chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 2 month old infant patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Pain and swelling at injection site - unable to raise arm above head  Treated with Tylenol.  Resolved in 36 hours. Severe generalized headache, myalgia, arthralgia, extreme fatigue, loss of appetite, but no fever.  No analgesic helped symptoms.  Required bedrest for three full days.  Symptoms resolved after four days.
Had hepatitis vaccine; had sudden pain with HA after 1 hour. Took Ibuprofen, HA stopped then felt feverish with pain in upper arm. Seen in ER; labs drawn to rule out fever illness; none identified. Pain lasted 2 days.
Heavy, aching legs from the knee down. Knees throb. Right shoulder intermittent aching. Walking affected in that the aching reduced distance I could comfortably cover. Dragging body after a walk beyond a quarter of a mile. worst symptoms in the evening and night. Sleep disturbed on many nights. tylenol helped but did not always allow for a good sleep.
Sore arm and shoulder joint area. Started the day after the shot was given. Pain and soreness still felt today.
The day after vaccine he had low energy and a low grade fever, increased sleeping.  This persisted Through 5/24/2012.  Early evening of 5/24 he became violent kicking hitting, biting and unconsolable and would not let us touch him.  Screaming, crying, throwing himself on the ground, arching his back on the ground. This level of agitation and violence has never been previously exhibited by our child.  This episode lasted approximately 1 hour in which he finally cried himself to sleep.
On 10/02/2019, received Shingrix vaccination; 10//03/2019, noticed irritation under left arm pit, left arm was tender/sore around the injection sight; 10/04/2019, small rash appeared under left arm pit and rash appeared on back; 10/05/2019, noticed rash was getting larger on back, under left arm pit and small rash was starting to form on left breast and onto the breast/chest cavity, severe/sharp headaches in back of head behind left ear, chills, fever, fatigue and chest pains; on 10/06/2019 sharp severe headaches was occuring every 45 seconds - 1 minute apart, along with chest pains and the rashes had started to spread and grew larger in size, went to the Emergency Room due to the severe discomfort,
Apart from a little pain at the local site of injection which lasted fro two days, there were no complaints. However, suddenly 7 days after the injection, there was significant swelling ( 8cm) and pain at the injection site associated with a little feverish feeling. Lasted about a couple of days and subsided. Bringing it to agency's attention as there was none immediately after the injection, but something a week later on.
Morning day 2: Onset of overwhelming tiredness, slight headache and some "arthritis-like" discomfort in my joints . I had Lyme disease about 5 years ago and it felt very similar to those initial symptoms. The elbow that was most affected by the Lyme disease was much more uncomfortable than other joints.
Itchy and painful bumps on both toes and feet. Symmetrical on each foot, 1 bump on second toe, 3 bumps on outer foot, and 1 bump on heel of each foot.
pain in my throat; chest; down my arms each morning.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in my throat, chest and down my arms each morning on an unknown date in Mar2021 (In March the patient began experiencing pain in my throat, chest and down my arms each morning. It doesn't last all day and sometimes it lasts longer than others and sometimes it's really bad). The patient underwent lab tests and procedures which included blood test: normal on an unknown date in 2021 (Had an EKG and blood work done and they couldn't find anything), electrocardiogram: normal on an unknown date in 2021 (Had an EKG and blood work done and they couldn't find anything). The patient have been to the ER twice. Outcome of the events was unknown.  Information on batch/lot no. has been requested.
Information has been received from a pharmacist concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergy who on approximately 16-FEB-2009 was vaccinated with first dose of GARDASIL (Lot # not reported).  There was no concomitant medication.  On approximately 16-FEB-2009 since vaccine was administered the patient experienced headache.  At the time on the report on 23-FEB-2009 the patient was not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Janssen COVID-19 Vaccine EUA. Fever over 103 for several hours, reduced slightly by Tylenol, aches, muscle pain, severe headache. After about 8 hours, fever continually varied between 99 and 101 for 12 hours, continued headache, diminishing muscle pain and aches. Very tired for next 24 hours as headache and fever dissipated.
2nd vaccine started at 8pm soreness around the injection site, headache, minor body aches, chills and they progressed over the night, the headache wasn't getting better with Tylenol, at about 2am it was pretty severe I couldn't sleep after that, I used cold wash clothes to help with fever that was about 101. The next morning my fever was low grade with Tylenol. I called employee help line and they told me to rest. All symptoms were within the first 48 hours and I was completely fine after that 37 Weeks pregnant - due date: Feb 14, 2021,  Low risk, no issues, tests are all normal
Patient presented to the ED on 4/19/2021 and was subsequently hospitalized for subdural hematoma. This was within 6 weeks of receiving COVID vaccination.
