chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: heart to enlarge; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "heart to enlarge".  Additional Information: Reporter provided verification of contact address on 11May2022. . Caller stated "How can I sue you. This nonsense Covid vaccine has caused my son's heart to enlarge. He now has a heart doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW015B), in left arm and on 28Jan2022 as dose 3 (booster), single (Lot number: 33130BA) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "tubal ligation" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; PREVACID; RESTASIS; METOPROLOL; VITAMIN D NOS; CLARITINE; VITAMIN B COMPLEX. Past drug history included: Taviste-d, reaction(s): "known allergies Taviste-D", notes: known allergies Taviste-D. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course included Known allergies of Taviste-D. Treatment for COVID-19 included paxlovid.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events Vaccination failure , COVID-19  cannot be completely excluded based on temporal association.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: paxlovid: Treatment of COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: en5318), in left arm, on 25Feb2021 as dose 2, single (Lot number: en6201), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: ff2190), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN, stop date: 01May2022.  The following information was reported: COVID-19 (medically significant) with onset 03May2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 03May2022, outcome "unknown", described as "paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) positive; (08May2022) negative; (09May2022) negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Both my wife and I contacted covid she was positive on May 2, and I was on 03May2022 We both went to urgent care on 5May2022 and received Paxlovid and started symptoms improved and we both tested negative on 08May and 09May respectively. Both of us began a runny nose and chest congestion last night. I retested this am and am testing positive with Covid. She has not retested yet. Am wondering what the next step would be? Simply ride this out or is there some other prescribed treatment?   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9264), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 13Apr2022 at 15:45 as dose 4 (booster), single (Lot number: FJ5682) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic peripheral neuropathy" (unspecified if ongoing); "Bee venom" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12May2022) Positive, notes: Tested positive with home Binax test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. Treatment start date was May2022 and treatment stop date was May2022. The patient finished Paxlovid with morning dose on 07May2022. Symptoms started returning 11May2022. Tested 12May2022 as symptoms seemed to get worse (sore throat, runny nose, slight cough). Tested positive with home Binax test. Other medication in 2 weeks was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Restless legs syndrome, Tremor
Clinical narrative: awful nausea occurred; Restless legs and couldn't stop shaking; Restless legs and couldn't stop shaking; Diarrhea once as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Raynauds Syndrome (circulation deficiency)" (unspecified if ongoing); "B12 deficient" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "Known allergies: Gluten allergies" (unspecified if ongoing), notes: Gluten allergies. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious), 4 hrs after the suspect product(s) administration, outcome "recovering", described as "awful nausea occurred"; RESTLESS LEGS SYNDROME (non-serious), TREMOR (non-serious), outcome "recovering" and all described as "Restless legs and couldn't stop shaking"; DIARRHOEA (non-serious), outcome "recovering", described as "Diarrhea once as well". Therapeutic measures were not taken as a result of nausea, restless legs syndrome, tremor, diarrhoea.  Additional information: Age group: Adult (18-64 Years). Other medication in 2 weeks: Yes. COVID 19 Treatment started on 11May2022 with Anti viral brand Paxlovid stopped on 11May2022 via Oral route. Dose 2 date 21Mar2022. Adverse event: 4 hours after taking 1st dose, awful nausea occurred. Restless legs and couldn't stop shaking. Diarrhea once as well. Adverse event start date: 11May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 21Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Raynauds Syndrome (circulation deficiency)" (unspecified if ongoing), notes: circulation deficiency; "B12 deficient" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "Known allergies: Gluten allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. The clinical course reported as 4 hours after taking 1st dose, awful nausea occurred. Restless legs and couldn't stop shaking. Diarrhea once as well and adverse event start date: 11May2022. The patient did not received other medication in 2weeks. The patient received COVID 19 Treatment, brand: Paxlovid, treatment start date/ stop date: 11May2022 and indication: treatment of COVID-19 administrator route: oral. The patient Known allergies: Gluten allergies. The patient Other medical history: Raynauds Syndrome (circulation deficiency), B12 deficient, facial paralysis/concussion  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 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 on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "immune system compromise" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROXYCHLOROQUINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (09May2022) Positive, notes: Home test positive. Therapeutic measures were taken as a result of covid-19.  