chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin A, Blood immunoglobulin A increased, Blood immunoglobulin G, Blood immunoglobulin G increased
Clinical narrative: stage 3 Chronic Kidney Disease; igA and igG are elevated as well as her polyclonal antibodies; igA and igG are elevated as well as her polyclonal antibodies; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with stage 3 chronic kidney disease (CKD). She clarified she had no reaction to the vaccine and that she had the intention of getting the 2nd dose. Her healthcare provider (HCP) also recommended that she get the 2nd dose, but delayed it due to being diagnosed with CKD on an unspecified date. The patient mentioned that she had done several tests and found out that her igA and igG were elevated as well as her polyclonal antibodies on an unspecified date. The patient asked if her high polyclonal antibody did suggest that she had a good immune response to the 1st dose. She also asked that since both her igA and igG were elevated, if those showing too much of an immune response already and did that mean that her overreacting to the vaccine or the CKD. The patient asked if she still needed to receive the second dose even with the high polyclonal antibody found on her test. The patient further asked what would be the recommendation, since she was already way past beyond the recommended 3-week interval of the 2 doses. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chronic kidney disease
Clinical narrative: stage 3 Chronic Kidney Disease; igA and igG are elevated as well as her polyclonal antibodies; igA and igG are elevated as well as her polyclonal antibodies; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with stage 3 chronic kidney disease (CKD). She clarified she had no reaction to the vaccine and that she had the intention of getting the 2nd dose. Her healthcare provider (HCP) also recommended that she get the 2nd dose, but delayed it due to being diagnosed with CKD on an unspecified date. The patient mentioned that she had done several tests and found out that her igA and igG were elevated as well as her polyclonal antibodies on an unspecified date. The patient asked if her high polyclonal antibody did suggest that she had a good immune response to the 1st dose. She also asked that since both her igA and igG were elevated, if those showing too much of an immune response already and did that mean that her overreacting to the vaccine or the CKD. The patient asked if she still needed to receive the second dose even with the high polyclonal antibody found on her test. The patient further asked what would be the recommendation, since she was already way past beyond the recommended 3-week interval of the 2 doses. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dehydration, Heart rate, Hypertension, Palpitations
Clinical narrative: racing heart/pulse of 130; blood pressure of 166/102; dehydrated; This is a spontaneous report from Pfizer Sponsored Program. A non-contactable consumer (patient's mother) reported that a 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 10Jul2021 (batch/lot number and expiry date unknown) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother informed that the patient received her first dose and afterwards (unspecified date) she experienced a racing heart for 30 hours (medically significant) and was taken to "urgent care" where she was dehydrated with a blood pressure of 166/102 (medically significant) and pulse of 130. The patient experienced no other side effects. The patient's mother was seeking information if other patients have experienced the same side effects as her daughter. The patient's mother stated, "they were seeking medical care today with the cardiologist". The mother was advised from a document and was referred to HCP for treatment. The patient's mother was seeking information if her daughter should receive the second dose following her symptoms reported. The mother was advised from a document and was referred to HCP to make that decision. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blindness unilateral, Blood test, Cerebrovascular accident, Fatigue
Clinical narrative: small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Headache, Mobility decreased, Muscular weakness
Clinical narrative: small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Thrombosis, Transient ischaemic attack
Clinical narrative: small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Migraine, Nausea, Paraesthesia
Clinical narrative: Bad migraine; Nausea; Tingling sensation in the face, head, and upper temples; Cold sensation in the face and head; Headache; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EW0196), via an unspecified route of administration, administered in the left arm on 25Jun2021 (at the age of 34-years-old) as dose 1, single for COVID-19 immunization. The patient has no relevant medical history and has no concomitant medications. The patient has no prior vaccinations within 4 weeks of the COVID vaccine. On 25Jun2021 (the day of vaccination), the patient received the first dose of BNT162B2 at a hospital. The patient was fine after the vaccination. On 30Jun2021 (5 days after the vaccination), the patient started to have bad headaches with subsequent mild headache, nausea, tingling/cold sensation in the face, head, and upper temples for about a week and a half. The patient had never had this type of headache prior. The patient almost went to the emergency room. On 03Jul2021, the patient experienced a bad migraine. The patient has been on Tylenol and Excedrin migraine on