chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 11 days after receiving the shot, I started experiencing chest tightness/pain. The pain persisted for four days and I went to urgent care. Urgent Care referred me to ER to screen for blood clots. After returning from ER, I started feeling sharp pains in multiple places all over my body?hands, fingers, toes, feet, calves, shins, forearms, back. Chest pain also continued.   The chest pain has subsided, but I still experience shooting pains in arms, legs, hands, feet, toes, fingers, and occasionally my back.  Pain is a 3-4/10 on average, but persistent. Some days are better than others. Some days the pain is mostly in a forearm (sometimes both) and the next day it's in a leg (sometimes both). Some pain seems to be in/along muscles, some in/along bones. It sort of feels like there's a small electrical storm in my body.   Movement does not seem to have any effect on the pain.
hurts like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a Shingles vaccine shot and stated it hurts like crazy. The follow-up could not be possible as no contact details were available.
Patient was done receiving vaccine at 0921, approximately 5-10 minutes later reported feeling flush, metallic taste in mouth (first symptom), heart racing. VS taken: 152/93, HR 120. Pt seated, calm, given water to drink, speaking full sentences, NAD and no difficulty breathing or swallowing. At 0948 VS: 132/91, HR 96, SpO2 98% room air. At 0955, patient continued to feel waves of heart racing, HR on monitor 90-108, SpO2 98%. At 1002, notified ED charge nurse that patient will be escorted for further monitoring, work up if necessary. Still no respiratory or swallowing symptoms. At 1002, patient escorted to ED by RN, ambulated without difficulty. Upon ED arrival, patient reported feeling "fine" without symptoms.
Pharmacist gave patient the vaccine in the left arm intramuscularly. Moments after the injection the patient felt a discomfort. Patient reported that there was swelling along the arm when she got home. Patient had a fever of 102. Patient took Tylenol 500mg three times a day to treat the fever and pain. Days after the pain still persists but the patient is able to return to work now.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M040267 with expiration date on 14-MAY-2018; and lot # M025563 with expiration date on 06-NOV-2017) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015171: US-009507513-1705USA015170: US-009507513-1705USA015169: US-009507513-1705USA015168:
Patient has not reported any event.  The wrong  vaccine was administered. The Pediatric Pfizer was administered to an adult patient
Prolonged emesis occurring day following vaccination. Patient was instructed to contact primary care provider or emergency department.
9/4/13 onset of rash, abdominal cramping diarrhea, headache. 9/5/13 total body itchy rash including hands palms of and feet bottoms - Seen in Occ Health states she was treated last week for sinus infection and was treated with Amoxicillin for which she says was allergic as a child. Tested by allergist - skin tested and blood work tested - No longer considered allergic. Seen by doctor, Infectious Disease, feels it is measles.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6204), at the age of 50, via an unspecified route of administration, in the right arm, on Mar 11, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient has no medical history or known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications. On Mar 11, 2021 at 12:00, patient experienced underarm lymph lump in right arm pit. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, patient has not tested for COVID-19. The outcome of underarm lymph lump in right arm pit: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
joint nerve pain in left shoulder/neck/elbow/back starting several hours after the first covid 19 vaccine was received in the right arm.  started taking tylenol after 14 days because the pain was getting worse but switched to advil as tylenol was not helping with the pain.  after a couple weeks, the pain was still present even with the advil.  so went to my primary doctor today (3-19-21) who prescribed gabapentin for the pain as i am scheduled to receive the second covid 19 shot next week.
61-year-old male with a history of chronic intermittent dizziness/weakness/falls with related hospitalizations and clinic visits, severe episodes of recurrent MDD, chronic myofascial pain on narcotic pain agreement, type 2 diabetes, uncontrolled, with neuropathy, nephropathy and chronic left hallux amputation site ulceration, hypertension, HLD, PAD, CKD 3, IDA, presented to the ER with worsening dizziness/weakness and several falls over the last 24 hours. Felt this episode is the same as priors, except he experienced vomiting with this one. Completed stroke w/u negative for acute neurologic event. CXR and u/a negative for infection.
Received both doses and still get shingles/Suspected vaccination failure; Get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine (dose received on unknown date years before reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient received the original shingles vaccine years ago from date of reporting, then two years ago. The patient received both the doses of Shingrix and still got shingles.  The patient wanted to ask that, was there anything that he/she could do perhaps booster. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as permission denied.
