chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, PNC13, PPV
Symptoms: No adverse event
Clinical narrative: really hurts; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose for immunization, pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose for immunization and influenza vaccine (unknown formulation), via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient received his COVID vaccine injection yesterday and he doesn't have any side effects. He was calling because he wants to thank Pfizer and everybody that worked on it for developing for the vaccine because he has been scared to death of this stuff. Patient states "everybody was saying his arm hurts and everything, but what really hurts was a flu shot and the other thing that really hurts was when he gets the Prevnar 13 and other pneumonia shot on an unspecified date". The outcome of the event was reported as unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Fatigue, Investigation, Malaise
Clinical narrative: Nausea; Slight temperature 99.7; Fatigue; General feeling of aches and pains; Sore throat; Throat seemed red; Sick; Feeling heavy with her chest. She went to the ER; This is a spontaneous report from a contactable nurse. This nurse reported for a 35-year-old female patient (Daughter) received 2nd dose of BNT162B2 (COVID-19 Vaccine lot number: EK9231, Expiry date: Apr2021) on 16Jan2021 at single dose for covid-19 immunization. Medical history reported was She was positive, our whole family had COVID and we all came down which was about the same time which was 29Dec. Concomitant drug were not reported. Retired Nurse stated, "I am calling for my daughter. She received her 2nd vaccination yesterday morning and she had some side effects. Like about 6 o'clock this morning she came in, she came in 6:35, she came and woke me up and said that she felt some of the reaction she is having. She has nausea, she has slight temperature 99.7, fatigue. Just a general feeling of aches and pains. It does not seem like it's an emergency. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd. She works in a hospital, she got her 2nd dose of vaccine like I said yesterday morning. "Retired Nurse stated, "I am not sure causality. I mean it is not an emergency. She was feeling fine yesterday. We all are feeling better now. She had the vaccine and last night she said she had a sore throat when I looked at her throat. Her throat seemed red but there was no angioedema or anything like that, she went to sleep and she came in 'feeling really' (voice distortion) sick. So, I do not know. Did they have relapses from the COVID? I do not know." Treatment was "Tylenol." Like I had said that she was feeling heavy with her chest. She went to the ER. She was at her work. She went to the ER." "Probably close to 10 days ago, they did lab work I think they might have been looking for a clot. They did do some lab work at the hospital with unknown results." Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pharyngeal erythema, Pyrexia
Clinical narrative: Nausea; Slight temperature 99.7; Fatigue; General feeling of aches and pains; Sore throat; Throat seemed red; Sick; Feeling heavy with her chest. She went to the ER; This is a spontaneous report from a contactable nurse. This nurse reported for a 35-year-old female patient (Daughter) received 2nd dose of BNT162B2 (COVID-19 Vaccine lot number: EK9231, Expiry date: Apr2021) on 16Jan2021 at single dose for covid-19 immunization. Medical history reported was She was positive, our whole family had COVID and we all came down which was about the same time which was 29Dec. Concomitant drug were not reported. Retired Nurse stated, "I am calling for my daughter. She received her 2nd vaccination yesterday morning and she had some side effects. Like about 6 o'clock this morning she came in, she came in 6:35, she came and woke me up and said that she felt some of the reaction she is having. She has nausea, she has slight temperature 99.7, fatigue. Just a general feeling of aches and pains. It does not seem like it's an emergency. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd. She works in a hospital, she got her 2nd dose of vaccine like I said yesterday morning. "Retired Nurse stated, "I am not sure causality. I mean it is not an emergency. She was feeling fine yesterday. We all are feeling better now. She had the vaccine and last night she said she had a sore throat when I looked at her throat. Her throat seemed red but there was no angioedema or anything like that, she went to sleep and she came in 'feeling really' (voice distortion) sick. So, I do not know. Did they have relapses from the COVID? I do not know." Treatment was "Tylenol." Like I had said that she was feeling heavy with her chest. She went to the ER. She was at her work. She went to the ER." "Probably close to 10 days ago, they did lab work I think they might have been looking for a clot. They did do some lab work at the hospital with unknown results." Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Nausea; Slight temperature 99.7; Fatigue; General feeling of aches and pains; Sore throat; Throat seemed red; Sick; Feeling heavy with her chest. She went to the ER; This is a spontaneous report from a contactable nurse. This nurse reported for a 35-year-old female patient (Daughter) received 2nd dose of BNT162B2 (COVID-19 Vaccine lot number: EK9231, Expiry date: Apr2021) on 16Jan2021 at single dose for covid-19 immunization. Medical history reported was She was positive, our whole family had COVID and we all came down which was about the same time which was 29Dec. Concomitant drug were not reported. Retired Nurse stated, "I am calling for my daughter. She received her 2nd vaccination yesterday morning and she had some side effects. Like about 6 o'clock this morning she came in, she came in 6:35, she came and woke me up and said that she felt some of the reaction she is having. She has nausea, she has slight temperature 99.7, fatigue. Just a general feeling of aches and pains. It does not seem like it's an emergency. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd. She works in a hospital, she got her 2nd dose of vaccine like I said yesterday morning. "Retired Nurse stated, "I am not sure causality. I mean it is not an emergency. She was feeling fine yesterday. We all are feeling better now. She had the vaccine and last night she said she had a sore throat when I looked at her throat. Her throat seemed red but there was no angioedema or anything like that, she went to sleep and she came in 'feeling really' (voice distortion) sick. So, I do not know. Did they have relapses from the COVID? I do not know." Treatment was "Tylenol." Like I had said that she was feeling heavy with her chest. She went to the ER. She was at her work. She went to the ER." "Probably close to 10 days ago, they did lab work I think they might have been looking for a clot. They did do some lab work at the hospital with unknown results." Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Heartbeats irregular/heart rate was all over the place/up to like a 101; This is a spontaneous report from two contactable consumers (patient self and patient's husband). This 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) on 15Jan2021 15:00 at single dose for COVID-19 immunisation, and received cetirizine hydrochloride (ZYRTEC, lot# 1663312, expiry date: Jan2022) from unspecified date at unknown dose for unknown indication. Medical history included allergic rhinitis, blood cholesterol abnormal. Concomitant medications included atorvastatin for cholesterol, fluticasone propionate (FLONASE) for allergic rhinitis. The patient received her first dose on Friday (15Jan2021), about 3 o' clock in the afternoon. And she was experiencing an irregular heartbeat from yesterday (16Jan2021). Reported that on 16Jan2021 morning, she woke up and heart rate was all over the place. She was in bed and it was up to like a 101 already. She had also taken cetirizine hydrochloride the night before. So, she didn't know if that's the problem also. No treatment received for the event. The action taken for cetirizine hydrochloride was unknown. Outcome of event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable Consumer. This Consumer reported for self that the patient of unknown age and gender who received bnt162b2 (BNT162B2) via unknown route of administration on 16Jan2021 21:30 at a single dose for covid-19 immunization. Medical history and concomitant medications were unknown. Consumer stated, "I got the Pfizer shot (Later clarified as Covid-19 Vaccine by Pfizer) yesterday about 09:30 at night and they told me not to take any Tylenol, if I can help it and how long I can actually take the Tylenol as I have the headache all night and all this morning, so when I can take Tylenol, do I have to wait like 2 days, 3 days, how long?" The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Eye swelling, Ocular hyperaemia, Pain in extremity
Clinical narrative: his eye felt irritated; swollen eye; red eye; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021), via an unspecified route of administration in arm on 13Jan2021 02:00 at single dose for COVID-19 immunisation. Medical history included blood pressure (as reported). Concomitant medication included hydrochlorothiazide and lisinopril, both for blood pressure. The patient just took the vaccine on Wednesday (13Jan2021) and had a reaction, not sure if it was from the vaccine or not and he was just calling that in to report that as it can be related. The patient got vaccinated on Wednesday at 2 O' clock and no major issues, just sore arm. However, Friday (15Jan2021) afternoon he had woke from a nap and his eye felt irritated. He was still experiencing a swollen eye. So, he was calling about the swollen eye, red eye. He never had something like this before, didn't take anything that might cause it, the only thing unusual was because he got the vaccine. Treatment included using a cold compress only, not ingesting anything. The outcome of events sore arm, eye felt irritated and red eye was unknown, swollen eye was not recovered.