chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Swollen arm; Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2021, the patient received the 1st dose of Shingrix .5 ml. On 11th August 2021, less than a day after receiving Shingrix, the patient experienced headache, swelling arm and pain in arm. On 12th August 2021, the outcome of the headache and swelling arm were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the headache, swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient stated that, she received her first dose of Shingrix,  later that same day, she began to experience headache, swollen arm and pain in arm.  The headache and arm swelling resolved by the next day on 12th August 2021. The patient stated that, the soreness in her arm has not resolved.  No lot number or expiration date of the vaccine was known.  The reporter consented to follow up.
can't eat anything while feeling so nauseated; also has a bad headache; felt really horrible; really nauseated since yesterday evening for at least 8 hours now; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (can't eat anything while feeling so nauseated), FEELING ABNORMAL (felt really horrible), NAUSEA (really nauseated since yesterday evening for at least 8 hours now) and HEADACHE (also has a bad headache) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 1:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced FEELING ABNORMAL (felt really horrible) and NAUSEA (really nauseated since yesterday evening for at least 8 hours now). On an unknown date, the patient experienced FEEDING DISORDER (can't eat anything while feeling so nauseated) and HEADACHE (also has a bad headache). At the time of the report, FEEDING DISORDER (can't eat anything while feeling so nauseated), FEELING ABNORMAL (felt really horrible), NAUSEA (really nauseated since yesterday evening for at least 8 hours now) and HEADACHE (also has a bad headache) had not resolved.            No concomitant medication were reported. It was reported that patient received the bivalent booster yesterday at 1:30 PM central time. She was okay at first, but felt really horrible, really nauseated since yesterday evening for at least 8 hours now. She did not know when it was okay for her to vomit. She did not know if she was going to reduce the effectiveness of the vaccine if she vomits. She also had a bad headache, and she cannot take something for it because she had to eat food to coat her stomach and she cannot eat anything while she was feeling so nauseated. No treatment medication was provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; Dose 1: Pfizer, Dose 2: Moderna, Dose 3: Pfizer; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 66 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 02Oct2021 as dose 1, single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24May2022 as dose 2, single (Lot number: 057M214), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Known allergies: Soy" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: Wheat" (unspecified if ongoing); "Known allergies: Eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24May2022, outcome "unknown", described as "Dose 1: Pfizer, Dose 2: Moderna, Dose 3: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive; (06Jul2023) Negative; (07Jul2023) Negative; (09Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The event was treated with Paxlovid (lot number: GG0163) from 01Jul2023 to 05Jul2023. The patient tested negative of COVID-19 on 06Jul2023 and 07Jul2023. Rebound of COVID-19, positive again on 09Jul2023. The following medications was taken by the patient: N-Acetyl Cysteine (Country Life, lot number: 22C620A) from 01Jul2023 to 08Jul2023, Vit C And D from 01Jul2023 to 09Jul2023, and Zinc Lozenges (Nature's Way, lot number: 20168173) from 01Jul2023 to 08Jul2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300246185 same patient and drug; different dose and event;
Information has been received from a physician (degree not specified) concerning a 6 year old white female pt with no allergies and no past medical history who on 10/19/98 was vaccinated IM in the left arm with a first dose of varicella virus vaccine live (Lot # 627332/1243H). There was no illness at the time of vaccination. There was no concomitant medication. On 11/12/03, the pt developed 10 crusted lesions on her trunk and face. Medical attention was not sought and lab tests were not performed. On 11/15/03, the pt recovered. Additional information is not expected.
Patient had an Allergic Reaction  unknown cause . Onsite EMS was called vitals were taken BP 136/80 BG 74 HR 92. Patient treated, and released aginst medical advice.
Patient was administered 1 mL IM left arm of GARDASIL 9 instead of 0.5mL by Medical Assistant 1. She was also administered 1mL of Hep B in the same arm by Medical Assistant 2. Due to misdocumentation in patients chart by Medical Assistant 1.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored VAQTA (lot# L009445, expiry date: 01-JUN-2017, five doses) (Incorrect product storage). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006821, 1509USA006823, 1509USA006824 and 1509USA006825 (same reporter link). Additional information has been requested.
Fever to 103.4 evening of vaccine 11-4-15 101 at 7 am 11-5-15. No local reactioned noted.
