chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Malaise; Nausea; Headache; Confusion; Aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 27Jun2021 at 11:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included attention deficit hyperactivity disorder (ADHD), depression and generalized anxiety disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexamfetamine sulfate, amfetamine sulfate, dexamfetamine saccharate, amfetamine aspartate monohydrate (MYDAYIS) from an unknown date for an unspecified indication and unknown if ongoing and venlafaxine (MANUFACTURER UNKNOWN), from an unknown date for an unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 06Jun2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 27Jun2021 at 11:30, the patient experienced malaise, nausea, headache, confusion, aches, chills and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events malaise, nausea, headache, confusion, aches, chills and fatigue were resolving at the time of this report.
Fever, aches, chills, headache, nausea, vomiting, fatique for 48 hours.  Night sweats remain, 3rd night. No treatment,  but I consulted with Dr to confirm reaction was not uncommon.  I have no regrets about receiving vaccine and would do it again.
A report was received from a health care professional on 10/21/2002 concerning a 50 year old female vaccinee who developed diarrhea and experienced a large welt over the deltoid region of her arm which was described as red, swollen, painful, warm and itching on 10/16/02,  after receiving 0.5 ml of Fluvirin on 10/15/02. The vaccine was administered intramuscularly. The welt was treated with ice and paracetamol. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200602, PJP200200598, PJP200200597 and PJP200200596.
Immediately after giving Gardasil-9 (the 3rd and final vaccine received today), the patient fainted and was unconscious for approximately 5 seconds. The patient was laid down on the couch in the immunization room and had regained consciousness. The patient was able to later walk and was monitored for an additional 15 minutes. No further incident occurred.
Positive COVID-19 rapid test; Positive COVID-19 rapid test; Positive COVID-19 rapid test; Patient got sick; 2 weeks of on and off fever and unproductive cough; Patient got sick; 2 weeks of on and off fever and unproductive cough; Patient got sick; 2 weeks of on and off fever and unproductive cough; Lost sense of taste and smell; Lost sense of taste and smell; sore throat; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 16Dec2020, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. On 17Dec2020 patient got sick; 2 weeks of on and off fever and unproductive cough. In Dec2020 the patient also experienced lost sense of taste and smell. On 20Dec2020 the patient underwent COVID-19 rapid POC test and was found positive. The events required emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with Tylenol 650 every 4 hours. The events recovered on unspecified date except unproductive cough and sore throat that were recovering.   The information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19 rapid POC test) with BNT162b2 can not be completely excluded.
Left deltoid, at the site of injection: edema, erythema, mild pruritus, slightly warmer comparing with comparing with surrounding skin. The edema increased in size from 2cm diameter to 6x7 cm diameter with demarcated erythematous margins and central clearing. No pain. No systemic symptoms, no wheezing or dyspnea, no cough, no swallowing difficulties, no neurological symptoms, no other skin lesions.
unspecified rash on her face; This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) ( GARDASIL 9) intramuscularly (dose, lot # and expiration date were not provided) for routine vaccination.  On an unknown date (reported as a day after being vaccinated), the patient experienced rash on her face. The patient sought for medical attention by returning to the physician's office.  The outcome of the event was reported as recovered/resolved on an unknown date.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) ( GARDASIL 9) was not provided.
Received shot in right arm.  Woke up with sharp pain and tingling  in right finger tips. Pain and tingling slowly went away over next days.
Developed vesicular lesions on back of right calf which tested positive for varicella and was consistent with diagnosis of shingles.   Treated with acyclovir with good results.
Notable changes in menstration. Period started 2 days after vaccination ( 10 days early ) and has continued until current date.