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: his eye felt irritated; swollen eye; red eye; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021), via an unspecified route of administration in arm on 13Jan2021 02:00 at single dose for COVID-19 immunisation. Medical history included blood pressure (as reported). Concomitant medication included hydrochlorothiazide and lisinopril, both for blood pressure. The patient just took the vaccine on Wednesday (13Jan2021) and had a reaction, not sure if it was from the vaccine or not and he was just calling that in to report that as it can be related. The patient got vaccinated on Wednesday at 2 O' clock and no major issues, just sore arm. However, Friday (15Jan2021) afternoon he had woke from a nap and his eye felt irritated. He was still experiencing a swollen eye. So, he was calling about the swollen eye, red eye. He never had something like this before, didn't take anything that might cause it, the only thing unusual was because he got the vaccine. Treatment included using a cold compress only, not ingesting anything. The outcome of events sore arm, eye felt irritated and red eye was unknown, swollen eye was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Eye swelling, Ocular hyperaemia, Pain in extremity
Clinical narrative: He woke up and his eye felt like it was hurting; He has a swollen eye and it is still like this today; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 13Jan2021 as a single dose for COVID-19 immunisation. The patient's medical and concomitant medications were not reported. The patient stated that he received the first dose of the vaccine on Wednesday, the 13th of Jan2021 at 2:00. The symptoms began on Friday (15Jan2021) after he had taken a nap. He woke up and his eye felt like it was hurting. He has a swollen eye and it was still like this today. He stated there was a delay in the reaction and he has never experienced anything like this before. He was trying to determine if this was from something he ate or something else, but the only thing different was that he got the vaccine. He asked if this has been reported by other people. Outcome of the events was not recovered. The events were reported as non-serious.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: He woke up and his eye felt like it was hurting; He has a swollen eye and it is still like this today; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 13Jan2021 as a single dose for COVID-19 immunisation. The patient's medical and concomitant medications were not reported. The patient stated that he received the first dose of the vaccine on Wednesday, the 13th of Jan2021 at 2:00. The symptoms began on Friday (15Jan2021) after he had taken a nap. He woke up and his eye felt like it was hurting. He has a swollen eye and it was still like this today. He stated there was a delay in the reaction and he has never experienced anything like this before. He was trying to determine if this was from something he ate or something else, but the only thing different was that he got the vaccine. He asked if this has been reported by other people. Outcome of the events was not recovered. The events were reported as non-serious.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness
Clinical narrative: Dizziness/ dizzy; got really sick/ got pretty sick; This is a spontaneous report from a contactable nurse (reported for herself). A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not specified), via an unspecified route of administration on an unspecified date at single dose in upper arm for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). Nurse stated she took the second shot. She believed she had some adverse reactions to it. When probed for the adverse event Nurse stated, "Dizziness, horrible dizziness". She had the shot on Monday and this was Sunday. She didn't know if this was to be expected but it was really getting worse. She first noticed it on Friday it went too bad on Saturday but it's worse today. Right was that an expected side effect. She got really sick with that second shot, really sick but by Thursday she was going better, she got the shot on Monday but on Friday she noticed the dizziness but it was much worse today. She was just so dizzy. For Causality, Nurse stated she didn't know. She meant she immediately thought it was. She had a rough go with the second shot she got pretty sick so yes. She would think it could be. Nurse stated No Treatment, it just started. No Investigation Assessment. For lot number, the nurse stated, "It looks like EL1283 or it could be 083. But it looks like 1283". The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Rash, Ultrasound thyroid
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date (reported as on the 15th) in Right Arm at single dose for COVID-19 immunization. Medical history included Schizophrenia. The patient had done images done, he went to endocrinologist, he went for ultrasound for his thyroid, all before the vaccine on unspecified dates. The patient's concomitant medications included unspecified medications (he had 'MR'). It was reported that patient had the shot on the 15th and had a rash now on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash erythematous, Rash vesicular
