chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Odynophagia, Oropharyngeal pain, Pain, Pharyngeal oedema, Rhinorrhoea
Clinical narrative: sore and swollen throat; sore and swollen throat; runny nose; after 10 days I am still in pain; I can not eat because of the pain in my throat; 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), administered in arm left, administration date 19Aug2021 22:00 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MACROZIT. The following information was reported: OROPHARYNGEAL PAIN (non-serious), PHARYNGEAL OEDEMA (non-serious) all with onset 24Aug2021 01:00, outcome "not recovered" and all described as "sore and swollen throat"; RHINORRHOEA (non-serious) with onset 24Aug2021 01:00, outcome "not recovered", described as "runny nose"; PAIN (non-serious) with onset 24Aug2021 01:00, outcome "not recovered", described as "after 10 days I am still in pain"; ODYNOPHAGIA (non-serious) with onset 24Aug2021 01:00, outcome "not recovered", described as "I can not eat because of the pain in my throat". Therapeutic measures were taken as a result of oropharyngeal pain, pharyngeal oedema, rhinorrhoea, pain, odynophagia.  Additional information: The patient did not know if she could take anything other than Ibuprofen. Ibuprofen because it only eliminated the pain for a short time. The patient had Macrozit medication in two weeks. Facility type vaccine was pharmacy or Drug Store. The patient did not have Covid prior vaccination. The patient has not been tested Covid 19 post vaccination. Patient did not have known allergies. The patient did not have any other vaccine in four weeks. All the events started on the fifth day after her vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia, Urticaria
Clinical narrative: sick; fever; chills; hives; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "chills"; URTICARIA (non-serious) with onset Feb2021, outcome "unknown", described as "hives".  Additional information: Patient stated that she had the first 2 vaccines, she came home she was sick, chills and fever to 24 hours and she got hives that was in February  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling on his left chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A 50-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious) with onset 29Aug2021, outcome "unknown", described as "Swelling on his left chest".  Additional information:  The patient had Reaction and event as reported by primary source of Swelling on his left chest. The Characterization of drug role was Suspect and Proprietary medicinal product name: COVID Vaccine. The unknown Batch/Lot number and Action taken with drug. The Narrative case summary and further information about Case Description was Submitted. The report related to a study or programmed and Details: 159558. The patient was not a reporter also with his wife. The Reporter type was Consumer or other non-health professional. The Primary / Prescribing Healthcare Professional Info and HCP postal address: The Dates for Swelling on his left chest was From Unspecified to Unspecified. The patient was administered COVID Vaccine a Pfizer product. The COVID Vaccine manufacturer by Unspecified. The Dates for COVID Vaccine was Start: Unspecified and Stop: Unspecified. The unknown NDC number of COVID Vaccine and UPC number of COVID Vaccine. The Reason for no lot number: of COVID Vaccine: Other: Reporter stated: "He said, he doesn't have it here with him mam." The unknown Expiry Date of COVID Vaccine.  The patient was transferred (159558) Transferring agent stated, "I have a caller here on the line who have the questions about the side effects of the vaccine. So, her family got the vaccine on Friday, but then her husband woke up today with swelling on his left chest. They just wanted to know if that was the part of the side effects of the vaccine. The age was 50 years (Age at the time of adverse event was not clarified, hence not captured in tab)." When paraphrased the above concern reporter confirmed the same. The Reporter was provided with the number of Pfizer Medical Information Department. In response to further probing, reporter stated, "No, I just wanted to say if you have an answer for me, no, that's fine."  The did not reported LOT and Reporter stated, "He said, he doesn't have it here with him." The Reporter was unwilling to share further information, hence, product details (Expiration date, NDC, UPC) and other details were unknown. Limited information was available over the call. The Reporter type was not available over the call as the reporter was unwilling to answer further questions; hence reporter type was captured as consumer or non-healthcare professional by default.  Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Headache, Mobility decreased, Pain in extremity