Around 6 p.m. I started to have tingling and metallic taste in my mouth followed by a headache I took a hot shower I went to bed I began to have chills and sweating throughout the night I took two Tylenol and continued to have aches and pains throughout the night. When I woke up this morning to brush my teeth I have a black tongue. And a fever of 100.7
got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; This is a spontaneous report from a contactable pharmacist.  A 7-decade-old (65 years or 66 years) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The stated, "my uncle got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible Covid. He got tested for covid today (11Jan2021). He's supposed to get the second dose on 15Jan2021. If he is positive for covid, what does that mean for his second dose?  If he is positive, and waits for quarantine, then he wouldn't be able to get the second dose until day 36."  The outcome of the events was unknown.   Information on the Lot/Batch Number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Information has been received from an unknown age licensed practical nurse via field representative referring to herself. There was no information about the nurse's medical history. On an unknown date, when the nurse was a child, she received M-M-R II injection, (lot number, expiry date, route and dose were not reported). On an unknown date after she received M-M-R II, the nurse was treated with chemotherapy for an unspecified condition. Subsequently, on an unknown date, the nurse was fully recovered. Upon internal review, the nurse was treated with chemotherapy for an unspecified condition was considered to be medically significant. Additional information has been requested.
warm to the touch; itchy (itches like the dickens); swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy (itches like the dickens)) and VACCINATION SITE SWELLING (swollen) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy (itches like the dickens)) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy (itches like the dickens)) and VACCINATION SITE SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided. Treatment information provided as applying cold washcloth sparingly as treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: outcome updated to recovered as patient (consumer) reported
About 5 minutes after the vaccine, patient reported to mom that she didn't feel good. Mom said her face went white, and then she fainted. Her head layed back on the chair, and when I went out to go help she was sliding down the chair, and I moved to lay her down on the floor. At this point she was conscious and asking what happed.  We gave her some water, and an icepack to cool her down. After about 15 minutes patients mom was going to take her to her pediatrician.
First set of Anthrax (set of three Mar 99-May 99 Lot # FAV033) I developed a severe rash inside of mouth, lasted 6 months from May 99 thru Nov 99, prescribed steroid ointment used until conditioned improved.  Second set of Anthrax shots(Oct 99-May 00 Lot # FAV024 & 008) I developed facial alopecia, this condition lasted for eight months from June 00 to Feb 01.  USAF doctors prescibed steroid ointment.
After needle entered my arm the nurse leaned in and pushed and twisted needle in my arm. Pain level 10. After 4 weeks my pain level is a 10 with normal use. I've woken up every night since because my arm hurts, I fear permanent damage.
Patient came to see PCP on 12/15 for annual checke up. PCP reviewed immunization record, last dose of covid vaccine was given on 04/15/2022 which was monovalent, pt denied any other covid vaccine received afterwards. Then PCP offerred Pfizer Bivalent booster, pt agreed and received on same day, left office w/o any complaint after 15 min observation. Later afternoon, patient called PCP office that he found vaccine record at home which showed he had Moderna Bivalent booster on 10/18/2022 by Pharmacy already. Pt denied any discomfort at that time. Nurse called pt on 12/16  for f/u. Pt reported doing well, denied fever, body aches/chills or any discomfort. No erythema or swelling noted at injection site. Reported
SLEEPING PATTERN OFF; NAUSEOUS; SHOOTING PAIN FROM INJECTION SHOT; FREQUENT HEADACHES; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: carpal tunnel syndrome. 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 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sleeping pattern off, nauseous, shooting pain from injection shot, and frequent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleeping pattern off, nauseous, shooting pain from injection shot and frequent headaches was not reported. This report was non-serious.