Clinical narrative: there is like a red rash, it is about the size of a quarter and it is going all the way around the side and on her back and it is red, raw looking and it hurts; there is like a red rash, starts like a 'blister'; it hurts; This is a spontaneous report from a contactable Consumer (Patient's daughter). An 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history reported as none. The patient had been on different medications for all these years, and she had never had a rash. On 16Jan2021 there was like a red rash and it was unknown if it had been anything to do with that or not but it started like a 'blister' and it was about the size of a quarter and it was going all the way around the side and on her back and it was red, raw looking and it hurt. The patient did not receive treatment. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Pain in extremity
Clinical narrative: Hard of hearing; My left arm where the shot was is sore; It is hurting so bad; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (Covid Vaccine) on 17Jan2021 09: 00 AM at single dose on left arm for covid-19 immunization. Medical history and concomitant drug were not reported. Consumer stated, 'I just wanted to call and see what to do, I got my Vaccine shot (Covid vaccine) at 9 AM this morning on 17Jan2021 and then all of a sudden my left arm where the shot was is sore. I want to know what to put on it ice or heat. I don't want to put on the wrong thing and make it worse. It is hurting so bad.' Consumer stated 'I am hard of hearing. I am a retired sales man.' Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Hard of hearing; My left arm where the shot was is sore; It is hurting so bad; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (Covid Vaccine) on 17Jan2021 09: 00 AM at single dose on left arm for covid-19 immunization. Medical history and concomitant drug were not reported. Consumer stated, 'I just wanted to call and see what to do, I got my Vaccine shot (Covid vaccine) at 9 AM this morning on 17Jan2021 and then all of a sudden my left arm where the shot was is sore. I want to know what to put on it ice or heat. I don't want to put on the wrong thing and make it worse. It is hurting so bad.' Consumer stated 'I am hard of hearing. I am a retired sales man.' Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: She is been throwing up; Chills; Her arms are kind of swollen and red and it's kind of painful; Her arms are kind of swollen and red and it's kind of painful; Her arms are kind of swollen and red and it's kind of painful; Fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 15Jan2021 at the second single dose , via an unspecified route of administration on an unspecified date at the first single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient got the Pfizer Covid shot on 11th, the second dose on 15Jan2021. The patient started having fever 100.3 on 16Jan2021. The patient is been taking Tylenol almost every six hours. Her temp was 101.3 and been throwing up on 17Jan2021. Her arms were kind of swollen and red and it's kind of painful and chills on 17Jan2021. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: She is been throwing up; Chills; Her arms are kind of swollen and red and it's kind of painful; Her arms are kind of swollen and red and it's kind of painful; Her arms are kind of swollen and red and it's kind of painful; Fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 15Jan2021 at the second single dose , via an unspecified route of administration on an unspecified date at the first single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient got the Pfizer Covid shot on 11th, the second dose on 15Jan2021. The patient started having fever 100.3 on 16Jan2021. The patient is been taking Tylenol almost every six hours. Her temp was 101.3 and been throwing up on 17Jan2021. Her arms were kind of swollen and red and it's kind of painful and chills on 17Jan2021. The outcome of events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Body temperature abnormal, Chills, Diarrhoea
Clinical narrative: Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This is a spontaneous report from a contactable other healthcare professional (patient). This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3249) via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunisation. Relevant medical history included penicillin allergy and allergy to clindamycin and doxycycline. Concomitant medications were not reported. The patient had a nasal swab COVID test result positive on 01Jan2021 after the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1685) administered on 21Dec2020 in the left arm for COVID-19 immunization. On 11Jan2021 at 21:00, the patient experienced temperature, chills, body aches, headaches, nausea, vomiting, diarrhea, fatigue and stomach pains. The patient underwent a Nasal Swab on 11Jan2021 which was positive. The patient did not receive corrective treatments. The patient had not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030273 same reporter/patient, different dose of COVID-19 vaccine/event
