chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is 68 y/o female, PMHx of CAD, COPD, DM, MI, PVD, HTN, AFib, and hiatal hernia, admitted for reaction to Regeneron. Pt was receiving Regeneron infusion when she had an acute onset of confusion, slurred, speech, left-sided facial droop, left upper and lower extremity weakness. Pt began to have chest congestion, runny nose, cough, HA, etc on 9/28/21 and tested positive on 9/29/21. Pt was placed on observation status and discharged on 10/5/21.
Information has been received from a pharmacist concerning a 63 years old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included FLUAD. On 07-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose and frequency were unknown, lot# L035687, expiration date 16-FEB-2017), intramuscularly in the deltoid area of her left arm. On 08-SEP-2016, the patient experienced swelling and redness "in a straight line, from her deltoid down to her elbow." The patient had called a pharmacist for medical attention, but no treatment was received. No lab diagnostics studies were performed. The outcome of the events was not recovered at the report time. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Very fussy, slight fever, then rash starting on her trunk and spreading out to limbs and later face and head.  Also was diagnosed with an ear infection in both ears.
January 4th was the first shot and February 20 was the second shot; Bad headaches; My temperature is 101.2 and it is going to 100.4 and then goes up back; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL9266) via an unspecified route of administration on 20Feb2021 as 2nd dose, single for covid-19 immunisation. Medical history included high blood pressure, pre diabetic. Concomitant medication included losartan taken for high blood pressure. Patient previously received first dose of BNT162B2 (Batch/lot number: EK9231) on 04Jan2021 at the age of 39 years for COVID-19 immunisation and got COVID two weeks after first shot, qualitative PCR positive after 1st dose. Patient reported that January 4th was the first shot and February 20th was the second shot. After the second dose of Pfizer vaccine, patient was having symptoms of bad headaches and her temperature was 101.2 and it was going to 100.4 and then went up back, all on an unspecified date in Feb2021. She took paracetamol (TYLENOL) every six hours as treatment. Patient did some lab work last week (Feb2021) and went to see the doctor for the results. Patient asked if there is anything else she can do to get rid of her symptoms other than drinking lots of fluids. Outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
One day after receiving vaccine patient complained of swelling and redness at injection site. Patient went to PCP and was diagnosed with cellulitis and given Cephalexin 500mg #40 1 PO Q 6 H x10 days. Still being treated with antibiotics.
Information has been received from a nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. The nurse reported that the patient broke out in a rash all over her body after receiving the second dose of vaccine. The patient declined to receive her third dose. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Patient describes high fever of almost 102, extreme chills and shivers, intense body aches especially in the neck and back, headache and bilateral muscle pain in the arm.
Within 24 hrs after vaccine administration, patient with several episodes of projectile vomiting. Patient seen at local emergency department and followed up with PCP today.
Information has been received from a certified medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient may have received an improperly stored dose of one of the following vaccines: ROTATEQ lot # M044395, expiration date 31-MAY-2018, oral for prophylaxis (dose and frequency were not reported), RECOMBIVAX HB lot # L045117, expiration date 06-OCT-2018 for prophylaxis (dose, frequency and route of administration were not reported), M-M-R II lot # M034856, expiration date 27-JUL-2018 for prophylaxis (dose, frequency and route of administration were not reported), and GARDASIL 9 lot # M020103, expiration date 15-FEB-2018 for prophylaxis (dose, frequency and route of administration were not reported) or PEDVAXHIB  lot # reported as M046133 and expiration date reported as 26-SEP-2019 for an unknown indication (dose, frequency, route of administration were not reported). No adverse effect reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 47 Farentheit degrees and 77 Farentheit degrees for 27 hours. The certified medical assistant reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report.
Tiny red dots (right arm) between her wrist and elbow; Slept a lot; Feverish; Arm was sore(inj site); Felt tired; Had chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow), HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)) and FATIGUE (Felt tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)), FATIGUE (Felt tired), CHILLS (Had chills) and MYALGIA (Muscle aches). On 06-Feb-2021, the patient experienced RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow). At the time of the report, RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow), HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)), FATIGUE (Felt tired), CHILLS (Had chills) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
The patient was admitted with CVA with L hemiparesis. The patient was also found to be Covid (+). The patient has a medical HX of recent CVA 10/21 (L side affected), alcohol abuse, cerebrovascular disease, HBP, hyponatremia, and tobacco abuse among other CO morbidities.
