chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, No reaction on previous exposure to drug, Polyneuropathy
Clinical narrative: I had Peripheral Neuropathy in my feet for many years. It was well managed and little trouble. I am not diabetic. Similarly I have had fibromyalgia. I worsened in symptoms of both shortly after the second booster shot and I had additional discomfort in legs and lower back. These kept getting more serious. This became cause for a trip to the ER on 5th May. This result in a new diagnosis of Polyneuropathy and a prescription for Gabapentin. As of today,  13th June, symptoms are worsened and/or break through the medication. Note that this was my second booster shot for Covid and that I had *absolutely* no reaction to any of the other three shots. All were administered at the same pharmacy. I did notice that the second booster shot was "Grey cap" and the earlier three shots were "Purple cap"
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Allergy test, Confusional state, Mental disorder, Muscular weakness, Nausea
Clinical narrative: Sever neurological symptoms, muscle weakness, leg weakness, confusion, altered mental state, hives, nausea, vomiting, and fevers over 103 for the following 2 weeks.
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Neurological symptom, Pyrexia, Urticaria, Vomiting
Clinical narrative: Sever neurological symptoms, muscle weakness, leg weakness, confusion, altered mental state, hives, nausea, vomiting, and fevers over 103 for the following 2 weeks.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Full blood count, Infusion, Joint swelling, Red blood cell sedimentation rate
Clinical narrative: Female pt. Age 66. RA since 1972. Taking Actemra infusions monthly. I received 3 Pfizer COVID vaccines spaced by 6 mo intervals with no side effects, then rheumatologist recommended I get a Moderna for cross immunity. Immunized with Moderna on 05/23/2022. 28MAY, I began having more joint pain which grew into a major flare; pain level: 7. Small joints very swollen. Needed Norco to relieve pain. Had Actemra infusion 03JUNE. Still in flare. My rheumatologist is away on vacation. Having an acute flare in the small joints of my hands which are already severely damaged was counter-productive.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Female pt. Age 66. RA since 1972. Taking Actemra infusions monthly. I received 3 Pfizer COVID vaccines spaced by 6 mo intervals with no side effects, then rheumatologist recommended I get a Moderna for cross immunity. Immunized with Moderna on 05/23/2022. 28MAY, I began having more joint pain which grew into a major flare; pain level: 7. Small joints very swollen. Needed Norco to relieve pain. Had Actemra infusion 03JUNE. Still in flare. My rheumatologist is away on vacation. Having an acute flare in the small joints of my hands which are already severely damaged was counter-productive.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Audiogram abnormal, Blood electrolytes abnormal, Blood pressure increased, Brain scan normal
Clinical narrative: I was diagnosed with psoriatic arthritis in October of 2019 and started taking immuno-suppressive medications. Had initial COVID vaccines (Pfizer) and another COVID booster 8/22/2021. I have yet to have 2nd COVID booster. Noticed slight ringing of the ears around the beginning of 9/1/2021. Mentioned this to my PCP during annual physical 9/24/2021. Was awakened by extreme ear ringing, "buzzing" sensation in my head, panicked feeling, and nausea the morning of 9/30/2021. Tinnitus, head buzzing, and anxiety diminished throughout the week, but nausea remained for about 10 days. On 10/24/2021 I again had a severe attack with same symptoms, but ear ringing was more like a loud clanging and was accompanied by a headache and elevated blood pressure. Afraid I was experiencing an aneurism or stroke; I went to an ER. They did brain scan and blood tests. Scan was clear, but electrolytes were abnormal and magnesium, potassium, and sodium were administered. Although tinnitus and nausea persisted, I felt better until I experienced the same kind of severe event on 11/1/2021 and returned to the ER. Once again, my electrolytes were abnormal and same treatment was administered. Over a period of 2 weeks, I began feeling better but continue to have persistent and moderate tinnitus for which I have sought further medical assistance. Sought chiropractic help for tinnitus and am currently trying PT for tinnitus and neck discomfort.