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This is a spontaneous report from a contactable other healthcare professional (patient). This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3249) via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunisation. Relevant medical history included penicillin allergy and allergy to clindamycin and doxycycline. Concomitant medications were not reported. The patient had a nasal swab COVID test result positive on 01Jan2021 after the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1685) administered on 21Dec2020 in the left arm for COVID-19 immunization. On 11Jan2021 at 21:00, the patient experienced temperature, chills, body aches, headaches, nausea, vomiting, diarrhea, fatigue and stomach pains. The patient underwent a Nasal Swab on 11Jan2021 which was positive. The patient did not receive corrective treatments. The patient had not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030273 same reporter/patient, different dose of COVID-19 vaccine/event
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This is a spontaneous report from a contactable other healthcare professional (patient). This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3249) via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunisation. Relevant medical history included penicillin allergy and allergy to clindamycin and doxycycline. Concomitant medications were not reported. The patient had a nasal swab COVID test result positive on 01Jan2021 after the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1685) administered on 21Dec2020 in the left arm for COVID-19 immunization. On 11Jan2021 at 21:00, the patient experienced temperature, chills, body aches, headaches, nausea, vomiting, diarrhea, fatigue and stomach pains. The patient underwent a Nasal Swab on 11Jan2021 which was positive. The patient did not receive corrective treatments. The patient had not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030273 same reporter/patient, different dose of COVID-19 vaccine/event
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; minor headache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 08Jan2021 at 17:00 at single dose on left arm for COVID-19 immunisation. Medical history included penicillin allergy, histoplasmosis and degenerative disk disease.  Historical vaccine included 1st dose of BNT162B2 (Lot number=EK5730) administrated on 18Dec2020 at 7:00 am on left arm for COVID-19 immunisation at age of 50-year-old. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), diclofenac sodium (DICLOFENAC NA), atorvastatin (LIPITOR [ATORVASTATIN]) and methocarbamol, all from unknown date for unknown indication.  The patient experienced chills, minor headache, tiredness, all on 09Jan2021 at 04:00 with outcome of recovering.  No treatment was received.
Sex: M
Vaccine: FLU3
Symptoms: Blister, Pruritus
Clinical narrative: develop a vesicle; It began to itch and he scratched it; Initial information received on 20-Oct-2017 regarding an unsolicited valid non-serious case received from other health professional via sales representative.  This case involves a male patient of unknown age who develop a vesicle (blister) and it began to itch and he scratched it (pruritus), while he received vaccine INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE [FLUZONE INTRADERMAL].  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE [lot number: unknown and expiration date: unknown] at a dose of 0.1 ml once via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) the patient developed a vesicle (blister) and it began to itch and he scratched it (pruritus) following the administration of suspect vaccine. The vesicle broke open and clear fluid came out.  He was wondering if the vaccine is going to work if the fluid came out.  He denies redness, induration, or itchiness since the vesicle popped open.  Lab data was not provided.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as resolved on an unknown date.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUR4
Symptoms: Injection site rash, Rash
Clinical narrative: rash down the arm; Rash near the injection site; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to case 2021SA027041 (same reporter).  This case involves 4 patients (unknown demographics) who experienced rash down the arm (rash) and rash near the injection site (vaccination site rash), when received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (beginning of November), the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2016 and expiry date: 30-Jun-2021) via an unknown route in the deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash down the arm (rash) and rash near the injection site (vaccination site rash), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The details of laboratory data were not reported.  The patient was treated with HYDROCORTISONE for the events.  On an unknown date, patients recovered from events.