Thursday Nite starting at 11 PM:  A warm feeling at the top of my head like a heat lamp.  Lasted 15 Minutes.  Then Left Leg, Two Toes start pulsating/shaking uncontrollably.  I rubbed with the right foot...it would stop...then start back up.  Lasted 30 Minutes.  Then my chest started feeling like I had a bad sunburn on my skin.  Lasted 30 Minutes...all the while these strange things were going on, I noticed I had asthma.  I ONLY get asthma if I have a cold or flu.  I thought to get up and take an inhaler but decided against it worried about an adverse reaction to the vaccination. I fell back to sleep and awoke with no asthma and all strange symptoms gone. Then Friday afternoon I developed chills and a queasy stomach (belching and gas and loose stools.)  I checked my temperature (on multiple occasions) and it was normal. These two conditions lasted until  Saturday.  Also on Saturday, I developed aches in my neck. Then very late Saturday Night, I awoke to a sweat drenched tee shirt but chills were gone. Sunday...today....I feel perfect.
FELT LIKE STIR FRIED CRAP; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-NOV-2021, the patient experienced felt like stir fried crap. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like stir fried crap was not reported. This report was non-serious. This case, from the same reporter is linked to 20211118830.
Client was not available  for adult dose.  She was given 0.03 of Pfizer instead of 0.02 ml. There were no negative effects to the client.  She did not complain of any problems.
ball under my armpit on the same side that I received the vaccine, it was scary; Warm to touch around the injection site; it is a sensitive area, around the injection site; an incontrollable fever up to 108F; 2nd dose was given >36 days after the 1st dose; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose), PYREXIA (an incontrollable fever up to 108F), LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE WARMTH (Warm to touch around the injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2016, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose). On 15-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (an incontrollable fever up to 108F). On 16-Jun-2021, the patient experienced LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE WARMTH (Warm to touch around the injection site) and VACCINATION SITE DISCOMFORT (it is a sensitive area, around the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 milligram. On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was given >36 days after the 1st dose) had resolved. At the time of the report, PYREXIA (an incontrollable fever up to 108F), LYMPHADENOPATHY (ball under my armpit on the same side that I received the vaccine, it was scary), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE WARMTH (Warm to touch around the injection site) and VACCINATION SITE DISCOMFORT (it is a sensitive area, around the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature: 108 (High) Fever.         No concomitant medication information provided.  Treatment also included Ice on patient's head on 15Jun2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   This case was linked to MOD-2021-225644 (Patient Link).
4 hrs p/inject pt became irritable, cold, clammy & pale, very lethargic; extremities-cyanotic dec resp rate w/grunting-lips were blue; no temp during episode; episode lasted 1 hr-self resolved; t102R in office;
Swelling in left lymph and into side of breast, radiating to right armpit lymph node. Also pain into the left side of neck.
24jan90 pt vax heptaB. ex n/& h/a at base of skull. fever thirst. 26feb90 2nd vax. ex n/v & h/a persisted for 6 days. treated w/ meprobamate, aspirin, and lomodin.
Reviewing client's medical record and describing what vaccines were for to client. Did not look further down on medical record to see that client had gotten the Shingrix vaccine 4/2019. Administered varicella vaccine to client as she stated that she is a "believer in getting vaccines," and she wanted all of what the medical record said she needed.  I realized that the error occurred once I went to record the dose given.
Extremely painful tendonitis.  Aspirin with food (650 mg) and Tylenol partially alleviated symptoms.  This is day 2 and it is still painful.
Intense injection site reaction with large swollen arm all the way from the shoulder down to the elbow. Hot to the touch. was counseled to monitor symptoms and take benadyrl as well as ice and ibuprofen. Was also told to follow up with provider especially not resolving after another 24-48 hours.
Lump on Tongue; Red mark on injection site; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site) outcome was unknown.            The patient's concomitant medication was not reported.  It was reported that the patient was better now.  The action taken with mRNA with the events was considered as not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: The follow-up was received on 6-JULY-2021 and date of onset of event was updated.
On date on second dose, 2/27/2021,  the pt began have fatigue and diarrhea at around 10:30 am.  This continued to the following day.  On 2/28/2021, the patient was last seen around 4:20 pm by his wife in their residence.  She found him unresponsive at 5:30 pm in their bedroom.  EMS was called and the decedent was declared deceased.    The pt had his first dose on 2/9/2021.  Both doses were given at the hospital. Per family, the pt had no adverse affects following the first dose.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M003659 with expiration date: 20-SEP-2017, lot # L026602 with expiration date: 19-OCT-2017 and lot # L038503 with expiration date: 18-DEC-2017 (dose and route of administration were not reported). Administered doses of vaccine experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
6.5 x 4.5 cm raised erythematous dermatitis over right deltoid. Treatment: BANADRYL elixir.