hand ever since. The patient wanted to schedule an appointment with the neurologist, but they were busy. The patient mentioned that she does not plan on getting the second dose because these side effects were frightening to her. The outcome of events headache and migraine was recovering while the outcome of the remaining events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Ear infection, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: severe upper respiratory infection; ear infection; he sounds like a barking dog; coughing; This is a spontaneous report from a contactable consumer (patient's parent). A 20-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 25Jun2021 (in the afternoon, between 13:00 and 16:00, at the age of 20-years-old) at dose 1, single in the right arm for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The was reported that the reporter's son was scheduled to take the second dose of BNT162B2 either on 15Jul2021 or on 18Jul2021. However, the patient currently has an ear infection and a severe upper respiratory infection which started on Jul2021. Further reported that the patient sounds like a barking dog. The patient has been on amoxicillin and then went back to his doctor because the amoxicillin prescribed wasn't strong enough and the other antibiotic was already used up. The patient still has upper respiratory infection but has no fever now. The reporter down not want the patient to have the shot and have another problem. The reporter doesn't know if the events were due to the vaccine or maybe at the time the patient was starting to get the problem, it seems like it coincided. The reporter stated that the events started 3 weeks ago, on Jul2021. Currently, the ear infection was improving slightly. The patient went to work and was sent home since the co-workers were complaining that the patient was coughing which started on Jul2021. The patient's doctor won't let the patient come until he had a COVID test, so the patient went to urgent care, where the patient underwent a COVID-19 test on Jul2021 and saw a doctor there. About a week or later, the patient's doctor let him come since his COVID-19 test last Jul2021 was negative. The doctor saw the patient and because of no improvement of the patient's upper respiratory infection, the patient was put on steroids and was changed to stronger antibiotics. The reporter wanted to know if it was safe for the patient to take the second dose even if his symptoms are still ongoing. The events resulted in physician's office visit and therapeutic measures were given as a result of the events. Outcome of the event upper respiratory infection was not recovered, for ear infection was recovering, and for other events was unknown.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Feeling abnormal, Malaise, Positron emission tomogram
Clinical narrative: Was so ill after took the Covid shot; has been so ill and feeling so bad since taking it; Did not feel good; This is a spontaneous report form a contactable consumer (patient). A 69-year-old (also reported as 69 1/2 years old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 69-years-old, via an unspecified route of administration, administered in Arm Left on 22Apr2021 11:00 (Batch/Lot Number: EW0171) as dose 1, single for COVID-19 immunization. Medical history included 2 unspecified cancers that was why his doctor told him to get vaccinated. No family history. There were no concomitant medications. The patient stated that he had gone back to the doctor and because he was so ill/ did not feel good after he took the Covid shot. He has been going back the doctor and they told him to call Pfizer because there was nothing else, they can do. Literally that shot just about killed him. He has been so ill/not feeling well and feeling so bad since taking it. His life was literally destroyed, and he does not know where to go or what to do. He has also sent an email to the website and has not heard anything back. Again, stated he does not know what to do because he has symptoms. Does not clarify symptoms had. Has had a CAT and PET scans and bloodwork and he knows his body. He was almost 70 years old and after taking this shot, he has been down for the count. Does not know what else to do and called to ask Pfizer what else he can do. His doctor advised him not to get the second dose. He had 2 cancers in past before Covid shots and with his immune system was told by doctor to get it. No other vaccines given the same day or 4 weeks prior. No history of problems with vaccines in past ever. The events resulted to a visit in a physician office. The outcome of the events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: had just ended her period and as soon as she got up the next morning she was bleeding heavily/ bled for about 3-4 weeks straight; bleeding heavily; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm right on 22Jun2021 (Batch/Lot Number: EW0186) as dose 1, single for COVID-19 immunisation. Medical history included headaches. Family medical history relevant to events was none. No other vaccines given the same days as the COVID vaccine and no problems with vaccines in the past. She has never even had the flu shot before. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Concomitant medication(s) included ibuprofen taken for headache, start and stop date were not reported. Got the first dose on 22Jun2021 and the second dose on 13Jul2021 15:00 (Batch/Lot Number: EW0198) administered in arm left. Three days before the first COVID shot, she had just ended her period and as soon as she got up the next morning (on 23Jun2021), she was bleeding heavily. Stated that technically she bled for about 3-4 weeks straight (reported as from Jun2021 to Jul2021). Heavy bleeding for 3-4 weeks until she got the second dose. She just got the second dose on 13Jul2021 and she has just stopped bleeding. Was told she should let Pfizer know about this since it was not normal to be bleeding like that. Her period ended Saturday (19Jun2021) before her first dose and then she woke up the morning after that dose to the heavy bleeding. At time of report, she has stopped bleeding. Stated she was not in any pain or hurting anywhere and just had to deal with it. Didn't go to doctor or emergency room because she just got done paying those past bills off and didn't want to be in anymore debt. Outcome of event bleeding heavily was recovered on 14Jul2021, while other event was recovered on Jul2021.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Paraesthesia, Product dose omission issue
Clinical narrative: Bell's Palsy; Tingling in both arms and hands; Did not receive second dose of the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a female patient. A female patient of an unspecified age received first dose of 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 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she (the pharmacist) was involved in administering the Pfizer COVID-19 vaccines at her work and due to the increase in concerns about Guillain-Barre syndrome developing, prompted her to call Pfizer because she remembered one patient who was diagnosed with Guillain-Barre syndrome after receiving the second dose and she remembered two patients who experienced Bell's Palsy after receiving their first doses of the Pfizer COVID-19 vaccines and they were not given the second doses due to those adverse events. On an unspecified date, caller stated that the patient had bell's palsy, Later in the call that the patient also experienced tingling in both arms hands that lasted for at least 6 weeks. The caller stated that she was at home and did not have the reports or details of the patients on hand. She stated that she did report those events through the VAERS reporting system as per their protocol. These doses were given to outpatient. The caller stated that she did not call and report these adverse events to Pfizer at that time because she did not want to double report and she would like to know of VAERS, shared these AE reports with Pfizer. Outcome of the events was reported as unknown.            Information about lot/batch number can be requested.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between reported event Bell's palsy and suspect product BNT162B2 cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021895192 same reporter/drug/event, different patient
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Gait inability, Nervous system disorder
Clinical narrative: Neurological problems; Was imbalanced; Unable to walk; This is a spontaneous report from a contactable consumer (patient's daughter). A 79-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 2 at vaccination age of 79-year-old via an unspecified route of administration in the right arm on 20Mar2021 10:30 (Lot Number: EN6207) as dose 2, 0.3 ml single for covid-19 immunisation. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) on 27Feb2021 (LOT: EN6202) injection in the right arm at dose 1, 0.3 mL single at vaccination age of 79-year-old for COVID-19 Immunization. The patient medical history, family medical history and relevant Tests were none. The patient's concomitant medications were not reported. The patient did not receive other vaccination 4 weeks prior to the first administration date of the suspect vaccine. The reporter stated that she called with regards to the Pfizer vaccine that her father received two weeks within (Mar2021) having the second dose, he started to have neurological problems, he was imbalanced, and unable to walk. She added that he is in hospice and they don't think he's going to make it. She stated that she wanted to report just to let Pfizer know so maybe Pfizer can prepare someone else. The patient was first hospitalized from 28May2021 to 02Jun2021 and the patient came home on 02Jun2021 but went back to the hospital on 04Jun2021 to 05Jun2021 (second hospitalization). The third hospitalization was on Saturday (05Jun2021), he went to a rehabilitation center and was there until 14Jun2021. The reporter stated that they weren't allowed to see him for 10 days because of the COVID stuff and when they saw him on 14Jun2021, he had diminished drastically so he went back to the hospital. The daughter stated that he went right into the Palliative care unit. The adverse events resulted in emergency room and physician office visit. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Headache