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging normal, Musculoskeletal discomfort, Nausea, Panic reaction
Clinical narrative: I was diagnosed with psoriatic arthritis in October of 2019 and started taking immuno-suppressive medications. Had initial COVID vaccines (Pfizer) and another COVID booster 8/22/2021. I have yet to have 2nd COVID booster. Noticed slight ringing of the ears around the beginning of 9/1/2021. Mentioned this to my PCP during annual physical 9/24/2021. Was awakened by extreme ear ringing, "buzzing" sensation in my head, panicked feeling, and nausea the morning of 9/30/2021. Tinnitus, head buzzing, and anxiety diminished throughout the week, but nausea remained for about 10 days. On 10/24/2021 I again had a severe attack with same symptoms, but ear ringing was more like a loud clanging and was accompanied by a headache and elevated blood pressure. Afraid I was experiencing an aneurism or stroke; I went to an ER. They did brain scan and blood tests. Scan was clear, but electrolytes were abnormal and magnesium, potassium, and sodium were administered. Although tinnitus and nausea persisted, I felt better until I experienced the same kind of severe event on 11/1/2021 and returned to the ER. Once again, my electrolytes were abnormal and same treatment was administered. Over a period of 2 weeks, I began feeling better but continue to have persistent and moderate tinnitus for which I have sought further medical assistance. Sought chiropractic help for tinnitus and am currently trying PT for tinnitus and neck discomfort.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I was diagnosed with psoriatic arthritis in October of 2019 and started taking immuno-suppressive medications. Had initial COVID vaccines (Pfizer) and another COVID booster 8/22/2021. I have yet to have 2nd COVID booster. Noticed slight ringing of the ears around the beginning of 9/1/2021. Mentioned this to my PCP during annual physical 9/24/2021. Was awakened by extreme ear ringing, "buzzing" sensation in my head, panicked feeling, and nausea the morning of 9/30/2021. Tinnitus, head buzzing, and anxiety diminished throughout the week, but nausea remained for about 10 days. On 10/24/2021 I again had a severe attack with same symptoms, but ear ringing was more like a loud clanging and was accompanied by a headache and elevated blood pressure. Afraid I was experiencing an aneurism or stroke; I went to an ER. They did brain scan and blood tests. Scan was clear, but electrolytes were abnormal and magnesium, potassium, and sodium were administered. Although tinnitus and nausea persisted, I felt better until I experienced the same kind of severe event on 11/1/2021 and returned to the ER. Once again, my electrolytes were abnormal and same treatment was administered. Over a period of 2 weeks, I began feeling better but continue to have persistent and moderate tinnitus for which I have sought further medical assistance. Sought chiropractic help for tinnitus and am currently trying PT for tinnitus and neck discomfort.
Sex: U
Vaccine: MMR
Symptoms: Cough, Croup infectious, Injection site rash, Otitis media, Pyrexia
Clinical narrative: 13 month old boy received 1st dose of MMR vaccine on 11/19/2021. He developed rash at injection site immediately after vaccination, followed by fever, runny nose, cough on 11/20/2021. Patient was diagnosed with croup on 11/22/2021 and treated with dexamethasone. On 11/23/2021, patient developed bilateral suppurative otitis media which was treated with antibiotics.