Dizziness; Pain in neck; Pain in legs; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Pain in legs) and ARTHRALGIA (Pain in shoulder) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00121A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Pain in legs) and ARTHRALGIA (Pain in shoulder). At the time of the report, DIZZINESS (Dizziness), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Pain in legs) and ARTHRALGIA (Pain in shoulder) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is skeptical about second dose because of the events. She stated she normally walks 4 miles a day. Patient wanted to knowthe effectiveness after one dose. No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a 36-month old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Jan-2008. The reporter stated that she received 100 doses of FluMist from the vaccines program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinical did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006659; MEDI-0006669; MEDI-0006670; MEDI-0006671 MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Information has been received from a RN concerning a 78 yr old female with some food and environmental allergies and no medication allergies, who on 24Feb06 was vaccinated IM into the upper outer quadrant of right thigh with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). On 27Feb06 the pt presented to the office with right thigh pain, right thigh warmth and swelling at the injection site. The pt was treated with warm compress and oral diphenhydramine hydrochloride (Benadryl) as needed. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Thyroiditis subacute; This is a spontaneous report received from a contactable consumer or other non-health care professional. A contactable consumer reported different events for 29 patients. This is 3 of 29 reports. A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 44-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thyroiditis subacute on an unspecified date. Calculated Time to onset: 2 Months. Summary: Subacute thyroiditis (SAT) was a typically painful inflammatory condition of the thyroid. A safety signal of subacute thyroiditis following vaccination with the novel mRNA and vector-based COVID-19 vaccines was found during a screening of the regulatory authority database of individual case safety reports. Subacute thyroiditis (SAT) was an inflammatory disease of the thyroid caused by viral infections or autoimmune reactions. Up to 08Jun2021, VigiBase, the regulatory authority database of individual case safety reports, contained 29 reports of SAT (MedDRA preferred term (PT): thyroiditis subacute) following immunisation with the novel COVID-19 vaccines. Furthermore, VigiBase comprised 50 cases reporting the PT autoimmune thyroiditis and another 50 cases reporting the PT thyroiditis following COVID-19 vaccination up to 08Jun2021. In 30 of the 50 cases reported the PT autoimmune thyroiditis. The cases reported the MedDRA PT thyroiditis subacute as it was the only PT found to be disproportionately reported. In-depth analysis of the other mentioned PTs can be made available on demand. The radioactive iodine uptake (RAIU) test was a reliable test to differentiate between causes of hyperthyroidism. Low uptake suggests thyroiditis and high uptake suggests Grave's disease. In the current case series, RAIU was performed in three cases confirming the diagnosis of SAT. The presented signal was aimed to increase patient's and healthcare professional's awareness of the will be necessary. The potential benefit of the COVID-19 vaccines was considered to outweigh the possible associated risk of subacute thyroiditis. The outcome of the event was reported as not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Patient no adverse symptoms Patient was given too much vaccine 1mL instead of 0.5 mL
Patient reports 104 fever, cold sweats, achy back, headache, chills, insomnia, and loss of appetite. Left arm was hot to the touch and painful to move. Symptoms started 12/8/2020 8pm and continued until 12/11/2020 9am.
Information has been received from a physician concerning a 18 year old male patient who on 30-JUL-2010 was vaccinated with a dose of GARDASIL (Lot# unknown) and a dose of VAQTA (manufacturer unspecified). The physician reported that shortly after the patient received the dose of GARDASIL on 30-JUL-2010, the patient had fainted. The physician reported that the patient was given some Coke and something to eat and within a half hour the patient was fine and was able to leave the office (on 30-JUL-2010). There were no laboratory tests or diagnostic studies performed. The patient sought unspecified medical attention. Follow-up information has been received concerning the male patient with no preexisting allergies, birth defects or medical conditions and no illness at time of vaccination who on 30-JUL-2010 was vaccinated intramuscularly into his left deltoid with his first dose GARDASIL (lot number 663559/1178Y). Suspect secondary vaccination included a first dose IM of VAQTA (lot number 667262/0245Z) IM, in the right deltoid. Concomitant therapy included an IM first dose of ADACEL (lot number C3629BA) in the right deltoid. It was reported that immediately after receiving GARDASIL, the patient fainted. Fainting lasted about three seconds and the patient kept in office for 40 minutes. No laboratory tests were performed. On 30-JUL-2010 the patient recovered. Additional information is not expected.
