chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed severe generalized pain in chest, most severe centrally around 10 pm.  Pain scale 8/10. No nausea or sweating BP 200/98. Rechecked in approximately 10 minutes and had decreased to 160/82.  Pain lasted about 30 minutes, lessening gradually. Felt extremely  weak afterward. Continuing to have weakness and lethargy today (pain last night), but no pain.
Received injection listed and the very next morning demonstrated temp of 105and febrile seizure. Hospitalized for one day. physician unable to associate symptoms with illness.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L002310, expiration date: 08-JUL-2016), dose and route were not reported. On 12-AUG-2015, the patient came back to the office with a 'skin and local reaction, warmth and minimal pain'. The outcome of the events was not reported. The causality assessment was not provided. Additional information has been requested.
severe prolonged cricopharyngeal spasm; This is a spontaneous report from a contactable physician (patient)  A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 09Feb2021 at single dose for covid-19 immunisation at hospital. Medical history included rheumatoid arthritis, allergy to penicillin, asthma vaccine, pollen, cats, sea food and latex. Concomitant medication included methotrexate (unknown manufacturer) and methylprednisolone (unknown manufacturer). The patient experienced severe prolonged cricopharyngeal spasm on 09Feb2021 with outcome of recovering. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe prolonged cricopharyngeal spasm and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Information has been received from a physician concerning a 62 year old male patient with a history of carpal tunnel syndrome and no known drug allergies who on 19-OCT-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot# 663888/0627Y) IM into the right arm. Concomitant therapy included FLONASE, PREVACID, ZYRTEC and Alprazolam. On 21-OCT-2009 the patient developed redness at the injection site of the right upper arm. ON 02-NOV-2009 the patient developed widespread arthralgia. A complete blood count was normal. The patient was referred to an unspecified rheumatologist and was prescribed unspecified corticosteroids. At the time of the report, the arthralgia had not improved. Follow-up information has been received from a physician who reported that the patient's whole upper arm was red. At the time of the report, the patient now had hypertension, hyperkalemia and thrombocytopenia. The patient continued to have arthralgia. The patient visited the physician. At the time of the report, the patient had not recovered. Widespread arthralgia was considered to be disabling by the reporter. Follow-up information has been received from a physician concerning a 62 year old male patient with allergic reactions to CODEINE and TETRACYCLINE who on 19-OCT-2009 at 15:00 PM was vaccinated with a dose of PNEUMOVAX 23 (lot# 663888/0627Y) IM into the deltoid muscle. On 19-OCT-2009 afternoon the patient reported that he experienced erythema and fever, which lasted for 1 to 2 days. At the time of the report, the patient's myalgia, fever and erythema were resolved. Additional information has been requested.
The patient was given a vaccine that was left in the freezer too long  and was expired.  There has been no adverse reactions reported .
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.
SkinRash, Rash,  pt developed rash on face chest,abdomen and forearms the following day she recieved vaccine. Went to urgen care and treated with antibiotics by mouth and medrol pack. Called clinic today 1/15/21 and reported all her symptoms resolved and she's back to wor Narrative:
Nausea, 102 fever for 3 days, headache, exhaustion, irregular EKG, viral infection, rash, hives, mouth sores, cold sores, burning mouth and gums, unable to chew, sores on gums
Hives. Starting on my face on 12/24 & progressively getting worse & spreading EVERYWHERE. Face, chest, neck, back, genitals, etc except for my legs. Insane itching. Antihistamines barely provide any relief. Facial swelling . I am currently receiving xolair shots & they do help alleviate the symptoms
Father states that child was at Orthodontist office for afternoon appointment and suddenly felt sweaty with "clastrophobic sensation." Was seen at Urgent Care and diagnosed with adverse reaction to H1N1 vaccine. No previous similar reactions to vaccines. Was treated with Benadryl. Symptoms improved prior to administration of Benadryl and continued to improve.
This non-serious initial spontaneous case, was received on 01-NOV-2017, from a Pharmacist, concerning a patient of unspecified age and gender. On 31-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). It was reported that pharmacy temperature was 70-degree F. Multi dose vial (MDV) was left out on the pharmacy counter for 1 hour and 20 minutes. Hence first temperature excursion occurred and was administered to the patient. It was reported that MDV had been used that morning (as reported), that was left out, administered to the patient and was finally discarded.
Information has been received from a nurse practitioner (NP) concerning an approximately 6-month-old female who on approximately 27-Nov-2006 was vaccinated PO with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The NP reported that on approximately 29-Nov-2006, the patient developed bloody stool. Unspecified medication attention was sought and a stool Clostridium difficile toxin test was performed (results not provided). At the time of this report, the patient's bloody stool persisted. Upon internal review, bloody stool was determined to be an other important medical event (OMIC). Additional information has been requested.