Clinical narrative: pain in arms; Fever; Fatigue; Headache; Weakness; arm was red from shoulder to wrist; This is a spontaneous report received from a contactable reporter(s) (Other HCP: dentist) from medical information team. The reporter is the patient.  A 68 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administered in arm left, administration date 2015 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "asthma" (not ongoing); "high blood pressure" (unspecified if ongoing); "She has an allergy to pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asmanex for asthma, reaction(s): "affecting her vocal cords". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2015, outcome "recovered" (2015), described as "pain in arms"; PYREXIA (non-serious) with onset 2015, outcome "recovered" (2015), described as "Fever"; FATIGUE (non-serious) with onset 2015, outcome "recovered" (2015), described as "Fatigue"; HEADACHE (non-serious) with onset 2015, outcome "recovered" (2015), described as "Headache"; ASTHENIA (non-serious) with onset 2015, outcome "recovered" (2015), described as "Weakness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2015, outcome "recovered" (2015), described as "arm was red from shoulder to wrist".  Additional information: She is 74 years old. She did not get her covid vaccine yet. Her husband did he is 80 years old and he is ok. In 2015 she got a flu shot (unspecified) and Prevnar 13 vaccines together. Her reaction was so bad that she spent three days in bed. Right when she got home she got so weak and had pain in her arms and everything. She was bedridden for 3 days. She had fever, fatigue, headache, weakness, and her arm was red from shoulder to wrist. Her husband had to take her to the bathroom. She was a dentist. She is a non smoker and non drinker. Her doctor passed away, she will go to another doctor in two weeks. She does not know the name of the flu shot. This was the first time she had the flu shot and Prevnar 13 and never got them again. She recovered three days after the shots by a Sunday or Monday she felt better. She does not recall the exact dates. She had the shots on Friday. She did not call doctor or do anything. She just stayed in bed waiting. She is going to cardiologist tomorrow. She used to have asthma and was taking asmanex, a corticosteroid, and the inhaler was affecting her vocal cords and she does not have any anymore. She is not taking it anymore. She also used to have high blood pressure and took medications, then she decided to not watch tv and have less stress and does not need blood pressure medication anymore and she is ok. She has an allergy to pollen and things like that which was diagnosed when she was 40 or 50 years old.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: pain in arms; Fever; Fatigue; Headache; Weakness; arm was red from shoulder to wrist; This is a spontaneous report received from a contactable reporter(s) (Other HCP: dentist) from medical information team. The reporter is the patient.  A 68 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administered in arm left, administration date 2015 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "asthma" (not ongoing); "high blood pressure" (unspecified if ongoing); "She has an allergy to pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asmanex for asthma, reaction(s): "affecting her vocal cords". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2015, outcome "recovered" (2015), described as "pain in arms"; PYREXIA (non-serious) with onset 2015, outcome "recovered" (2015), described as "Fever"; FATIGUE (non-serious) with onset 2015, outcome "recovered" (2015), described as "Fatigue"; HEADACHE (non-serious) with onset 2015, outcome "recovered" (2015), described as "Headache"; ASTHENIA (non-serious) with onset 2015, outcome "recovered" (2015), described as "Weakness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2015, outcome "recovered" (2015), described as "arm was red from shoulder to wrist".  Additional information: She is 74 years old. She did not get her covid vaccine yet. Her husband did he is 80 years old and he is ok. In 2015 she got a flu shot (unspecified) and Prevnar 13 vaccines together. Her reaction was so bad that she spent three days in bed. Right when she got home she got so weak and had pain in her arms and everything. She was bedridden for 3 days. She had fever, fatigue, headache, weakness, and her arm was red from shoulder to wrist. Her husband had to take her to the bathroom. She was a dentist. She is a non smoker and non drinker. Her doctor passed away, she will go to another doctor in two weeks. She does not know the name of the flu shot. This was the first time she had the flu shot and Prevnar 13 and never got them again. She recovered three days after the shots by a Sunday or Monday she felt better. She does not recall the exact dates. She had the shots on Friday. She did not call doctor or do anything. She just stayed in bed waiting. She is going to cardiologist tomorrow. She used to have asthma and was taking asmanex, a corticosteroid, and the inhaler was affecting her vocal cords and she does not have any anymore. She is not taking it anymore. She also used to have high blood pressure and took medications, then she decided to not watch tv and have less stress and does not need blood pressure medication anymore and she is ok. She has an allergy to pollen and things like that which was diagnosed when she was 40 or 50 years old.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Ear pain, Rash
