chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 09-JUL-2014 at 10:58 AM, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 04-JUL-2014 at 11:39 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
brain zapping  jolts throughout the day, pins and needles sensation in fingers, hand, toes, and random parts of body
Patient felt dizzy  less than 5 minutes after vaccine, patient became light headed and pale, had difficulty opening eyes. She remained sitting, but was on the verge of passing out. Our technician then called 911 and they advised not to give patient any water. Paramedics arrived and took her to the hospital for observation. Appears to be a vasovagal response to the vaccine.
itching around noon on 16Jan2021 to her right arm/injection site; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included Low Thyroid Function, High Blood Pressure, IBS, High cholesterol. Concomitant medication included simvastatin for high cholesterol, metoprolol tartrate (METOPROLOL) for high blood pressure, levothyroxine sodium (SYNTHROID) for thyroid. Patient received the first dose of the bnt162b2 on 07Jan2021 on her right arm. She started to experience itching around noon on 16Jan2021 to her right arm/injection site and reported the area was red, swollen, warm, and measured about 5 inches in diameter. Also reported as starting 16Jan2021 she started to experience in the same injection site area warmth, redness, swelling, itching and she reported that it was measured about 5 inches in diameter around the injection site. She reported taking Benadryl and icing the affected area and stated it felt a little better as of 17Jan2021. The outcome of the events was recovering.
extreme thirst for weeks after, long term and short term memory lapses, discomfort at injection site.
The morning  after getting the second shot, I do not remember it but I had passed out and was taken to the ER. My blood pressure was 88/33. I am not sure what they did. I was sent home the next day.
Chest pain on right side of chest.; Pain between shoulders.; Patient received  third dose/ Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 10Nov2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 27Mar2021 (at the age of 30-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EV10151) via an unspecified route of administration on 17Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 10Nov2021 at 16:00, on the day of vaccination, the patient experienced chest pain on right side of chest and pain between shoulders. Reportedly chest pain was present the following day but was less severe. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain on right side of chest and pain between shoulders were resolving at the time of this report.
Reported by patient 12/14/10 arm swollen "like baseball" red & numbness & facial pain. Not warm to touch. No fever. Experienced HA & nausea. Advised by Dr. on call to take BENADRYL. Overall improved just a little red & mild numbness and asked pt to call if not resolved in a few days or worsens (no - call back).
This spontaneous report was received from a nurse refers to currently 6-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 29-JAN-2018, the patient was vaccinated with improperly stored PROQUAD (Lot # N020618 and expiration date 22-JAN-2019), (Lot# N025923 and expiration date 18-MAR-2019) (product storage error) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that PROQUAD (lot # N020618) could still be used. Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
EXPLOSIVE DIARRHEA; PAIN IN LEFT ARM; HEADACHE; DIZZY; FOGGY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced dizzy. On 05-APR-2021, the subject experienced foggy. On 05-APR-2021, the subject experienced pain in left arm. On 05-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced explosive diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left arm, dizzy, foggy, explosive diarrhea, and headache. This report was non-serious.
Patient was administered Menactra 4 weeks after receiving a dose of Menactra instead of the ordered Men B vaccine with no reported adverse event; Patient was administered Menactra 4 weeks after receiving a dose of Menactra instead of the ordered Men B vaccine with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old male patient who was administered meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] 4 weeks after receiving a dose of menactra instead of the ordered men b vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Aug-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D conj) vaccine once (formulation and strength not reported; lot U7492AA, expiry date: 26-Oct-2023) via intramuscular route in the left deltoid for immunization.  On 18-Aug-2022 the patient was administered menactra 4 weeks after receiving a dose of menactra instead of the ordered men b vaccine with no reported adverse event (wrong product administered) and (extra dose administered) following the administration of meningococcal A-C-Y-W135 (D conj) vaccine.   It was reported, the patient received MENACTRA 4 weeks ago 18JUL2022 and returned today for a Men B vaccine. The patient was mistakenly given this 2nd dose of MENACTRA within a 4 week time frame. Caller is also asking how long to wait before given MEN B since the patient did get an extra dose of MENACTRA.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 guidelines. 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.
One day, post vax, fever started, swollen glands. Peak fever of 105F on 1/26/01 but glands better. Vomiting and diarrhea for 3 days. On 1/26/01, testicles/leg/thigh were bright red and swollen from knee to groin and tender. Redness traveled up to chest. Advised to be seen at local clinic. Started on Duricef because of questionable infection from injection site on right leg. Had temperature 103F and was given ibuprofen. On 1/29/01, still fussy with increased sleeping but doing better. Occasional runny stool, tolerating liquids and leg is better; no red streaking. Scrotum still slightly streaked but swelling down. On 2/1/01, 9 days, post vax, rash started with red splotches on legs and back; fever to 101-102F, lasting intermittently, for 3 days.
Patient received 1st dose of shingles vaccine and then got a red, swollen and inflammed reaction on her arm. She went to the doctor and had to looked at. Prescriber concluded that she may have had strep bacteria present on her skin at the time of the injection which caused the infection. Proper vaccination technique was performed at the time of the injection including wearing proper PPE and cleaning the injection site with an alcohol swab. Patient was given antibiotics for the infection. No further adverse reactions noted.
