chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; Information has been received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or around February 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of neuropathy to be related to zoster vaccine live (ZOSTAVAX).  The event of neuropathy was considered to be disabling.  Upon internal review, the event of neuropathy was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Fear, Malaise, Pyrexia
Clinical narrative: real sick; with a high fever; Was a little scary; This case was reported by a consumer and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (for the tolerance of 1st dose, refer case- US2020AMR239664).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, fever and fear. On an unknown date, the outcome of the sickness, fever and fear were recovered/resolved.   It was unknown if the reporter considered the sickness, fever and fear to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 2nd dose of Shingrix and got real sick with a high fever and was a little scary. The events got better after a couple of days.
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal swelling, Urticaria
Clinical narrative: hive like rash that went up her arm and neck; swelling in throat; This case was reported by a nurse vi and described the occurrence of rash urticaria-like in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced rash urticaria-like and throat swelling. On an unknown date, the outcome of the rash urticaria-like and throat swelling were unknown.   It was unknown if the reporter considered the rash urticaria-like and throat swelling to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced a hive like rash that went up her arm and neck and swelling in throat. No further information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparesis, Hypoaesthesia, Injection site pain
Clinical narrative: right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; bad headache; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 41 unknown unit) received the first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know how long side effects last after receiving the first dose of the Covid vaccine. The patient received first dose of Covid vaccine on Thursday (unspecified date) and reported side effects. She reported side effects of right sided weakness with numbness from her face down her entire body. She describes the feeling as if she's been "shot up with novocaine on the right side of her body." She was also experiencing a really bad headache and pain at the injection site. She reported that the side effects do not seem to be wearing off. She wanted to know if this has been reported as a common side effect. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysgeusia, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Photophobia, Pleuritic pain
Clinical narrative: Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Chest X-ray, Dyspnoea, Fatigue
Clinical narrative: tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient).  A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered.   The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Malaise, Palpitations, Tachycardia
Clinical narrative: tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient).  A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered.   The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood test normal, Chest X-ray normal, Dyspnoea
Clinical narrative: tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient).  A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered.   The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Illness, Myalgia, Tachycardia
Clinical narrative: tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient).  A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered.   The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Scleritis
Clinical narrative: started having a lot of left eye pain/he diagnosed her with Scleritis; This is a spontaneous report from a contactable other healthcare professional (HCP) a Nurse Practitioner, who reported for herself.  A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685 also reported as ES1685), intramuscular in left deltoid on 24Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing anxiety diagnosed years ago, maybe when she was 23. Concomitant medication included ongoing celecoxib (CELEXA) for anxiety started about a year, or year and a half ago. She did not take other vaccines on the same day as the COVID vaccine. She had no recent labs. On 02Jan2021 the patient experienced scleritis. Event was described as follows: patient got her first COVID vaccine on 24Dec2020 and on 02Jan2021 she started having a lot of left eye pain. She went to her Ophthalmologist and he diagnosed her with Scleritis. She had no history of anything with her eyes or any vascular or autoimmune issues; no eye disorder history or rheumatology history. Patient is due to get her second dose of the vaccine on 14Jan2021, and she spoke with her primary care doctor and her ophthalmologist, and neither of them have any answer on if she should get the second dose or not, they did not have much guidance for her as this was such a new product. Patient reported that scleritis was persisting, but it has improved and she was on Prednisone eye drops. Event scleritis was considered serious as Medically significant because of what it is and what it can do, but this was not a severe case (as reported). Final outcome of scleritis was recovering.; Sender's Comments: The reported scleritis was more likely an intercurrent disease, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Appendicitis perforated, Chills, Nausea, Vomiting
Clinical narrative: Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer.  A consumer reported that her 65-year-old mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), into the arm at single dose on 31Dec2020  for COVID-19 immunization. The patient did not have any medical history and did not receive any concomitant products.  On 31Dec2020 the same evening of vaccination, the patient experienced vomiting, nausea and chills  that were considered flu like. On 03Jan2021 or 04Jan2021 her appendix ruptured. She entered emergency room on 07Jan2021 and was diagnosed with appendicitis. She was admitted to hospital on 07Jan2021. She has been given hospital care for past four days. She will have surgery in 6 weeks to repair and right now they are cleaning ruptured area. Her care team is wondering if she should get second dosage. The patient is currently hospitalized. The patient recovered from the event vomiting on 31Dec2020, recovered from the events Nausea and Chills on 07Jan2021 and was Recovering from the appendicitis.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Myalgia, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: c/o temp 100.6, chills, sore throat, & muscle aches 12 hours after receiving vaccine. Symptoms resolved in 48 hours
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal discomfort, Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: Chills, Bodyaches, Nausea & Back Discomfort developed 12 hours after receiving vaccine - resolved after 48hrs.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Headache, chills, low grade fever developed 24 hours after receiving vaccine - resolved in 2 days.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, SARS-CoV-2 test negative