Clinical narrative: he had sort of pimples as if it were a rash; rash was in his left ear area only; he had pain, only at the area of his left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date 28May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid 19", start date: Jul2020 (unspecified if ongoing); "varicose vein" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ACNE (non-serious) with onset 2021, outcome "unknown", described as "he had sort of pimples as if it were a rash"; RASH (non-serious) with onset 2021, outcome "unknown", described as "rash was in his left ear area only"; EAR PAIN (non-serious) with onset 2021, outcome "unknown", described as "he had pain, only at the area of his left ear".  Additional information: Varicose veins were not swollen but they were visible on his legs behind the calves, to the side of the calf and on the sides of the leg. He had heard some vaccines had caused clots or things like that. He received his 1st dose on 28May2021, he then developed a rash that was causing him pain; the rash was in his left ear area only. A few days after bnt162b2 that, he had sort of pimples as if it were a rash. Because of the rash, he did not get the 2nd dose because they did not know if it was recommended after getting the rash. Agent states that she referred caller to speak with her husband's healthcare professional regarding the 2nd dose. When he was due the second dose, he did not receive it, he was told to come back at 8 weeks or her wife did not remember the exact date. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Nausea
Clinical narrative: felt little queasy like and it is got a little worse this afternoon at the later in the afternoon last couple of hours; little pressure in the chest; some discomfort on the left side of my stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 28Aug2021 16:00 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL TARTRATE; XARELTO; ATORVASTATIN CALCIUM; GLIPIZIDE; VITAMIN B COMPLEX; PENTOXIFILLINE; ASPIRIN (E.C.); PROTONIX [OMEPRAZOLE]. The following information was reported: NAUSEA (non-serious) with onset Aug2021, outcome "unknown", described as "felt little queasy like and it is got a little worse this afternoon at the later in the afternoon last couple of hours"; CHEST DISCOMFORT (non-serious) with onset Aug2021, outcome "unknown", described as "little pressure in the chest"; ABDOMINAL DISCOMFORT (non-serious) with onset Aug2021, outcome "unknown", described as "some discomfort on the left side of my stomach". Therapeutic measures were taken as a result of nausea, chest discomfort, abdominal discomfort treated with Aspirin 325mg, it has a sodium bicarbonate acid.  Additional information: Consumer stated, "Novolog and some that's on a sliding scale as needed, B-50 once a day."(further clarification unknown, hence not captured in tab). Patient stated, No test done in the last two weeks, it had been about a six weeks ago since I have had a last lab work." No prior vaccination (within Four weeks).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: her arm is still red and hurting; her arm is still red and hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "her arm is still red and hurting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: having a little bit of pain in the middle of her chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "having a little bit of pain in the middle of her chest".  Additional information: Patient states it was the BioTech or something like that, it was for the pandemic. Patient clarifies further she finally decided to get the vaccine for the COVID pandemic and she has concerns regarding the paperwork she received after the shot. The operator she was speaking with told that she should speak to a nurse. She clarifies she did not have a reaction or anything, she is just concerned with what she read in the paperwork she was given. She is hoping someone can put her mind at ease. Patient having a little bit of pain in the middle of her chest and she did read about myocarditis and their being a concern with heart problems. However, this all may be in her head because she was thinking about it a little bit. Patient states she also is out of shape and was playing with her baby, lifting her up, the day before the vaccine, so maybe she pulled something in her chest, who knows. The patient had not experiencing anything crazy, she will keep an eye on it. The paperwork talks about side effects. Patient mentions on the bottom right it says revised 23Aug2021. A little down the top, under the side effects the last sentence reads: 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. That is why she was hesitant to get the vaccine to begin with. Patient does not know if she should get the second dose or not.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: his arm is sore; his shoulder is a little sore; he woke up with discomfort; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "his arm is sore"; ARTHRALGIA (non-serious), outcome "not recovered", described as "his shoulder is a little sore"; LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "he woke up with discomfort"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". additional information: States that his shoulder is a little sore and that's one of the side effect on the poster along with fever, chills and soreness.  States it's alright, like if you work out a lot and it feels like you haven't used that muscle. States it is his left shoulder where he took the shot, he woke up with discomfort but nothing alarming.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Vomiting; Low grade fever; Arm extremely sore; Achy all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm extremely sore"; PAIN (non-serious), outcome "unknown", described as "Achy all over". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Laboratory test, SARS-CoV-2 test, Tachycardia