Sex: U
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: 13 month old boy received 1st dose of MMR vaccine on 11/19/2021. He developed rash at injection site immediately after vaccination, followed by fever, runny nose, cough on 11/20/2021. Patient was diagnosed with croup on 11/22/2021 and treated with dexamethasone. On 11/23/2021, patient developed bilateral suppurative otitis media which was treated with antibiotics.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Blood pressure decreased, Body temperature increased, Cold sweat, Discomfort, Heart rate decreased
Clinical narrative: After receiving the Meningococcal A,C,W,Y vaccine in their upper left arms, both of my children went into distress and passed out. Their temperature spiked, extreme sweating ensued, and cold clammy like conditions were evident. Their blood pressure, heart rate, and pulse dropped to half the normal rate. Cold compresses were given and all vitals were monitored in the doctors office for 90 minutes.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: After receiving the Meningococcal A,C,W,Y vaccine in their upper left arms, both of my children went into distress and passed out. Their temperature spiked, extreme sweating ensued, and cold clammy like conditions were evident. Their blood pressure, heart rate, and pulse dropped to half the normal rate. Cold compresses were given and all vitals were monitored in the doctors office for 90 minutes.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Blood pressure decreased, Cold sweat, Emotional distress, Heart rate decreased, Hyperhidrosis
Clinical narrative: After receiving the Meningococcal A,C,W,Y vaccine in their upper left arms, both of my children went into distress and passed out. Their temperatures spiked, extreme sweating ensued, and cold clammy like conditions were evident. Their blood pressure, hear rate, and pulse dropped to half the normal rate. Cold compresses were given and all vitals were monitored in the doctor's office for 90 minutes.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Loss of consciousness, Pyrexia
Clinical narrative: After receiving the Meningococcal A,C,W,Y vaccine in their upper left arms, both of my children went into distress and passed out. Their temperatures spiked, extreme sweating ensued, and cold clammy like conditions were evident. Their blood pressure, hear rate, and pulse dropped to half the normal rate. Cold compresses were given and all vitals were monitored in the doctor's office for 90 minutes.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: 07/04/2021 F.D.A. Representative; I am writing for two reasons; 1). On April 27, 2021, I recieved a Phizer Vaccination #ER8731 On July 02, 2021 I recieved my second vaccination however it is Moderna Vaccine #026C21A. I am experiencing a Front & Back headache/slight and the snifles so far 4 hours after the Moderna shot. The lady assured me that it was safe due to the lapse of time between the two. (This came to her through higher channels).  What does F.D.A. say? 2). I need the History of the down fall of Darvon, between 2002 - Now "Thank you". PS.---(8:30)pm small fever, achey/Neck/Back/Joints/Feel bad/Headache. 11.30 Body Aches/Headache Bad Fever/Chills 2:01 am 07/03/21 lungs congested, BodyAches Headaches/Still neck; Chills. Fever feel Bad. 800 am Flat on my back 12.00 Flat on my back sick 3:00 Feel a little better eat 1 soup. 07/04/21 Feeling Better still a little Feverish - Diarea a little
Sex: U
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Interchange of vaccine products, Malaise, Neck pain
Clinical narrative: 07/04/2021 F.D.A. Representative; I am writing for two reasons; 1). On April 27, 2021, I recieved a Phizer Vaccination #ER8731 On July 02, 2021 I recieved my second vaccination however it is Moderna Vaccine #026C21A. I am experiencing a Front & Back headache/slight and the snifles so far 4 hours after the Moderna shot. The lady assured me that it was safe due to the lapse of time between the two. (This came to her through higher channels).  What does F.D.A. say? 2). I need the History of the down fall of Darvon, between 2002 - Now "Thank you". PS.---(8:30)pm small fever, achey/Neck/Back/Joints/Feel bad/Headache. 11.30 Body Aches/Headache Bad Fever/Chills 2:01 am 07/03/21 lungs congested, BodyAches Headaches/Still neck; Chills. Fever feel Bad. 800 am Flat on my back 12.00 Flat on my back sick 3:00 Feel a little better eat 1 soup. 07/04/21 Feeling Better still a little Feverish - Diarea a little
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pulmonary congestion, Pyrexia, Rhinorrhoea
Clinical narrative: 07/04/2021 F.D.A. Representative; I am writing for two reasons; 1). On April 27, 2021, I recieved a Phizer Vaccination #ER8731 On July 02, 2021 I recieved my second vaccination however it is Moderna Vaccine #026C21A. I am experiencing a Front & Back headache/slight and the snifles so far 4 hours after the Moderna shot. The lady assured me that it was safe due to the lapse of time between the two. (This came to her through higher channels).  What does F.D.A. say? 2). I need the History of the down fall of Darvon, between 2002 - Now "Thank you". PS.---(8:30)pm small fever, achey/Neck/Back/Joints/Feel bad/Headache. 11.30 Body Aches/Headache Bad Fever/Chills 2:01 am 07/03/21 lungs congested, BodyAches Headaches/Still neck; Chills. Fever feel Bad. 800 am Flat on my back 12.00 Flat on my back sick 3:00 Feel a little better eat 1 soup. 07/04/21 Feeling Better still a little Feverish - Diarea a little