Shake so bad, they put me in the emergency room 5 and half hours; Over three months, and I still get the shakes; they gave it to me 'in my leg'; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported for self that the 76-year-old patient of an unspecified gender received second dose of bnt162b2 (BNT162B2) at the age of 76-year-old, dose 2 via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: EN6198) as dose 2, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Verbatim: Rheumatoid arthritis, osteoarthritis from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing (Blood pressure high), breast cancer from an unknown date and unknown if ongoing , knee arthroplasty (knee replacement) from an unknown date and unknown if ongoing. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); gabapentin (GABAPENTIN); levothyroxine (LEVOTHYROXINE) taken for thyroid disorder (It's a generic for thyroid problem, I don't know I can't pronounce this thing."); diazepam (VALIUM) (Diazepam which is Valium 5 mg). The patient previously took first dose of (BNT162B2, LOT# for the first shot: EL9265) on 18Feb2021 for covid-19 immunization. The patient experienced shake so bad, they put me in the emergency room 5 and half hours; over three months, and i still get the shakes on 11Mar2021 with outcome of unknown , they gave it to me 'in my leg' on 11Mar2021 with outcome of unknown. The patient was hospitalized for shake so bad, they put me in the emergency room 5 and half hours; over three months, and i still get the shakes from 11Mar2021 to an unknown date. The clinical course was reported as follows: Consumer stated, "Okay, I got the first shot in Jan2021, they gave it to me 'in my leg' because of breast cancer issues. They got permission to give it to me in my 'leg', two weeks 'of debate they wanted to give it in my legs'. When I had the second shot at # Hospital and they made me sit for 15 minutes, so it did take 15 minutes to sign up that I had the shake so bad, they put me in the emergency room 5 and half hours. I went back to the hospital to report this and they won't give me the 'shot anymore so they sent me down in the street but that offices never open', its been over three months, and I still get the shakes. So I need you all to know this because evidently Hospital did not report this. And I, from the nurse and the doctor I think this happened to a lot people. I want to report it." Consumer stated, "Well they wanted me to go to the neurologist, so as to know why was I shaking. I 'lied' to get out of the hospital and so I wasn't shaking, but for 3 days I could feel my inside is just 'quivering' and every now and then at least once or twice a day I'm getting the shake." The consumer was hospitalized for 5 and half hours they did on the same date 11Mar2021. The patient don't take no beta blockers. No vaccination prior to the COVID 19 Vaccine. No anyone else facing same issues in family.
Patient states soreness and swelling in arm around injection site. She says that this occurred after the injection and never went away.
Pressure and blurry vision in my right eye; Pressure and blurry vision in my right eye; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female (no pregnant) patient received the first dose of BNT162B2 via an unspecified routed of administration on the right arm on 17Apr2021 at 13:15 (Lot Number: EW0250) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Known allergies is sulfa. The patient was not diagnosed with COVID-19 prior vaccination. The patient had not been tested for COVID-19 post vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydroxychloroquine (PLAQUENIL). On 21Apr2021 at 12:00, the patient experienced pressure and blurry vision in right eye. The treatment was not received. The adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of events was both not recovered.  No follow-up attempts are possible. No further information is expected.
Vaccine administered after use by date. Efficacy study done by Moderna and vaccine deemed effective and no re-vaccination needed Moderna Case ID Unknown.
Pt says arm still hurts - felt pain in arm when given shot. Has other shots with no problem. Felt like different pain with this administration. After 3 weeks went to MD. Could not find anything wrong but arm still hurting.
Pt reports numbness and tingling in hands and feet that started 2 days post-vaccination. Pt reports numbness and tingling is still ongoing, 1 month post-vaccination. Pt reports PCP prescribed Gabapentin, which is helping with pain and sensations, but reports sensation is still there.
expired MENACTRA being administered to a patient, with no adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 20 years old male patient who was administered expired Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra], with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jul-2022, the patient received (0.5 mL 1X) dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (lot U6952AA; expiry date; 09-Jun-2022, strength, formulation not reported) via intramuscular route in the left deltoid for immunization.  On 13-Jul-2022  (latency: same day) the patient developed a non-serious expired menactra being administered to a patient, with no adverse event (expired product administered).  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Immediately after my first dose I started spotting. By day 3 it was very heavy vaginal bleeding. Alongside the bleeding I have been getting lightheaded, nauseous and experiencing heavy cramping. This is very unusual for me to have heavy bleeding longer than 4 days in a row. I am positive this came from the vaccine because not only did the problem arrive the same day but it was too early for my normal period.  The type of cramps are also more severe than what I'm normally use to. I reported this to my job and took time off but the problem still persist.