Clinical narrative: Headache, weakness & dizziness starting afternoon after receiving vaccine and lasting 6 hours. Afterwards c/o weakness & dizziness lasting for 2-3 days.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Tremor
Clinical narrative: PATIENT RECEIVED VACCINE AT 9 AM AND WHEN HER 15 MINUTE MONITOR PERIOD WAS UP SHE REPORTED DIZZINESS AND TREMORS. THE TREMORS WERE VISIBLE IN HER HANDS AND LEGS. HER V/S WERE TAKEN AND HER B/P WAS 140/100, HR WAS 103. NO HX OF HTN. RESPIRATIONS AND O2 SAT WERE NORMAL. SHE WAS KEPT AND MONITORED FOR A TOTAL OF 45 MINUTES AND SYMTOMS WERE STILL PRESENT WITH HER B/P 140/103 AND PULSE AT 110. SHE WAS ESCORTED TO ER FOR EVALUATION. NO TREATMENT WAS WARRENTED , HER B/P CAME DOWN TO 122/87 AND THE TREMORS RESOLVED. SHE WAS DISCHARGED HOME AT 1130 AM. FOLLOWED UP WITH
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 15 when vaccine was administered (authorized for 18 and older). No known adverse reactions.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Felt like a bloody nose, like blood running down his throat. Got up to go to restroom and spit out blood into the toilet.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Lymphadenopathy, Nausea
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Nausea-Mild, Systemic: Swollen Lymph nodes in armpit-Medium; symptoms lasted 6 days
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Serious flu like sypmtons (aka Covid sypmtons) started 6 hours after vaccination.  Severe body ache, headache, slight fever and chills.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Flushing, Malaise
Clinical narrative: Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy.  Unable to fully concentrate on tasks.  Flushed in face and unsteady lasting approximately 1 hour.  Developed headache lasting remainder of shift.  Developed body aches/chills in evening
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Tremor
Clinical narrative: Chills and shaking from chills. Pounding headache that has not gone away.  Sweating and body aches
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature normal, Dyspnoea exertional, Headache, Lethargy
Clinical narrative: Low grade fever (99...typical is 96-97 for me), intense lower back pain and headache. Also, lethargy and a heaviness to my breathing when exercising.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; stored at an improper temperature; the shingles shot (manufacturer unknown) at the same time as PNEUMOVAX 23); This spontaneous report was received from a the patients mother, and  refers to a female patient of unknown age.  The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   In August 2020 (exact date unknown) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter (lot #, expiration date and route of administration were unknown) for prophylaxis. The reporter stated that the patient had the shingles shot (manufacturer unknown) at the same time as pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had been stored at an improper temperature, No additional adverse events or product quality complaints were reported.
Age: 19.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No further AE; a pattient accidentaly received an expired MMRII dose; This spontaneous report was received from a pharmacist referring to a 19-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions and previous drug reactions or allergies was not reported.   On 04-JAN-2021, the patient accidently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # R030808, expiration date 24-OCT-2020, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The reporter had not contacted the patient yet but had not been made aware of any further adverse event, complaints or other information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Fatigue, Malaise
Clinical narrative: On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling
Clinical narrative: On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction to PNEUMOVAX23, reaction inclueded rash; This spontaneous report was received from a physician regarding a 77 year-old female patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, concomitant therapies were not provided.   On 18-NOV-2008, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml intramuscular, as routine immunization (prophylaxis), lot number 0980x has been verified to be a valid lot number, with expiration date 24-MAY-2010.    On an unspecified date, the physician was calling to inquire if patient had allergic reaction to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), was a chance she would have an allergic reaction to either of the current COVID vaccine available. This because on 18-NOV-2009, the patient had an allergic reaction to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (drug hypersensitivity), reaction included rash, and the extent of the allergic reaction was unknown by the reporter.   The outcome of the event drug hypersensitivity was not provided.   The causal relationship between the event drug hypersensitivity and therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was reported as related.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Tremor
Clinical narrative: tremors and balance issues; tremors and balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient currently 69-year-old and unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for tremors and balance issues. The outcome of tremors and balance issues was not reported. The reporter considered tremors and balance issues to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Nodule, Peripheral swelling
Clinical narrative: Has a knot on her hand; Knot on her hand and it was swollen; This case was reported by a other health professional and described the occurrence of induration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced induration and hand swelling. On an unknown date, the outcome of the induration and hand swelling were unknown.   It was unknown if the reporter considered the induration and hand swelling to be related to Shingrix.  Additional details were provided as follows: The reporter gave Shingrix this afternoon on the day of reporting and patient called back 2.5 hours later and had a knot on her hand and it was swollen. No reaction at the injection site but the hand was on the arm of the injection.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 17 when vaccine was administered  No known adverse reactions.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: itchy rash with bumps; rash; bumps; This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number P9733, expiry date 12th March 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix. In September 2020, 24 hrs after receiving Shingrix, the patient experienced itchy rash, rash and papular rash. On an unknown date, the outcome of the itchy rash and rash were not recovered/not resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the itchy rash, rash and papular rash to be related to Shingrix.  Additional details were reported as follows: The patient received the dose of Shingrix in her left deltoid and 24 hours later experienced an itchy rash with bumps from her left deltoid until her elbow.  The symptoms were still going on two months later. Consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles around her eye; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2020, 4 days after receiving Shingrix, the patient experienced shingles. Shingrix was discontinued. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient developed shingles around her eye. The patient's doctor suggested to the patient not to receive a second Shingrix shot. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial paralysis, Hypoaesthesia oral, Lymph node pain, Swelling face
