chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2) at the age of 29-year-old, dose 3 via an unspecified route of administration, administered in Arm Right on 04Oct2021 10:45 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Facility type Vaccine: Pharmacy or Drug Store. Medical history was none. No other vaccine in four weeks; no other medications in two weeks. No covid prior vaccination. There were no concomitant medications. No Known allergies. Historical vaccine included BNT162B2 for COVID-19 immunization on an unknown date (Dose Number: 2, Prev dose product= covid 19, Prev dose brand= pfizer, Prev dose dose number=2); BNT162B2 for COVID-19 immunization on an unknown date (Dose Number: 1, Prev dose product= covid 19, Prev dose brand= pfizer, Prev dose dose number=1, Prev dose vaccine location=Right arm). The patient experienced slightly blacked out for about a second on 04Oct2021 14:15 with outcome of recovered on 04Oct2021; started to feel slightly nauseous on 04Oct2021 13:45 with outcome of recovered, felt terrible on 04Oct2021 14:15 with outcome of recovered, vomited about 4 times on 04Oct2021 14:15 with outcome of recovered on 05Oct2021 00:30, started to get terrible stomach cramps that felt like agony on 04Oct2021 14:45 with outcome of recovered on 04Oct2021 16:45 lasted for 2 hours, had some diarrhea the following day on 05Oct2021 with outcome of recovered. Detail information about adverse event includes: Shot 1 and 2 the patient had of average symptoms. She was reporting now on booster shot 3 that received at 10:45 am. About 1:45 pm she started to feel slightly nauseous. About 30 minutes later felt terrible and slightly blacked out for about a second and vomited about 4 times. About 30 minutes later started to get terrible stomach cramps that felt like agony. The cramps lasted for maybe 2 hours and then finally went away. She threw up another 4 times and then a few hours later another 4 times and then a few hours later another 4 times. The patient felt nauseous. She stopped puking at 12:30 ish am- about 14 hours after receiving the vaccine. The next month she felt nauseous but overly much better. She had some diarrhea the following day as well. By the end of the day she was able to walk around some and do household chores. The day she felt back to normal. It was unknown If treatment AE. No Covid tested post vaccination. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event blacked out cannot be excluded based on temporal association and available information. 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.
Patient complains of hand and finger joint stiffness and fever after receiving flu vaccine Monday Oct 15th at pharmacy. Fever of 102F that 1st appeared on Friday Oct 19th, relieved by APAP. 2nd fever Wed Oct 24th, with chills, awake most of night with fever up to 105F, treated with cold compress on forehead with relief of fever w/ APAP. Since then pt is experiencing stiffness and pain in joints, alleviated with tiger balm patches. Fever 99.2 - 100.1 over last 24 hours. Assessment questions were asked per triage protocol and the patient answered "no" to all questions except for the following: Pt has been exercising regularly and is losing approx 1 lb per week, no other significant health status changes. Pertinent negatives include never had a vaccine rxn in past. Fingers and hands are not cold or blue; normal daily movements are possible with accompanying pain. Pt describes thick red blotch on knuckles with shiny skin. Vaccine reaction review: Pt denies cough, itching, hoarseness, rash or reaction at injection site, breathing difficulties. Recommendation Disposition: Instructed patient to seek medical care within 2-4 hours at Care Clinic for assessment by provider for possible vaccine reaction vs exposure to a different virus. RN conferred with triage MD to and decided to report moderate vaccine reaction to VAERS reporting system. RN completed. Advice Agreement: Patient verbalizes understanding and agrees to follow through with the recommended disposition and advice given. Pt advised to give the clinic a call early next week to make f/u appt with her PCP. Denies additional questions and concerns.
09/01/22 presents to ED for "weakness/lightheadedness and frequent falls". PMHx of " CHF, DM2, HLD, HTN, anxiety"
Information has been received from a registered nurse, concerning a 16 year old female patient, who on 15-SEP-2007 was vaccinated IM with the first dose of Gardasil (lot # not reported). After the vaccination, the patient passed out and stopped breathing. The patient remained at the physician's office and recovered (time duration not reported). On approximately 15-NOV-2007 ("two months later"), the patient was vaccinated IM with the second dose of Gardasil (lot # not reported). Following the second vaccination, she vomited. She again remained at the physician's office for observation, and recovered (duration of time not specified). Upon internal review the event of stopped breathing was considered serious, as an other important medical event. Additional information has been requested.
Day 1 tired and achy, Day 2 & 3 Severe watery diarrhea, every 20 minutes about 50 times in 48 hours. Day 4 & 5 migraine, tired, achy and loss or appetite. Day 6-10 achy, tired and loss of appetite. Basically felt poisoned.
Case number PHHY2011US33910 is a combined initial and follow-up spontaneous report from a pharmacist on 19 Apr 2011. This report concerns a 30-year-old female patient. She was vaccinated with MENVEO (batch number: 100001) intramuscularly on 19 Apr 2011. The pharmacist was not able to draw the 0.5 ml complete dose into the syringe. The patient received less than 0.5 ml dose (more than 0.4 ml but less than 0.5 ml). No adverse event was reported following this underdose.