Woke up the next morning she had a terrible nausea. Then she started having chills and couldn't get warm. The chills has been constant.
Flu-like symptoms; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route administration in left Arm on 27Mar2021 at 1145 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included as mild asthma and overstimulated amygdala. The patient had no known allergies to medications, food, or other products. The patient had received other unspecified medications in two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in left Arm on 06Mar2021 at 1130 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 2100, the patient experienced sore arm and flu-like symptoms (headache, body aches, weak, fatigue and fever). The patient did not receive any treatment for the events The patient did not receive any treatment for the reported events The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm and flu-like symptoms (headache, body aches, weak, fatigue and fever were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
This was the second influenza vaccination this patient received. 1st dose given 9/9/22, 2nd dose given 10/5/22.
2 days after vaccination you noted changed smell and taste.  This is still going on and has not changed since the beginning.  Did have COVID in Oct. 30 confirmed by test and client lost her smell and taste at that time.  these were her only symptoms at that time.
4 month old was inadvertently given a FLUZONE QUADRIVALENT with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via  (Reference number- 00804995).   This case involves a 4-month-old male patient who was inadvertently given a INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (off label use).    The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7347NA and expiry date: 30-Jun-2022] strength: standard via an intramuscular route in left thigh for prophylactic vaccination.  On 07-Oct-2021, the patient inadvertently received a dose of fluzone quadrivalent(Off label use in unapproved age group) (Latency same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.   It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Fever: 102.4*F. Sore left shoulder, body aches. Took a Tylenol.
she experienced really bad hives on her face and lips.; This is a spontaneous report from a Pfizer sponsored program. The contactable female consumer of unspecified age reported for herself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection) (Lot number& expiry date not reported) via unspecified route of administration on 03, Apr 2021 at single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient mentioned that after the 1st dose, she experienced really bad hives on her face and lips. The patient wanted to know if she should continue with the 2nd dose despite what she experienced which she was scheduled on 28, Apr 2021. Outcome of event was unknown. No follow-up attempts are needed; Information about Lot/Batch number cannot be obtained.
3FEB96 rhinitis x 3 days;7FEB96 numbness in hands & feet;seen in ER inc numbness & fatigue,malaise-presently dx w/GBS on a ventilator;
itching at injection site; redness at injection site; swelling at injection site; malaise; lethargy; not feeling himself; discomfort at the injection site; sleeping more; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix. On 17th August 2019, 1 days after receiving Shingrix, the patient experienced malaise, lethargy, feeling abnormal, injection site discomfort and hypersomnia. On 18th August 2019, the patient experienced injection site itching, injection site erythema and injection site swelling. On an unknown date, the outcome of the malaise, lethargy and feeling abnormal were recovered/resolved and the outcome of the injection site discomfort, hypersomnia, injection site itching, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the malaise, lethargy, feeling abnormal, injection site discomfort, hypersomnia, injection site itching, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced just not feeling himself. This lasted for a couple days along with discomfort at injection the injection site and he was sleeping more. About 48 hours after the vaccination, he developed redness, itching and swelling at the injection site and it extend a couple of inches below the site. The reporter did not consent to follow-up.
I got a booster shot a Club Pharmacy. At the time of injection, I felt more pain than 1st and 2nd. doses. After the shot, I had pain in the injection area, the second day I started to have a rash, after a few days the rash disappeared then I had itchiness until now and sometimes I have discomfort in that area.
Developed appetite few days after HIB (Pedvax), five rash 2-3 days after decrease appetite.
2 weeks after the injection I felt a dull pain in my arm at the injection site. The following day there was pain when I pressed on the site and minimal pain when I lifted my arm at the shoulder. A light rash developed on my shoulder above the injection site. The symptoms occurred for 5 day's never increasing in severity.
