chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarhhea; Body aches; Bad headaches; Felt very fatigued; Chills; Very tender arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Very tender arm), DIARRHOEA (Diarhhea), MYALGIA (Body aches), HEADACHE (Bad headaches) and FATIGUE (Felt very fatigued) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol since 2000. Concomitant products included PRAVASTATIN from 2010 to an unknown date, TAMSULOSIN from 2019 to an unknown date, VITAMIN C [ASCORBIC ACID] from 1990 to an unknown date, MULTIVITAMIN [VITAMINS NOS] and GLUCOSAMINE HYDROCHLORIDE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Low grade fever). On 05-Mar-2021, the patient experienced TENDERNESS (Very tender arm), MYALGIA (Body aches), HEADACHE (Bad headaches), FATIGUE (Felt very fatigued) and CHILLS (Chills). On an unknown date, the patient experienced DIARRHOEA (Diarhhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, TENDERNESS (Very tender arm), DIARRHOEA (Diarhhea), MYALGIA (Body aches), HEADACHE (Bad headaches), FATIGUE (Felt very fatigued), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved.            This case was linked to MOD-2021-044530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07 May 2021 contains contact information of the reporter,  patient's demographics, anatomical location of first and second dose, medical history, concomitant medications and onset date of the event fever On 14-Jul-2021: follow-up information recived on 14-jul-2021, non significant follow up.
All over body rash; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the arm left on 23Mar2021 at 08:00(at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy,  pollen allergy and minor soy allergy. Concomitant medications included vitamin d nos (VITAMIN D) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021 at 01:00, the patient experienced all over body rash. The patient received  zyrtec as the treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event all over body rash was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
She presents to the emergency room this evening via EMS with out-of-hospital cardiac arrest. Her husband tells me that for the last days she has had some shortness of breath. Tonight, shortness of breath got worse and he decided to bring her to the emergency room to be evaluated. He was assisting her to the car when she collapsed. He states at that time she would not respond to him and he called 911. He believes it took them 5-10 minutes to get their when they arrived they immediately started CPR. EMS reports that the patient was found to be PEA. She received 2 rounds of epinephrine and had return of spontaneous circulation. Unfortunately, once the patient was in the ambulance she again lost her pulse and ACLS protocol was initiated. She was intubated with 200 mg of   ketamine and there was a question of tonic clonic  seizure activity. Patient was initiated on transcutaneous pacing and brought into the emergency room. On the emergency room, patient  was taking off pacing briefly and noted to be in AFib with RVR, but quickly deteriorated became hypotensive therefore norepinephrine was initiated. Patient did lose her pulse and was placed back on transcutaneous pacing.
I been feeling a little dizzy the last few days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I been feeling a little dizzy the last few days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I been feeling a little dizzy the last few days). At the time of the report, DIZZINESS (I been feeling a little dizzy the last few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Eyes rolling in head, drooling, left arm twitching, tongue protruding and then tired; fell asleep. He also had a reaction to MMR 9/23/96 (0395D). Same type after that, he started regressing and diagnosed at 24 months with autism.  Per annual follow up report: autism severe sensory disorder hyper active stomach problems ect. I still believe the vaccinations DPT and MMR cause my sons autism.
Pt received Covid-19 vaccine, 2nd dose Moderna @ 0925.  At 0935 pt c/o throat tightening and she was flush with a red rash to face.  EMS notified, VS 120/80, P-70, O2 Sats-97%RA. 0940 EPI 0.3ml IM given in L deltoid.  Benadryl 50mg  prepared, pt declined stating "I am a bus driver, I can't be drowsy". Pt able to speak in clear nonlabored sentences. EMS arrived @ 097, pt reassessed and transported to ambulance.  Pt's condition worsened and Benadryl 50mg IM given in R deltoid.  EMS established an IV and transported to the local hospital.
