chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation
Clinical narrative: lump in her neck area; Booster; This is a spontaneous report from contactable consumer. This 68-year-old female consumer (Patient) reported for herself. A 68-year-old female patient received third dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/lot number: FF8839) via unknown route of administration on 05Oct2021 (at the age of 68 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient did not have relevant medical history and concomitant medications were not reported. Historical vaccines included first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/lot number: EM9809) via unknown route of administration on 07Feb2021 as DOSE 1, SINGLE and second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/lot number: EN6203) via unknown route of administration on 28Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. It was reported that after first dose patient did not have side effects but on her 2nd dose last 28Feb2021, she developed a lump in her arm below her elbow and this summer she was diagnosed to have a Lipoma, according to caller she still had it. It had mostly stayed the same since it began and one day, this was the reason she finally got it addressed, it got firm and hard and she could feel. It was a muscular lipoma and maybe her muscle did something. She was curious as to getting the booster and wondering if that lump would get bigger. She thought it was just a coincidence with the lipoma in her arm but when this occurred with the booster she was not so sure. It might be bigger or it might not be, in her arm, but now recently she had noticed the one in her neck. On 05Oct2021 she had her booster dose, and this morning 07Oct2021 she woke up with another lump in her neck area. It is slightly different because it has a hard center and when she went to the bathroom she realized that she had a big puff all around her neck sticking out. She wanted to know if this had been reported before and was there any information on what can stop this and if this side effect that she had was not Lipoma and just swollen lymph nodes. The outcome of the event was not recovered.  Follow-up (19Oct2021): Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Immunisation, Vaccination site pain
Clinical narrative: Tender and sore arm at vaccination site; Tender and sore arm at vaccination site; feeling of coldness that abated after a hot shower; Bad headache; Off label use; Booster dose administered; This is a spontaneous report from a contactable other healthcare professional. A 22-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an intramuscular route of administration in the right arm on 06Oct2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable. 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 concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the right arm on 19Jan2021 at 13:00 (at the age of 22-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the right arm on 09Feb2021 at 13:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 06Oct2021 at 15:00, the patient experienced tender and sore arm at vaccination site and a  feeling of coldness that abated after a hot shower. On  06Oct2021 morning, after the third dose, the patient had a bad headache. The adverse 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 reported events included treatment with ibuprofen (MANUFACTURER UNKNOWN) of 400mg on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tender and sore arm at vaccination site, feeling of coldness that abated after a hot shower and bad headache were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Contusion, Erythema, Fatigue
Clinical narrative: Booster; Off label use; Bruising, redness under her armpit and on left breast; Redness under her armpit and on left breast; Chills; Fatigue; Sore under armpit; This is a spontaneous report from a non-contactable healthcare professional. A 38-year-old female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on 24Sep2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown if the patient received 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 on an unknown date as a single dose and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Sep2021, the patient experienced bruising, redness under her armpit and on left breast and soreness under her armpit. On 24Sep2021, she also started to experience chills and fatigue. As of 28Sep2021, she was still sore under her armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) every 6 hours and ibuprofen (MOTRIN) along with using a hot compress. The clinical outcome of the events bruising, redness under her armpit and on left breast, chills and fatigue, sore under armpit was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation
Clinical narrative: Booster; Off label use; Bruising, redness under her armpit and on left breast; Redness under her armpit and on left breast; Chills; Fatigue; Sore under armpit; This is a spontaneous report from a non-contactable healthcare professional. A 38-year-old female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on 24Sep2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown if the patient received 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 on an unknown date as a single dose and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Sep2021, the patient experienced bruising, redness under her armpit and on left breast and soreness under her armpit. On 24Sep2021, she also started to experience chills and fatigue. As of 28Sep2021, she was still sore under her armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) every 6 hours and ibuprofen (MOTRIN) along with using a hot compress. The clinical outcome of the events bruising, redness under her armpit and on left breast, chills and fatigue, sore under armpit was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Breast swelling, Hypervolaemia, Immunisation
Clinical narrative: Just fluids and sore in those two areas - under left arm pit, left breast; Just fluids and sore in those two areas - under left arm pit, left breast; Just fluids and sore in those two areas - under left arm pit, left breast; The next morning (06Oct) left arm felt sore; noticed a swollen pocket of fluid under my left armpit.; swelling mass; swelling mass; accumulating fluid; sore; Dose number: 3; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported that:  A 62-years-old male patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; Solution for Injection, Lot Number: FF8839; Expiration Date: Dec2021), dose 3 via an unspecified route of administration, administered in left arm on 05Oct2021 11:15 (at the age of 62-Years-old) as DOSE 3 (BOOSTER), SINGLE for Covid-19 Immunization. Medical history included patient had Waldenstrom cancer (blood) and had known allergies to sulpha and allergic to bees-all were from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Unknown and Expiry date was not provided) via unspecified route of administration in left arm on 28Feb2021 12:00 as DOSE 1, SINGLE and also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Unknown and Expiry date was not provided) via unspecified route of administration in left arm on 21Mar2021 12:00 as DOSE 2, SINGLE both doses taken for COVID-19 immunization (at the age of 62-years-old). There were no other vaccine in four weeks and no other medications in two weeks. Patient did not have covid prior vaccination and did not covid tested post vaccination. On 06Oct2021 01:00 after the booster dose, the patient experienced the next morning (06oct) left arm felt sore and noticed a swollen pocket of fluid under my left armpit. On 06Oct2021 swelling mass, accumulating fluid and Sore. On 08Oct2021 the patient experienced Just fluids and sore in those two areas - under left arm pit, left breast. Patient took dose number 3 on 05Oct2021. it was reported that, Pharmacist stated, I am calling because I want to report an adverse effect for the booster COVID shot. Pharmacist was informed about Pfizer drug safety department. When asked to specify the adverse reaction: Pharmacist stated, The patient said, he has swelling mass that was accumulating fluid, sore and he said its not itchy but he said its about an inch big and he said once near where he got vaccine once shifted to under his, he said his chest area (Further clarification unknown hence not captured in event). No treatment was received for the events. The events were assessed as non serious. The outcome of events swelling mass and accumulating fluid and sore was reported as unknown, while the outcome of other events was reported as recovering.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Oedema peripheral, Pain, Pain in extremity, Swelling
Clinical narrative: Just fluids and sore in those two areas - under left arm pit, left breast; Just fluids and sore in those two areas - under left arm pit, left breast; Just fluids and sore in those two areas - under left arm pit, left breast; The next morning (06Oct) left arm felt sore; noticed a swollen pocket of fluid under my left armpit.; swelling mass; swelling mass; accumulating fluid; sore; Dose number: 3; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported that:  A 62-years-old male patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; Solution for Injection, Lot Number: FF8839; Expiration Date: Dec2021), dose 3 via an unspecified route of administration, administered in left arm on 05Oct2021 11:15 (at the age of 62-Years-old) as DOSE 3 (BOOSTER), SINGLE for Covid-19 Immunization. Medical history included patient had Waldenstrom cancer (blood) and had known allergies to sulpha and allergic to bees-all were from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Unknown and Expiry date was not provided) via unspecified route of administration in left arm on 28Feb2021 12:00 as DOSE 1, SINGLE and also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Unknown and Expiry date was not provided) via unspecified route of administration in left arm on 21Mar2021 12:00 as DOSE 2, SINGLE both doses taken for COVID-19 immunization (at the age of 62-years-old). There were no other vaccine in four weeks and no other medications in two weeks. Patient did not have covid prior vaccination and did not covid tested post vaccination. On 06Oct2021 01:00 after the booster dose, the patient experienced the next morning (06oct) left arm felt sore and noticed a swollen pocket of fluid under my left armpit. On 06Oct2021 swelling mass, accumulating fluid and Sore. On 08Oct2021 the patient experienced Just fluids and sore in those two areas - under left arm pit, left breast. Patient took dose number 3 on 05Oct2021. it was reported that, Pharmacist stated, I am calling because I want to report an adverse effect for the booster COVID shot. Pharmacist was informed about Pfizer drug safety department. When asked to specify the adverse reaction: Pharmacist stated, The patient said, he has swelling mass that was accumulating fluid, sore and he said its not itchy but he said its about an inch big and he said once near where he got vaccine once shifted to under his, he said his chest area (Further clarification unknown hence not captured in event). No treatment was received for the events. The events were assessed as non serious. The outcome of events swelling mass and accumulating fluid and sore was reported as unknown, while the outcome of other events was reported as recovering.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Erythema, Hypersensitivity, Localised infection
Clinical narrative: She had developed some type of outbreak with little, red marks; They thought she had an allergic reaction to something and couldn't figure out what it was; An allergic skin reaction; Several red bumps on my arm and legs and 2 of them formed water blisters; Water blisters; Has one on her leg that is healing now, but still visible; It's extremely big and red itchy one; One blister is burning; Turned jet black in color; This is a spontaneous report from a contactable consumer (patient reported for herself). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm right on 22Jul2021 17:40 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Arm right on 12Aug2021 17:30 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included was none. The patient concomitant medications were not reported. On an unknown date 2021 patient experienced an allergic skin reaction, Several red bumps on his arm and legs and 2 of them formed water blisters. After they drained, they became hard and turned jet black in colour. On 07Sep2021 she had developed some type of outbreak with little, red marks that looked like water blisters or a bug bite. On Sep2021 patient experienced they thought she had an allergic reaction to something and couldn't figure out what it was. Patient touched anything, but nothing had changed other than getting the vaccine. Patient Stated the outbreak started 07Sep2021. Has one on her leg that is healing now, but still visible On an unknown date 2021. Have not had any new ones since then. Patient didn't received other vaccines on same day and no problems with vaccines in the past. List all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. What are her options to counteract this. If it was the vaccine she definitely would not be getting the booster. both of the Pfizer Covid19 shots and patient experienced a little red marks that turned into water blisters, Patient described it as itchy little red marks scattered over her arm and legs that turned into blisters and it's extremely big and red itchy one. The blisters will leak out and will turn into a black scar. And as we speak one blister is burning on an unknown date 2021. This side effects of the vaccine will have a mark on her body. Patient went to the first emergency room probably almost 3 weeks ago or it could have been sooner than that and the second emergency room about 2 weeks ago. Patient was visited to Physician Office. The outcome of the event erythema was reported as not recovered and while for all other events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular, Skin discolouration, Skin reaction
Clinical narrative: She had developed some type of outbreak with little, red marks; They thought she had an allergic reaction to something and couldn't figure out what it was; An allergic skin reaction; Several red bumps on my arm and legs and 2 of them formed water blisters; Water blisters; Has one on her leg that is healing now, but still visible; It's extremely big and red itchy one; One blister is burning; Turned jet black in color; This is a spontaneous report from a contactable consumer (patient reported for herself). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm right on 22Jul2021 17:40 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Arm right on 12Aug2021 17:30 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included was none. The patient concomitant medications were not reported. On an unknown date 2021 patient experienced an allergic skin reaction, Several red bumps on his arm and legs and 2 of them formed water blisters. After they drained, they became hard and turned jet black in colour. On 07Sep2021 she had developed some type of outbreak with little, red marks that looked like water blisters or a bug bite. On Sep2021 patient experienced they thought she had an allergic reaction to something and couldn't figure out what it was. Patient touched anything, but nothing had changed other than getting the vaccine. Patient Stated the outbreak started 07Sep2021. Has one on her leg that is healing now, but still visible On an unknown date 2021. Have not had any new ones since then. Patient didn't received other vaccines on same day and no problems with vaccines in the past. List all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. What are her options to counteract this. If it was the vaccine she definitely would not be getting the booster. both of the Pfizer Covid19 shots and patient experienced a little red marks that turned into water blisters, Patient described it as itchy little red marks scattered over her arm and legs that turned into blisters and it's extremely big and red itchy one. The blisters will leak out and will turn into a black scar. And as we speak one blister is burning on an unknown date 2021. This side effects of the vaccine will have a mark on her body. Patient went to the first emergency room probably almost 3 weeks ago or it could have been sooner than that and the second emergency room about 2 weeks ago. Patient was visited to Physician Office. The outcome of the event erythema was reported as not recovered and while for all other events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Menstruation delayed, Pain
Clinical narrative: Painful lumps (multiple) in both breasts and underarms; Painful lumps (multiple) in both breasts that have still not gone away 3 months later; Painful lumps underarms that have still not gone away 3 months later; My period was 5 days late after my second dose and I spotted 2 weeks after until my period came again.; This is a spontaneous report from a contactable consumer (Patient) and other healthcare professional. A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0196, Expiry Date: Not Reported), via an unspecified route, administered in Arm Right on 03Jul2021 (at the age of 35-year-old) at 13:45 as dose 2, single for covid-19 immunization. The patient did not have any medical history. The patient was allergy to animal (cats) and pollens. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269, Expiry Date: Not Reported), via an unspecified route, administered in Arm Right on 06Feb2021 (at the age of 35-year-old) at 13:15 as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 05Jul2021, the patient experienced Painful lumps (multiple) in both breasts and underarms that have still not gone away 3 months later (more prominent leading up to now consistently late periods). The patient period was 5 days late after her second dose and She spotted 2 weeks after until her period came again. Her next period came 45 days later. She has had very regular periods since the age of 12 except for when she was pregnant and nursing with her only child. It was unknown if the patient received any treatment for the reported event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Case was considered as non- Serious. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19, UNK
Symptoms: Limb discomfort
Clinical narrative: Touchy arms; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN,SINGLE for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 125 mg for an unspecified indication. The patient medical history and  concomitant medications were not reported. The patient experienced touchy arms on an unspecified date. The action taken in response to the event for palbociclib was unknown. The outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Infection, Pneumonia, Pyrexia
Clinical narrative: had all kinds of infection with head and lung; had all kinds of infection with head and lung; always running a low grade fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 27Jan2021 13:30 (Batch/Lot Number: FC3181) (at the age of 75 years old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was pharmacy/drug store. The patient medical history included COPD. It was reported that before receiving the vaccine, she was misdiagnosed with a brain disorder and Myasthenia Gravis (as reported), and she was taking medications for it. Prior to any Covid 19 vaccines she was diagnosed with a brain disorder and she was in bad shape at that time and they brought her to the emergency room. She had pain in her abdomen, a CT scan was done and she was in the emergency room for over 8 hours. She had also been transferred with the ambulance because they thought she was going to have massive respiratory failure. She was taking medication for those conditions. The medication to treat the conditions (unspecified) were also prior to any vaccines and she no longer takes it, had been on it since Oct2018 and last took it Oct2020. This was all when she was misdiagnosed and given pyridostigmine. Came to find out that this medicine was killing her and she was misdiagnosed. She had some bloodwork done (unknown results) because they were trying to track down her thyroid and that was done at the hospital. There were no concomitant medications. No previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. On an unspecified date, the patient experienced had all kinds of infection with head and lung and always running a low grade fever. Serious stuff was going on before her second dose of the Pfizer COVID-19 vaccine. The outcome of the events was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Chest pain, Chills
