; CHILLS (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022); PYREXIA (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "fever ~101.5"; MYALGIA (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of back pain, headache, pyrexia, chills, myalgia.  Additional information: Dose received More than 3. Around 7 pm on Friday 08Apr her back began to hurt. Later in the evening a headache started and she ran a fever 101.5, had chills and had muscle aches. This lasted until Saturday afternoon. Unknown If COVID prior vaccination. Unknown If COVID tested post 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
Symptoms: Pyrexia
Clinical narrative: Her back began to hurt.; Headache; fever ~101.5; chills; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 11:00 as dose 4 (booster) single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1), for COVID-19 Immunization; Bnt162b2 (dose:2), for COVID-19 Immunization; Bnt162b2 (dose:3), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022); BACK PAIN (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "Her back began to hurt."; CHILLS (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022); PYREXIA (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "fever ~101.5"; MYALGIA (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of back pain, headache, pyrexia, chills, myalgia.  Additional information: Dose received More than 3. Around 7 pm on Friday 08Apr her back began to hurt. Later in the evening a headache started and she ran a fever 101.5, had chills and had muscle aches. This lasted until Saturday afternoon. Unknown If COVID prior vaccination. Unknown If COVID tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Lymphadenopathy, Periarthritis, SARS-CoV-2 test
Clinical narrative: Lymph Nodes in neck, clavicle and underarm swollen; Lymph Nodes in neck, clavicle and underarm swollen; Lymph Nodes in neck, clavicle and underarm swollen; Frozen shoulder in both arms; inflammation in both shoulder joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: sulfa drugs" (unspecified if ongoing); "Alllergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 31Mar2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 10Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PERIARTHRITIS (non-serious) with onset 10Mar2022, outcome "recovering", described as "Frozen shoulder in both arms"; LYMPHADENOPATHY (non-serious), LYMPHADENOPATHY (non-serious), LYMPHADENOPATHY (non-serious) all with onset 10Mar2022, outcome "recovering" and all described as "Lymph Nodes in neck, clavicle and underarm swollen"; ARTHRITIS (non-serious) with onset 10Mar2022, outcome "recovering", described as "inflammation in both shoulder joints". The events "lymph nodes in neck, clavicle and underarm swollen", "frozen shoulder in both arms" and "inflammation in both shoulder joints" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, lymphadenopathy, lymphadenopathy, periarthritis, arthritis.  Additional Information: No the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Reported Events Lymph Nodes in neck, clavicle and underarm swollen for 4 months, frozen shoulder in both arms inflammation in both shoulder joints. What treatment received for the adverse event. Physical Therapy for Frozen Shoulders. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, yes the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Had a little sore shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6203) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anemic" (ongoing), notes: was diagnosed with after son was born 31 years ago. Concomitant medication(s) included: VITAMIN B 12 [CYANOCOBALAMIN] taken for anaemia. The following information was reported: ARTHRALGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "Had a little sore shoulder".  Additional information: The patient received first dose Pfizer BioNTech vaccine (expiration date and NDC number was unknown) in the morning between 08:00 and 09:30. Other Conditions reported as Yes. Investigations reported as No. No additional Vaccines administered on same Date of the Pfizer Suspect. Patient had no Vaccinations within four weeks prior to the first administration date of the suspect vaccine. After the first dose Pfizer BioNTech Vaccine the caller wasn't really bothered, had a little sore shoulder. After first dose patient had a little sore shoulder. This began on 16Mar2021 and went away in about a day. Further asked if recovered completely or with lasting effects and the patient clarifies, maybe the next week his arm continued to be sore, and he put ice on arm. AE does not required visit to Emergency Room or Physician Office. Stayed at home. No relevant tests.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild-to-moderate soreness in her left arm deltoid region; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 85-year-old female patient received BNT162b2 (COMIRNATY), on 10Apr2022 as dose 2 (booster) single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, Dose number Unknown), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2022, outcome "unknown", described as "mild-to-moderate soreness in her left arm deltoid region".  Description of Event: During a telephone conversation today 14Apr2022, this family member mentioned that she received her second Pfizer Comirnaty booster vaccine at withheld on Sunday 10Apr2022 (4 days ago). She is an 85-yearold woman who describes mild-to-moderate soreness in her left arm deltoid region (where she received the Comirnaty booster vaccine). There is no bruising or discoloration. The soreness does not interfere with arm movement or usual activities. She will contact her primary care physician regarding this. 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: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: has a running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF2593) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacture by- Unknown, Dose No- 1), for COVID-19 Immunization; Covid-19 vaccine (Manufacture by- Unknown, Dose No- 2), for COVID-19 Immunization. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "has a running nose". Therapeutic measures were taken as a result of rhinorrhoea.  Additional information: Caller said her husband took all 3 shots and had running nose. She said his nose runs like a sieve and runs constantly. She doesn't want to speak for him. He has to take a decongestant. Unable to obtain full details. Caller declined to complete report. He was taking a decongestant twice a day since his nose was running. Husband's nose started running after hers and husband has had all three shots.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Endoscopy, Eye swelling, Pharyngeal swelling, Sneezing
