chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Skin disorder, Vaccination site pain
Clinical narrative: My face became red with tiny bumps; My face became red with tiny bumps; Hard chills; Headache; Body aches; I got up to bathroom & had to hold on to the wall because I was wobbly. On the way back to bed, when I let go of the wall, I fell backwards into the floor.; Temperature was 101.2 F; My arm where I had the injection is still sore to touch with itching.; My arm where I had the injection is still sore to touch with itching.; fell backwards into the floor; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female (not pregnant) patient received the third dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration on the left arm on 27Oct2021 at 09: 15 (Batch/Lot Number: FH8027) at the age of 69-year-old as single dose for COVID-19 immunization. Medical history included hypertension, hypercholesterolemia, low thyroid, tachycardia, right knee replacement from Apr2021 and hysterectomy. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), lisinopril, vitamin c [ascorbic acid] and vitamin d3. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 08Mar2021 at 09:30 AM (Batch/Lot No: EN6201), the first dose on 15Feb2021 at 09:15 AM (Batch/Lot Number: EN6201), both via an unspecified route of administration on the left arm at the age of 69-year-old as single dose for COVID-19 immunization. On 27Oct2021 at 09:15 AM, 2 hours after the vaccine, the patient's face became red with tiny bumps. That evening the patient started having hard chills, headache and body aches. During the night, the patient got up to bathroom and had to hold on to the wall because he was wobbly. On the way back to bed, when he let go of the wall, he fell backwards into the floor. The next day the temperature was 101.2 F. Continued with headache & body aches the next day. Her arm where he had the injection was still sore to touch with itching. Treatment was not received. The outcome of events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: My face became red with tiny bumps; My face became red with tiny bumps; Hard chills; Headache; Body aches; I got up to bathroom & had to hold on to the wall because I was wobbly. On the way back to bed, when I let go of the wall, I fell backwards into the floor.; Temperature was 101.2 F; My arm where I had the injection is still sore to touch with itching.; My arm where I had the injection is still sore to touch with itching.; fell backwards into the floor; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female (not pregnant) patient received the third dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration on the left arm on 27Oct2021 at 09: 15 (Batch/Lot Number: FH8027) at the age of 69-year-old as single dose for COVID-19 immunization. Medical history included hypertension, hypercholesterolemia, low thyroid, tachycardia, right knee replacement from Apr2021 and hysterectomy. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), lisinopril, vitamin c [ascorbic acid] and vitamin d3. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 08Mar2021 at 09:30 AM (Batch/Lot No: EN6201), the first dose on 15Feb2021 at 09:15 AM (Batch/Lot Number: EN6201), both via an unspecified route of administration on the left arm at the age of 69-year-old as single dose for COVID-19 immunization. On 27Oct2021 at 09:15 AM, 2 hours after the vaccine, the patient's face became red with tiny bumps. That evening the patient started having hard chills, headache and body aches. During the night, the patient got up to bathroom and had to hold on to the wall because he was wobbly. On the way back to bed, when he let go of the wall, he fell backwards into the floor. The next day the temperature was 101.2 F. Continued with headache & body aches the next day. Her arm where he had the injection was still sore to touch with itching. Treatment was not received. The outcome of events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Immunisation, Incorrect dose administered
Clinical narrative: The patient has dementia; patient received bnt162b2 as DOSE 3 (BOOSTER); Inappropriate dose of Vaccine administered; This is a spontaneous report from a Pfizer sponsored Program via contactable pharmacist.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine include COVID-19 Vaccine, Batch/Lot Number: Not reported via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and as DOSE 2, SINGLE both for covid-19 immunization (Primary Immunization series complete but unknown manufacturer). On an unspecified date, the patient has dementia, patient received bnt162b2 as DOSE 3 (BOOSTER) and had an Inappropriate dose of Vaccine administered. The reporter explains that they did a booster dose clinic yesterday and the patient had a copy of the card. The patient has dementia. The niece of the patient contacted them sharing that the patient had gotten the booster the week prior somewhere else and didn't tell anyone at the facility. The reporter wanted to know if there was anything the patient needs to look for or be aware of for the patient. The patient received 2 doses of the covid 19 booster vaccine and It was clarified the patient has gotten 4 doses total. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events (dementia, Booster, Incorrect dose administered) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Paralysis, SARS-CoV-2 test