Started to feel soreness in arm and throat about an hour after shot. Sore throat got worse overnight and worst one I?ve ever had hard times swallowing feels like throat is swollen but still able to breathe. A little stuffy and runny nose and ear soreness on left side. Drank emergen C in water and took a couple throat lozenges. Took a Tylenol for muscle pain last night around 9:30pm
PERSISTENT FEVER OF 99-100 DEGREES FARENHEIT; TIREDNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) 98-100 F. On an unspecified date, the subject experienced persistent fever of 99-100 f, and tiredness. Treatment medications (dates unspecified) included: Tylenol (paracetamol), and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the persistent fever of 99-100 f and tiredness was not reported. This report was non-serious.
Thrombocytopenia, platelet count 80,000, 9 days after shot.
cough; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and PAIN IN EXTREMITY (sore arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced COUGH (cough) and PAIN IN EXTREMITY (sore arm). At the time of the report, COUGH (cough) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was  not reported.
14 days after injection, large, itchy, warm rash at injection site - large, takes up a good portion of upper arm.  I am feeling a bit more tired than usual but no other symptoms.
There was not an adverse reaction to this vaccine but this dose was given beyond the storage date of 31 days in refrigeration. We contacted Pfizer and they approved use up to 34 days so this dose would be relevant.
This spontaneous report was received from a Speaker (other health professional) who was participating in an industry/regulatory/academic consortium via company representative referring to a unspecified patient of unknown ages and genders. The patients were immune compromised individuals. On unknown dates, the patients were vaccinated with unspecified commercial rubella vaccine; it was unknown if it was (Oka-Merck) PROQUAD, M-M-R II or one for another source. The lot numbers, expiration dates, doses, routes, frequencies were not reported. On unknown dates, the patients developed severe rash, and the reporting health professional stated that the causative agent of this adverse event, based on deep sequencing and specific Polymerase chain reaction (PCR), was the commercial rubella vaccine (it was not clear if it was (Wistar RA 27-3) M-M-R II or (Oka-Merck) PROQUAD). The outcome of severe rash was unknown. The reporter considered the rash was related to (Wistar RA 27-3) M-M-R 11 or (Oka-Merck) PROQUAD. Additional information has been requested.
Approximately two months after receiving the second dose of the Pfizer/BioNTech vaccine, I began experiencing a papular rash on my upper left arm.  The rash presents in 1-6 red, itchy, raised sites and has recurred approximately six times between June 25, 2021 and October 4, 2021.  The site was cultured in August 2021 but no pathogen was revealed.   The rash resolves on its own approximately 5 days from onset.
After about 25 minutes patient came back into pharmacy to report tingling and numbness in right arm. There was a palpable, large, red rash on right arm as well. Patient also complained about itchy top of throat. About 10:15am patient was injected with 50mg of diphenhydramine at site of injection. Pt's blood pressure was normal 148/98 at 10:00am and 147/90 at 10:03am. Patient felt much better in 10 minutes and 90% of rash went away. Patient's  husband drove patient home around 10:45am.
Within a few days post vax, pt developed and injection site reaction characterized by a large brawny induration and swelling.  The pt was treated with Augmentin and as of 11/11/1999 the symptoms were resolving.
Passed out September 24.  Nausea followed by dizziness followed by syncope.  Transported to a local Hospital by ambulance.  Follow up by cardiologist. Heart monitor for 30 days diagnosed with Afib.  Follow up with ECG  (normal).
Scheduled and received Covid booster shot (bivalent) and flu shot for the 27th of September 2022 and the 30th of September 2022, respectively. Notice itchiness and rash on the upper back on the 8th of October 2022. Started Benedryl (25mg) by mouth on the 10th of October 2022. Visited urgent care (virtual) on the 14th of October 2022. A prescription of prednisone (20mg, two tablets daily for 5 days) was given and recommendation of OTC Allegra (180mg, one tablet per day) and Benedryl. stopped taking the Benadryl after the 14th of October 2022. Prednisone alleviated rash and itchiness. After the completion of prednisone, I initiated Allegra on the 18th of October 2022 and through the 19th of October 2022. Allegra alleviated the rash and itchiness but I experienced nightmares both nights. Stopped taking Allegra on the third day, the 20th of October 2022. Attempted another dose on the 22nd of October 2022. Nightmares returned.
Vaginal bleeding, 1 episode of approximately 100-200cc, hysterectomy in 2014, no other symptoms, no abnormalities found at Dr appointment later that week
Pt had a major reaction to pneumonia shot. Dr said pt got cellulitis, red & swollen arm down to elbow.