Additional Information: COVID 19 Treatment with Paxlovid with start date 20Apr202 and stop date 24Apr2022. Adverse event: Rebound symptoms / internet shows it could happens. Home test positive. Adverse event start date: 09May2022. No treatment received. No known allergies present. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive NAAT and lateral flow antigen test on day 9 after initial symptoms, after completing Paxlovid series. Previously tested negative using NAAT on May 9 12 hrs after finishing final Paxlovid dose; Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: ER8736) and on 12May2021 as dose 2, single (Lot number: EW0182) at the age of 40 years for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose 3 (booster), single (Lot number: 065F21A) for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Other medication in 2 weeks was reported as no. The following information was reported: COVID-19 (medically significant), 8 days 9 hrs after the suspect product(s) administration, outcome "unknown", described as "Positive NAAT and lateral flow antigen test on day 9 after initial symptoms, after completing Paxlovid series. Previously tested negative using NAAT on May 9 12 hrs after finishing final Paxlovid dose"; DRUG INEFFECTIVE (medically significant), 8 days 9 hrs after the suspect product(s) administration, outcome "unknown", described as "Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed; (unspecified date) Positive, notes: Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed; (09May2022) Negative, notes: Previously tested negative using NAAT on May 9 at 9am (12 hours after finishing final Paxlovid dose). Currently asymptomatic. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Paxlovid started on 04May2022 and stopped on 08May2022 for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blisters; 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 received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: EN6202, Anatomical location: left arm.), administration date: 21Feb2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "no adverse effect"; BNT162b2 (Dose  2, Lot: FF2590, Anatomical location: left arm.), administration date: 14Mar2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (Dose 3 (BOOSTER), Lot: WA84764, Anatomical location: left arm.), administration date: 12Oct2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: BLISTER (non-serious) with onset 09May2022, outcome "recovering", described as "Blisters". Therapeutic measures were taken as a result of blister included Cortisone 1% cream.  Additional information: The patient reported that the side effects she had was blisters, she did not have any other side effects with other vaccines in the past, this was the first time. She stated that she got the blisters in the night on the day of vaccination. She said they started and she still had them in her hot spots: under her chest right underneath her breasts, her midriff area where underwear begins at the top of her thighs. Midriff area clarified to groin area, reclarified to not groin, over the top of her thighs where it meets the legs where underwear sits. She had been putting Cortisone 1% cream on her blisters. She said she had been putting it on twice a day, once in the morning and once at night, or BID. She said the blisters were somewhat better, she still had them. The patient had been taking all the same medicines (unspecified) she had been taking. No further details provided about her medications.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result= Positive; Covid test result= Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 at 09:30 as dose 1, single (Lot number: EL3247), in left arm, on 16Feb2021 at 11:00 as dose 2, single (Lot number: EL3247) intramuscular, in left arm and on 14Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 53 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. It was reported that the patient had no known allergies and no other medical history. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "Covid test result= Positive". On 12May2022 at 13:00, the patient reported having symptoms of congestion and very mild cough. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: Nasal Swab Covid test type. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021169419 Same patient and drug, different event separated in time
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Urticaria
Clinical narrative: Tongue numb for four days.; Hives in his face; Face and tongue numb that lasted for four days; The initial case was missing the following minimum criteria: suspect product unspecified. Upon receipt of follow-up information on 12May2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA ORAL (non-serious), outcome "recovered", described as "Tongue numb for four days."; URTICARIA (non-serious), outcome "recovered", described as "Hives in his face"; HYPOAESTHESIA (non-serious), outcome "recovered", described as "Face and tongue numb that lasted for four days".  