chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose: his arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: EW0185) at the age of 21 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Aug2021, outcome "recovered" (28Aug2021), described as "First dose: his arm hurt".  Additional information: Patient's Weight was 145 to 155 lbs and is a healthy young man. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available), No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse event did not required Emergency Room or Physician Office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. Family Medical History Relevant to AE was not reported.  No follow-up attempts are possible. No further information is expected.
Recieved chickenpox vaccination on 8/20/07, 10 hours later was experiencing seizure-like movements that were involuntary,OCD type behavior(ex. pacing in a circle not being able to stay still),cofused and anxious feelings.
Facial redness and tingling (specifically above eyebrows and lips).  Returned to vaccination clinic around 5pm reporting symptoms
For several days, I had upset stomach, diarrhea, nausea, and some vomiting. I couldn't eat or drink or anything, because I couldn't keep it down. On 5/27/2022, I called my PCP, and she told me that I should probably go to the ER. However, I did not go, because I hoped it would get better. It got worse over the weekend on 5/28/2022 and 5/29/2022, and I got weaker and weaker. I waited until 5/31/2022, I called my PCP again, and they insisted that I should go to the ER, so I went to the ER that morning. I underwent a COVID-19 test and bloodwork. They found that I was extremely dehydrated, so I was hooked up to intravenous fluids for about four hours. I tested negative for COVID-19. The bloodwork results also indicated a significant drop in potassium and the presence of a nonspecific virus of some type. I was then released and told to get Pedialyte and that I needed to rest and get rehydrated. I did this for about three weeks. It took about three or four weeks to regain my strength. I kept myself hydrated with Pedialyte and ate light meals. I also periodically got up and walked around to keep from getting lethargic. The nausea, diarrhea, and vomiting all ceased. I had a virtual visit with my PCP later on at about the end of June 2022, and although no specific virus had been detected in the bloodwork, my PCP suggested that my symptomology suggested norovirus. She said that it probably would have resolved itself sooner if I hadn't become dehydrated.
I felt tingling/pins and needles everywhere when I move my arm up and down; I feel like I am being electrocuted; my legs hurt all the time; causing me not to be able to sleep; big toe is asleep all the time; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 03Sep2021 15:15 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 03Sep2021 21:30, hours after the vaccine, the patient felt tingling/pins and needles everywhere when she moved her arm up and down. She felt like she was being electrocuted. Her legs hurt all the time causing her not to be able to sleep. Big toe was asleep all the time. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.
Information has been received from a doctor of pharmacy (Pharm. D.) concerning a male patient of unknown age. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and frequency were not provided) (Lot # and expiration date were not reported). On an unknown date, the patient developed a severe case of shingles after receiving ZOSTAVAX. Patient's condition was described as having nerve damage, loss of feeling in hands and his shingles had spread to his eye. On an unspecified date, patient sought unspecified medical attention and was hospitalized. Unspecified treatment was given for the events. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
an issue which may be an autoimmunity Polymyalgia rheumatica; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE ), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE ), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "an issue which may be an autoimmunity Polymyalgia rheumatica". Therapeutic measures were taken as a result of polymyalgia rheumatica. The patient reported that he wanted to get his 6th vaccination of Pfizer vaccine but recently had developed an issue which may be an autoimmunity Polymyalgia rheumatica. He'd like to know if there were any contraindications for him taking the vaccine while taking Prednisone or having autoimmune disease.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever with chills; Clenched teeth; Neck and back pain; Neck and back pain; shaking; psychosomatic versus allergic reaction; psychosomatic versus allergic reaction; This is a spontaneous report received from contactable reporter (Nurse) from medical information team.