Developed intussusception on 10 Jan 2007. Reduced by XR enema. 2/20/07 Received medical records from PCP which reveal patient experienced recurrent ear infections, cough & cold symptoms, sinusitis, vomiting illness approx 6 days prior to vax, temp 100.1 on day of vax.  On 12/19, seen for fever over past 2 days, decreased appetite, congestion & was dx w/left otitis media.  Treated w/antibiotics.  Received 2nd flu vax on 12/26.  On 1/10 awoke w/green emesis & drawing legs up, blood noted in jelly like stool, lethargic. Seen in PCP office that day & sent to hospital for xrays which were reported as WNL.  US of abdo showed possible mass in RUQ c/w IS.  Air contrast enema done which reduced the IS & was kept overnight for observation.  D/C home w/temp of 101.7, parent called PCP & was told to go to ER.  On 1/18/07 had temp of 104 w/rash, diarrhea then constipation.  Sent to hospital for labs which were reported as WNL.  Continued to have fever & was stuffy & congested.  Dx w/viral gastroenteritis. 3/29/07 Received medical records from hospital which reveal patinet experienced fussiness & drawing up of legs, vomiting & small bloody mucous stool on day of admit 1/10/07.  PCP sent to ER where IS was confirmed & successfully reduced with air enema. Admitted for overnight observation.  Progressed well & d/c home next am.  Later that same day returned to ER with fever of 101.2.  Treated w/fluids & antipyretic meds & d/c to home w/close observation by family.  FINAL DX: RUQ colonic intussusception, reduced by contrast enema.
Patient received expired vaccine-- vaccine expired on 5/14/2023 and was given on 05/16/2023.
Immediately after injection pt stated: "I feel like I'm going to pass out" complained of "ringing in ears"  EMS lowered the patient to cot, felt nauseas at that time.  Vitals: 94/56, HR 74, OxSat 98%.  At 1320 pt feeling a lot better.  At 1320 VS: BP 106/60, OxSat 94%, HR 66.  After standing patient has no complaints and is ready to be discharged with mom.
1wk p/vax pt exp flu like sx, extreme exhaustion, muscle cramps, spasms & aches, pains in hand, wrist, ankles, arthralgia, h/a;
This spontaneous report as received from an unknown source, as a part of market research, refers to an unspecified number of immunocompromised patients of unknown age and gender. There was no information about the patients' concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). It was reported that on unknown dates, PNEUMOVAX 23 was not as effective for immunocompromised patients. These patients must also receive PREVNAR. It needed to be given first, then PNEUMOVAX 23 one year later. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as there were no contact details provided.
redness; nausea; arm  soreness; This case was reported by a nurse via call center representative and described the occurrence of erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included levothyroxine.   On 28th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema, nausea and pain in arm. On an unknown date, the outcome of the erythema, nausea and pain in arm were unknown.   It was unknown if the reporter considered the erythema, nausea and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced redness, nausea and arm soreness. The patient takes glucozone and levothyroxine and her weight was only 85 pounds. No information about lot number and expiration date from shingrix first dose. The reporter consented to follow up.
No AE; HCP calling to report that 2 doses from PROQUAD lot, which expired on 4/6/2023, were administered on 4/11/2023. No further information provided, no additional AEs, no PQCs. (LOT U031564 EXP 4/6/2023); This spontaneous report was received from a site coordinator (also reported as medical assistant ), concerning to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 11-APR-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter/once, (lot #U031564, pending validation expiration date: 06-APR-2023) administered for prophylaxis (strength, and route of administration were not provided).  This is one of the two cases created from the same reporter; Sender's Comments:  US-009507513-2304USA005904: