chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of injection site redness in an 8-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (.5 ml, unknown) and experienced drug use for unapproved indication. No other vaccines were given on the same date. At an unspecified time after vaccination with FLULAVAL, the subject experienced redness (for a few days) and pain at injection site. The pharmacist considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the injection site redness was resolved and the outcome of the injection site pain was unknown. The pharmacist considered the injection site redness was probably related to vaccination with FLULAVAL, and the causality of the injection site pain was unknown. On 04 November 2009, the pharmacist reported that an eight-year-old female subject was given a dose of FLULAVAL. The subject developed redness and pain at the injection site. Specific dates were not known. The pharmacist noted that the parents may have given some medications to alleviate the redness and pain, but was not sure. It was unknown if the subject consulted a health care professional regarding the event(s).
Per neurologist "agree with dx of Guillain-Barre Syndrome secondary to COVID vaccine"
Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for  48 hours.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient allergic to penicillin. The patient's pertinent medical history was not reported. On 12-JUN-2015, the patient was vaccinated was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous  (lot number was reported as : L000447 with expiration date: 08-MAR-2016). Concomitant therapies included unspecified thyroid and blood pressure medications. On the morning of 18-JUN-2015, the patient developed redness at the injection site (injection site erythema). The patient went to see the pharmacist who noticed a 3 cm oval area of redness. The area was not raised, did not have a rash or lesion present. The outcome of injection site erythema was report4ed as not recovered. The reporting pharmacist did not provide a causality assessment for the event. Additional information has been requested.
Lump in left breast within 18 hours of receiving shot. Lump got larger over the next 2 days. What started as a ?ball? has become a larger ?mass?
had the two required shingles vaccines / 3 years ago / shingles; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had two required shingles vaccines three years ago of reporting and diagnosed with shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
PATIENT NOW DYING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced subject now dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient now dying was not reported. This report was non-serious.
1 day after receiving vaccine, patient developed progressively worsening periorbital ecchymosis and edema leading to almost swelling shut of eyes.  conjunctivitis bilaterally.  bilateral epistaxis.  no known trauma.  Outcome is ongoing.  patient currently in ER
Received vaccines below on 6/28/07. Later cried and did not want to bear weight on left leg. Taken to ER and diagnosed with left thigh immunization/decreased ambulation and prescribed Ibuprofen. Seen on F/U on 7/2/07 able to ambulate well. No fever. No swelling of left extremity.
Pt rec'd DTaP in left anterior thigh on 9/28/07. On 9/29/07 Mom noticed swelling of left leg distal to injection site going down to the upper thigh with warmth and erythema. When I saw him on 10/1/07 redness and warmth resolved and swelling was from mid thigh to knee.
Moderna COVID-19 Vaccine EUA 2/2/2021- starting 2 hours after injection= injection site tenderness (5/10), mild swelling of injection site with warmth. fatigue and body aches (mild/moderate) 2/3/2021- continued symptoms of above 2/4/2021- very mild tenderness to injection site if touched, other symptoms gone
This spontaneous case was reported by a consumer and describes the occurrence of BLOOD ELECTROLYTES DECREASED (Electrolytes were drained from body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD ELECTROLYTES DECREASED (Electrolytes were drained from body). At the time of the report, BLOOD ELECTROLYTES DECREASED (Electrolytes were drained from body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood electrolytes: Drained from body. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. It was reported that on an unspecified date patient received MODERNA COVID-19 VACCINE  at an unspecified dose or frequency. It was reported that the patient stated 24 hours after receiving first dose of Moderna vaccine, patient electrolytes were drained from body. HCP advised against second dose of Moderna covid vaccine series because of potential for heart attack. No treatment information was reported. Reporter did not allow further contact.
