chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse (L.P.N.) concerning a 20 year old female with no medical history or no known drug allergies who on 12-AUG-2008 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot # 658490/0802U). There was no concomitant medication. On 12-AUG-2008 the patient experienced syncope after administration of GARDASIL. The patient became warm and sweaty. She fainted and was unconscious for 45 seconds. The patient had only eaten fruit prior to administration of GARDASIL. Subsequently, on 16-MAY-2008 the patient recovered from the events. The adverse events happened during office visit. This is one of several reports from the same source. Additional information has been requested.
Pt devel inject site rxn (details not know) following PNU-IMUNE on 20NOV90;
Got COVID after vaccinations; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after vaccinations) and DRUG INEFFECTIVE (Lack of drug effect) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 204M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Got COVID after vaccinations) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Got COVID after vaccinations) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 antibody test: positive (Positive) Patient still had antibodies..         No concomitant medications reported. No treatment medications reported.  It was reported that patient did not experience any symptoms following vaccination. This case concerns a 75 year-old, male patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. Drug ineffective was considered as an additional event. The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 75 year-old, male patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. Drug ineffective was considered as an additional event. The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever with abnormal movements. Infant had flexion/stiffening of upper extremities on several occasions.
SOB and leg swelling Dx with DVT and PE, also c/o fatigue for past yr. In May 2011 developed another DVT.
Severe headache for approx 36 hours Fever to 100.4 Aches Chills Severe Fatigue
Information has been received on 22-FEB-2019 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 29-JAN-2009, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Patient inadvertently received a third booster dose earlier than the 6 months recommended. He is supposed to be due for his booster around 11/16/2021 but received the booster. No adverse reactions observed since being vaccinated.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as K001124, Expiry date: 16-OCT-2016) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was given after a needle was attached for over 24 hours in the fridge. Patient is not experiencing any side effects at this time and would like another vaccine to be administered.
3-30-21 5:35PM PT HAS RASH TO BOTH ARMS, CHEST AND 'FEELS WARM'.  BENADRYL 50MG GIVEN PO (SHE DID 'USE HER OWN INHALER'). A/O, W/D, NO RESP DISTRESS. 5:52PM PT STATES SHE 'IS FEELING BETTER NOW'. AMBULATORY TO EXIT GAIT BRISK AND STEADY. 3-31-21 8:40AM TC: PT STATES 'RASH IS MUCH BETTER TODAY'.
Soreness and swelling around injection site. Told him to use a cold compress and take Benadryl as directed.
Within days after the second injection I noticed I couldn?t taste  I was drinking just thought it was flat. Then I went and bought a new can of soda same reaction. I then tried a different brand of soda, same. I can't taste the flavor or the carbonation at all! They all seem flat! When the liquid reaches my throat it starts to feel a little normal so it?s just in my mouth. It?s still the same and it?s been like this since the injection.  My smell has also been affected slightly. I can smell things but not as well as I once did.  The reason I?m just speaking up is I had no idea I was supposed to report this. Thank you for your concern!
Patient claimed she has a history of passing out after vaccinations.  After shot, pt informed Mehul she feels like passing out.  She sat more in a supine position in chair for about a minute and Mehul gave pt two ice packs - one for forehead and one for stomach - and that did not help.  So, pt lied down on floor in immunization room with ice packs on her.  She felts better after about 1 minute.  She sat up and drank cool water.  After another couple of minutes, she felt better and waited in waiting area for another 10 minutes.  After that, mom claimed pt felt fine - so they went shopping in grocery store.
Received vaccine 9/9, reported can't move arm for 3 weeks, MD told her shot was high, hot and tender, received P.T.
rash on torso; This case was reported by a consumer via call center representative and described the occurrence of rash in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 86 or 85 years old at time of vaccination. The reporter was daughter of patient who received first dose of Shingrix in Aug 2019. The reporter stated that patient experienced rash on his torso that had not resolved. The reporter did not consent to follow-up. The reporter declined to provide demographics or follow up. This case has been linked with US2019164591, having same reporter.