Cannot find a local pharmacy that stocks Twinrix; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dsoe 1 month later of 1st dose).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive 3rd dose of Twinrix as patient could not find local pharmacy that stocks Twinrix, which led to product supply issue. The patent asked if he/she could get a separate Hepatitis A and Hepatitis B vaccine to substitute.
Patient reached out to clinic to reports severe arm pain since receiving the vaccine, which had not abated since 9/17 on 9/23/2021. She denies fever or chills or redness at the site. SHe reports the pain is significant and woke her from sleep.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM2" (unspecified if ongoing), notes: DM2; "CKD3 (on lower dose of paxlovid)" (unspecified if ongoing), notes: CKD3 (on lower dose of Paxlovid); "arthritis" (unspecified if ongoing); "Known Allergies: Latex" (unspecified if ongoing), notes: Known Allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
All over body hives a few hours after injection. Hives haven?t gone away and I have been on OTC antihistamines with little to no improvement. I have hair loss and tightness in chest/throat.
After receiving the vaccination in my arm I have been experiencing sharp pain with even the slightest movements of my arm.
Engerix b 0.5ml ped dose administered to 37yo patient. No adverse effects noted.  Patient is aware. Upon consultation with provider, Engerix B 1.0ml administered to patient . No adverse effects noted.
Myalgia Muscle twitching and spasms Narrative:  Employee reports post vaccination on 12/31/2020 about 6hrs post vaccination she developed shooting pains in right arm radiating down her arm and into her neck. She states these symptoms progressed through out her entire body into the evening. She developed muscles twitching and spasm all over.
Patient c/o red rash 2-3 inches below from site of injection, more on inner side of the left arm. Per patient, feel warm to touch and almost feels like a post tetanus vaccine tightness and soreness. Pt been taking Flurbiprofen and Amoxil for post dental work and has purchased OTC Benadryl today and will do cold compressions and Tylenol b/c pt now done with flurbiprofen.
This is a spontaneous report from a contactable other hcp (patient). A 26-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm right on 16Mar2021 at 14:45 (02:45 PM) (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included ADHD, depression, anxiety, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications included lisdexamfetamine mesilate (VYVANSE) at a dose of 40 mg, once a day; ethinylestradiol, norgestimate (FEMYNOR), both drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm right on 23Feb2021 at 02:45 PM as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 17Mar2021 02:00 AM, the patient experienced body aches, fever, chills. Query: Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response: The date of awareness was Wednesday, 17Mar2021. The patient received Tylenol as treatment medication for all the events. Outcome of all the events was recovering. Follow-up attempts are possible. No further information is expected.
I do not think it was related to the vaccine, I has some mild aches, tender at the injection site. I have recovered from my symptoms.
tc fr pts' mom stating that pt awakened this mornng w/fever; also had episode of vomiting;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "NonAlcholic Fatty Liver" (unspecified if ongoing); "asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "ICP" (unspecified if ongoing); "Meniere's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "anemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no known allergies. The patient did not receive any other medication in 2weeks. By the second treatment there was a rotten taste in mouth that won't go away, and the patient had semi-solid diarrhea. Taste went away temporarily when eating or using cough drops. Grateful to take Paxlovid because she could swallow now (throat was swelling up/swelling shut from covid) so she just wanted to notify you that she was part of the 6% that had the really bad rotten taste in mouth and could not seem to stop going to the bathroom. That had kept her out of the hospital and she will keep taking the full round. The patient thanked for developing this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax approx 4PM waited 20min in lobby states felt bad driving home;called pp-sent to ER c/o throat closing & welts, itching was given 2 shots in ER & observed x 6hr;went to amb care 1SEP97 & given steroid pack still c/o welts & itchi
Feeling very sick since vaccine, night sweats, diarrhea, Dry heaving in morning, loss of appetite, weight loss, flu like feeling, fatigue, aching, lack of concentration, no fever
Patient came in with his family for Pfizer booster shots. During verification of age, patient's father stated he was 16 years old and the vaccination was administered. Upon processing paperwork later, it was discovered he was 15 instead and therefore not eligible for the booster dose of Pfizer. Patient's parents were contacted and informed, his mother verified his age and stated he was fine.
Child received immunizations at 2:00 pm, Tuesday, September 25, 2007.  Parent states that evening child developed redness and a welt on Left thigh - applied cold washcloth.  Wednesday afternoon child then developed red, blotchy rash on both legs and blisters on her perineal area and both buttocks.  Went to ER - prednisone prescribed.
developed movements on his right leg and arm / doctors find nothing causing his right leg movements; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) (seriousness criterion hospitalization). At the time of the report, DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Debilitated and bed ridden for 30 days. Also, early onset of menopause. So fun!
Both of my children recieved the chicken Pox vaccine.  They both had identical reactions. At the site of injection that got a SQUARE rash, larger than a half dollar. It was hot to the touch and extremely itchy.  It lasted 3 weeks.
Anaphalaxis reaction, stridor an unable to breathe. Happened in 30 seconds
I have a very strong muscle back pain on both sides. Can not bend at all. Very strong muscle pain on the shoulder not able to put dresses or everything on me needs to use help. I had two days headache which I don't have any more. But the pain on the low back are very strong .Difficult to sleep. Difficult to move the shoulder and the hand. I never had this pain before in my Life. I'm very healthy person and now you and your vaccine make me feel half person. If something bad will happen with me and I died I give permit ion for my daughter to  sue .