Clinical narrative: lower body paralysis; Brand=Pfizer/ Dose number=3; prev dose brand, Moderna; prev dose brand, Moderna; This is a spontaneous report from a contactable Consumer. A 65- years- old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: FH8020) via an unspecified route of administration on 30Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization (at an age of 65 years).The patient medical history had included diabetes, neuropathy, heart condition and allergic to Fentanyl and Niacin.The patient concomitant medication had included Influenza vaccine (FLU) for unknown indication on 29-SEP-2021 and Flupentixol dihydrochloride, Melitracen hydrochloride(U) for unknown indication from unspecified date and ongoing: unknown. The patient previously took MODERNA COVID-19 VACCINE Batch/lot number: 026A21A) via an unspecified route of administration on 06Mar2021 as DOSE 1, SINGLE for covid-19 immunization (at an age of 64 years)and also took MODERNA COVID-19 VACCINE Batch/lot number: 0188218) via an unspecified route of administration on 06Apr2021 as DOSE 2, SINGLE for covid-19 immunization(at an age of 64 years). It was reported that patient did not have Covid-19 prior to covid-19 vaccination. The patient underwent for covid test after receiving the vaccination. On 30Oct2021at 20:00 the patient had experienced lower body paralysis .On 01Nov the patient underwent lab test and procedures which included SARS-CoV-2 nasal swab test and diagnosed with negative value. Therapeutic measures were taken for the AE and treatment was given with IV. The patient visited emergency room for the AE and was hospitalized for two days. The clinical outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Break through vaginal bleeding for 2-4 days per month for two months/Vaginal bleeding during sex the second month following the second dose; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0180 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 09Jun2021 at 10:45 hours (at the age of 44-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included COVID-19 (prior to vaccination) from an unknown date and unknown if ongoing. The patient previously took cefazolin and metoclopramide hydrochloride (Reglan) and had allergy to cefazolin and metoclopramide hydrochloride (Reglan). Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0185 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 at 16:00 hours (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been tested for COVID-19, since the vaccination. Concomitant medication(s) patient received within 2 weeks of vaccination included cetirizine hydrochloride (Zyrtec), mometasone furoate (Nasonex), montelukast sodium (Singulair), omeprazole (Prilosec) (all taken for an unspecified indication, start and stop date were not reported). On 12Jul2021 at 14:00 hours, patient experienced break through vaginal bleeding for 2-4 days per month for two months following the second vaccine/vaginal bleeding during sex the second month following the second dose. Patient had physician office visit for the events. Patient received no treatment for the events. The outcome for the event was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiomegaly, Vaccination complication
Clinical narrative: enlarge heart; would not go through all the symptoms, and she is very disturbed; Reaction to shot; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (batch or lot number was not reported) as dose 2, single dose for covid 19 immunization. Reporter stated that the patient did not receive any vaccination 4 weeks prior to covid 19 vaccine. Reporter stated that patient has always been very healthy. The patient's medical history reported as no and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (batch or lot number was not reported) as dose 1, single dose for covid 19 immunization. On unspecified date in Sep2021, the patient experienced she has an enlarge heart, would not go through all the symptoms, and she is very disturbed, reaction to shot. The patient had the side effects after the second shot and age at the time of reaction reported as 55 years. Reporter stated that calling about her daughter (patient) and stated both had the Pfizer vaccines in March and April. A couple months ago she started having symptoms, could not figure it out and reporter would not go through all the symptoms. But the point the doctor cardiologist, she just visited, gave her possible causes of the symptoms that she is having, one of them is a reaction to shot, she has an enlarge heart now. Reporter did not have the exact date and time of administration of COVID 19 Vaccine, reporter got in March and April and reporter stated maybe patient got hers in April and May but reporter not sure. Reporter was informed about the role of Pfizer drug safety and also informed that Pfizer medical information is the concerned department to answer the question that reporter have. Reporter was requested to probe to file a safety report. Reporter inquired that, do you have some ideas that you can give me about research, what we should look for, is this curably and also inquired to find out if it was, what symptoms were being reported or what she should be doing. Regarding treatment reporter stated that she has visited several doctors to try to find out what is wrong with her. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy, positive COVID19 test results with mild symptoms developing; Lack of efficacy, positive COVID19 test results with mild symptoms developing; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via intramuscular, administered in arm left on 22Feb2021 (Lot Number: EL3247) as dose 2, single, and received dose 1 via intramuscular, administered in arm left on 01Feb2021 (Lot Number: EL3247) (Age at Vaccination: 23 Years) as dose 1, single for covid-19 immunisation at Workplace clinic. The patient had no known allergies. Medical history was reported as none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient experienced lack of efficacy, positive covid19 test results with mild symptoms developing on 02Nov2021. The adverse events doesnot result to visit emergency room or physician office. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included Lumiradx sars-cov2 ag test: positive Nasal Swab on 03Nov2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Limb discomfort, Limb injury