This spontaneous reprot as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # H020901, expiration date: 05-JUL-2015), dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient recieved his Pfizer vaccine on 08/06/2021 @ 11:29 Am. The patient came back to the nurse complaining of being light headed, flushed, and a little shakey. , RN took the patient's vitals whcih were blood pressure 138/90, heart rate, 98, and oxygen 96%. The patient was given crackers and water and was advised to wait an additional 15 minutes to make sure he didn't have any more complications. The patient returned back to normal within about 4-5 minutes.
On 4/23/2021, Patient presented to the vaccine Center having made a first dose appt. for the Pfizer vaccine (record attached).  The nurse followed procedure asking all the necessary questions and administered the vaccine.  After patient left the clinical area, he returned to grab the drink he left and told the nurse ?Oh by the way, that was my second dose?.  The nurse proceeded to question him about this and his response was he received his first dose of Pfizer and today?s dose was actually his second dose.  He informed the nurse he will be returning in three weeks for his third dose which he considers the booster shot.  The nurse made it very clear this isn?t how it works and he is not to come back for a third dose.  On 5/14/2021, patient presented to the vaccine Center and received an additional dose of the COVID_19 Pfizer vaccine.
Flushing and diaphoresis beginning 45 minutes after vaccination.  Lasted about an hour.
high fever, loss of ability to ambulate, fell on floor.  Taken to hospital by ambulance.  Low blood pressure, low oxygen, numerous labs were outside of normal limits,, elevated lactic acid.  Received methyloredbuise 60mg every 6 hours (I think three times)  Admitted on Feb 14th. Discharged on Feb 16th.
Patient found to have thrombocytopenia (platelet 16K) on 4/17/2023 with gingival bleeding.  He is being treated acute ITP (today is day 2 of hospitalization) and will be receiving pulse dexamethasone as his platelet count continues to decrease.
Very sore upper arm for 2 days.  Lessening on the 3rd day.      No bruising.     Days 1-2: Considerable pain to the touch.   Considerable muscle pain when lifting arm above the shoulder.    Day 3:  Lessening pain.  More of a dull ache.  Movement less painful.
Patient fainted 5minutes after receiving the vaccine for 2 to 3 minutes. Excessive sweating was also noticed during this time.
Hard, red warm area that did not start until 7 days after vaccine. Reports tingling and pain down arm.
Fever, chills, body aches and fatigued during night.  Following day is just fatigue.
stomach cramping; Diarrhea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included medroxyprogesterone acetate (DEPO PROVERA), hydroxyzine (MANUFACTURER UNKNOWN) and lithium carbonate (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. 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 vaccination. On 31Mar2021, the patient experienced diarrhea and stomach cramping. No therapeutic measures were taken as a result of 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 the events of diarrhea and stomach cramps was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
10 days after receiving COVID booster in right arm and flu shot in left arm, developed hives. I have never had hives before. Hives have been o ongoing for more than three weeks. Tried to control with benadryl and OTC creams but was mostly unsuccessful. Saw dermatologist on 12/17/21 who confirmed they are seeing an uptick in hives related to covid booster, i started a treatment regimine (allegra 360mg BID, benadryl in the evening). after a week there was improvement. i experienced a major setback on 12/23/21-hives started coming back worse, breathing problems (tight chest like breathing through a straw, extreme itchiness inside and outside my check, coughing) seeming like asthma started up and my right arm became extremely sore again for several days. my PCP prescribed 80mg oral prednisone daily on 12/28/21 for a seven day course i am currently on-i have seen major improvement in breathing and hives since then, but am still experiencing both of them in a mild form.
Fever greater than 102 deg. F, chills, body aches, pinkness at site of injection, swelling of bicep at site of injection.
I had sore throat, runny nose and congestion, very deep cough, headache, high temperature 103.1 degrees, coughed up a lot of phlegm, I had a lot of phlegm, trouble breathing. I tested positive for COVID-19 and my doctor prescribed PAXLOVID. Symptoms started on 20DEC22. I started PAXLOVID on the 22nd and still had symptoms for a full week. I'm still a little hoarse right now but that's all the rest of the symptoms have gone away.
Sore arm, but got a nasty headache a couple of hours after the shot. Then I sweat enough to have to change shirts twice.  I took two ibuprofen 200mg each and slept it off.  Woke up symptom-free. However, my arm is still sore.
Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case received from a other health professional. This case is linked to case 2018SA280096 (same reporter). This case involves Elderly female patient (age not reported), who experienced developed band like around lateral side of her arm 1-2 inches below the injection site/cellulitis, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 03-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot: UJ004AB and expiry date: 30-Mar-2019) via intramuscular route in the left deltoid. On an unknown date, the patient developed a serious developed band like around lateral side of her arm 1-2 inches below the injection site/cellulitis (cellulitis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. No lab data was reported. Final diagnosis was developed band like around lateral side of her arm 1-2 inches below the injection site/ cellulitis. No corrective treatment was received. The patient outcome is reported as Unknown for developed band like around lateral side of her arm 1-2 inches below the injection site/ cellulitis. Documents held by the sender: none. Sender's Comments: This case involves an elderly patient who presented with cellulitis near vaccination site. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Knot on injection site; itching at injection site; hurts at injection site; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Knot on injection site), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (hurts at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Knot on injection site), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (hurts at injection site) and VACCINATION SITE SWELLING (swollen at injection site). At the time of the report, VACCINATION SITE INDURATION (Knot on injection site), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (hurts at injection site) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: As per TCR attached, patient declined further followups
Lower back pain, heaviness and significant pain in right thigh and mild pain and heaviness in right tricep.