taken to local hosp ER @ 845PM for crying;seen by ER MD T100.1, fussy & crying;no reference to character of cry;given rx for Nystatin cream to be applied to diaper rash  alternately w/cornstarch;
This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown single for COVID-19 immunization.  Patient has not taken medications such as Advil and High cholesterol medications a week now and wanted to know how long she should not take these medications before getting the second dose of the vaccine. Patient later stated that she is taking High cholesterol medications a week now and wanted to know how long she should not take these medication before getting the second dose of the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a physician assistant refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-AUG-2008, the patient was vaccinated with the first dose of hepatitis A vaccine (manufacturer unknown) (dose, route, lot # and expiry date were not reported). On 13-NOV-2015 (reported as "today"), the patient was in the office to receive the second dose of hepatitis A vaccine (manufacturer unknown) (dose, route, lot # and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Lot # given exp 8/31/22. We received information from the manufacturer indicating that stability data supports the use of this product for date given and revaccination is not required.  From Pfizer:  "Batch FL8095 was also manufactured on 28-Sep-21. The current expiration date is assigned 12 months from the last day of the previous month it was manufactured in, so the batch was assigned an expiration date of 31-Aug-22. We have stability data to support the use of the vaccine for 18 months from the date of manufacture plus seven days. Any doses administered on or before 04-Apr-23 are supported by stability data."
Left deltoid red, hot to touch, painful, very swollen. Child seems fine otherwise mother states he's eating and sleeping fine, playful. Mother worried will take to pediatrician for review.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 09-OCT-2013 the patient was vaccinated with the first dose of ZOSTAVAX (lot#, strength, dose and route unspecified). On 10-OCT-2014 the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (lot#, strength, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Patient lost consciousness and was in and out for roughly 5 minutes. Clammy, sweaty, confused. EMS was called. vitals checked. patient cleared. pt went home from pharmacy with wife.
Pt is under age at 14 yrs old. He complained of generalized body aches for the first two days
This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching) and PAIN OF SKIN (felt like she was stung by a wasp) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Allergy to penicillin) and Allergy to insect sting. Concomitant products included ALPRAZOLAM (XANAX) and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for an unknown indication. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced VOMITING (she woke up and started to throw up/threw up clear film). On 23-Aug-2021, the patient experienced HORDEOLUM (Stye) and EYE SWELLING (eye was swelling). On 24-Aug-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen). On 25-Aug-2021, the patient experienced URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), PAIN (still sore to the touch) and DYSPNOEA (short or breath as she is talking). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for Itching and Swelling, at an unspecified dose and frequency. At the time of the report, HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), DYSPNOEA (short or breath as she is talking) and VOMITING (she woke up and started to throw up/threw up clear film) outcome was unknown and PAIN (still sore to the touch), VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
anxiety; blacked out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19-year-old patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 22Apr2021, outcome "unknown", described as "blacked out"; ANXIETY (hospitalization), outcome "unknown". The event "blacked out" required physician office visit.  Clinical course: The patient stated that I got my first covid vaccine by you guys. The second day after I got it, I was working and randomly blacked out, and nothing felt real. ever since my anxiety has been so bad, and these moments keep happening. Today I went to the hospital and was told that the Pfizer vaccine triggered my anxiety into something worse than it ever had been. I am LIVID and would like to speak to someone about this. thank you! hello! my name is (name- withheld), and I am 19 years old. back on 20Apr2021 I got my first covid vaccine by you guys. The second day after I got it, I was working and randomly blacked out, and nothing felt real. ever since my anxiety has been so bad, and these moments keep happening. Today I went to the hospital and was told that the Pfizer vaccine triggered my anxiety into something worse than it ever had been. I am LIVID and would like to speak to someone about this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very severe pancreatitis after each vaccine,but really severe this time for two days.severe pain ,vomiting headache and low fever
Patient was born with an APGAR of 8.5 by C-section at about 10:00 PM March 7, 2001. Around 4:00 am March 7, I called for them to bring him to nurse. They administered a Hep-B shot and he had an oxygen desat incident immediately and ended up in the ICU for 4 days. A spinal tap showed nothing. He was perfectly healthy until he got the Hep B shot. Now he has autism.
started having nausea, vomiting, abdominal pain after 2nd vaccine.  Went to urgent care, then sent to ER and admitted to hospital on 2/22/21
This spontaneous report as received from a pharmacist refers to a 71 year old patient. On 02-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M039452 for prophylaxis. Concomitant therapies included sterile diluent. On 02-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected. Sender's Comments: US-009507513-1708USA012397: US-009507513-1708USA012398: US-009507513-1708USA012396: US-009507513-1708USA012399: US-009507513-1708USA012394: US-009507513-1707USA007162.
Evaluated in emergency dept on 10/15/2012 & 10/17/2012, and hospitalized on 10/17/2012 with pulmonary edema.