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 23Jun2022 as dose number unknown, 0.5 ml single (Lot number: ER2622, Expiration Date: 31Jan2024) at the age of 16 years, in right deltoid for immunization; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 23Jun2022 as dose number unknown, 0.5ml single (Lot number: U7299AC, Expiration Date: 04Aug2024), in left deltoid for immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRUXISM (medically significant) with onset 23Jun2022, outcome "recovering", described as "Clenched teeth"; PYREXIA (medically significant) with onset 23Jun2022, outcome "recovering", described as "Fever with chills"; NECK PAIN (medically significant), BACK PAIN (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "Neck and back pain"; SOMATIC SYMPTOM DISORDER (medically significant), HYPERSENSITIVITY (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "psychosomatic versus allergic reaction"; TREMOR (medically significant) with onset 23Jun2022, outcome "recovering", described as "shaking". The events "fever with chills", "clenched teeth", "neck and back pain", "shaking" and "psychosomatic versus allergic reaction" required emergency room visit. Therapeutic measures were taken as a result of pyrexia, bruxism, neck pain, back pain, tremor, somatic symptom disorder, hypersensitivity which included Benadryl. They have a patient who was administered Trumenba and Menquadfi to yesterday. Two (2) and a half hours after receiving the vaccines the patient complained of severe neck and back pain, fever, clenched teeth and chills and shaking. So the patient went to the Emergency Room and was given Benadryl and all symptoms seem to resolve. She said the Emergency Room called this a psychosomatic versus allergic reaction.; Sender's Comments: There is a reasonable possibility that the events pyrexia and hypersensitivity were related to TRUMENBA based on known drug safety profile and close temporal relationship. Based on the close temporal relationship, the association between the other events with TRUMENBA can not be fully 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.
12-14 HOURS AFTER RECEIVING THE VACCINE PATIENT REPORTS HE DEVELOPED HEADACHE, MUSCLE ACHES, CHILLS, SWEATS, LOSS OF APPETITE. HE ALSO NOTED A RASH ON HIS NECK, FIRST ON THE NECK AND NOW HAS SPREAD TO THE ENTIRE BODY. PATIENT ALSO REPORTS SHORTNESS OF BREATH WHEN LAYING FLAT ON HIS BACK THAT STARTED AT THE SAME TIME.
Stiff neck, injection arm pain/redness, headaches, dizziness, weakness, severe fatigue
Upper arm began to blister everywhere, large blisters the size of quarters, clear fluid and itchy, took up a large surface of the upper arm
18MAY98 pt exp a lesion on forehead, otitis, projectile vomiting, diarrhea, a weight loss of 3 pounds, & broke out in splotches;pt hosp x 5 days;wk later broke out again & exp severe fatigue;MD felt diarrhea,weight loss were from virus;
Patient came in to HD during the day for immunizations. Parent called 10/3/05 to report patient was taken to ER on same evening vaccine was given and treated for fever and rash. D/C same date and to follow up with doctor.
1st dose years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose into unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022  Reporter's comment: The case was self reported by the patient. The patient received only one dose of Shingles vaccine through her employer doctor over three years ago. Upon probing for vaccination date, the patient reported that it could have been ten years ago. The patient could not provide the name or brand of the administered Shingles vaccine nor the exact vaccination date, hence Shingles vaccine brand could not be identified.  The patient could not provide HCP's phone number and shingles vaccine information details. The patient declined providing her date of birth and reported that she was in her 60s, exact age was not provided. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021; received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: J&J COVID-19 vaccine (First COVID-19 full dose) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ACCIDENTAL OVERDOSE (received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine). On 30-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021). At the time of the report, ACCIDENTAL OVERDOSE (received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  It was reported that she went to a different pharmacy and did not tell them that she had a dose of Janssen COVID-19 vaccine.  Treatment information was not reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 25-FEB-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H009826, 0.5 ml, intramuscular). It was reported that the patient received an expired dose of PNEUMOVAX 23 as the expiration date was 11-FEB-2014. No symptoms were reported. No further details were provided. Additional information is not expected.
Swelling, redness, warm around injection, site 6-8 hours after injection. Patient treated with cold pack, BENADRYL. Saw MD and they prescribed an antibiotic.