Woke at midnight my face was burning and I had nausea. I had itching, pain and dryness and discharge in the vaginal area. I had temperature of 100.2. Later that evening I had chills, dizziness and nervousness. I took a Motrin 600mg.  By 2:19am, my temp decreases to 99.4 but I was sweaty. It normalized by the morning. I was prescribed Diflucan.
FEVER; FELT TIRED; RUNNY NOSE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting.  The patient's concurrent conditions included penicillin and codeine allergy, alcohol use, and smoker, and other pre-existing medical conditions included the patient had 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced runny nose. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose, fever, and felt tired. This report was non-serious.
Patient collapsed approximately 8 minutes after receiving the vaccine, legs were twitching before patient regained consciousness and attempted to walk out the front door of the pharmacy.   Patient reported not remembering anything about the collapse. Patient also hit face on shelving near chair where he was sitting. We provided ice packs, water, and cookies while patient rested.
72hr p/vax pt began gasping for air when taking nap;lethargic & low muscle tone when mom woke pt OK p/several minutes;
Nausea; feels tired; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had the first shot on Saturday, mid-day about 11:00. The past few days the patient had nausea in the morning and wanted to know if they were connected or not. The nausea comes for 10 to 15 minutes at a time and goes away. The patient also feels tired throughout the day. The patient wanted to know of these were possible symptoms or side effects. The patient recovered from nausea on an unspecified date while the outcome of the event feels tired was unknown.   No follow-up attempts are possible. No further information is expected.
swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
muscle stiffness was getting worse; muscle stiffness was getting worse; had abnormal blood work; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 18th November 2021 and experienced muscle stiffness that affected his mobility (tight hamstrings), refer case US2022084079). Concurrent medical conditions included muscle stiffness.   On 18th April 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle stiffness, condition aggravated and lab test abnormal. On an unknown date, the outcome of the muscle stiffness, condition aggravated and lab test abnormal were unknown.   It was unknown if the reporter considered the muscle stiffness, condition aggravated and lab test abnormal to be related to Shingrix.     Linked case(s) involving the same patient:  US2022084079   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient. The patient received second dose of Shingrix and around that time the muscle stiffness was getting worse and even with doing the yoga it was not improving. The patient had abnormal blood work. The patient did not remember what specific lab value was abnormal or if that value was high or low. The reporter did not have the lot number for the Shingrix but he did provide his doctor's contact information as he received the shots at his doctor's office and they should have the lot numbers on file. The consent to follow up was given.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084079:same reporter
Felt week and clammy, reported trouble swallowing then numbness in face; rapid response called, transferred to ED. 1:43: HR: 74, RR: 16, O2: 97%, BP: 112/66  END    Other daily meds: Protonix, Simbicort, Eliquis(Unable to type on 2nd page)
low-grade fever, body aches, fatigue, nasal congestion - could be my allergies, sore arm at injection site  I started feeling rough last night after I got the shot, and work up feeling really bad.  I had a similar reaction to the first dose but didn't know that I was supposed to report it. I learned this from the medical clinic Site.
On 1/11/01 at 5:30 PM the pt experienced a fever of 101. On 1/12/01 in the AM, the pt continued to have a fever. This continued through 1/13/01.
On the day following the booster, Wedneday 11/3, I experienced a 99 degree temperature and sluggishness.  This was not unexpected.  I had the same very mild side effects after shot 2.  On Thursday morning 11/4, I felt normal.    On Thursday afternoon at approximately 2 p.m I began having chills with extreme shaking and a temperature spike to 102.5 degrees.  The temperature had dropped to 100 by 6 p.m. and disappeared by Friday morning 11/5.  I have also experienced minor brain fog this time.
PT CALLED AND REPORTED WELPS, REDNESS, AND HIVES ON BOTH ARMS.
