chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BULGING VEINS IN LOWER LEGS; MUSCLE TWITCHING; NAUSEA; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle twitching. On 10-APR-2021, the subject experienced bulging veins in lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, nausea on APR-2021, and headache on 05-APR-2021, was recovering from muscle twitching, and had not recovered from bulging veins in lower legs. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
A fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient to whom fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Oct-2022, the patient received 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ919AD, expiry-30-06-23) (strength: unknown) via intramuscular route in the left deltoid for immunization.   On 17-OCT-2022 the patient developed a non-serious a fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event (product administered to patient of inappropriate age) (latency same day)  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  Outcome unknown    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 the 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.
Significant increase in throbbing pain after 2 days, Overall constant pain on left shoulder, difficulty sleeping on it w/o pain. Pain migrated into Left Bicep after approx 7 days. Approx 2 weeks after Vaccine Injection started feeling referred pain in neck and upper back on left side. No treatments suggested by Medical provider other than OTC Alieve. This treatment helped with mild relief, Pain is still present 30 days later.
Rash on stomach; Fever; Chills; Felt achy; Felt fatigued; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), PAIN IN EXTREMITY (Sore arm), RASH (Rash on stomach), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM, TAMOXIFEN and PROBIOTICS NOS for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2010, the patient experienced HEADACHE (Headache). On 22-Mar-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Mar-2020, the patient experienced FATIGUE (Felt fatigued). On 22-Mar-2021, the patient experienced PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills). On 24-Mar-2021, the patient experienced RASH (Rash on stomach). At the time of the report, PAIN (Felt achy), PAIN IN EXTREMITY (Sore arm), RASH (Rash on stomach), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were  provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR form received - Patient Declined to provide additional contact information.
This spontaneous report as received from an Epidemiologist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On the same day, the patient received influenza virus vaccine (name and manufacturer were unspecified, concomitant) along with ZOSTAVAX. The patient experienced rash around injection site after receiving ZOSTAVAX (date unspecified). At the time of the report the patient did not take medication for the treatment. The reporter inquired about how to treat the patient who came to the office on an unknown date. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. No PQC (product quality complaint) was involved. Additional information has been requested.
patient woke next day with swelling on right side of face, the following day, the left side of face was swollen as well as lips
The Moderna vaccine seemed to lower her blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (The Moderna vaccine seemed to lower her blood pressure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (The Moderna vaccine seemed to lower her blood pressure). At the time of the report, BLOOD PRESSURE DECREASED (The Moderna vaccine seemed to lower her blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: lowered Lowered blood pressure.         No concomitant medications was reported. No treatment drug details was reported.
Information has been received from a physician concerning a 6 month old female who was vaccinated PO with her first and second doses of ROTATEQ (lot# not available). Subsequently the patient experienced diarrhea for approximately 2 days after the first dose and prolonged diarrhea for approximately 2 weeks after the second dose. "They do not plan to administer the third dose of ROTATEQ." Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested. Follow-up information a consumer concerning a 6 month old white female (23.6 lbs. 32 in.) with a mild upper repiratory tract infection who on 24-APR-2007 in the evening (exact time unknown) was vaccinated PO with her second dose of ROTATEQ (lot# 656186/1235F). Suspect vaccination administered on that same day in the evening included the second dose of Hib conj vaccine (OMPC) (MSD) (lot# 654001/1019F) in the right vastus lateralis. Concomitant vaccinations administered on the same day in the evening included the second dose of PEDIARIX (lot# AC21B084BA) in the left vastus lateralis and the second dose of PREVNAR (lot# A5807714) in the right vastus lateralis. In May 2007, the patient experienced diarrhea for 3 weeks. No medical attention was sought. Laboratory diagnostic studies performed on 14-MAY-2007 included a negative stool culture, negative ova and parasite test, and negative results for C difficile toxin and rotavirus. Subsequently the symptoms resolved and the patient recovered. Additional information has been requested.