Sex: M
Vaccine: COVID19
Symptoms: Death, Surgery
Clinical narrative: Caregiver/Partner reported patient had surgery but did not make it and passed. No other details provided at this time.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Deep vein thrombosis, Peripheral swelling, Ultrasound scan
Clinical narrative: Leg swell Acute 6 - 05 - 2022 DVT Dx 6 - 06 - 2022 Traveled to state college for sports tournament. No other sick contacts Noticed DVT 6 - 5 - 22
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chondrocalcinosis, Condition aggravated, Influenza like illness
Clinical narrative: Severe onset 12/30/2021 severe pain and swelling in the left knee, have been previously diagnosed with  CPPD but have not had any issues with CPPD flare in 6 years. Saw orthopedic and received cortizone shot and predispose pills which helped temporarily. But as soon as the pills wore off the pain came back. Also tried Euflexxa injections.  Shots didn't help and pain expanded to right shoulder then left shoulder. Orthopedic doctor felt something else is going & referred to Rhuematologist. I saw Rheumatologist doctor in February 2021 he ran extensive tests & xrays and diagnosed with inflamatory Arthritis. Started treatments with prednisone and methotraxate. Now taking 25mg of Methotraxate Injection and Prednisone 5mg- and still in daily pain.  To add to reaction from booster-I felt flu like symptoms about 24 hours after shot.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Laboratory test abnormal, Magnetic resonance imaging abnormal, Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: Severe onset 12/30/2021 severe pain and swelling in the left knee, have been previously diagnosed with  CPPD but have not had any issues with CPPD flare in 6 years. Saw orthopedic and received cortizone shot and predispose pills which helped temporarily. But as soon as the pills wore off the pain came back. Also tried Euflexxa injections.  Shots didn't help and pain expanded to right shoulder then left shoulder. Orthopedic doctor felt something else is going & referred to Rhuematologist. I saw Rheumatologist doctor in February 2021 he ran extensive tests & xrays and diagnosed with inflamatory Arthritis. Started treatments with prednisone and methotraxate. Now taking 25mg of Methotraxate Injection and Prednisone 5mg- and still in daily pain.  To add to reaction from booster-I felt flu like symptoms about 24 hours after shot.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Headache, Neck pain, Pain in extremity
Clinical narrative: Pain in my arm that went all the way up my shoulder and into my neck that gave me horrible headaches.  It also made my whole heart muscle ache and hurt It also made my hips ache and hurt and it has not gone away
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bronchitis, Laryngitis, Uveitis
Clinical narrative: UVEITIS; BRONCHITIS; LARYNGITIS; LOW ENERGY; This spontaneous report received from a patient concerned a 61 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was an active person before, but then stopped her yoga and dancing lessons because of the symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced uveitis, bronchitis, trouble breathing, laryngitis, and low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bronchitis, uveitis, laryngitis, and low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220617228-  covid-19 vaccine ad26.cov2.s- uveitis.The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myositis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 at 10:00 as dose 1, single (Lot number: EN6202), in left arm, on 20Mar2021 at 10:00 as dose 2, single (Lot number: EP7534), in left arm and on 18Oct2021 at 15:00 as dose 3, (booster) single (Lot number: FE3592) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro for Allergy. The following information was reported: COVID-19 (medically significant) with onset 05Feb2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2022) Positive. Therapeutic measures were not taken as a result of vaccination failure. Therapeutic measures were taken as a result of Covid-19. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Product Quality Group investigation results: The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot EN6202 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for lack of effect of the Pfizer-Biontech Covid-19  lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 at 10:00 as dose 1, single (Lot number: EN6202), in left arm, on 20Mar2021 at 10:00 as dose 2, single (Lot number: EP7534), in left arm and on 18Oct2021 at 15:00 as dose 3, (booster) single (Lot number: FE3592) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro for Allergy. The following information was reported: COVID-19 (medically significant) with onset 05Feb2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2022) Positive. Therapeutic measures were not taken as a result of vaccination failure. Therapeutic measures were taken as a result of Covid-19. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Product Quality Group investigation results: The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot EN6202 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for lack of effect of the Pfizer-Biontech Covid-19  lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Diarrhoea, Dyspnoea, Hypophagia