Clinical narrative: and shortness of breath during any kind of exercise.; I have developed tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 10:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing), notes: Known allergies: Shrimp. Concomitant medication(s) included: LOSARTAN; METFORMIN; LIPITOR. The following information was reported: DYSPNOEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "and shortness of breath during any kind of exercise."; TACHYCARDIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I have developed tachycardia". The events "and shortness of breath during any kind of exercise." and "i have developed tachycardia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, tachycardia.  Additional information: Patient did not take any other vaccine in four weeks of vaccination. The other medications taken in two weeks of vaccination are Losartan, Metformin, & Lipitor. Patient was not tested COVID positive prior to vaccination. Patient underwent covid testing after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: chills; fever; muscle ache; muscle spasm; she felt really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 31Aug2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 31Aug2021, outcome "unknown", described as "fever"; MYALGIA (non-serious) with onset 31Aug2021, outcome "unknown", described as "muscle ache"; MUSCLE SPASMS (non-serious) with onset 31Aug2021, outcome "unknown", described as "muscle spasm"; FATIGUE (non-serious) with onset 31Aug2021, outcome "unknown", described as "she felt really tired".  Additional information: It was reported that, patient took the first dose of the vaccine yesterday August 31 and was scheduled to get the second dose September 22 (22 days). Later at night after receiving the first dose of the vaccine she experienced chills, fever, muscle ache, muscle spasm and she felt really tired. She wants to know how long this will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: This is a spontaneous report received from contactable other HCP (patient's parent). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 27, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. The patient developed trigeminal neuralgia, onset 2021, with outcome of unknown. Trigeminal neuralgia was evaluated at a physician office visit. Additional information: Patient's age is not specified but mentioned as older teenager or young adult. Do not have an exact age or any other known issues. Patient's mother asked if there was any known issue of trigeminal neuralgia with the COVID-19 vaccine. She said she was taking her daughter to the doctor now. Her daughter had her 2nd shot of the vaccine on Friday the 27th. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Cold; Flu; being achy; a little bit of fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for Covid-19 immunisation. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; INFLUENZA (non-serious), outcome "unknown", described as "Flu"; PAIN (non-serious), outcome "unknown", described as "being achy"; PYREXIA (non-serious), outcome "unknown", described as "a little bit of fever".  Additional information: Caller wanted to know if her son should have the second dose or not. Caller said that the rest of them did not experience anything like that, the first dose was fine, then for the second they had the regular symptoms of like cold or flu, being achy, a little bit of fever; but her son of course had to be different.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Reaction to excipient, Rhinorrhoea, Sneezing
Clinical narrative: I had a reaction to the something in the vaccine; My nose started running profusely; nose became completely blocked; I could not stop sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Lot number: FC3183) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had a reaction to the something in the vaccine" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue; "My nose started running profusely" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue; "nose became completely blocked" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue; "I could not stop sneezing" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]. The following information was reported: REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "I had a reaction to the something in the vaccine"; RHINORRHOEA (non-serious), outcome "unknown", described as "My nose started running profusely"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nose became completely blocked"; SNEEZING (non-serious), outcome "unknown", described as "I could not stop sneezing". Therapeutic measures were taken as a result of reaction to excipient, rhinorrhoea, nasal congestion, sneezing.  Additional Information: The patient took antihistamine as treatment medication. Events were probably for 6-7 hours. Within two hours the patient had a reaction to the something in the vaccine. Her nose started running profusely and her husband was a physician he thought it was moderate to severe was not, like she could breathe but her nose became completely blocked and she went to the whole box of the tissues. She could not stop sneezing and her nose was running continuously probably for like 6-7 hours. The patient had that happen only one other time when she had some injections in leg and she thought that injection caused the same thing (Further clarification unknown) otherwise it never had in her whole life like that for any kind of shot."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "Itchy all over my skin". Additional information: After I got the first shot, patient had few hives for the next few weeks. Like 1 hive on the top of my arm, 1 hive on the top of my thigh and then 1 hive on my neck. So, It was relatively minimal but I was kind of itchy all over my skin. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching in different parts of his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "Itching in different parts of his body".  Additional information: It was reported that within 24 hours of getting the second dose of the Pfizer, patient has been itching continuously and reporter wanted to known how long is it before it goes away and what are we able to do about it.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Investigation, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: swollen armpit; armpit was swollen; had swelling under his arm; felt soreness in his injection arm; had a cold sore on his lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 16:30 (Lot number: FD8448) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Covid-19", start date: May2021, stop date: May2021, notes: Patient reports he did get COVID about three months ago so he was told he had to wait, so that is the reason he waited to get the shot. Concomitant medication(s) included: CANDESARTAN HCT taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Aug2021, outcome "unknown", described as "felt soreness in his injection arm"; SWELLING (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "swollen armpit"; LYMPHADENOPATHY (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "armpit was swollen"; PERIPHERAL SWELLING (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "had swelling under his arm"; CHEILITIS (non-serious) with onset 22Aug2021, outcome "recovering", described as "had a cold sore on his lip". The events "swollen armpit", "armpit was swollen" and "had swelling under his arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, lymphadenopathy, peripheral swelling, cheilitis.  Additional information included: Caller was calling on behalf of her father who received his first Comirnaty vaccine dose on Sunday, 22Aug2021. The following day on Monday he felt soreness in his injection arm and the day after on Tuesday he experienced a swollen armpit. The swelling resolved after 1 week. The arm in which he received the vaccine he had swelling under his arm; in the armpit area so that he couldn't put his arm down and he had a cold sore on his lip in the week of vaccination. Caller stated he bought some Abreva to put on his cold sore and it has improved. His arm was back to normal now and the cold sore was almost gone. He went to his PCP who recommended he call Pfizer. He wanted to know if it was safe to get his second dose of the vaccine after having this adverse reaction.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swollen armpit; armpit was swollen; had swelling under his arm; felt soreness in his injection arm; had a cold sore on his lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 16:30 (Lot number: FD8448) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Covid-19", start date: May2021, stop date: May2021, notes: Patient reports he did get COVID about three months ago so he was told he had to wait, so that is the reason he waited to get the shot. Concomitant medication(s) included: CANDESARTAN HCT taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Aug2021, outcome "unknown", described as "felt soreness in his injection arm"; SWELLING (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "swollen armpit"; LYMPHADENOPATHY (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "armpit was swollen"; PERIPHERAL SWELLING (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "had swelling under his arm"; CHEILITIS (non-serious) with onset 22Aug2021, outcome "recovering", described as "had a cold sore on his lip". The events "swollen armpit", "armpit was swollen" and "had swelling under his arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, lymphadenopathy, peripheral swelling, cheilitis.  