Additional information: It was reported that the reporter was asking for medical information if it was necessary to take the booster shots. He mentioned that when he got the two doses of the vaccine, he experienced a side effect of having his face and tongue numb that lasted for four days. He also mentioned that he got two doses of the vaccine however he experience on 'hives in' his face and tongue numb for four days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision/ she looked at pictures and faces were blurry and she could not make them out; 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 81-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 at 01:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years 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, reaction(s): "she had no side effects from her first three doses of the vaccine"; Covid-19 vaccine (Dose:2, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "she had no side effects from her first three doses of the vaccine"; Covid-19 vaccine (Dose:3, Booster, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "she had no side effects from her first three doses of the vaccine". The following information was reported: VISION BLURRED (non-serious) with onset 10May2022, outcome "unknown", described as "blurry vision/ she looked at pictures and faces were blurry and she could not make them out". The events "blurry vision/ she looked at pictures and faces were blurry and she could not make them out" required physician office visit and emergency room visit.  Additional information: The patient had received dose and came home and everything seemed fine.  She did a few things and sat down for a while and dozed off for half an hour.  When she woke up, the pictures of her family in her living room were blurry.  She thought it was a temporary thing.  It continued, so she called her daughter at 4pm and said something was wrong.  She was having problems seeing a clear face.  She took her to the emergency room.  She went to the emergency room and sat there for approximately 6 hours because they did not have an eye doctor.  The doctor there checked her eye with something she was not familiar with.  They did not put anything in her eye, but made her look up, down, right and left.  He called her regular doctor and told symptoms and doctor's nurse answered.  She left the emergency room around 10:30 pm and the nurse said to come in today because that was when the retina doctor will be in her area.  She was seeing him at 2:40 today, but she wanted to know there were a myriad of symptoms with the different vaccines, not just Pfizer.  She would like to know if vision problems have been an issue with the Pfizer booster.   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: Blood test, Rheumatoid arthritis, Suspected COVID-19, Swelling, Vaccination failure
Clinical narrative: 4 months after the vaccination she got COVID; 4 months after the vaccination she got COVID; high RA/RA flares up; Swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "chemo" (unspecified if ongoing), notes: she has had chemo; "ADHD" (unspecified if ongoing); "hyper" (unspecified if ongoing), notes: hyper. Concomitant medication(s) included: ESCITALOPRAM taken for anxiety. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "4 months after the vaccination she got COVID"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "high RA/RA flares up"; SWELLING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: she hasn't gotten the results back yet. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19, rheumatoid arthritis, swelling.   Clinical course: Patient reported that 4 months after the vaccination she got COVID. She clarified the vaccination to Pfizer, it is good for 6 months. She clarified that she got the two shot dose, first shot then two weeks later the second shot. She clarified the vaccination to Pfizer COVID-19 vaccine. She stated she does not have the NDC/LOT/EXPIRY. She clarified that she does not have her vaccination card, she had it last year. She stated she is never getting a vaccination again she will just deal with that. She stated she does not know the count size, no strength just that it is Pfizer that (Name withheld) had. She stated she had no idea, just a shot in the shoulder. She stated it looked like it was, they opened up the needle thing and it looked clean. She clarified that everything was brand new.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Biopsy, Mass, Pain in extremity, Pruritus, Rash
Clinical narrative: experienced a rash on his arm that has moved to his back; A biopsy showed some skin irritation; Itching; got a MRSA boil from a sore on his leg; got a MRSA boil from a sore on his leg; He still has a little itch and bumps; 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 76-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 76 years, in right arm for covid-19 immunisation; atorvastatin calcium (LIPITOR), (Batch/Lot number: unknown) for blood cholesterol. The patient's relevant medical history included: "Heart attack" (unspecified if ongoing), notes: He had a heart attack and his gallbladder taken out. it was all before the COVID vaccine 6-7 years ago.; "gallbladder taken out" (unspecified if ongoing), notes: He had a heart attack and his gallbladder taken out. It was all before the COVID vaccine 6-7 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First vaccine: given on 14Apr2021; lot ER8731, Anatomical location: He got them in his right arm because he is left handed.), administration date: 14Apr2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (Second vaccine given on 10May2021; lot EW0176, Anatomical location: He got them in his right arm because he is left handed.), administration date: 10May2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (Third vaccine given on 19Nov2021; lot FH8030, Anatomical location: He got them in his right arm because he is left handed.), administration date: 19Nov2021, when the patient was 76-year-old, for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "experienced a rash on his arm that has moved to his back"; SKIN IRRITATION (non-serious), outcome "unknown", described as "A biopsy showed some skin irritation"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; PAIN IN EXTREMITY (non-serious), STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown" and all described as "got a MRSA boil from a sore on his leg"; MASS (non-serious), outcome "unknown", described as "He still has a little itch and bumps". The events "experienced a rash on his arm that has moved to his back", "a biopsy showed some skin irritation", "itching" and "got a mrsa boil from a sore on his leg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for atorvastatin calcium was unknown. Therapeutic measures were taken as a result of rash, skin irritation, pruritus, pain in extremity, staphylococcal infection, mass.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Skin irritation, Staphylococcal infection