Clinical narrative: This is a spontaneous report from a contactable physician (physician). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 09:30 (at the age of 56-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hyperlipidaemia, prediabetes, no prior history of respiratory disease, non-smoker. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX); duloxetine; pantoprazole; and liothyronine. Historical vaccine included BNT162B2 dose 1 on 09May2021 at 09:30 AM (at the age of 56 years old) in the left arm for COVID-19 immunization. The patient was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had no known allergies. It was reported that on 09Jun2021 09:30, the patient had immediate pain, soreness injection site. On 09Jun2021 21:30, 12 hours post injection the patient had chills, body aches, headache and nausea. On 11Jun2021, 48 hours post injection, she had ipsilateral auxiliary and supraclavicular adenopathy. In Jun2021, 4-5 days post injection, she had substernal chest discomfort radiating to back, continued nausea/chills/headache. In Jun2021, 18 days post injection with continued symptoms seen in ER and diagnosed with RLL pneumonia/pneumonitis. She was treated with antibiotics. 2 weeks later (2021) still same symptoms but now episodic coughing and more shortness of breath. Diagnosed with viral syndrome and placed on albuterol inhaler and prednisone. No resolution to date. No prior history of respiratory disease, no smoker. She had been tested for COVID-19 since the vaccination which included PCR (nasal swab) test with negative result on 12Jul2021. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events including antibiotics, prednisone, and albuterol inhaler. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy, Musculoskeletal discomfort, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable physician (physician). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 09:30 (at the age of 56-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hyperlipidaemia, prediabetes, no prior history of respiratory disease, non-smoker. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX); duloxetine; pantoprazole; and liothyronine. Historical vaccine included BNT162B2 dose 1 on 09May2021 at 09:30 AM (at the age of 56 years old) in the left arm for COVID-19 immunization. The patient was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had no known allergies. It was reported that on 09Jun2021 09:30, the patient had immediate pain, soreness injection site. On 09Jun2021 21:30, 12 hours post injection the patient had chills, body aches, headache and nausea. On 11Jun2021, 48 hours post injection, she had ipsilateral auxiliary and supraclavicular adenopathy. In Jun2021, 4-5 days post injection, she had substernal chest discomfort radiating to back, continued nausea/chills/headache. In Jun2021, 18 days post injection with continued symptoms seen in ER and diagnosed with RLL pneumonia/pneumonitis. She was treated with antibiotics. 2 weeks later (2021) still same symptoms but now episodic coughing and more shortness of breath. Diagnosed with viral syndrome and placed on albuterol inhaler and prednisone. No resolution to date. No prior history of respiratory disease, no smoker. She had been tested for COVID-19 since the vaccination which included PCR (nasal swab) test with negative result on 12Jul2021. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events including antibiotics, prednisone, and albuterol inhaler. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test, Vaccination site pain, Viral infection
Clinical narrative: This is a spontaneous report from a contactable physician (physician). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 09:30 (at the age of 56-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hyperlipidaemia, prediabetes, no prior history of respiratory disease, non-smoker. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX); duloxetine; pantoprazole; and liothyronine. Historical vaccine included BNT162B2 dose 1 on 09May2021 at 09:30 AM (at the age of 56 years old) in the left arm for COVID-19 immunization. The patient was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had no known allergies. It was reported that on 09Jun2021 09:30, the patient had immediate pain, soreness injection site. On 09Jun2021 21:30, 12 hours post injection the patient had chills, body aches, headache and nausea. On 11Jun2021, 48 hours post injection, she had ipsilateral auxiliary and supraclavicular adenopathy. In Jun2021, 4-5 days post injection, she had substernal chest discomfort radiating to back, continued nausea/chills/headache. In Jun2021, 18 days post injection with continued symptoms seen in ER and diagnosed with RLL pneumonia/pneumonitis. She was treated with antibiotics. 2 weeks later (2021) still same symptoms but now episodic coughing and more shortness of breath. Diagnosed with viral syndrome and placed on albuterol inhaler and prednisone. No resolution to date. No prior history of respiratory disease, no smoker. She had been tested for COVID-19 since the vaccination which included PCR (nasal swab) test with negative result on 12Jul2021. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events including antibiotics, prednisone, and albuterol inhaler. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Blood pressure measurement, Body temperature abnormal, Cerebrovascular accident
Clinical narrative: stroke brain; kidney infection; continuous temperature exaggerated; Lower pain; high blood pressure; I can even see my leg and it's getting worsen worse; my hair was tangled, was so much rougher side/ it's dry, it was falling; my hair was tangled, was so much rougher side/ it's dry, it was falling; have been sick, my condition is only getting deteriorated; have been sick, my condition is only getting deteriorated; headache; feel weak/ Energy loss; little fever; I guess the vaccine was expired two days prior.