Clinical narrative: lost taste and smell; lost taste and smell; chest has been hurting; When he walks up the stairs he has problem breathing, kind of hard to breathe;reported as worsened.; has been feeling weak; getting chills; It's just something that just hurts and it won't go away; This is a spontaneous report from contactable consumer reported for himself. This 39-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 08Oct2021 16:00 (Batch/Lot Number: FF2587, vaccinated at the same age) as DOSE 1, SINGLE for covid-19 immunisation. Patient's Medical History included diabetes type 1. None concomitant medication. Patient reported he took the Pfizer Covid vaccine and after he took it, his chest has been hurting and he has been feeling weak and getting chills. It's just something that just hurts and it won't go away. When he walks up the stairs he has problem breathing, kind of hard to breathe. Stated he got the first vaccine on 08Oct2021 and the events started after the second day. He has also lost taste and smell on the second day after the shot. They are a little worse and off and on. Has not seen a doctor or been to the emergency room. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: lost taste and smell; lost taste and smell; chest has been hurting; When he walks up the stairs he has problem breathing, kind of hard to breathe;reported as worsened.; has been feeling weak; getting chills; It's just something that just hurts and it won't go away; This is a spontaneous report from contactable consumer reported for himself. This 39-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 08Oct2021 16:00 (Batch/Lot Number: FF2587, vaccinated at the same age) as DOSE 1, SINGLE for covid-19 immunisation. Patient's Medical History included diabetes type 1. None concomitant medication. Patient reported he took the Pfizer Covid vaccine and after he took it, his chest has been hurting and he has been feeling weak and getting chills. It's just something that just hurts and it won't go away. When he walks up the stairs he has problem breathing, kind of hard to breathe. Stated he got the first vaccine on 08Oct2021 and the events started after the second day. He has also lost taste and smell on the second day after the shot. They are a little worse and off and on. Has not seen a doctor or been to the emergency room. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dysmenorrhoea, Fatigue, Loss of personal independence in daily activities, Menstruation irregular
Clinical narrative: Depression; Increasingly severe menstrual pain; Irregularity in period; Increased PMS type symptoms; Fatigue; Mood changes; It has significantly impacted functionality.; This is a spontaneous report from a contactable other HCP (patient). This 43-year-old no pregnant female patient received second dose of bnt162b2 (BNT162B2), intramuscular on 25Jan2021 (Batch/Lot Number: en5318) (vaccinated at the same age) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hx thyroid cancer, allergies to Mango and ginger. Patient was not diagnosed with COVID-19 prior to vaccination. Patient intramuscular received first dose of bnt162b2 on 07Jan2021 with Lot number ej1685. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); loratadine (CLARITIN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 6 months after the vaccine, patient have noticed increasingly severe menstrual pain, irregularity in period, and increased PMS type symptoms including fatigue, mood changes, depression. It has significantly impacted functionality. The events received medication treatment and result in Physician office/clinic visit. The outcome of events was not recovered. Since the vaccination, has the patient has not been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Premenstrual syndrome
Clinical narrative: Depression; Increasingly severe menstrual pain; Irregularity in period; Increased PMS type symptoms; Fatigue; Mood changes; It has significantly impacted functionality.; This is a spontaneous report from a contactable other HCP (patient). This 43-year-old no pregnant female patient received second dose of bnt162b2 (BNT162B2), intramuscular on 25Jan2021 (Batch/Lot Number: en5318) (vaccinated at the same age) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hx thyroid cancer, allergies to Mango and ginger. Patient was not diagnosed with COVID-19 prior to vaccination. Patient intramuscular received first dose of bnt162b2 on 07Jan2021 with Lot number ej1685. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); loratadine (CLARITIN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 6 months after the vaccine, patient have noticed increasingly severe menstrual pain, irregularity in period, and increased PMS type symptoms including fatigue, mood changes, depression. It has significantly impacted functionality. The events received medication treatment and result in Physician office/clinic visit. The outcome of events was not recovered. Since the vaccination, has the patient has not been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Diarrhoea, Dyspnoea, Magnetic resonance imaging thoracic