Clinical narrative: experienced a rash on his arm that has moved to his back; A biopsy showed some skin irritation; Itching; got a MRSA boil from a sore on his leg; got a MRSA boil from a sore on his leg; He still has a little itch and bumps; 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 76-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 76 years, in right arm for covid-19 immunisation; atorvastatin calcium (LIPITOR), (Batch/Lot number: unknown) for blood cholesterol. The patient's relevant medical history included: "Heart attack" (unspecified if ongoing), notes: He had a heart attack and his gallbladder taken out. it was all before the COVID vaccine 6-7 years ago.; "gallbladder taken out" (unspecified if ongoing), notes: He had a heart attack and his gallbladder taken out. It was all before the COVID vaccine 6-7 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First vaccine: given on 14Apr2021; lot ER8731, Anatomical location: He got them in his right arm because he is left handed.), administration date: 14Apr2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (Second vaccine given on 10May2021; lot EW0176, Anatomical location: He got them in his right arm because he is left handed.), administration date: 10May2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (Third vaccine given on 19Nov2021; lot FH8030, Anatomical location: He got them in his right arm because he is left handed.), administration date: 19Nov2021, when the patient was 76-year-old, for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "experienced a rash on his arm that has moved to his back"; SKIN IRRITATION (non-serious), outcome "unknown", described as "A biopsy showed some skin irritation"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; PAIN IN EXTREMITY (non-serious), STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown" and all described as "got a MRSA boil from a sore on his leg"; MASS (non-serious), outcome "unknown", described as "He still has a little itch and bumps". The events "experienced a rash on his arm that has moved to his back", "a biopsy showed some skin irritation", "itching" and "got a mrsa boil from a sore on his leg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for atorvastatin calcium was unknown. Therapeutic measures were taken as a result of rash, skin irritation, pruritus, pain in extremity, staphylococcal infection, mass.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound infection - I tested negative for COVID on 10May and 11May. Tested Positive again and had symptoms on 13May; Rebound infection - I tested negative for COVID on 10May and 11May. Tested Positive again and had symptoms on 13May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound infection - I tested negative for COVID on 10May and 11May. Tested Positive again and had symptoms on 13May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Rebound infection; (10May2022) Negative, notes: tested negative for COVID on 10May; (11May2022) Negative, notes: tested negative for COVID on 10May and 11May; (13May2022) Positive, notes: Tested Positive again and had symptoms on 13May. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle tightness
Clinical narrative: Muscle tightness, which lead to joint popping and pain; Muscle tightness, which lead to joint popping and pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 at 01:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing), notes: Other medical history: High cholesterol. Concomitant medication(s) included: LOVASTATIN. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline; Actonel, reaction(s): "Known allergies: Actonel", notes: Known allergies: Actonel. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary immunization complete, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Primary immunization complete, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 3, First booster dose.), for Covid-19 Immunization.  The following information was reported: ARTHRALGIA (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 30Apr2022, outcome "not recovered" and all described as "Muscle tightness, which lead to joint popping and pain". Therapeutic measures were taken as a result of arthralgia, muscle tightness.  Additional information: patient was not received any other vaccine in four weeks. Patient did not had covid prior vaccination nor covid tested post vaccination. Treatment for the events included Myofascial release massage and regular massage.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "allergies Kiwi persimmons" (unspecified if ongoing); "allergies eggplant" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19 with NyQuil DayQuil Advil.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: joint pain; tiredness; muscle pain; chills; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 74 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); "obesity" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered"; MALAISE (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "feeling unwell"; ARTHRALGIA (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "joint pain"; MYALGIA (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "tiredness". Therapeutic measures were not taken as a result of arthralgia, fatigue, myalgia, chills, malaise.  