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is "with fire department, thought she needed to take it, she had early breast cancer, is around lots of people". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and "the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like" and, "where the ear thing is", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is "with fire department, thought she needed to take it, she had early breast cancer, is around lots of people". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and "the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like" and, "where the ear thing is", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal discomfort, Pharyngeal swelling, Throat irritation, Throat tightness
Clinical narrative: throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms.   This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow. The patient condition was life threatening. The patient described the events as follows: 40 min after injection my throat and tongue started to feel weird and tight. Pharmacy at my work hospital  gave me 25 mg Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn't  swallow. I went to nearest  emergency room hospital they  administered Decadron orally, Pepcid  P.O. (orally), and Toradol via IM (Intramuscular). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms.   This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow. The patient condition was life threatening. The patient described the events as follows: 40 min after injection my throat and tongue started to feel weird and tight. Pharmacy at my work hospital  gave me 25 mg Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn't  swallow. I went to nearest  emergency room hospital they  administered Decadron orally, Pepcid  P.O. (orally), and Toradol via IM (Intramuscular). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: itching and swelling at injection site ongoing x 3 days, swelling reduced
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Nightmare
Clinical narrative: facial and eye flushing, hot breath
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site haemorrhage
Clinical narrative: Initially had sore arm starting 12 hours after receiving shot and lasting about 48 hours. Slight redness at injection site.  12 days after injection injection site became hard, red, hot and small red dots appeared, some which bled minimally. This condition has continued for the past two days. Additionally have experienced nausea, Diarrhea, headache and fatigue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site macule, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: Initially had sore arm starting 12 hours after receiving shot and lasting about 48 hours. Slight redness at injection site.  12 days after injection injection site became hard, red, hot and small red dots appeared, some which bled minimally. This condition has continued for the past two days. Additionally have experienced nausea, Diarrhea, headache and fatigue.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 5th of 8 patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed unexpectedly; This is a spontaneous report from a contactable nurse communicated to a Pfizer colleague. This nurse reported similar death events for 8 patients. This report is for 8th of 8 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient passed unexpectedly on an unspecified date. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.  The case will be reassessed if additional information becomes available.  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.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: passed unexpectedly
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Hypertension, Tachycardia
Clinical narrative: :hills, Systemic: Headache, Systemic: Hypertensive, tachycardic, tremors, severe anxiety
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: :hills, Systemic: Headache, Systemic: Hypertensive, tachycardic, tremors, severe anxiety
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Sleep disorder
Clinical narrative: Shoulder pain; Trouble sleeping due to the pain; Still in pain when she lays down or does motion exercises. It hurts when she is taking her shirt off; Arm pain; This spontaneous case was received on 22-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05910) and concerned a 55-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included levothyroxine, used for an unreported indication.  On 28-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was P100267084.  On 30-Oct-2020, 48 hours after receiving Afluria Quadrivalent, the patient felt shoulder pain, arm pain and had trouble sleeping due to the pain. She was in pain when she was laying down or did motion exercises and it hurt when she was taking her shirt off.  On an unspecified date in 2020, the patient visited physician's office three times and was treated with muscle relaxants tizanidine and hydrocodone.   At the time of initial reporting, on 22-Dec-2020, the patient had not recovered from all events. The patient was still on muscle relaxant.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.   This case is linked to case 202008405 (due to same reporter).  Company comment: A 55-year-old patient was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient arthralgia, pain in extremity, pain upon movement and had trouble sleeping due to the pain. Sleeping disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for arthralgia, pain in extremity and pain upon movement.; Sender's Comments: A 55-year-old patient was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient arthralgia, pain in extremity, pain upon movement and had trouble sleeping due to the pain. Sleeping disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for arthralgia, pain in extremity and pain upon movement.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Red bumps/spot on face and neck
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Oropharyngeal discomfort, Rash, Rash erythematous
Clinical narrative: Red bumps/spot on face and neck
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Hallucination, Hallucination, auditory, Laboratory test, Magnetic resonance imaging normal
Clinical narrative: 1 day following administration of 2nd COVID vaccine in series, patient began to experience voices, delusions and hallucinations. Jesus visiting her. Poor eating. Poor sleeping. Denied fevers, chills, muscle aches.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Sexually transmitted disease, Sleep disorder, Unhealthy diet, Urine analysis
Clinical narrative: 1 day following administration of 2nd COVID vaccine in series, patient began to experience voices, delusions and hallucinations. Jesus visiting her. Poor eating. Poor sleeping. Denied fevers, chills, muscle aches.