neuromuscular syndrome; adverse side effect; numbness in the fingers; Low grade fever; Body aches; specific pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NEUROMYOPATHY (neuromuscular syndrome) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROMYOPATHY (neuromuscular syndrome) (seriousness criterion medically significant), VACCINATION COMPLICATION (adverse side effect), HYPOAESTHESIA (numbness in the fingers), PYREXIA (Low grade fever), MYALGIA (Body aches) and VACCINATION SITE PAIN (specific pain at injection site). The patient was treated with IBUPROFEN (IBUPROFEN IB) (oral) at a dose of UNK dosage form. At the time of the report, NEUROMYOPATHY (neuromuscular syndrome), HYPOAESTHESIA (numbness in the fingers), PYREXIA (Low grade fever), MYALGIA (Body aches) and VACCINATION SITE PAIN (specific pain at injection site) had not resolved and VACCINATION COMPLICATION (adverse side effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient reported that he got the second dose seven weeks ago and still had significant pain at injection site in the bicep muscle and right shoulder region. The patient didn't have reactions with the 1st dose.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Additional information received on 21-Jun-2021 contain no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.
Diarrhea after first Bivalent booster shot; Achiness after first Bivalent booster shot; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea after first Bivalent booster shot) and PAIN (Achiness after first Bivalent booster shot) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 vaccination.  Concurrent medical conditions included Irritable bowel syndrome (Diagnosed many years ago. Patient normally tooks Imodium or Lomotil for IBS.). Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Irritable bowel syndrome.    On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced DIARRHOEA (Diarrhea after first Bivalent booster shot) and PAIN (Achiness after first Bivalent booster shot). At the time of the report, DIARRHOEA (Diarrhea after first Bivalent booster shot) and PAIN (Achiness after first Bivalent booster shot) outcome was unknown.            Patient received the first dose on 07-Feb-2021 (Lot: 030M20A), second dose on 07MAR2021 (Lot: 032M20A), First Monovalent Booster dose on 01NOV2021 (Lot: 032F21A) and 2nd Monovalent Booster dose on 27APR2022 (Lot: 057M21A). Patient states that got her 5th shot yesterday and she always had the same reaction after all Moderna COVID-19 shots. No treatment medications were reported.
Pt recv vax on 3/2/99(possible not given IM); on 3/4/99 pt exp red area; tx=Keflex, Benadryl
Acute hypoxic respiratory failure due to Covid-19 pneumonia. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 25780). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 17-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # T027118, expiration date 07-FEB-2022, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
injection site pain; felt tired; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A 6 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 08Nov2021 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose: 1), for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Nov2021, outcome "unknown", described as "injection site pain"; FATIGUE (non-serious) with onset 10Nov2021, outcome "unknown", described as "felt tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 18NOV96 & approx 2 days later pt devel flu-like sx including excruciating pain in both arms, shoulders & hands;hip pain off & on;edema bilat;dx DJD;vascular necrosis;aches worse since vax;inc stiffness;arthritis;arthralgia
This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M043836 with expiry date 17-JUN-2018, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1708USA003308: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
A Itchy red rash at injection site  Raised and swollen   Just started a few days ago   Still there but seems to be getting better
pt recv vax & got real sick w/fever, couldn't sit w/o falling;had all kind of test;pt hosp;pt states can't hold anything in hand because of the shaking;
03/13/2021 I started to have stomach pain, and gradually got worse over a period of three weeks. I began to have fevers, Upper left quad under last left rib- I went to the hospital on 04/06/2021 was released on the 04/07/2021, at the time they thought it was Colitis.  Even on antibiotics for that 04/09/2021 began running fever and went back to the hospital, extreme pain in upper left quad, sweating.  Was sent home to continue antibiotics, I never got better. I returned to the hospital on 04/14/2021 was admitted. Doctor did the EGD on the 15th.  05/16/2021 when all my tested come back DOCTOR says I have severe inflammation, and sends me to see DOCTOR on 20th of May 2021,-he said it sounds like you have a blood parasite or autoimmune something going on.   When May 20th results came back it was found I have an autoimmune disorder or disease.  On 05/26/2021 I went back to DOCTOR did bloodwork.
Fever 103.8 4-6 hours past shot fussiness; Fever 103.8 4-6 hours past shot fussiness; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2365961-1. The original narrative from the sender is the following:  Fever 103.8 4-6 hours past shot fussiness.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Fever 103.8 4-6 hours past shot fussiness".  No further information is expected.