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 24Apr2021 for COVID-19 immunization. Patient had her first dose at the end of April and second dose towards the end of May and since the second dose, patient have been sick and (incomplete sentence), her condition was only getting deteriorated. She used to walk two miles in the morning, two miles at the night. She had no existing condition and So, how it is started was. It started with Lower pain which is, and then stroke brain, mind and then continuous temperature exaggerated, energy loss. She has kidney infection, high blood pressure. She had beautiful healthy curly hair, her hair was tangled, was so much rougher side. She was having, thinking 30 minutes to brush it, it's dry, it was falling and so her question was, and she was just okay before the second dose and it was getting worsen worse. So, my question is to you is, I don't have health insurance in Withheld and emergency, If I go to emergency, emergency is not going to diagnose me for. So, what she needed and she knew was the second dose, because she never felt this week, she came she will just in the shower and she can even see her leg and it was getting worsen worse. "So, my question for Pfizer is Do you have any medical system that uninsured people can go treat themselves without paying 1000s of dollar emergency fees and you know emergency rooms are not going to look anything, if with the Vaccine or not, how am I going to get might, I know, it is the second dose. The first two weeks you know, everybody is prepare for that. You going to feel weak, you going to have little fever, you going to have a headache, okay so that was it but I had recover from any of them since then. I don't know what is that and my second dose date is, I am sorry, and my second dose date is 17May2021. So, I guess the vaccine was the expired 2 days prior". Outcome of the events asthenia, little fever and headache was recovered on an unspecified date while unknown for the other events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Expired product administered, Hair disorder, Headache, Hypertension
Clinical narrative: stroke brain; kidney infection; continuous temperature exaggerated; Lower pain; high blood pressure; I can even see my leg and it's getting worsen worse; my hair was tangled, was so much rougher side/ it's dry, it was falling; my hair was tangled, was so much rougher side/ it's dry, it was falling; have been sick, my condition is only getting deteriorated; have been sick, my condition is only getting deteriorated; headache; feel weak/ Energy loss; little fever; I guess the vaccine was expired two days prior.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 24Apr2021 for COVID-19 immunization. Patient had her first dose at the end of April and second dose towards the end of May and since the second dose, patient have been sick and (incomplete sentence), her condition was only getting deteriorated. She used to walk two miles in the morning, two miles at the night. She had no existing condition and So, how it is started was. It started with Lower pain which is, and then stroke brain, mind and then continuous temperature exaggerated, energy loss. She has kidney infection, high blood pressure. She had beautiful healthy curly hair, her hair was tangled, was so much rougher side. She was having, thinking 30 minutes to brush it, it's dry, it was falling and so her question was, and she was just okay before the second dose and it was getting worsen worse. So, my question is to you is, I don't have health insurance in Withheld and emergency, If I go to emergency, emergency is not going to diagnose me for. So, what she needed and she knew was the second dose, because she never felt this week, she came she will just in the shower and she can even see her leg and it was getting worsen worse. "So, my question for Pfizer is Do you have any medical system that uninsured people can go treat themselves without paying 1000s of dollar emergency fees and you know emergency rooms are not going to look anything, if with the Vaccine or not, how am I going to get might, I know, it is the second dose. The first two weeks you know, everybody is prepare for that. You going to feel weak, you going to have little fever, you going to have a headache, okay so that was it but I had recover from any of them since then. I don't know what is that and my second dose date is, I am sorry, and my second dose date is 17May2021. So, I guess the vaccine was the expired 2 days prior". Outcome of the events asthenia, little fever and headache was recovered on an unspecified date while unknown for the other events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Kidney infection, Limb discomfort, Pain, Pyrexia
Clinical narrative: stroke brain; kidney infection; continuous temperature exaggerated; Lower pain; high blood pressure; I can even see my leg and it's getting worsen worse; my hair was tangled, was so much rougher side/ it's dry, it was falling; my hair was tangled, was so much rougher side/ it's dry, it was falling; have been sick, my condition is only getting deteriorated; have been sick, my condition is only getting deteriorated; headache; feel weak/ Energy loss; little fever; I guess the vaccine was expired two days prior.