This spontaneous report has been received from a 78 year old female patient referring to herself who was pre-diabetes and had many unspecified reactions/allergies. In December 2016 the patient was vaccinated with ZOSTAVAX (one dose, subcutaneous, lot# not reported) as prevent shingles. Concomitant therapies included CYMBALTA, SYNTHROID and ATIVAN. It was reported that the patient developed shingles across her back, a week after receiving the ZOSTAVAX vaccine (in 2016 or 2017). There was unspecified treatment given for the event. Thyroid check was performed. The patient was talking with the physician to seek medical attention. The outcome of the event was recovering. The causality was not reported. Additional information is not expected as there is no consent for follow up.
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is everywhere, hands, feet, legs, whole body,skin rash,real bad rash), RASH PRURITIC (bad rash in the whole body. It was itching), VACCINATION SITE PAIN (pain in the left arm) and MYALGIA (sore) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced RASH PRURITIC (rash is everywhere, hands, feet, legs, whole body,skin rash,real bad rash) and RASH PRURITIC (bad rash in the whole body. It was itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the left arm) and MYALGIA (sore). The patient was treated with ANTIHISTAMINES for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash is everywhere, hands, feet, legs, whole body,skin rash,real bad rash), RASH PRURITIC (bad rash in the whole body. It was itching), VACCINATION SITE PAIN (pain in the left arm) and MYALGIA (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Antihistamine. Also said 2 allergy medications. No concomitant drug details were reported.
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 29-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Initial and follow-up information has been received from a registered nurse concerning several females who were vaccinated with 0.5 ml doses of Gardasil.  Subsequently the nurse reported that the needle is "dull after withdrawing the medication from the vial and is causing the patients extreme pain".  The office was replacing the needle on the syringe in order to lessen the pain.  Unspecified medical attention was sought.  At the time of the report the patients' outcomes were unknown.  Additional information has been requested.
No adverse effects reported; the patient was administered an improperly stored dose of Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S015460 and expiration date 20-MAY-2021 (exact dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. No adverse effect were reported. The temperature was from 6°F to 14°F (7.4F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved.
Child had 2 doses of VARIVAX  07/12/2014 and 08/08/2017. On 05/08/2018- child was seen in office with mild case of varicella- 20-25 pox on trunk and bilateral thighs, 3 crusted, most vesicular, 3-5 new.
On the first day, I started having pain in the center of my chest. On the second day it was not come and go anymore, it was just sharp to the point I could not even inhale. 3 days after that the pain moved to different parts of my chest, it is come and go, but the pain is persistant, sharp and painful. It has been 3 months and I have not yet recovered from it. I have been to urgent care over 3 days, ER once, and now I am seeing a personal doctor about it.
Severe pain in right deltoid/shoulder with hypersensitivity, limited ROM of shoulder.
3/9/15 developed local reaction (2 small bumps on L thigh). 3/10/15 developed urticarial rash over much of body, lasting 3-4d. No other clear source for urticarial (pt otherwise well, no new foods/meds). She was seen by her allergist who felt this was c/w rxn to vaccines (vaccines given included VZV, Flu, MMR, HIB) & requested a report be made.
8/22 - MENACTRA site felt tingly right away and spread to other arm - the same day - during night - had headache, SOB, dizziness and racing heart. 8/23 - legs felt "weird", numb/heavy from pelvis down similar feeling in arms. Paresthesias and generalized weakness persisted x 2d.