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: fever upto 38.9 degree Celsius; Initial information was received on 16-Jan-2021 regarding an unsolicited valid non-serious case from Physician via Health Authorities under reference 2021030767.  This case involves a male patient who experienced fever up to 38.9 degree Celsius (pyrexia), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatments, past vaccinations, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Food allergy and Drug hypersensitivity.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot number and expiration not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever up to 38.9 degree Celsius (pyrexia), (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Relevant laboratory test results included: Body temperature was 38.9 degree Celsius on an unknown date.  It was not reported if the patient received any corrective treatment or not.  The patient was recovered from the fever on an unknown date.  The reporter assessed the causal relationship for event with the DAPTACEL as related.  There will be no information on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first vaccination on 28-Dec-2020 and then mistakenly received the second vaccination on 14-Jan-2021 (18 days apart)/no AE; Initial information received on 15-Jan-2021 regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number-00432089) and transmitted to Sanofi on 17-JAN-2021.  This case involves a 4 year-old male patient who was administered with second dose of FLUZONE QUADRIVALENT 18 days after initial dose (Inappropriate schedule of product administration).  The caller stated that this dose was 14 days before the next scheduled dose. The patient reported that the health care professional administering the vaccine did not check the chart first to see the last date of the previous Fluzone Quadrivalent.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Dec-2020 and 14-Jan-2021, the patient received 0.5 mL first and second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ562AA and expiry date 30-Jun-2021) via intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due drug dose administration interval too short (latency was on same day).  At the time of reporting, no adverse event reported.  Product used: Used, First time product used: No, Still using product : No,  Was Device Used : Yes.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error, Product preparation issue
Clinical narrative: patient was administered only the Dtap-IPV component of Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Agency (Reference number- 00437689) and transmitted to Sanofi on 20-Jan-2021.  This case involves a patient (age and gender not reported) who was administered only the DTaP-IPV component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via an unknown route in an unknown administration site on 12-Jan-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue, latency same day).  Caller asked about what needs to be done? And stated that she did not had any additional information and had referred to Pentacel for reconstitution video.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Acute kidney injury
Clinical narrative: acute kidney injury; Initial information received on 22-Jan-2021 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a patient of unknown age who was currently being in the hospital with acute kidney injury (acute kidney injury), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history included stem cell transplant.  Medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date (a year ago), the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/ HIB(PRP/T) VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) the patient currently being in the hospital with acute kidney injury (acute kidney injury) following the administration of suspect vaccine. The patient was hospitalized for this event.  Seriousness criteria was assessed as medically significant as per important medical event (IME) list.  It was reported Pharmacist had a patient in the hospital needing vaccinations prior to discharge and wanting to know if there was any information on using Pentacel on a patient post Stem cell transplant from a year ago. Pharmacist asked if Pentacel could be used in an adult who has had a stem cell transplant.  Lab data was not provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  Information on batch number was requested.; Sender's Comments: Sanofi company comment dated 28-Jan-2021: This case concerns a patient of unknown age who had acute kidney injury after vaccination with company suspect PENTACEL. The time to onset was compatible. However, patient's concomitant medications and laboratory data ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Her arm felt warm to touch and tight; Her arm felt warm to touch and tight; her arm was swollen about 3 inches past her elbow; There was no pain at the injection site but more toward her elbow; her arm was red; unable to sleep because of the pain in her arm; unable to sleep because of the pain in her arm; This spontaneous report was received from a 66 years old female patient referring to herself. The patient's pertinent medical history and drug allergies were reported as none. The patient's concomitant medications included thyroid medications, blood pressure medication, cholesterol medication, vitamins, and zinc.   On 08-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route and lot #, expiration date were reported as unknown) for prophylaxis (reported as vaccine).  On the same date, the patient was unable to sleep because of the pain in her arm. On 09-JAN-2021, the patient took acetaminophen (TYLENOL) to help with the pain, and there was no pain at the injection site but more toward her elbow. On the same date, she also reported her arm was red. On 10-JAN-2021, the patient's arm was swollen about 3 inches past her elbow, and her arm felt warm to touch and tight. She called urgent care and they advised her to take diphenhydramine hydrochloride (BENADRYL). On 10-JAN-2021 and 11-JAN-2021, she took diphenhydramine hydrochloride (BENADRYL) as treatment. On 11-JAN-2021, she felt 70% better. She had slight pain along with swelling and the arm color improved to a light pink. She left a message with her physician's office in the morning of 11-JAN-2021 but had not heard back.  