Vesicular Rash on extremities, more concentrated near the area of injection; 3 days or so after receiving MMR, Varicella and Hep A vaccines.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010106, intramuscular for prophylaxis. On 24-AUG-2017, 5 days after onset of therapy the patient experienced chills, hyperhidrosis and injection site pain. The outcome of hyperhidrosis, injection site pain and chills is unknown. Sender's Comments: US-009507513-1708USA011999.
Only adjuvant portion administered; Only adjuvant portion administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 39YM7, expiry date 1st September 2023) for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Shingrix. On 26th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The pharmacist stated that  a pharmacy intern administered the adjuvant portion only to a patient.  The patient was administered a properly reconstituted dose on the same day as the non-reconstituted dose. The reporter consented to follow-up via postal. Additional supportive information: The patient received only adjuvant portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
left shoulder pain at injection site starting the day after moderna vaccine. No ROM changes. Pain radiates to the scalupla, neck and into the forearm. Treatment plan will be referral to PT and pain management.
Client verbalized numbness to left arm after receiving the vaccine.  Client was assessed by Rescue Paramedics.  According to client "I feel better." patient was released to go home at 9:45 am after symptom was resolved.  Per Paramedic no further evaluation needed.
4/6/07 - woke up morning with left knee pain/swelling Advil, 4/7/07 - seen at walk in clinic _ CPK normal Advil continued, 4/9/07 L Knee pain, seen another MD - Osgood Schlater, 4/10/07 L knee pain/swelling - seen another MD - arthralgia - Prednisone, 4/13/04 R knee swelling Hosp ER admitted. 1/1/10 follow up - continues to have pain in knees during sports activity and stiffness and aching when sitting for long periods of time.
Nauseous, chills, headache, soreness, arm soreness.  Still felt ill the next day but recovered after one day and was able to resume normal activity.
Patient reports that she has asthma and usually begins coughing when she has an asthma attack. She reported coughing and felt like there was a lump in her throat like throat may be closing. Patient said that she did not have difficulty breathing. Patient said that she took 75mg of Benadryl and drank tea with caffeine. She went to bed and said she woke up and feels fine. Only reports a mild temperature and a headache.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
In 2018 /received the first /received the second /on/ Feb 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2018).   In February 2021, the patient received the 2nd dose of Shingrix. In February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided are as follows: The case was reported by pharmacist. The age at the vaccination was not reported. The patient received 2nd dose of Shingrix over the recommended dosing interval, which led to drug dose administration interval too long. The reporter consented to follow up. The email address was unavailable for the pharmacist.
I had Covid-19 in December 2020. On the following day of my first vaccine, in the middle of the night, I experienced chills, body aches. At 7am the next day I woke up feeling light headed and passed out. When I woke up I had thrown up on myself and started to hear a whooshing sound in my ears and I went back to bed. At 9am my symptoms started all over again. I live with my house maid and since I did not look well, she took me to urgent care. My BP had dropped and I was super dizzy. I got an IV drip for an hour, anti-nausea medication. My blood was also drawn and found to have underlying anemia. My urine test was negative. The pulse oximetry was fine and by the next day I slowly started to feel better.
27-year-old gentleman with history of mild intermittent asthma, anxiety, presented with complaints of fever of 99.8 °F on  5/22/2021 associated to fatigue and body aches and then chest pain, generalized with radiation to left arm since afternoon of 5/23/2021, which got worse on 5/24/2021 and he was admitted for further evaluation with initial troponin of 472. Had an NSTEMI; chest tightness, pain in left arm, lightheadedness, dizziness, presyncope. Discharge diagnosis - probable myocarditis; clinical picture most consistent with viral myocarditis.
Information has been received from a retired licensed practical nurse concerning herself, an approximately 64 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. In approximately March 2007 (reported as: 10 years ago), the patient developed a local reaction described as "1 inch by 1 inch area that was red and swollen located above the elbow".  At the time of the report, the patient was recovered from the events. The relatedness between the events and the ZOSTAVAX was not reported. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 and experienced runny nose, laryngitis, cough, itching, swelling and erythema (MARRS 1703USA002923). Additional information has been requested. Sender's Comments: US-009507513-1703USA002923.