Clinical narrative: It was about a seven hours after the shot, I sneeze and then my eyes swelled up and almost closed so that was swollen closed eyes, my throat as well.; It was about a seven hours after the shot, I sneeze and then my eyes swelled up and almost closed so that was swollen closed eyes, my throat as well.; I sneeze and then my eyes swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose number unknown (booster), single (Lot number: FK9894) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "hearing is not great" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: SNEEZING (non-serious) with onset Apr2022, outcome "unknown", described as "I sneeze and then my eyes swelled up"; EYE SWELLING (non-serious), PHARYNGEAL SWELLING (non-serious) all with onset Apr2022, outcome "not recovered" and all described as "It was about a seven hours after the shot, I sneeze and then my eyes swelled up and almost closed so that was swollen closed eyes, my throat as well.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eye swelling, pharyngeal swelling, sneezing.  Additional information: Consumer stated, "The side effects was, it was about a seven hours after the shot, I sneeze and then my eyes swelled up and almost closed so that was swollen closed eyes.''When paraphrased the concern: Consumer stated, ''I am not understanding that. I can hear you but I am not understanding what you are saying? Could you verse that a little differently may be.''When again paraphrased the concern: Consumer stated, ''Yes that's correct and my throat as well. Reporter and Consumer stated, ''Seven hours.'' If still persisting or improved: Reporter stated, ''Still persists.'' Consumer stated, ''Yes the swelling has gone down but it's pretty swollen.'' Treatment:  Consumer stated, ''Yes I am, I took Benadryl.'' Laboratory tests: Consumer stated, ''I did have an Endoscopy and colonoscopy on Monday 11Apr (Year not clarified hence not captured in tab).'' Other Medications: Consumer stated, Yes  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in unknown arm; 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.  An 86-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), on 07Apr2021 as dose 2, single (Lot number: EW0153) and on 30Oct2021 as dose 3 (booster), single (Lot number: SH8028) at the age of 86 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "recovered", described as "pain in unknown arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: first dose: pain in the unknown arm, second dose: pain in unknown arm and first booster: pain in unknown arm. Is report related to a study or programme was No. No Other Conditions, No Investigations, No Other Products. Patient Stated that the others were last Oct and Apr and she does not recall which arm. Stated that the next day that she got a little bit of pain in the arm but no bad effects. Event details Stated that the pain only lasted one day with it. Later clarified that the pain in the arm happened on the day of the shots. Treatment was None.   Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Cardiac disorder, Ear disorder, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Blood pressure; Heart problems; She has blockage in her ear now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 31-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: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "Blood pressure"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart problems"; EAR DISORDER (non-serious), outcome "unknown", described as "She has blockage in her ear now". The events "rheumatoid arthritis", "blood pressure", "heart problems" and "she has blockage in her ear now" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 45-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), 6 hrs. after the suspect product(s) administration, outcome "recovered", described as "experienced a high fever of 101.5"; FATIGUE (non-serious), 6 hrs. after the suspect product(s) administration, outcome "recovered", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Verbatim and Event Description: Patient mentioned during an interview on pneumonia vaccine, that after her second dose of the Pfizer Covid-19 vaccine, that she experienced a high fever of 101.5 and also felt tired and needed to stay in bed. The reaction came on about 6 hours after receiving the dose and lasted about 24 hours. She felt back to normal after that. From information provided in the interview, the respondent has asthma, allergies, and fibromyalgia unrelated to the vaccine. 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: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: He feels like heat on his head, he feels warm on his head; It was just seasonal fever; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID:. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 12Apr2022 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), administration date: 2021, for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), administration date: 2021, for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "He feels like heat on his head, he feels warm on his head"; PYREXIA (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "It was just seasonal fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal, pyrexia.  Additional information: He was calling because he was reporting an adverse event after getting the third dose the booster shot, he feels like heat on his head, he feels warm on his head. Consumer (physician) stated, he has been through a regular doctor for, he did not quite understand what was said, he took this shot at the pharmacy. Consumer stated, no, he beat it for about 15 to 20 minutes, he rub with some alcohol on his forehead and it went away, so it was just seasonal fever like you know and you know it did not last that about 20 minutes, after when he rub alcohol on it went away, it was clear colour rubbing alcohol, he rub it across his forehead and then around his neck and hypothroatic gland around back his neck so, it went away. Consumer stated, no, if only he was taking medication, what medication should he not take If he took the Pfizer shot booster shot. Consumer stated, that was about that all about he wanted to ask, he had so Pfizer came up on his phone and he saw somebody might had call him concerning this shot and see what kind reaction he had, to see that was what he was thinking and by time he got to his phone and it stopped ringing so, he just thought he had to call Pfizer back and see if anyone call him so that was his real reason for calling. He was at his primary physician today and he said, you know he did not go down for that he went down for something there, but everything was ok. Consumer stated, no, that would be okay. Further probing could not be initiated as consumer was not willing to complete the report. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 at 14:45 as dose 1, single (Lot number: FL3209) at the age of 56 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peanut butter Milk" (unspecified if ongoing); "Known allergies: gluten food" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: DYSPNOEA (non-serious) with onset 14Apr2022 at 16:00, outcome "recovering", described as "Difficult breathing"; HEART RATE INCREASED (non-serious) with onset 14Apr2022 at 16:00, outcome "recovering", described as "Fast heart beat"; RASH (non-serious) with onset 14Apr2022 at 16:00, outcome "recovering", described as "Rash on body all over". The events "fast heart beat", "difficult breathing" and "rash on body all over" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, dyspnoea, rash. Additional information: No other vaccine in four weeks. Other medications in two weeks included Ibuprofen. No Covid tested post vaccination. Other medical history: Many "concoctions". No follow-up attempts are possible. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Myocardial infarction
Clinical narrative: passed away shortly after receiving the Pfizer vaccine, sudden heart attack; heart ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 2, single (Lot number: EN6206, Expiration Date: Jun2021) at the age of 94 years for covid-19 immunisation in the pharmacy out of a grocery store lane. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), note: the patient was taking very low dose of a Diabetic medication. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, lot number unknown), administration date: 19Mar2021, when the patient was 94-year-old, for COVID-19 immunisation. The following information was reported: MYOCARDIAL INFARCTION (death, hospitalization, medically significant), outcome "fatal", described as "passed away shortly after receiving the Pfizer vaccine, sudden heart attack"; ANGINA PECTORIS (death, hospitalization, medically significant), outcome "fatal", described as "heart ache". The patient was hospitalized for myocardial infarction, angina pectoris (start date: 06Apr2021). The events "passed away shortly after receiving the Pfizer vaccine, sudden heart attack" and "heart ache" required emergency room visit. Therapeutic measures were taken as a result of myocardial infarction, angina pectoris. The patient date of death was unknown. Reported cause of death: "passed away shortly after receiving the Pfizer vaccine, sudden heart attack", "heart ache". It was not reported if an autopsy was performed. Clinical course: The reporter stated it was the day after this shot(2nd dose) patient started complaining about the heart ache and that was on to the last days she lived. The reporter took patient to the emergency room in hospital on the same day she had a 2nd dose on 06Apr2021. The patient was in emergency room, the reporter didn't know what they were doing for patient. She came and shortly after she passed away, she was not taking anything else, they just did the heart surgery for her. Reporter stated, the patient experienced heart ache and then ended up with sudden heart attack. The patient passed away shortly after receiving the Pfizer vaccine, sudden heart attack. It was reported the patient was dead like about 8-9 months now.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200584288 same patient, different dose and event; Reported Cause(s) of Death: heart ache; passed away shortly after receiving the Pfizer vaccine, sudden heart attack
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Eye swelling, Ocular hyperaemia, Visual impairment
Clinical narrative: My eyes are really burning and they are really red; My left eye looks like a little swollen; It's hard to for me to see; My eyes hurt; My eyes are really burning and they are really red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9895) for COVID-19 immunization. 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: VISUAL IMPAIRMENT (non-serious) with onset 14Apr2022, outcome "unknown", described as "It's hard to for me to see"; EYE IRRITATION (non-serious), OCULAR HYPERAEMIA (non-serious) all with onset 14Apr2022, outcome "unknown" and all described as "My eyes are really burning and they are really red"; EYE PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "My eyes hurt"; EYE SWELLING (non-serious) with onset 14Apr2022, outcome "unknown", described as "My left eye looks like a little swollen".  Additional information: The patient had 4th Pfizer booster shot. Patient came home and washed face and patients eyes were really burning and they were really red. Patient tried rinsing them out with water but nothing was helping and Patient left eye looks like a little swollen. So, Patient did not know if it was a possible side effect of the booster shot or not?" When paraphrased the concern, consumer stated, "Yes, that was I wanted to know and what to do about it?" Date of administration: Consumer stated, "Today at 2 o'clock." (Clarified as 14April2022).   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On Wednesday 13Apr I took a home covid test and tested positive for covid.; On Wednesday 13Apr I took a home covid test and tested positive for covid.; This is a spontaneous report received from a contactable reporter (Other Health Professional). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications in two weeks. Prior to vaccination patient was not diagnosed with COVID-19.  Patient has not received other vaccine in four weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Apr2022 at 16:45, outcome "recovering" and all described as "On Wednesday 13Apr I took a home covid test and tested positive for covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with home rest and over the counter medication.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information  a causal relationship between the reported events and suspected drug BNT162B2 cannot be excluded