The causality assessment between all above events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Her arm felt warm to touch and tight; Her arm felt warm to touch and tight; her arm was swollen about 3 inches past her elbow; There was no pain at the injection site but more toward her elbow; her arm was red; unable to sleep because of the pain in her arm; unable to sleep because of the pain in her arm; This spontaneous report was received from a 66 years old female patient referring to herself. The patient's pertinent medical history and drug allergies were reported as none. The patient's concomitant medications included thyroid medications, blood pressure medication, cholesterol medication, vitamins, and zinc.   On 08-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route and lot #, expiration date were reported as unknown) for prophylaxis (reported as vaccine).  On the same date, the patient was unable to sleep because of the pain in her arm. On 09-JAN-2021, the patient took acetaminophen (TYLENOL) to help with the pain, and there was no pain at the injection site but more toward her elbow. On the same date, she also reported her arm was red. On 10-JAN-2021, the patient's arm was swollen about 3 inches past her elbow, and her arm felt warm to touch and tight. She called urgent care and they advised her to take diphenhydramine hydrochloride (BENADRYL). On 10-JAN-2021 and 11-JAN-2021, she took diphenhydramine hydrochloride (BENADRYL) as treatment. On 11-JAN-2021, she felt 70% better. She had slight pain along with swelling and the arm color improved to a light pink. She left a message with her physician's office in the morning of 11-JAN-2021 but had not heard back.  The causality assessment between all above events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Injection site swelling, Malaise, Nausea
Clinical narrative: Node in back of arm; Arm still hurt; Nausea; Received a sub-cutaneous injection; Felt like she had a ball in her throat; Thought she was going to pass away; Dizziness; Weakness; A spontaneous report was received from a nurse, concerning herself, a 60 year-old female patient, who received Moderna's COVID-19 vaccine and experienced dizziness, weakness, nausea, felt like she had a ball in her throat, arm still hurt, node in the back of arm and received a subcutaneous injection.  No relevant medical history was provided. Concomitant medications reported included metoprolol, omeprazole, and melatonin.  On 15-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 011J20A) subcutaneously in her left arm for COVID-19 infection prophylaxis.  On 15-Jan-202, patient received her first dose of the vaccine at background of left arm. On the same date, after administration of vaccine, she stayed in place for 25 minutes/1hour as she experienced dizziness, weakness and nausea, she also felt like she had a ball in her throat and thought that she was going to pass away. Few minutes later, patient was feeling little better but then started again, hence stayed back for an hour in the same place. On 19-Jan-2021 (today) her arm was still hurt pretty much and had a node in her back arm. Patient also stated that vaccine was not administered in her muscle instead injection was provided sub-cutaneous.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, received a sub-cutaneous injection, was considered to be resolved on 15 Jan 2021.The outcome of the events dizziness, weakness, nausea, felt like she had a ball in her throat, was considered to be unknown. The outcome of the events arm still hurt, and node in the back of arm was considered to be not resolved.; Reporter's Comments: This case concerns a 60-year-old, female patient. The patient's medical history was not provided. The patient experienced a non serious event of dizziness, malaise, nausea, asthenia, lump in throat, subcutaneous injection, pain and swelling in arm. The event occurred the day the patient received the first dose of mRNA-1273 (lot number 011J20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Sensation of foreign body
Clinical narrative: Node in back of arm; Arm still hurt; Nausea; Received a sub-cutaneous injection; Felt like she had a ball in her throat; Thought she was going to pass away; Dizziness; Weakness; A spontaneous report was received from a nurse, concerning herself, a 60 year-old female patient, who received Moderna's COVID-19 vaccine and experienced dizziness, weakness, nausea, felt like she had a ball in her throat, arm still hurt, node in the back of arm and received a subcutaneous injection.  No relevant medical history was provided. Concomitant medications reported included metoprolol, omeprazole, and melatonin.  On 15-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 011J20A) subcutaneously in her left arm for COVID-19 infection prophylaxis.  On 15-Jan-202, patient received her first dose of the vaccine at background of left arm. On the same date, after administration of vaccine, she stayed in place for 25 minutes/1hour as she experienced dizziness, weakness and nausea, she also felt like she had a ball in her throat and thought that she was going to pass away. Few minutes later, patient was feeling little better but then started again, hence stayed back for an hour in the same place. On 19-Jan-2021 (today) her arm was still hurt pretty much and had a node in her back arm. Patient also stated that vaccine was not administered in her muscle instead injection was provided sub-cutaneous.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, received a sub-cutaneous injection, was considered to be resolved on 15 Jan 2021.The outcome of the events dizziness, weakness, nausea, felt like she had a ball in her throat, was considered to be unknown. The outcome of the events arm still hurt, and node in the back of arm was considered to be not resolved.; Reporter's Comments: This case concerns a 60-year-old, female patient. The patient's medical history was not provided. The patient experienced a non serious event of dizziness, malaise, nausea, asthenia, lump in throat, subcutaneous injection, pain and swelling in arm. The event occurred the day the patient received the first dose of mRNA-1273 (lot number 011J20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.