I had a very severe reaction from ADACEL vaccination that included severe skin rash, red bumps, hives, on my chest, neck back, arms and head, scalp was itchy, dandruff which I've never had. Metal taste in my mouth the first day. It has been 1 month since I had the vaccination, it has gotten a little better but still have small red bumps on my chest and back, and have some hives but not as much as the first 2 weeks, it was horrible, felt like bugs crawling on me. I had some testing done at my chiropractor office and it was confirmed I had heavy metal in my system from the Aluminum phosphate in the vaccine and other ingredients. I was given some ALLERPLEX supplements and ChelaCo supplement to detox my body and a foot bath that revealed I had metal in my system. I've used Aloe Vera and lavender oil and other natural treatments which has helped me to relieve the itchiness I have been feeling.
Acute onset transient hives one hour after immunization.  Administered in left leg swelling for 24 hours benedryl and tylenol with relief
Tachycardia, muscle and body aches, extreme fatigue, extreme chills and sweats, chest pain (started around 2 pm the day after vaccination and still persisting), heart palpitations, headache, loss of appetite.
swelling of the joint at the base of left thumb; Pain with movement, especially with carrying a mug or large glass; This is a spontaneous report from a contactable physician (patient). This physician reported that a 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration, on 24 Dec2020 08:15 in left arm at single dose, for COVID-19 immunisation, at workplace clinic. Medical history included sulfa allergy; hypothyroid; high cholesterol; mitral valve prolapse. There were no other vaccine in four weeks. Patient was not pregnant. There was no COVID prior vaccination. Concomitant medications included levothyroxine; liothyronine; atorvastatin calcium. The patient previously took nitrofurantoin and experienced allergy to it. Patient reported that swelling of the joint at the base of left thumb starting at 10:00 AM on 26Dec2020. Pain with movement, especially with carrying a mug or large glass. Some improvement with time but still present on 13Jan2021. There was no treatment received. Outcome of the events was recovering. COVID-19 was not tested post vaccination.
Patient left facility after vaccine and had only waited 12 minutes in lobby.  Patient states she walked to her car to go home and developed metallic taste in her mouth with nausea and diaphoresis.  Patient came back into the clinic.  She was placed in the cardiac care chair.  Denies any shortness of breath, chest pain, difficulty swallowing or hives. Skin warm but she is diaphoretic.  BP 144/70, pulse 71, pulse oximeter 100%.  Patient states she still has nausea and feels like vomiting.  After 10 minutes, patient transferred to ER at hospital.
Patient presented to Emergency Center with chest pain and shortness of breath on 3/25/22, and tested positive for COVID on 3/25/22
Area Red approx. 2-3 inches round. Arm swollen in area of vaccination. Some itching.
Day after vaccine (12/7/12) pt had redness around injection site extending 2 inches around. Day 2 (12/8) pt had redness on the whole back of the arm from elbow up to armpit. Injection site had a blister that started at dime size and grew to size of silver dollar. Sent pt to urgent care and they never saw anything like it. They gave her steroid shot & told her to take BENADRYL. Day 3 (12/9) redness not as bright but blister still silver dollar size.
Dizziness Migraines Swelling in back of head and Neck Severe Chest Pain Symptoms get very unbearable around 2pm, need to sleep to continue day.
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot#, dose and route not reported) series which was improperly stored. No adverse events were reported. This is one of several reports (triplets patients, MARRS# 1502USA004588, 1502USA009115 and 1502USA009116) received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-DEC-2015 during the same visit, the patient was vaccinated with PROQUAD (Merck) lot # L027634, expiration date: 21-JAN-2017 and VARIVAX (Merck) lot # K010442, expiration date: 22-JUL-2017. No adverse experience was reported. Additional information has been requested.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case was linked to cases 2018SA292282, 2018SA292283 and 2018SA292284 (same reporter). This case involves a 32 years old female patient who accidentally received vaccine FLUZONE HIGH DOSE along with other three patients. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No vaccine was concomitantly given during that time. On 18-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UJ038AA (expiry date: 03-May-2019) via intramuscular route in the left deltoid. It was also reported that one of the patients received FLUZONE QUAD  appropriately for their age but unable to report which of the patients received it at that time. It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose accidental. It was unknown whether patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore left arm continues 5 days after injection; chills, sore joints started within 24 hours after injection.