Dizzy, nauseous, chills, fever, whole body ache, pain in left arm from injection Ibuprofen once dizziness gone Approximately 6 hours
I was diagnosed with Pityriasis  Rosea on 06/30/21. I am 44 years old and out of the typical age range of who commonly gets the rash. I read that it has been reported with Covid or with the vaccination. Rash began to appear around 06/15/21.
His shots were given in the morning. He seemed fine that afternoon, but by evening he was fussing and had a fever 101-103. Mom gave him TYLENOL, but it wasn't helping. That night he cried all night--he was in pain & whimpering. His legs were swollen & sore; he couldn't bear to be touched anywhere on his body. He finally fell asleep on his stomach. He also had "projectile" vomiting that night around 10 pm. On 12/28/18, he was given a dose of children's acetaminophen prior to the shots, but he did not like the taste & probably spit out 1/2 the dose. His mom brought him in to see me on 12/29/18. She told me his last fever was that morning up to 102. On 12/29/18, his leg swellings, fussing, and pain were getting better.
couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; This is a spontaneous report from a Contactable Consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: E20792 (but she doesn't know for sure) and Expire Date: unknown) intramuscularly administered in left arm on 04Feb2021 10:15 (at the age 76-year-old) as dose 2, single for COVID-19 immunisation. Patient took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) intramuscularly administered in left arm on 14Jan2021 (at the age of 76 years), and stated that arm was really, really painful on 15Jan2021. Vaccination facility type was physician's office.  The patient's medical history was not reported. She mentions she takes thyroid pills as concomitant medication. No further details provided or obtained regarding this statement. None of the additional vaccines administered on same date of the suspect. The patient did not receive any Prior vaccines within 4 weeks. With the second vaccine in feb2021, her arm hurts but it is not anything she cannot stand. However, she didn't sleep again all night last night. She was so tired but she could not sleep. She has taken other medications and she does have insomnia. She has tried melatonin for sleep and it worked just the opposite. It kept her up all night. Caller verifies she has no NDC, Lot number or expiry date for the melatonin, this was a while back. She mentions someone also told her to take Benadryl which typically makes one sleepy but she stayed up all night when she took it. She confirms she has no NDC/UPC, Lot, or expiry date to provide. She took that a while back. She was just wondering if the vaccine could cause patient not to sleep it was weird. The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. She just inquired if this could be a side effect of the vaccine and there been any reports of this. In  Feb2021,She also had the chills which she read was normal. She mentions she does have sleep medication but she didn't know if it was safe to take after having a shot. Every once in a while she takes it. Caller mentions she did have a blood test done, not too long ago. Like cholesterol and everything and it was good. Caller verifies this was prior to receiving the vaccine. Caller was curious if this common or anybody else have trouble sleeping after receiving the vaccine. No emergency room visit and physician office visit was reported. Treatment was received for couldn't sleep, up all night. The outcome of events was unknown.  No further details were provided or obtained. Follow-up attempts are completed. No further information is expected.
Face became very flushed and hot late afternoon.  Continued until about 11 PM.  My blood pressure raised to 192/94.  My legs felt weak and cold.  My granddaughter is an RN and came and double checked my BP at 9Pm.  Still high.  I took my BP meds 2 hours early.  By 11 PM my face cooled and BP dropped to 171/86.  My husband also experienced higher blood pressure readings than normal but not critically high
She is concerned because she has urinated on herself twice today without the sense of urgency. It happened this am while putting her key in the door to bring groceries in and this afternoon while watching TV on the couch. She has made an appt with her MD on Friday at 11:30am. I told her that we will follow up with her on Friday around 3pm to see how her appt went and to see if she has had more episodes or if it ceased.  Doctor's appt 4/16/21 @ 11:30
Patient received 5 ml of vaccine; A spontaneous report was received from a healthcare professional concerning a 35-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient received 5 milliliters (mL) of vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Jan 2021, approximately 0 days prior to the onset of the event, the patient received doses of mRNA-1273 (Lot number 013L20A) intramuscularly in the right and left arms for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the patient received 5 mL of the vaccine. She was given 2.5 mL in the left arm and 2.5 mL in the right arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received 5 ml of vaccine, was considered resolved on 18 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number 013L20A), where 5 ml of vaccine was administered. There were no reported AEs associated with this case of Incorrect dose administered.