Clinical narrative: worsened back pain; chest tightness; shortness of breath; mild diarrhea; This is a spontaneous report from contactable Physician from a Pfizer Sponsored Program. A 82-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 22Jan2021 (at the age of 82 years old) as dose number unknown, single for COVID-19 immunisation; Palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at 75 mg for Metastatic Breast Cancer. Medical history included DM (diabetes mellitus), HTN (hypertension), Crohn's disease, ED (erectile dysfunction), right-sided back pain all from an unknown date and unknown if ongoing. Concomitant medication(s) included letrozole (LETROZOLE) taken for an unspecified indication from an unspecified start date and ongoing. On an unspecified date, the patient experienced worsened back pain, chest tightness, shortness of breath, mild diarrhoea. Initially worsened back pain was attributed to the vaccine, however, symptoms persisted, accompanied by some chest tightness and shortness of breath, therefore, she presented to the ER for further evaluation. The patient was doing pretty well and eating pretty well. The patient underwent lab tests and procedures which included multiple studies completed, including MRI T-/L-spine (magnetic resonance imaging) showing widespread osseous metastatic disease on an unknown date. The action taken in response to the event(s) for Palbociclib was dose not changed. The clinical outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, SARS-CoV-2 test, X-ray
Clinical narrative: his wrists, hands, and knees started swelling, his doctor said it was arthritis; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection; Lot Number: EN6200 and expiry date not reported), via an unspecified route of administration, on 19Feb2021 (at the age of 70-year-old), as dose 1, single, for COVID-19 immunisation. Medical history included ongoing arthritis which started since he was in his 20's and COVID-19 in the first week of Mar2020. The patient's concomitant medications were not reported. On 19Feb2021, the patient received first dose of COVID vaccine, and he sat for 15 minutes and had no reaction, but 3 days later (22Feb2021), his wrist started swelling and hands and it went to his knees. He went back to care provider on 06Mar2021, and his hands were like baseball mitts. He could not move his hands or fingers. His doctor took X-rays and said he had arthritis. The patient went to 2 nerve specialist and they said he had a reaction to the vaccine. The patient was supposed to get second vaccine on 12Mar2021, but his hands were swollen for 2 months. It took that long for them to go down. He went back when he got better to see if he could get the second shot. It was reported that, he got the email from Pfizer not to get second vaccine though. His doctor said she was not clearing him to get second dose. The patient wanted to know how he could get cleared to get vaccine and if he has to start over again and if it would still be okay to get the 2nd dose even if it has been so long. The patient also wants to know if Pfizer would recommend him to get the Moderna or the Johnson & Johnson Covid-19 Vaccine instead of the Pfizer-BioNTech Covid-19 Vaccine even if he was already had his 1st dose of the Pfizer Covid-19 Vaccine. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunodeficiency, Macular degeneration, Neovascular age-related macular degeneration
Clinical narrative: runs out of immunity; fatigue; her macular degeneration had gotten markedly worse; the macular degeneration in her left eye had "severely changed from dry to wet macular degeneration"; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing stable disease for 11 years with "dry macular degeneration in both eyes". The patient's concomitant medications were not reported.  Caller stated that she was thinking about taking Pfizer booster. Stated that she took the first two Pfizer shots. The patient wanted to know had anyone complained about their macular degeneration problem getting worst. The patient stated that after she got first shot on 11Feb2021, about 12 days later in Feb2021 her macular degeneration had gotten markedly worse and the macular degeneration in her left eye had "severely changed from dry to wet macular degeneration". Stated that it had been watched by the hospital every 6 months and wanted to know if it showed up in the literature with people that had had macular degeneration. She stated that the right was still the dry eye of macular degeneration and wanted to know if it was safe to get booster shot. The patient also reported fatigue after vaccination on an unknown date. She also stated that it was said that she ran out of immunity for 6-8 months and because of that she was getting the booster. The outcome was unknown for "runs out of immunity" and not recovered for rest of the events.   Information regarding lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dysstasia, Headache, Paraesthesia