Patient experienced pain in her neck and shoulder on her left side the day after the injection.  The pain started easing after about three days and is now almost entirely gone.
Migraine with nausea, vomiting, diarrhea, headache, light sensitivity, smell sensitivity, and neck and shoulder pain. Additional fatigue and arm soreness.
I woke up late the following night after receiving the vaccine I felt something in my left arm that was different. I looked in the mirror and saw swelling above my clavicle at the base of my next going over to my shoulder. I went to see the doctor on Monday morning around 11AM to have his check this out. He advised me to wait a week or two see if the swelling would go down. Most of the swelling has come down.
10:29 patient was on her way out from observation room. Patient went unconscious but was breathing. 10:32 patient had a seizure for 15 second. Placed patient on her side and called code. Medics took patient to the ER and her husband reported she has seizure history. Patient observation time was 10:27
Td and Menactra administered simultaneously 3:30PM. Pt attended football practice 5:30-7:00PM. About 9:00PM experienced tingling in throat, difficulty swallowing chest tightness with shortness of breath, went to ER.
Treatment for COVID-19; Treatment for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil (SP)", notes: Verbatim: Known allergies: Cefzil (SP). The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: There was no other medications in two weeks. Treatment was from 11May2022 to 15May2022. Rebound on 21May. Felt fine for a week and woke up with headache, cough and stuffy head. No fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No other issues or concerns noted.; Customer calling to report that PROQUAD and VARIVAX were administered at the same time.  No PQC.  No other information provided.  No other issues or concerns noted.  PROQUAD:  LOT: W007748 EXP: 7/4/2022 VARIVAX: LOT: U028164 EXP: 9/9/2023 ADMIN ON:; This spontaneous report was received from a medical assistant concerning to a 12-month-old patient with unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The reporter calling to report that on 25-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # W007748, and expiration date: 04-SEP-2023, since it matched the autopopulated expiration date (strength and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164 and expiration date: 09-SEP-2023, since it matched the autopopulated expiration date (strength and route of administration were not provided) at the same time as a prophylaxis. No other information provided. No other issues or concerns noted.
Vaccine brand=Pfizer / BioNTech, product=COVID 19 Treatment; Vaccine brand=Pfizer/BioNTech, product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 07Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovering", described as "Vaccine brand=Pfizer / BioNTech, product=COVID 19 Treatment"; COVID-19 (medically significant), outcome "recovering", described as "Vaccine brand=Pfizer/BioNTech, product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: 100.1 Centigrade, notes: began running a fever 100.1; SARS-CoV-2 test: positive, notes: Tested positive for COVID-19 after having been negative for 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 15 minutes of the patient getting her dose someone reported that she was complaining that her tongue was feeling "tingly" and that she felt light-headed/dizzy.  Patient had some redness around her chest but I couldn't tell if that was normal for her and she couldn't tell either.  I had the patient sit down and give me more details - she could still breath and the tingling wasn't getting worse but it wasn't feeling better either. The only reaction she can recall is to Wellbutrin where she got hives from an oral dose, and the only medications she mentioned to me were thyroid medication and phentermine.  During this time I had her drink some water and took her blood pressure. Blood pressure was normal/high (around 140/90mmHg). I gave patient 50mg diphenhydramine and had her continue to sit down drink some more water. Probably around 30 minutes in a friend mentioned her tongue no longer felt tingly but that she needed some space to breathe since she was feeling anxious. No other reactions or side effects were reported to me after.
Pt developed hives on face and front of scalp.  No  respiratory difficulty.  No lip /mouth swelling.   Pt given oral diphenhydramine.  Hives beginning to resolve.   Pt discharged home.
No additional AEs reported; temperature excursion (TE)/ administered on 07-JUN-2021; This spontaneous report was received from a medical assistant and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 07-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, dose: 0.5 ml, intramuscularly (IM), lot # T001212, expiration date was reported and also validated as 12-JAN-2022, for prophylaxis (strength and anatomical location were not reported) (improper storage of product in use).  The digital data logger registered, that on 07-MAY-2021, unsupported temperature excursion (TE) occurred and the vaccine was stored at the temperature of 54 degree Fahrenheit (F) for 10 hours. No previous TE was detected. The vaccine was not removed from the inventory and was administered to the patient. No additional adverse event (AE) reported (no adverse event).