A 65 year old female patient received one dose of AFLURIA (batch unknown) on 10-SEP-2010. The patient had a history of coeliac disease. Concomitant medications were unknown. The patient had previously had BENICAR tablets once before approximately 2 years ago and had a violent reaction in which she became nauseated, vomited and had profuse diarrhoea to the extent that she became dehydrated and had to be hospitalised. On 10-SEP-2010, the day of vaccination with the suspect drug AFLURIA, the patient also had additional suspect drug BENICAR at the same time. The patient developed the same reaction (violent reaction, nauseated, vomited, had profuse diarrhoea and was dehydrated). The patient sought medical attention. The patient recovered after stopping therapy. The event outcome was recovered. The patient suffers no lingering effects of the experience. The reporter was almost certain the reaction was due to a substance in the BENICAR. The reporter did not give a causality assessment to the suspect drug AFLURIA. The case was reported as serious due to significant disability or incapacity and was considered life threatening. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Pain on my right side of the back. Pain during movement of my back.; Pain during deep breathings; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 10Feb2021 at 10:30 AM (age at vaccination: 46 years), as a single dose for COVID-19 immunization at workplace clinic. The patient's medical history included Type 2 diabetes. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 20Jan2021 at 09:30 AM (age at vaccination: 46 years), as a single dose for COVID-19 immunization at workplace clinic. The patient did not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 12Feb2021 at 06:30 AM, the patient experienced pain on his right side of the back. Pain during movement of his back. Pain during deep breathings. The patient did not received any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Stretching in a way that is not normal for her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Stretching in a way that is not normal for her) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 021B21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Stretching in a way that is not normal for her). At the time of the report, VACCINATION COMPLICATION (Stretching in a way that is not normal for her) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.  The patient was running and she experienced stretching in a way that was not normal for her.
Patient received 2nd dose at approximately 4:07 pm administered by immunizing technician supervised by pharmacist.  At approximately 4:20 patient stated that she felt tightness when breathing. At this time of complaint, the patient said that she felt tightness in her chest when breathing but has asthma. The patient said that her breathing was getting better. Pharmacist administer 10ml of liquid oral  benadryl at 4:30 and at 4:36 to equal a total of 50mg. Monitoring of the patient continues, with patient stating that breathing is better.  At 4:47pm patient complains that the tip of her tongue feels numb. patient did state that she had no trouble breathing. At 4:55pm, patient complains that she thinks she might have trouble swallowing , at this point pharmacy called 911.  Emergency Medical Technicians came and patient  stated to the EMT that she does have anxiety and refused to go the hospital because she stated that she was feeling better. At 7:36 pm called and followed up with patient and patient states that her she has no problem breathing but her tongue feels a little numb  On 8/1/21, called patient and patient states that she is having aches and body pains and that her tongue was feeling numb still. Pharmacist urged patient  to see physician.
Events: upper arm very sore; upper arm painful in resting position and painful upon movement unable to sleep on right shoulder, fever at 99.5 degrees. treatment; taking regular strength Tylenol every 4 hrs; applying rubbing alcohol to upper arm near injection site and resting in bed. outcome; fever is normal after 4th day. upper arm is still sore on the 4th day but not  as painful.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 21-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 516 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
-tingling/twitching of fingers and toes -dizzy -foggy thoughts/slow response time -rapid heartbeats  -migraines  -ear inflammation -ear ringing
Patient came in for Chickenpox vaccine but received Janssen Covid vaccine. She already received Pfizer Covid vaccine on 3/29 and 4/19/2021.
fatigue; Severe throat pain, it's hard to swallow any liquid right now; It really hurts to talk; Severe throat pain, it's hard to swallow any liquid right now; It really hurts to talk; Diarrhea; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 30Dec2020 15:20 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the vaccine two days ago on Wednesday at about 3:20 PM and have been feeling like very fatigue. The patient added "like I know injection site pain is normal but I have been having diarrhea as well and severe throat pain, it's hard to swallow any liquid right now". The patient further stated that it started this morning with the throat pain and can't swallow anything and really hurts to talk. The outcome of events was unknown.
Mild fever, moderate headache, moderate dizziness, full body aches, mild nausea and anorexia, generalized malaise
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medication information was provided. The vial was initially thawed on 10Jun2023. No treatment drug information was provided.   The case corresponds to 23rd out of 30 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up received, updated vaccination date and initial vial thaw date information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Vaccine administered more than 6 hours after reconstitution (given 13h 24 minutes after).  The vaccine was drawn up immediately before administration.