Bilateral pulmonary emboli-hospitalized on January 21, 2022 X 2 days. Currently taking Eliquis 5mg BID Also has discolored circular large ring on arm at the injection site
pt said she had redness swelling and area was warm to touch.  went to md and md said looked like a localized reaction but gave her an antibiotic just in case
Extreme lethargy/exhaustion, nausea, severe headaches, fever spikes.
May have received a higher dose of vaccine due to insufficient diluent. The individual was unable to be reached by phone. A report was made in the city immunization information system. No side effects were identified during the observation period.
hard; very itchy; swollen; a large red circle (2.5x3 inch) formed at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (a large red circle (2.5x3 inch) formed at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (a large red circle (2.5x3 inch) formed at the injection site). At the time of the report, VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (a large red circle (2.5x3 inch) formed at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Confirmed Shingles treated with Val acyclovir and gabapentin. Rash (scaring) is still present but pain has subsided
27 YEAR FEMALE WITH DIZZINESS AND SHAKINESS FOR 10 MINUTES.  SECOND DOSE GIVEN TODAY. 1ST DOSE GIVEN WITHOUT ADVERSE REACTION. PATIENT HAD NOT EATEN SINCE LAST EVENING. DR ONSITE. PATIENT GIVEN WATER 17 OUNCES WHICH SHE CONSUMED.  VS: 144/93 HEART RATE 103, BG 322. 135/91 HEART RATE 107 RELEASED AT 10:05 DR REINFORCED NEED TO MAKE WISE DIETARY CHOICES AND INCREASE HYDRATION.
it looks like rheumatoid arthritis.; Arm pain left arm (site of injection); Swelling of fingers on opposite hand and fingers/Unable to close right hand due to swelling; Unable to close right hand due to Swelling; appear abnormally swollen around the joints; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   On 22-MAY-2023 11:30, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced rheumatoid arthritis (Verbatim: it looks like rheumatoid arthritis.) (serious criteria GSK medically significant), injection site pain (Verbatim: Arm pain left arm (site of injection)), hand swelling (Verbatim: Swelling of fingers on opposite hand and fingers/Unable to close right hand due to swelling), movements reduced (Verbatim: Unable to close right hand due to Swelling) and swollen joints (Verbatim: appear abnormally swollen around the joints). The outcome of the rheumatoid arthritis, injection site pain, hand swelling, movements reduced and swollen joints were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, injection site pain, hand swelling, movements reduced and swollen joints to be related to Shingrix.     It was unknown if the company considered the rheumatoid arthritis, injection site pain, hand swelling, movements reduced and swollen joints to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023. The patient's daughter reported that on 22 May 2023 at 11:30 AM the patient received 1st dose of Shingrix vaccine on and has experienced swelling of her fingers.  The patient was unable to close her hand.  It was abnormally swollen and unknown timeframe of when the swelling started.  Arm pain left arm (site of injection).  Swelling of fingers on opposite hand and fingers (right hand).  The hand and fingers appear abnormally swollen around the joints, it looks like rheumatoid arthritis.  The patient had an autoimmune issue as well. The reporter did consented to follow up.
Patient received 2 doses of the Covid19 vaccine, one in each arm.  Requested Covid19 and flu vaccine today.
Patient developed shaking (reported as seizure-like activity) and became non-responsive within 15 minutes of vaccination.  IV started and patient was transported to ER by EMS.
Feeling sick and I think I having a bad reaction to it; Feeling sick and I think I having a bad reaction to it; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 69-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0177, Expiration date: Unknown), via an unspecified route of administration, in left arm on 19May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had experienced feeling sick and thought that having a bad reaction to it on 19May2021. The patient received treatment as Norco medication but that was it, 7.5mg. The outcome of the events was unknown.  Additional information is requested.
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient).   A 54-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL 3247, Expiry date: not reported), via an unspecified route of administration in left arm on 01Mar2021 10:30 (at age of 54-years-old) as dose 1, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included depression, Adult ADHD (attention deficit hyperactivity disorder). The patient previously took erythromycin, amoxicillin, avelox, zithromycin, Inderal and experienced drug hypersensitivity. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; liraglutide (SAXENDA) taken for an unspecified indication, start and stop date were not reported; methylphenidate (METHYLPHENIDATE) taken for an unspecified indication, start and stop date were not reported; eletriptan (ELETRIPTAN) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 01Mar2021 22:00, the patient experienced soreness at injection site. No therapeutic measures were taken in response to the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site pain). At the time of the report, VACCINATION SITE PAIN (injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.