was cold and clammy; Clammy; diaphoretic; having to clear his throat; blood sugar was 245; blood pressure was 175/111; runny nose; delayed allergic response; This case was reported by a nurse via other manufacturer and described the occurrence of cold in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included partial gastrectomy and stroke. Previously administered products included Flu vaccine with an associated reaction of no adverse event (kind of vaccine with no reaction) and Hepatits vaccine with an associated reaction of no adverse event (kind of vaccine with no reaction). Concurrent medical conditions included dementia, diabetes (since from 2005) and allergy nos.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure, runny nose and allergic reaction. On an unknown date, the outcome of the cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure and allergic reaction were recovered/resolved and the outcome of the runny nose was unknown.   It was unknown if the reporter considered the cold, clamminess, diaphoresis, throat clearing, blood sugar increased, increased blood pressure, runny nose and allergic reaction to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's spouse. The age at vaccination was not reported but it could be 71 or 72 years old. The patient was allergic to various things and would had to clear patient's throat. The patient has not had the reaction in the past to the vaccines received and he had every kind of vaccine with no reaction. The patient did not have the reaction to the Flu or Hepatitis vaccines. The patient received 1st dose of Shingrix vaccine that summer and had clod, clammy, diaphoretic, he was having to clear his throat. The patient dose had the little dementia and was diabetic and his blood sugar was 245, his blood pressure was 175/111 and he had a runny nose. The patient did not have any chest pain. The patient was unable to explain what was happening. The patient's spouse checked his blood pressure again manually and the results were the same. The patient went to the hospital and they monitored the patient and they said that was not because of the vaccine. The patient did not have NDC, lot or expiry to provide. The reporter tried to saw if there were components that match up but she did not see any components that were the same. The reporter consented to follow up. For further tolerance of 2nd dose, refer case US2021AMR032634, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032634:Same patient, same reporter, same product, different dose (2nd dose)
pt presented to clinic 9-8-2008 with about a 6 cm red, raised, warm area around injection site.  pt also reported arm pain from shoulder to hand.  pt advised to take ibuprofen 800mg tid and use ice on area tid, if no better follow up in clinic in 2 days.  pt returned to clinic on 9-11-08 with less redness, but still had pain from shoulder to elbow.  diagnosis brachial neuritis.  9/22/08 Office records received for DOS 9/8 & 9/11/2008 with DX: Reaction to Adacel causing Brachial Neuritis.  Pt initially presented 3 days s/p Adacel and HPV vax with c/o injection site redness and arm pain.  Instructed to use ice and ibuprofen and RTO in 48 hrs if not better.  Seen 9/11/08  for recheck.  PE (+) for 8x8cm area of warmth, redness and pain with palpation initially, now reduced in size but with numbness and tingling in the hand
Same day & after administering immunizations, infant was irritable & cried inconsolably for 4 hrs. He wouldn't nurse for 14 hrs.
Breathing issues; Swollen lips; Severe hives in throat, in mouth and in nose. Very large on hives on face  not going away; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old non-pregnant female patient received BNT162B2 (Lot. EP7534) on an unspecified date, in 2021, at single dose, for COVID-19 immunisation. COVID-19 vaccine was administered at Hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included multiple sclerosis from an unspecified date and sulfa allergy from an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were unknown. On 15Apr2021 at 17:30, the patient experienced breathing issues, swollen lips, severe hives in throat, in mouth and in nose. Very large on hives on face not going away. Physician office/clinic visit required. Treatment was received (high doses steroids). The patient did not recover from the adverse events at time of this report. Post the vaccination, the patient has not been tested for COVID-19.
PATIENT DESCRIBED IT AS A SWOLLEN TONGUE THAT FEELS AS IF SHE BURNT IT. ULCERS ON TONGUE WITH SORENESS. SYMPTOMS WERE NOTICED 24 HOURS AFTER VACCINATION, BUT WORSENED ON DAY 5.
Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to patient past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 003C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The BUD was reported as 08-Apr-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information was provided. Date Stored in Standard Freezer for the lot 003C21A was 2 degrees F high, -1 degrees F low on 22-Apr-2021.  No treatment medications were reported.
Very mild, not noticeable lip swelling after 3-5 min after ZOSTAVAX administration. Pt reported no difficulty breathing no major face, mouth, tongue swelling. Gave patient 25 mg diphenhydramine and monitored patient for 1 hour. Asked at several different times if condition was worsening. Patient said no, it was improving.
After the 2nd injection on April 29, 2021 on appx May 2nd, I woke up at 2am in severe pain in my right hip joint.  Every single time I tried to turn over, reposition myself or get out of bed to use the restroom, I felt pain in my hip. It hurt so bad that it felt like someone was stabbing me directly in the joint!  I began to take between 600 - 800 milligrams of Ibuprofen at night before bed.  Sometimes it helps. It can be so severe that I wake up moaning and crying from the pain.  It has NOT subsided yet.  I just began taking 2 Acetaminophen arthritis pain tabs at night as well as turmeric for the pain every night.  What is so extremely crazy is that the pain is not as severe during the day ONLY when I'm lying down?!?!?!
pt recvd vax & was sleepy that evening woke 7PM screaming; thought was going to vomit; kept asking for mom even when she was there; eyes were glassy; t102.4 orally; APAP given; these sx lasted 1/2 hs cont to be sleepy; had restless noc;