Information has been received from a registered nurse concerning a 12 month old female with no allergies, who was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently, seven days after receiving the vaccination, the patient developed a fever and eleven days post vaccination she developed a measles like rash. Unspecified medical attention was sought. The child was treated with diphenhydramine hydrochloride Benadryl. The outcome was reported as recovered. No product quality complaint was involved. Additional information has been requested.
She had acute death 72 hours after administration of the vaccine on 12/02/2022.  There were no signs of other acute illness or expected death.
Day after vaccinations, patient experienced swollen lips. Later experienced hives starting on face then on trunk
no appetite; feeling achy; continued having a headache; did not sleep well; unable to do anything for 2 days; she is unable to get up; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep well), DECREASED APPETITE (no appetite), IMPAIRED WORK ABILITY (unable to do anything for 2 days), DYSSTASIA (she is unable to get up) and PAIN (feeling achy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Psoriatic arthritis (she takes methotrexate once weekly on Friday and folic acid). Concomitant products included METHOTREXATE for Psoriatic arthritis, FOLIC ACID for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced INSOMNIA (did not sleep well). On 13-Nov-2021, the patient experienced HEADACHE (continued having a headache). On 15-Nov-2021, the patient experienced DECREASED APPETITE (no appetite) and PAIN (feeling achy). In November 2021, the patient experienced IMPAIRED WORK ABILITY (unable to do anything for 2 days) and DYSSTASIA (she is unable to get up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (did not sleep well), DECREASED APPETITE (no appetite), IMPAIRED WORK ABILITY (unable to do anything for 2 days), DYSSTASIA (she is unable to get up), PAIN (feeling achy) and HEADACHE (continued having a headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, Body temperature: 99.5 f (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated she felt like she had low-grade migraine pre-vaccination.She stated that she got the 100% of booster dose because she is immunocompromised. also stated symptoms are persisting.She was told not to take methotrexate on the vaccination date 12Nov2021 by her rheumatologist. Reporter states that the patient received 1st dose on 25Jan2021 and 2nd dose on 28Feb2021 (date not exact, per patient). Vaccine was administered on her left arm except for one dose that patient does not remember
Pinpoint papular rash involving anterior trunk occurring about 30 hours after injection; faded in 1-2 days. Redness and swelling at injection site (left thigh) at 30 hours after injection. Resolved in 2-3 days.
This is a spontaneous report from a contactable pharmacist via Pfizer Company representative. A patient of unspecified age ethnicity and gender received PREVNAR 13 single dose for immunisation. The medical history and concomitant medications were not reported. The patient experienced pain at the injection site for about 3-4 days after use of product. Event outcome was unknown.
Itchy torso (front and back; torso only) at night that woke me up and disrupted my sleep. Never happened before. I am fair skinned and apply body lotion about once a week. Dermatologist said " dry skin" and suggested certain lotion, soap, laundry. Prescribed hydrocortisone pill which had no impact. I lotioned daily for 10 days and it subsided. I subsequently returned to lotion once a week, if that. Itching has never returned despite discontinuing lotion regiment. I did adopt permanently the mild soap and laundry.
fever up to 100.4 F; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever up to 100.4 F) and MYALGIA (body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (chills). On 04-Feb-2021, the patient experienced PYREXIA (fever up to 100.4 F) and MYALGIA (body aches). On 03-Feb-2021, CHILLS (chills) had resolved. At the time of the report, PYREXIA (fever up to 100.4 F) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 100.4 (High) 100.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment details were not provided.
Pt. received vaccination on 2/6. On 2/7 pt stated she was fine. On 2/8 daughter found her in the evening unable to speak.  She was brought to the ED.