Clinical narrative: 11/29/21 presents to ED for "fevers, weakness, decreased PO intake, SOB and diarrhea". PMHx of "CHF, Atrial fibrillation, CAD, HTN, CKD, CLL, lower GIB, gout, testicular Ca"
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 11/29/21 presents to ED for "fevers, weakness, decreased PO intake, SOB and diarrhea". PMHx of "CHF, Atrial fibrillation, CAD, HTN, CKD, CLL, lower GIB, gout, testicular Ca"
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, COVID-19, Interchange of vaccine products
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LOWER ABDOMEN CRAMPING LIKE MENSTRUAL CRAMPS OR DIARRHEA CRAMP; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, chronic migraine, cleft lip and palate, and drug allergy (Dynacin), and other pre-existing medical conditions included: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total, administered on right arm on 14-MAR-2021 for prophylactic vaccination. Age at time of vaccination 31 years old. The batch number was not reported and has been requested. The patient additionally received non-company suspect vaccine Elasomeran (Spikevax) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, 1 total administered in right arm on 24-OCT-2021 for prophylactic vaccination. Age at time of vaccination 32 years old. Concomitant medications included escitalopram. On an unspecified date, the patient experienced covid-19 (coded as suspected covid-19 infection) (dose number in series 2) and suspected clinical vaccination failure (dose number in series 1). The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 28-MAY-2022 for treatment of covid-19. On 31-MAY-2022 at 07:00, the patient experienced lower abdomen cramping like menstrual cramps or diarrhea cramp (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and Elasomeran was not applicable. The patient recovered from lower abdomen cramping like menstrual cramps or diarrhea cramp, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220615516-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LOWER ABDOMEN CRAMPING LIKE MENSTRUAL CRAMPS OR DIARRHEA CRAMP; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, chronic migraine, cleft lip and palate, and drug allergy (Dynacin), and other pre-existing medical conditions included: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total, administered on right arm on 14-MAR-2021 for prophylactic vaccination. Age at time of vaccination 31 years old. The batch number was not reported and has been requested. The patient additionally received non-company suspect vaccine Elasomeran (Spikevax) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, 1 total administered in right arm on 24-OCT-2021 for prophylactic vaccination. Age at time of vaccination 32 years old. Concomitant medications included escitalopram. On an unspecified date, the patient experienced covid-19 (coded as suspected covid-19 infection) (dose number in series 2) and suspected clinical vaccination failure (dose number in series 1). The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 28-MAY-2022 for treatment of covid-19. On 31-MAY-2022 at 07:00, the patient experienced lower abdomen cramping like menstrual cramps or diarrhea cramp (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and Elasomeran was not applicable. The patient recovered from lower abdomen cramping like menstrual cramps or diarrhea cramp, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220615516-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID- 19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 47 year old male. Initial information was processed with the additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: malignant melanoma (35 years ago), high blood pressure, and drug allergy (name of drug not reported). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total, administered on APR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 46 years old. Concomitant medications included doxycycline, finasteride, and lisinopril.  The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on NOV-2021 in right arm for prophylactic vaccination.  