Clinical narrative: high fever/ temperature rose to about 104; dizzy; throwing up; Second dose: felt like needles; Second dose: couldn't stand up; headache; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 26Feb2021 11:30 (at the age of 71-year-old) (Lot Number: EN6206) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 (at the age of 71-year-old) (Lot number E51666) via an unknown route of administration in the left arm for COVID-19 immunisation. The patient experienced high fever/temperature rose to about 104 (medically significant) on 26Feb2021 with outcome of recovered in Mar2021, dizzy (non-serious) on 26Feb2021 with outcome of recovered in Mar2021, throwing up (non-serious) on 26Feb2021 with outcome of recovered in Mar2021, headache (non-serious) in Feb2021 with outcome of recovered in Mar2021, second dose: felt like needles (non-serious) on 26Feb2021 with outcome of recovered in Mar2021 and, second dose: couldn't stand up (non-serious) on 26Feb2021 with outcome of recovered in Mar2021. Her fever was 103-104 F for 2.5 days.    Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383308 same reporter/patient, suspect vaccine, different events with different doses
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: high fever/ temperature rose to about 104; dizzy; throwing up; Second dose: felt like needles; Second dose: couldn't stand up; headache; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 26Feb2021 11:30 (at the age of 71-year-old) (Lot Number: EN6206) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 (at the age of 71-year-old) (Lot number E51666) via an unknown route of administration in the left arm for COVID-19 immunisation. The patient experienced high fever/temperature rose to about 104 (medically significant) on 26Feb2021 with outcome of recovered in Mar2021, dizzy (non-serious) on 26Feb2021 with outcome of recovered in Mar2021, throwing up (non-serious) on 26Feb2021 with outcome of recovered in Mar2021, headache (non-serious) in Feb2021 with outcome of recovered in Mar2021, second dose: felt like needles (non-serious) on 26Feb2021 with outcome of recovered in Mar2021 and, second dose: couldn't stand up (non-serious) on 26Feb2021 with outcome of recovered in Mar2021. Her fever was 103-104 F for 2.5 days.    Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383308 same reporter/patient, suspect vaccine, different events with different doses
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Reading disorder, Sinus headache, Vision blurred
Clinical narrative: vision became blurry/I couldn't focus on objects; I could not read at all; severe sinus headache; This is a spontaneous report from a contactable Other HCP (patient). A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 13Oct2021 10:30 (Lot Number: 301308A) (at the age of 55-year-old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Sep2021 11:00 AM (lot number=FC3183) (at the age of 55-year-old) in left arm for COVID-19 immunisation, and the patient experienced COVID-19. Medical history included COVID-19 prior vaccination. No COVID tested post vaccination, there was no known allergies. There were no concomitant medications. On 13Oct2021, the patient's vision became blurry. She couldn't focus on objects. She could not read at all. It lasted about 15-20 minutes. Also, on 13Oct2021, a severe sinus headache came on shortly after her vision recovered, lasting approximately 24 hours. No treatment received. The patient was recovered from vision became blurry and could not read at all on 13Oct2021, recovered from severe sinus headache on 14Oct2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Off label use, Pain
Clinical narrative: Dose number: 3; Dose number: 3; body aches; headache; chills; arm that rec'd the shot was extremely sore; This is a spontaneous report from a contactable consumer (Patient).   A 70-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in arm left on 11Oct2021 11:00 (at the age of 70-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation, administered a Pharmacy or Drug Store.  Medical history included thyroid disorder. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) in two weeks included omega-3 [omega-3 nos] (OMEGA-3 [OMEGA-3 NOS]); vit d [vitamin d nos] (VIT D [VITAMIN D NOS]); ubidecarenone (COQ-10); cholesterol (CHOLESTEROL), all taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right Feb2021 11:00 AM (at the age of 69-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right Mar2021 10:00 AM (at the age of 69-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced arm that received the shot was extremely sore during the night (medically significant) in Oct2021 10:00 PM with outcome of recovered in Oct2021, received dose number: 3 (non-serious) on 11Oct2021 11:00 with outcome of unknown, body aches (non-serious) in Oct2021 10:00 PM with outcome of recovered in Oct2021, headache (non-serious) in Oct2021 10:00 PM with outcome of recovered in Oct2021, chills (non-serious) on Oct2021 10:00 PM with outcome of recovered in Oct2021. No treatment received. COVID was not tested post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.