Pt received flu shot at approximately 11am - at approx 2:30pm felt itching around shoulders which spread down her arm palms also - to rash on site.
lot expired 10/13 and given to pt on 10/19, moderna investigation confimed the lot should give full coverage. no adverse event reported
This case was reported by a physician via sales rep and described the occurrence of leukopenia in a 17-year-old male patient who received BEXSERO (batch number 149001, expiry date 30th September 2016). Concomitant products included HPV Vaccine. In March 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In March 2016, 1 day after receiving BEXSERO, the patient experienced leukopenia (serious criteria GSK medically significant and other; serious as per reporter) and fever. On an unknown date, the outcome of the leukopenia and fever were recovered/resolved. The reporter considered the leukopenia to be probably related to BEXSERO. The reporter considered the fever to be possibly related to BEXSERO. Additional details were provided as follows: The reporter stated the patient did not have a history of cancer. The patient received the 1st dose of BEXSERO in a series of 2 doses. The exact date of vaccination was unknown but was sometime in March 2016. On the same day, the patient also received a HPV vaccine (non-GSK) in a separate arm. Within 24 hours (unknown if it was after vaccination or event onset), the patient visited an urgent care where it was discovered he had febrile leukopenia with a complete blood count (CBC) at 2.9. The physician had seen the patient since administration and the adverse event was resolved. The physician reported that he knew that the patient did not have any reaction to an other previous vaccination. It was not known if the patient was on any other medications.
Light headed and dizzy. BP 60/40. Pale white, felt like she couldn't breathe.  Hot and cold. Fingers tingled.
Before bed patient realized that his arm was swollen, red and sensitive to touch (w/ shirt or hand). Patient took TYLENOL to try to ease the pain.
Throat swelling, felt like closing up, tingling roof of mouth and tongue swelling at back of mouth with tingling - Took Benadryl and Tylenol seemed to get better but 12 hours later happened again. Still have swelling in right side of throat minor but still swollen
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For 1st dose, refer case US2018219433). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX. On 3rd February 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain, chills, tremor, fever, pain in arm and drug dose administration interval too long. In February 2019, the patient experienced injected limb mobility decreased, nausea, dizziness and influenza-like symptoms. The patient was treated with ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fever and drug dose administration interval too long were unknown and the outcome of the chills and tremor were recovering/resolving and the outcome of the pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, tremor, fever, pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient received the 2nd dose of SHINGRIX late than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced the same symptoms (pain in arm, injected limb mobility decreased, nausea, dizziness, flu like symptoms), which she had received after receiving the 1st dose of SHINGRIX. Within a couple of hours of receiving the vaccine, she experienced some aching in her left arm in which she received the vaccine in the muscle. She then experienced chills and shakiness throughout her body. Her temperature had gone from 99 to 101 which had lessened the chills and shaking. The patient received treatment with ibuprofen the night before the date of reporting, before she went to bed. She was taking it about for every 5 hours as needed. There was soreness around the injection but the pain was not as with the 1st dose of SHINGRIX.
A report has been received from a physician concerning a patient of unknown gender and age. Medical history of the patient was not reported. There was no information on the concomitant medication. The physician reported about two patients (this case related one of them) who experienced nosebleeds immediately after receiving FLUMIST (Intranasal). Action taken with FLUMIST and outcome of the event was unknown. The report was considered to be non-serious by the reporter.
administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 168 doses/vials were given for LOT  048C21A.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
This spontaneous report as received from a other health professional (medical student) refers to a currently 15 years old male patient with T cell precursor lymphoblastic leukemia (ALL) undergoing chemotherapy. On an unknown date the patient's brothers were vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) lot # dose not reported, it was not known if the patient had been vaccinated. On an unknown date, the patient experienced disseminated varicella (hospitalization) and died (on an unspecified date). The cause of death was unknown. At the time of the report the outcome for disseminated varicella, patient's brothers were vaccinated with a dose varicella virus vaccine live were unknown. Additional information has been requested.
Immediately following the patient's second dose of the Pfizer vaccine on 5/12/21, the patient experienced B/L hand and foot numbness. The patient was given Duloxetine by her PCP to address her side effects. The patient reported Duloxetine helped, but she was still experiencing B/L finger numbness. The patient reported she has never experienced these symptoms before.
Patient had appointment scheduled at another facility for 21 day interval because it scheduled based on Pfizer, his first dose was moderna, they almost gave him Pfizer. He came here and all our safety check failed and he received the  mderna vaccine   21 days from 1st dose. We realized after a few dates the error. Patient was contacted and reported no issue or side effect more than after the first dose.
no additional AE's were reported; received a dose of RECOMBIVAX HB after expiry; This spontaneous report was received from a nurse, referring to a patient with unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapy and drug reactions/allergies were not reported.  On 03-JAN-2023, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (thimerosal free) (0.5 milliliter (ml), lot number U008328 has been verified to be a valid lot number, expiration date was reported as 16-DEC-2022, anatomical location was not provided) intramuscularly for prophylaxis (expired product administered). No additional adverse event (AE) details were provided and no additional AE's were reported (no adverse event).