Covid ?moderna? arm, brain fog, ALOPECIA, nausea, fatigue , deppressed mood
Patient c/o wheezing and coughinin that started within three hours after the immunization.  She also states that she had mild diarrhea for the following two days.
shortness of breath; body aches; weakness in arms and legs; headaches; chills; This is a spontaneous report received from a contactable consumer. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced shortness of breath, body aches, weakness in arms and legs, headaches, chills on 03Apr2021 with outcome of recovered on 06Apr2021.  Therapeutic measures were taken as a result of events included Acetaminophen and Ibuprofen.  No follow-up attempts are needed. No further information is expected.
Baby was admitted to hospital for altered mental status < 24 hours after receiving Hep A vaccine in clinic. All tests were normal at hospital.
c/o severe abd pain, hyptension, BP 70/50, pulse 68, cold, clammy, diaphoretic 911 called-taken to ER-released p/several hrs in ER; saw PMD next day & given ulcer medication
Slight change in taste bud; This is a spontaneous report from a contactable consumer. An 84-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL9261, expiration date and NDC number were not reported) via an unspecified route of administration on 25Jan2021 at 11:40 in right arm as a single dose for COVID-19 immunization. The patient took the COVID vaccine because she had COPD and was a cancer survivor. The patient's medical history (including any illness at time of vaccination) included blood disorder. Family medical history relevant to adverse event and Investigation assessment was not reported. No other prior vaccination (within 4 weeks) and no additional vaccines were administered on same date of the Pfizer suspect. The patient did not experience any adverse event prior vaccination. There was no history of previous immunization with the Pfizer vaccine considered as suspect. Concomitant medication included hydroxycarbamide (HYDROXYUREA) 500mg tablets by mouth twice daily taken for blood disorder, start and stop date were not reported. The chemo pill started may be 4 years ago, when it was discovered she had blood problem. As per the description, it was reported that the patient had Pfizer shot, later clarified as COVID vaccine on last Monday 25Jan2021. On 4th day, 29Jan2021 at 08:10, she woke up in morning and had a slight change in taste bud, not as sharp as it was, she still had her sense of smell. There was no emergency room or physician office visit. She will get her second dose on 15Feb2021. There were no relevant tests reported. The outcome of all events was recovering/resolving.   Follow-up attempts are completed. No further information was expected.
Child's menstrual cycle - for 2 1/2 yrs was always very regular - with 1st GARDASIL child's cycle was 6 wks late, with 2nd vaccine child was 4 wks late - with 3rd vaccine only the child had a very painful cycle.
Fever 104.8 several hrs p/shots 6APR92; responded poorly to APAP (T102 lowest for 3 days afterward); Also c/o red, swollen lt arm; mom neglected to tell staff of similar rxn to DTP in 1989 (fever to 102 x 2 days);
Severe headache and fatigue, body aches and back pain this started around 7 this morning and my soreness at site of injection started about 5 hours post injection and is worse the next day where I cannot lift my arm above my head due to pain
Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The vial was initially stored in the refrigerator on 13SEP2021 and was administered on 14OCT2021
After I got the shot I feel like all this like anxiety; it seems like anxiety or something; Fast heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 04Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset Jan2022, outcome "unknown", described as "After I got the shot I feel like all this like anxiety; it seems like anxiety or something"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "Fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. On 05-OCT-2015, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K011952, expiration date 17-JUN-2016, route: oral, dose not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
2 days p/vax pt exp fever of 104 & had 2 febrile szs;treated in ER & sent home;preliminary cult neg;inc WBC;febrile illness felt to be unrelated to vax by MD
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 18-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This case is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Nursing Home CNA received the COVID vaccine at 1810, began itching and noted hives upper extremity and trunk around 1930 and sx. progressed to lips and tongue swelling and mild difficulty breathing. Employee presented to attached hospital ED at 2030.  Employee was treated with Benadryl 25 mg. IV, Epinephrine 0.5 mg IM, Pepcid 20 mg IV and solumedrol 125 mg. IV. Employee was discharged from the ED at 2145 in stable condition. Employee reported no further issues the next day.