Additional information: No other vaccine received in four weeks. No Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: 09Oct2021; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: 09Oct2021; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose number unknown, single (Lot number: FF8841) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Known allergies: antibiotics" (unspecified if ongoing), notes: Known allergies: antibiotics; "Known allergies: sulfur" (unspecified if ongoing), notes: Known allergies: sulfur; "high blood pressure" (unspecified if ongoing); "high BMI" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Lisinopril, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03May2022, outcome "unknown" and all described as "Pfizer / BioNTech: 09Oct2021; Paxlovid: COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose number unknown, single (Lot number: ER8731), in left arm and on 03Jun2021 as dose number unknown, single (Lot number: EW0175) at the age of 21 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Dec2021 as dose number unknown, single (Lot number: 060H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Apendicitus" (unspecified if ongoing); "Pericarditis" (unspecified if ongoing); "vaccine brand=Pfizer / BioNTech;vaccine brand other=Moderna" (unspecified if ongoing), notes: vaccine brand=Pfizer / BioNTech,, vaccine brand other=Moderna. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.Clinical Course : Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as no. the patient previously receive a COVID-19 Vaccine was reported as Yes. Known allergies was reported as no. Anti-viral details: product COVID 19 Treatment, brand Paxlovid, treatment start date 12May2022, treatment stop date May2022, indication Treatment of COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: 01Oct2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: 01Oct2021; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Pfizer / BioNTech: 01Oct2021; Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 02May2022 to 06May2022, the patient was given treatment (Paxlovid) for COVID-19.  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 information available , a possible contributory role of the suspect  BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 82-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "htn" (ongoing). Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZIDE; LABETOL; IRBESARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that the patient received other vaccine in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; positive test; Treatment of COVID-19; positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chrons" (unspecified if ongoing), notes: other medical history: Chrons. Concomitant medication(s) included: DICYCLOMINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19; positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: positive test. Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient received treatment for COVID-19 from 5MAy2022 to 9May2022. On 13May2022 the patient experienced reappering symptoms, congestion, short of breath and positive test. The patient was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Malaise
Clinical narrative: my left arm and side of face went numb; my left arm and side of face went numb; felt ill for 2 wks; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 19Apr2021 as dose 1, single (Lot number: Er8731) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks.  Patient has not received other vaccine in four weeks. Patient has no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The following information was reported: MALAISE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "felt ill for 2 wks"; HYPOAESTHESIA (disability) all with onset 19Apr2021 at 16:30, outcome "not recovered" and all described as "my left arm and side of face went numb". Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia, malaise. AE treatment (reported as): Doctor, therapy, chiropractor and even heart doctor. Clinical course: On 19Apr2021 patient received my first shot...30mins later his left arm and Side of face went numb...felt ill for 2 wks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200716747 same reporter/patient, different dose/event
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Back pain, Bone disorder, Cardiac stress test abnormal, Chest pain
Clinical narrative: my left arm and side of face went numb; my left arm and side of face went numb; felt ill for 2 wks; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 19Apr2021 as dose 1, single (Lot number: Er8731) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks.  Patient has not received other vaccine in four weeks. Patient has no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The following information was reported: MALAISE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "felt ill for 2 wks"; HYPOAESTHESIA (disability) all with onset 19Apr2021 at 16:30, outcome "not recovered" and all described as "my left arm and side of face went numb". Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia, malaise. AE treatment (reported as): Doctor, therapy, chiropractor and even heart doctor. Clinical course: On 19Apr2021 patient received my first shot...30mins later his left arm and Side of face went numb...felt ill for 2 wks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200716747 same reporter/patient, different dose/event