On an unspecified date, the patient got a sore throat and a stuffed nose (which was led to confirmed clinical vaccination failure (dose number in series 1), and confirmed covid-19 infection (dose number in series 2). On an unspecified date in MAY-2022, it was reported that patient had rebound effect. After testing negative, once again patient got a sore throat and a stuffed nose. The patient had been tested positive again starting on day 8 after initial positive test and still positive on day 12 (dose number in series 2). The patient started Paxlovid on 29-MAY-2022 within hours of initial positive test. Paxlovid discontinued on 02-JUN-2022. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed Covid- 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235047.; Sender's Comments: V0:20220614612-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID- 19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 47 year old male. Initial information was processed with the additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: malignant melanoma (35 years ago), high blood pressure, and drug allergy (name of drug not reported). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total, administered on APR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 46 years old. Concomitant medications included doxycycline, finasteride, and lisinopril.  The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on NOV-2021 in right arm for prophylactic vaccination.  On an unspecified date, the patient got a sore throat and a stuffed nose (which was led to confirmed clinical vaccination failure (dose number in series 1), and confirmed covid-19 infection (dose number in series 2). On an unspecified date in MAY-2022, it was reported that patient had rebound effect. After testing negative, once again patient got a sore throat and a stuffed nose. The patient had been tested positive again starting on day 8 after initial positive test and still positive on day 12 (dose number in series 2). The patient started Paxlovid on 29-MAY-2022 within hours of initial positive test. Paxlovid discontinued on 02-JUN-2022. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed Covid- 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235047.; Sender's Comments: V0:20220614612-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: ankylosing spondylitis. On 10-MAR-2022 at 14:00, patient received Covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Covid-19 vaccine ad26.cov2.s (Dose number in series: 1). On 12-JAN-2022 at 16:00, patient received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin not reported, batch number: 003J212A expiry: UNKNOWN) dose was not reported, administered to left arm for prophylactic vaccination. Concomitant medications included colecalciferol, ginkgo biloba, indometacin, lisinopril, and omeprazole. Treatment medication included Paxlovid which was administered on 21-MAY-2022 till 25-MAY-2022 for treatment of Covid-19. On 01-JUN-2022 at 19:00, the patient experienced slight congestion, and runny nose (Dose number in series: 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight congestion, and runny nose. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: ankylosing spondylitis. On 10-MAR-2022 at 14:00, patient received Covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Covid-19 vaccine ad26.cov2.s (Dose number in series: 1). On 12-JAN-2022 at 16:00, patient received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin not reported, batch number: 003J212A expiry: UNKNOWN) dose was not reported, administered to left arm for prophylactic vaccination. Concomitant medications included colecalciferol, ginkgo biloba, indometacin, lisinopril, and omeprazole. Treatment medication included Paxlovid which was administered on 21-MAY-2022 till 25-MAY-2022 for treatment of Covid-19. On 01-JUN-2022 at 19:00, the patient experienced slight congestion, and runny nose (Dose number in series: 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight congestion, and runny nose. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diarrhea all the time; was dragging my life; for 13 months, I was so sick; ruined my bowel; I could hardly walk; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Cholesterol" (ongoing), notes: I take for Cholesterol, it is Atorvastatin. Concomitant medication(s) included: LISINOPRIL taken for hypertension; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization. The following information was reported: DIARRHOEA (medically significant), outcome "unknown", described as "diarrhea all the time"; QUALITY OF LIFE DECREASED (medically significant), outcome "unknown", described as "was dragging my life"; ILLNESS (non-serious), outcome "unknown", described as "for 13 months, I was so sick"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "ruined my bowel"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I could hardly walk"; ANXIETY (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Lab work: unknown result (had some and a checkup).  