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 24Apr2021 for COVID-19 immunization. Patient had her first dose at the end of April and second dose towards the end of May and since the second dose, patient have been sick and (incomplete sentence), her condition was only getting deteriorated. She used to walk two miles in the morning, two miles at the night. She had no existing condition and So, how it is started was. It started with Lower pain which is, and then stroke brain, mind and then continuous temperature exaggerated, energy loss. She has kidney infection, high blood pressure. She had beautiful healthy curly hair, her hair was tangled, was so much rougher side. She was having, thinking 30 minutes to brush it, it's dry, it was falling and so her question was, and she was just okay before the second dose and it was getting worsen worse. So, my question is to you is, I don't have health insurance in Withheld and emergency, If I go to emergency, emergency is not going to diagnose me for. So, what she needed and she knew was the second dose, because she never felt this week, she came she will just in the shower and she can even see her leg and it was getting worsen worse. "So, my question for Pfizer is Do you have any medical system that uninsured people can go treat themselves without paying 1000s of dollar emergency fees and you know emergency rooms are not going to look anything, if with the Vaccine or not, how am I going to get might, I know, it is the second dose. The first two weeks you know, everybody is prepare for that. You going to feel weak, you going to have little fever, you going to have a headache, okay so that was it but I had recover from any of them since then. I don't know what is that and my second dose date is, I am sorry, and my second dose date is 17May2021. So, I guess the vaccine was the expired 2 days prior". Outcome of the events asthenia, little fever and headache was recovered on an unspecified date while unknown for the other events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: nerve pain down her groin and down her leg; This is a spontaneous report from a contactable consumer reporting for a patient (reporter's friend). A female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at dose number unknown, single for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced nerve pain down her groin and down her leg on an unspecified date. The reporter stated that nothing helps with her pain, however therapeutic interventions were not specified. The reporter stated the patient is a school teacher and the only thing that helps is not moving it. The clinical outcome of the event nerve pain down her groin and down her leg was unknown.  The batch/lot numbers for the vaccine were not provided and will be requested during follow up.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Vaccinated and wears a mask, he got COVID, it was mild; Vaccinated and wears a mask, he got COVID, it was mild; This is a spontaneous report from a contactable consumer.   A 24-years-old male patient received BNT162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose (at the age of 24 years old) for COVID-19 immunization. The dose number received was not specified.  The patient's medical history and concomitant medications were not reported.  This patient who worked in a pharmacy, was vaccinated and wore a mask, and he got COVID on an unspecified date. It was mild. The outcome of the event "got COVID" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: received first covid vaccine, contracted covid 19/Infected lungs; received first covid vaccine, contracted covid 19/Infected lungs; This is a spontaneous report from a contactable healthcare professional and consumer (patient). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient received first COVID vaccine, contracted COVID 19 and was hospitalized for 7 days (also reported as 1 week). Reported infected lungs recently cleared-oxygen still required. The outcome of the event COVID-19 pneumonia was recovering while unknown for the other event.  Information on lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported rapid COVID-19 pneumonia  based on the known safety profile.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: started feeling lump in breast; turned out to be breast cancer upon evaluation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Jun2021 19:00 (Batch/Lot number was not reported), at the age of 40 years old, as dose 2, single for covid-19 immunisation. Medical history included prior breast cancer that was in remission. Has not been diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 12May2021 11:00, at the age of 40 years old, for covid-19 immunisation. On 10Jun2021 09:00, the patient started feeling lump in breast 9 days after 2nd dose of Pfizer covid vaccine. It turned out to be breast cancer upon evaluation. This lump did not exist before taking the vaccine. Chemotherapy planned for 22Jul2021. The event was reported as serious (life-threatening and disabling). The patient had not recovered from the event.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: bubbles in her arms, kind of looked a smidgeon like poison ivy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced bubbles in her arms, kind of looked a smidgeon like poison ivy on an unspecified date. The patient was hospitalized for the event for 30 days (patient was in the hospital for about a month). Reporter stated she is calling regarding the Pfizer Covid 19 second dose, the vaccine. Reporter was reporting her own experience with the Pfizer Covid 19 vaccine, she mentioned that she did some research online and read about 2 people's reactions. When she googled the second dose of Pfizer and reactions to the Pfizer vaccine, she typed in the words burning in arms, legs, feet and hands. She pulled up one article from the newspaper of a woman who was in the hospital about a month. In the picture, it looked like bubbles in her arms, kind of looked a smidgeon like poison ivy. The other was a man, and she does not know the location. It was in the newspaper that he had a rash. It might have been reversed but she does not remember their names. The other one had a rash. Outcome of the event was unknown.  Information about Lot/batch number has been requested.