Clinical narrative: a lot of abnormal bleeding with cuts; shaving her legs cutting her knee and the cut bled for over a day; receiving a paper cut on her finger and it bleed for a couple of hours; something looked like a mole on her arm that is more of a bunch of blood vessels that burst; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a lot of abnormal bleeding with cuts, shaving her legs cutting her knee and the cut bled for over a day, receiving a paper cut on her finger and it bleed for a couple of hours and something looked like a mole on her arm that is more of a bunch of blood vessels that burst. The outcome of the events shaving her legs cutting her knee and the cut bled for over a day, receiving a paper cut on her finger and it bleed for a couple of hours was recovered on an unspecified date in 2021 and rest of the events was unknow.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness; Breathing problems; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. With first shot, was fine. Had flu like symptoms for a couple days. Was fine. With second dose within minutes had chest tightness and breathing problems. Was administered a steroid injection and was on prednisone for about a month. Her doctor asked if she had hives, which reporter said no, just had the breathing issues. After she had the steroid injection, she was kept for a couple hours. She felt better. The place that administered the steroid injection said she had a reaction. Her doctor is saying she did not have a reaction because she did not have hives and she is perfectly safe to take the booster. The reporter was not sure. She does not have a problem getting the booster and having to take another steroid injection. But it does not make sense to her. Seeking clarification on whether to take the booster shot. Also asking if that was a side effects she should be concerned about for the next round. Since doing the Prednisone, does that affect the efficacy of the vaccine? Wanted to know if it was safe for her to get the booster shot. Does not wanted to involve her doctor with that. Wanted to know if that sounded like a valid reaction and if there should be concern. Stated she had a reaction on an experimental drug. It was so crazy with all the information and went on and on. By the end of it, they could not really give her any information. It was just for their record keeping. The reporter provided no further details on this. After second dose of COVID-19 Vaccine, experienced chest tightness and breathing problems. Was given a steroid injection and on Prednisone for about a month. Asking if the Prednisone affects the efficacy of the vaccine. Outcome of the events was unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: Feels like she was run over by a truck; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer. An adult female patient (unknown if pregnant) received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown, whether the patient received any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first and second doses of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN);  both on unknown dates for COVID-19 immunisation. On 05Nov2021, after the patient received the third dose, she felt like "she was run over by a truck." The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of "felt like she was run over by a truck" was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Immunisation, Nasal congestion
Clinical narrative: 16-30 hours after injection: Fatigue; 16-30 hours after injection: Headache; 16-30 hours after injection: Minor congestion; 16-30 hours after injection: Lightheadedness; 16-30 hours after injection: Soreness at injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received third/booster dose of BNT162b2 (COMIRNATY; Lot Number: FF8841) via an intramuscular route of administration in the left arm on 03Nov2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 27-years-old) and the second dose of BNT162b2 (COMIRNATY; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 27-years-old) as single doses for COVID-19 immunisation. On 04Nov2021 at 07:00, 16-30 hours after injection, the patient experienced fatigue, headache, minor congestion, lightheadedness and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, minor congestion, lightheadedness and soreness at injection site was resolved on an unknown date in Nov2021.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 16-30 hours after injection: Fatigue; 16-30 hours after injection: Headache; 16-30 hours after injection: Minor congestion; 16-30 hours after injection: Lightheadedness; 16-30 hours after injection: Soreness at injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received third/booster dose of BNT162b2 (COMIRNATY; Lot Number: FF8841) via an intramuscular route of administration in the left arm on 03Nov2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 27-years-old) and the second dose of BNT162b2 (COMIRNATY; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 27-years-old) as single doses for COVID-19 immunisation. On 04Nov2021 at 07:00, 16-30 hours after injection, the patient experienced fatigue, headache, minor congestion, lightheadedness and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, minor congestion, lightheadedness and soreness at injection site was resolved on an unknown date in Nov2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she is COVID positive right now and had received Pfizer's COVID vaccines; she is COVID positive right now and had received Pfizer's COVID vaccines; This is a spontaneous report from a Pfizer-sponsored program via contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced COVID positive right now and had received Pfizer's COVID vaccines. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: positive. The events was medically significant. The outcome of the events was unknown.  DSU: AE discovered after call, thus, e-transmitted with limited demographics. Caller stated she is COVID positive right now and had received Pfizer's COVID vaccines but has not gotten her booster dose yet. PAXLOVID (ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101551011 Same patient, same drug, different event (split)
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Drug ineffective, Fatigue, Nasal congestion
Clinical narrative: breakthrough case of Covid with very mild symptoms / get tested and was positive; breakthrough case of Covid with very mild symptoms / get tested and was positive; bad stomachache; tired; chronic congested nose; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP. A 64-years-old female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Feb 2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced breakthrough case of COVID with very mild symptoms / get tested and was positive, bad stomach ache, tired and chronic congested nose. It was reported that she had the vaccine in February and March and had a breakthrough case of COVID with very mild symptoms at the beginning of September. She stated, the symptoms she had were a bad stomach ache and went to get tested and was positive. She stated, while she was home quarantining she found she was tired and had a chronic congested nose which she has had numerous times since. She asked when was she eligible for the booster because of the breakthrough case. She stated, she was exposed a lot and wondered if the congestion was the body fighting off the exposure she had. She stated, she talked to someone already who screened her about her breakthrough case. She stated someone told her she needs to wait 90 days after having COVID and she was 60 days from this. The outcome of the events breakthrough case of Covid with very mild symptoms / get tested and was positive, bad stomach ache, tired and chronic congested nose was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Paraesthesia, Peripheral coldness
Clinical narrative: Bilateral pinky and ring finger tingling; Bilateral pinky and ring finger tingling/numbness; Tingling is uncomfortable and feels "cold"; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration in the left arm on 14Oct2021 at 07:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration on 10Feb2021 (at the age of 45-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration on 03Mar2021 (at the age of 45-years-old); both as single doses for COVID-19 immunisation. On 30Oct2021, the patient experienced bilateral pinky and ring finger tingling and numbness. The patient noticed it on a daily basis, it appeared to come and go. It had not affected her dexterity, but tingling was uncomfortable and the patient felt cold. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bilateral pinky and ring finger tingling and numbness; the patient noticed it on a daily basis, it appeared to come and go; it had not affected her dexterity, but tingling was uncomfortable and felt cold was not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Gastritis
Clinical narrative: Gastritis; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 25Aug2021 at 16:15 (at the age of 41-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 20Sep2021 at 09:00 (at the age of 41-years-old); as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Aug2021 at 16:30, the patient experienced gastritis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with Prilosec (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event gastritis was not resolved at the time of this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Facial pain, Fatigue, Feeding disorder, Headache
Clinical narrative: Severe headache; Cheek and jaw pain; Cheek and jaw pain; Fever between 99.3 and 100.6; Severe fatigue; Unable to eat; Severe shaking started about 10 hours after shot, lasted almost 2 hours,; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 03Nov2021 at 13:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included mild high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) for immunisation on 26Oct2021 in the left arm. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), amlodipine besilate (AMLODIPINE BESYLATE) and krill oil (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 71-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 23:30 10 hours after the shot, the patient experienced severe shaking and lasted almost 2 hours. On 04Nov2021, day following the shot patient experienced severe headache, cheek and jaw pain, fever between 99.3 and 100.6 (unspecified units), severe fatigue and unable to eat. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe shaking was resolved on 04Nov2021 at 01:30; while that of the events severe headache, fever between 99.3 and 100.6, cheek and jaw pain, severe fatigue and unable to eat were resolving at the time of this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in jaw, Pyrexia, Tremor