Clinical course: Patient reported as on 05May I had my first Pfizer Vaccine, the first shot. It created what it did was it attacked my nervous system, it attacked my muscles, it attacked my bowel, it attacked my immune system. it was 13 months later; I have both Vaccines and I will not take the vaccine again. I went in and I had the, for 13 months, I was so sick. I now have diarrhea all the time and it has ruined my bowel. I caught the virus anyways, at the first two months, they were telling us how wonderful it was. I ended up in getting the latest strain a few weeks ago. So, I went, and I got the Olympus, that the Monoclonal Infusion (Intent Treatment) and next morning half my symptoms were gone. I was dragging my life. I could hardly walk. I was so sick, and I had so much anxiety because no Doctors would, they did not want to believe me. Because if they had to believe me then they would have to report it, there is a horrible side effect. I see my Chiropractor all the time, I see my Chiropractor and the doctors were not interested because they said that the Vaccine was safe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Anxiety, Diarrhoea, Gait disturbance, Illness
Clinical narrative: diarrhea all the time; was dragging my life; for 13 months, I was so sick; ruined my bowel; I could hardly walk; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Cholesterol" (ongoing), notes: I take for Cholesterol, it is Atorvastatin. Concomitant medication(s) included: LISINOPRIL taken for hypertension; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization. The following information was reported: DIARRHOEA (medically significant), outcome "unknown", described as "diarrhea all the time"; QUALITY OF LIFE DECREASED (medically significant), outcome "unknown", described as "was dragging my life"; ILLNESS (non-serious), outcome "unknown", described as "for 13 months, I was so sick"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "ruined my bowel"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I could hardly walk"; ANXIETY (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Lab work: unknown result (had some and a checkup).  Clinical course: Patient reported as on 05May I had my first Pfizer Vaccine, the first shot. It created what it did was it attacked my nervous system, it attacked my muscles, it attacked my bowel, it attacked my immune system. it was 13 months later; I have both Vaccines and I will not take the vaccine again. I went in and I had the, for 13 months, I was so sick. I now have diarrhea all the time and it has ruined my bowel. I caught the virus anyways, at the first two months, they were telling us how wonderful it was. I ended up in getting the latest strain a few weeks ago. So, I went, and I got the Olympus, that the Monoclonal Infusion (Intent Treatment) and next morning half my symptoms were gone. I was dragging my life. I could hardly walk. I was so sick, and I had so much anxiety because no Doctors would, they did not want to believe me. Because if they had to believe me then they would have to report it, there is a horrible side effect. I see my Chiropractor all the time, I see my Chiropractor and the doctors were not interested because they said that the Vaccine was safe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Quality of life decreased
Clinical narrative: diarrhea all the time; was dragging my life; for 13 months, I was so sick; ruined my bowel; I could hardly walk; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Cholesterol" (ongoing), notes: I take for Cholesterol, it is Atorvastatin. Concomitant medication(s) included: LISINOPRIL taken for hypertension; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization. The following information was reported: DIARRHOEA (medically significant), outcome "unknown", described as "diarrhea all the time"; QUALITY OF LIFE DECREASED (medically significant), outcome "unknown", described as "was dragging my life"; ILLNESS (non-serious), outcome "unknown", described as "for 13 months, I was so sick"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "ruined my bowel"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I could hardly walk"; ANXIETY (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Lab work: unknown result (had some and a checkup).  Clinical course: Patient reported as on 05May I had my first Pfizer Vaccine, the first shot. It created what it did was it attacked my nervous system, it attacked my muscles, it attacked my bowel, it attacked my immune system. it was 13 months later; I have both Vaccines and I will not take the vaccine again. I went in and I had the, for 13 months, I was so sick. I now have diarrhea all the time and it has ruined my bowel. I caught the virus anyways, at the first two months, they were telling us how wonderful it was. I ended up in getting the latest strain a few weeks ago. So, I went, and I got the Olympus, that the Monoclonal Infusion (Intent Treatment) and next morning half my symptoms were gone. I was dragging my life. I could hardly walk. I was so sick, and I had so much anxiety because no Doctors would, they did not want to believe me. Because if they had to believe me then they would have to report it, there is a horrible side effect. I see my Chiropractor all the time, I see my Chiropractor and the doctors were not interested because they said that the Vaccine was safe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.