This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age. No details or demographics were provided for the patient. On an unknown date, the patient was vaccinated with ZOSTAVAX, dose (unknown) and router of administration (unknown). No concomitant medications were reported. On an unknown date (also reported as the next day), the patient developed rash at the injection site and pain in her neck. No details given for which pharmacist administered the ZOSTAVAX vaccine. No time frame was provided. No further symptoms or treatments provided. Action taken with respect to ZOSTAVAX was not applicable. No Product quality complaint was involved. The outcome of events was unknown. Causality was not provided. No further adverse event information was provided. Additional information has been requested.
Pt had first Pfizer vaccine on 4/10, 2nd dose give on 4/26/2021
Patient called next day (8/27). States that within 30 minutes of receiving FLUZONE, she got "real sick" with extreme diarrhea (soiled clothing), shakes/sweats went home and to bed. Sick all night. Better next day.
Patients left arm was swollen, red, warm and hard to touch - no rash noted.  Diagnosed with Cellulitis.  Treated with Augmentin 600mg/5ml, UML twice a day for 10 days, Atarax as needed.  Mom reports rash before this.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. The healthcare worker reported that, on unknown date, ROTATEQ (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion hs been administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
The next day severe headache or Migraine. Could not get out of bed. Arm was unusually red and sore. Went to the doctor that week, symptoms lasted 2 weeks. Had an all over body rash, hot and inflamed. Vaccine site stayed red for months. No medication was given, only to take Ibuprofen.
All over body Aches, Left arm Quarter-sized redness & swelling, Sore Throat, pain reported in both arms but swelling occured in Lt arm where Tdap was given.  No allergies reported on screening No history of reactions to Dtap as a child.
mom phone stating pt has been having pale & blue skin color; instructed to taken pt to ER;
REDNESS, SWELLING, WARMNESS TO THE TOUCH. REDNESS EQUIVLAVENT TO THE SIZE OF PATIENTS HAND ON HIS LEFT BICEP. PATIENT WAS SEEN IN THE EMERGENCY ROOM. GIVEN ZYRTEC 10MG - 1 TAB EVERYDAY FOR 5 DAYS THEN PRN. CLARITIN 150 MG - 1 TAB BID FOR 5 DAYS.
FATIGUE; HEADACHE; MUSCLE SORENESS ALL OVER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug usage . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: 21-OCT-2021) dose was not reported, administered on 11-SEP-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced fatigue. On 12-SEP-2021, the patient experienced headache. On 12-SEP-2021, the patient experienced muscle soreness all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, headache, and muscle soreness all over on 13-SEP-2021. This report was non-serious.
Case number PHEH2013US016402, is an initial spontaneous report received from the pharmacist on 31 JUL 2013. This report refers to an unspecified age and gender patient. Past medical history and concomitant medication were not reported. The patient received only MenCYW-135 liquid conjugate component of MENVEO (batch number: M12129) on an unspecified date. The patient did not receive Men A lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error. No additional information was available.
hand tremors 14JUL95-17JUL95 & loss of balance; vax given 19JUN95
Itchy abdomen on R side not itchy prior to vaccination. Given 50 mg BENADRYL elixir PO at 5:27 pm. By 6 pm no longer itchy. Will go home w/mom to eat. Call 911 if prob reoccurs.
The next day I got the vaccine, I started to feel acidic in my stomach. At first it was a very mild annoyance and now it is moderate. Apparently it is a gastroesophageal reflux.
Patient noticed red blotch on right eye at 5:10pm. He came back to us at around 5:39pm because he was worried the blotch has expanded the length of his lower lid. First thing the patient was asked if he wanted us to call 911. The patient refused. The pharmacist asked if he was okay, he stated he was fine & felt no different, just the spot on his eye. The pharmacist asked again if he wanted us to call 911, he refused a second time. The Pharmacist ask if he's ever gotten a red blotch in his eye and patient said he rarely gets them, about three times a year. He was asked if this has ever happened with getting vaccines, he said he doesn't get vaccines. He was asked if this has happened when he takes any medication, the patient said he doesn't take medication. The pharmacist asked if he has told his doctor about this, the patient stated he has not told his doctor because it goes away on its own
5min post vax pt was standing by doorway while cousin was being immunized;a thump was heard & pt was seen lying on back;ammonia inhalent strips were used & pt responded quickly to verbal stimuli & aware of surrounding;referred to ER;
Inflammatory nodules; This spontaneous case was reported by a physician and describes the occurrence of NODULE (Inflammatory nodules) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Restylane Lyft.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NODULE (Inflammatory nodules). At the time of the report, NODULE (Inflammatory nodules) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient took moderna covid-19 vaccine. case is valid.