Clinical narrative: Severe headache; Cheek and jaw pain; Cheek and jaw pain; Fever between 99.3 and 100.6; Severe fatigue; Unable to eat; Severe shaking started about 10 hours after shot, lasted almost 2 hours,; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 03Nov2021 at 13:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included mild high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) for immunisation on 26Oct2021 in the left arm. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), amlodipine besilate (AMLODIPINE BESYLATE) and krill oil (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 71-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 23:30 10 hours after the shot, the patient experienced severe shaking and lasted almost 2 hours. On 04Nov2021, day following the shot patient experienced severe headache, cheek and jaw pain, fever between 99.3 and 100.6 (unspecified units), severe fatigue and unable to eat. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe shaking was resolved on 04Nov2021 at 01:30; while that of the events severe headache, fever between 99.3 and 100.6, cheek and jaw pain, severe fatigue and unable to eat were resolving at the time of this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaginal haemorrhage
Clinical narrative: The patient received the third/booster dose of BNT162b2.; Vaginal bleeding (light); This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration on 03Nov2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included chlorphenamine maleate/dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride (THERAFLU) taken on an unknown date in Oct2021, two weeks before vaccination for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration on 12Apr2021 (at the age of 32-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 03May2021 (at the age of 32-years-old); both as single doses for COVID-19 immunisation. On 03Nov2021, the patient experienced vaginal bleeding, which was light. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event vaginal bleeding which was light was not resolved at the time of this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Immunisation, Pain
Clinical narrative: Full body aches; Increased body temperature; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 05Nov2021 at 16:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 28Mar2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 07:00, the patient experienced full body aches and increased body temperature of 99.8-100.2 Fahrenheit, at 08:00 101.2-101.5 Fahrenheit and took two 200 milligram (mg) ibuprofen. On the same day at 09:30, body temperature was found to be 103.3-103.7 Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events full body aches and increased body temperature were not resolved at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Supraventricular tachycardia
Clinical narrative: Supraventricular tachycardia episodes; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Feb2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included trazodone (MANUFACTURER UNKNOWN) at a dose of 200 mg per night for unspecified indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jan2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 19Feb2021 at 12:00, the patient had been having many supraventricular tachycardia episodes since February 2021. They occurred many times a day and the patient had none prior to February. The patient wore a heart monitor in August to confirm this. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had been tested for COVID-19. On 25Oct2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event many supraventricular tachycardia episodes since February 2021, they occur many times a day was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation, Interchange of vaccine products, Pain
Clinical narrative: Severe, all over body pain; Severe, all over body pain (particularly difficult in joints); Fatigue; Interchange of vaccine products; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 06Nov2021 at 11:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ethinylestradiol/etonogestrel (NUVARING) and ibuprofen (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE; Lot number: 001B21A) via an unspecified route of administration in the left arm on 17Mar2021 at 09:30 (at the age of 46-years-old) and also the second dose of COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE; Lot number: 038B21A) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 46-years-old); both as single doses for COVID-19 immunisation. On 07Nov2021 at 01:30, the patient experienced severe, all over body pain, it was particularly difficult in joints and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe, all over body pain, it was particularly difficult in joints and fatigue was unknown at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Mass, Pyrexia
Clinical narrative: Fever for 2 days; Red spot on arm with hard lump in center; Red spot on arm with hard lump in center; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, patient. A 60-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 04Nov2021 at 07:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN); via an unspecified route of administration on an unknown date and second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN); via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 05Nov2021, the patient experienced fever for 2 days, red spot-on arm with hard lump in the centre. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on 07Nov2021, while that of the events red spot-on arm with hard lump in centre were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.