Additional information included: Caller was calling on behalf of her father who received his first Comirnaty vaccine dose on Sunday, 22Aug2021. The following day on Monday he felt soreness in his injection arm and the day after on Tuesday he experienced a swollen armpit. The swelling resolved after 1 week. The arm in which he received the vaccine he had swelling under his arm; in the armpit area so that he couldn't put his arm down and he had a cold sore on his lip in the week of vaccination. Caller stated he bought some Abreva to put on his cold sore and it has improved. His arm was back to normal now and the cold sore was almost gone. He went to his PCP who recommended he call Pfizer. He wanted to know if it was safe to get his second dose of the vaccine after having this adverse reaction.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The day after the shot a nickel sized lumped developed in my armpit. It took about a week for it to go away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 11:00 (Lot number: FC3181) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed generalized anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: SEROQUEL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Aug2021 09:00, outcome "recovered" (2021), described as "The day after the shot a nickel sized lumped developed in my armpit. It took about a week for it to go away.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, List of other medications the patient received within 2 weeks of vaccination are Seroquel 250mg, multivitamin, prior to and since vaccination, patient was not diagnosed with COVID-19. Device date was 09Sep2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: diarrhea; Chills; fever; headache; muscle aches; fatigue; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 13:00 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: FC3183, lot unknown: False, administration date: 19Aug2021, administration time: 02:30 PM, dose number: 1, vaccine location: Left arm), administration date: 19Aug2021, when the patient was 64 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "diarrhea"; CHILLS (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "muscle aches"; FATIGUE (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of diarrhoea, chills, pyrexia, headache, myalgia, fatigue, nausea, vomiting.  Additional information: The patient had not received other vaccine in four weeks and received other medications in two weeks. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: diarrhea; Chills; fever; headache; muscle aches; fatigue; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 13:00 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: FC3183, lot unknown: False, administration date: 19Aug2021, administration time: 02:30 PM, dose number: 1, vaccine location: Left arm), administration date: 19Aug2021, when the patient was 64 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "diarrhea"; CHILLS (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "muscle aches"; FATIGUE (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of diarrhoea, chills, pyrexia, headache, myalgia, fatigue, nausea, vomiting.  Additional information: The patient had not received other vaccine in four weeks and received other medications in two weeks. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: She coughed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "She coughed".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Eye swelling, Rash macular, Swelling of eyelid
Clinical narrative: has eczema around her eyes/eczema flare around her eyes, up to her eyebrows and forehead; Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot; Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot; Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ECZEMA (non-serious) with onset 2021, outcome "unknown", described as "has eczema around her eyes/eczema flare around her eyes, up to her eyebrows and forehead"; SWELLING OF EYELID (non-serious), EYE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot"; RASH MACULAR (non-serious) with onset 2021, outcome "unknown", described as "Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot.". Therapeutic measures were taken as a result of eczema, swelling of eyelid, eye swelling, rash macular.  Additional information: Reporter seriousness for Eczema flared up around eyes: around her eyes, up to her eyebrows and forehead, Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot was unspecified. Reporter seriousness for She is supposed to go for her second shot today and is uneasy was Unspecified. The patient stated that she now has eczema around her eyes, she got the shot, 3 weeks ago today, and after a few days, her eczema flared up around her eyes, her left eye lid swelled up, her right eye was swelled up in a 2 inch round red spot. The patient had an eczema flare around her eyes, up to her eyebrows and forehead. The patient has been using a steroid ointment that her doctor gave her last year. she used it on the third day after the shot and has been using it for 10 days.The medication is IC-Desonide 0.5% ointment, and patient stated that it was helping her. The patient stated that she was supposed to go for her second shot today and was uneasy. Caller wanted to know if anyone else with skin issues had flared up.  \No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.