Within one or two minutes I felt extreme heat from my head to my toes,  my whole body began tingling,  heat became extreme from my belly button down to my toes,  blood pressure dropped, lightheadedness, dizziness, chills and shaking of whole body.
pt recv vax & approx 30min post vax pt devel a h/a;MD inidcated that 8 other pt had similar exp (WAES 97100694, 97100696, 97100697, 97100699 through 97100703);
Nauseous; Fell very ill; Stomach was very upset; Dizziness; Developed severe vertigo; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), ILLNESS (Fell very ill), ABDOMINAL DISCOMFORT (Stomach was very upset), DIZZINESS (Dizziness) and VERTIGO (Developed severe vertigo) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous), ILLNESS (Fell very ill), ABDOMINAL DISCOMFORT (Stomach was very upset), DIZZINESS (Dizziness) and VERTIGO (Developed severe vertigo). At the time of the report, NAUSEA (Nauseous), ILLNESS (Fell very ill), ABDOMINAL DISCOMFORT (Stomach was very upset), DIZZINESS (Dizziness) and VERTIGO (Developed severe vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case number PHEH2014US024317 is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This reports to a 63 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into right deltoid intramuscularly at a dose of 0.5 ml on 14 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration 9incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Sinus infection; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4275676-00 (AbbVie).  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 11Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155481) at citrate free for ankylosing spondylitis, rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jan2022, outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovering" and all described as "COVID-19"; SINUSITIS (non-serious), outcome "recovering", described as "Sinus infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID and SINUS INFECTION with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the event(s) of COVID and SINUS INFECTION with BNT162B2 was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events and the suspect product bnt162b2
Hives, severe, face and generalized body (arms, trunk, legs). 5 weeks pregnant when vaccine recieved. 7 weeks when adverse effect. Hives required prenisone shot and 5 day course. Edd 8/31/21
Cellulitis (R) arm, swollen. Mild fever to 100.3 F started around 8 pm on 8/2/11. Pt was treated with KEFLEX 250 mg/ml 8 ml po BID x 7d and Hydrocortisone 2.5% apply to affected area BID.
that evening severe abnormal cry;seen  @ ER sent home back to MD office next day;cried for 2 days;
While technician was getting ready to inject the vaccine to patient, she accidently pricked her finger with the vaccine needle. The technician wasn't sure if she pricked her finger and so went on to inject the patient with the same needle. Once the technician completed the vaccination she realized she had forsure pricked her finger because she saw blood on the glove.
This spontaneous report as received from a physician via a company representative refers an 8 year old female patient. On an unspecified date the patient developed chicken pox after receiving VARIVAX (Merck) (lot# unspecified) (dose, route and location unspecified). At the time of report, the outcome of event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Intense head pressure and constant headache on day 1. Next day injection site was red, bumpy, and warm to the touch followed by little red bumps (almost like hives) in random spots on my hands and feet. The next day the "hives" had gotten worse an were spreading all over my hands, knees, ankles, thighs. Head ache has also continued. I  only took Tylenol extra strength that didn't do anything for my headache.
1st dose 14Apr2022, 2nd 23Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 26-year-old male patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29th April 2023) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 14th April 2022).   On 23rd September 2022, the patient received the 2nd dose of Engerix B. On 23rd September 2022, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's comment: Pharmacist reported that the patient received a late 2nd dose of Engerix B. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Engerix B later than the recommended interval, which led to lengthening of vaccination schedule.
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. It was reported that on 30-JAN-2018, the patient was vaccinated with PROQUAD lot # N015623, expiration date 15-NOV-2018, by intramuscular route rather than subcutaneous for prophylaxis (strength was not provided).
HURTS IN THE BACK WHEN BREATHS DEEPLY; CHEST PAIN ON LEFT SIDE; BLACK BRUISE ON RIGHT HAND (VEIN  BECAME BLACK); PAIN IN ENTIRE BODY; SENSITIVITY TO LIGHT; DIFFICULTY BREATHING; PAIN IN LEG; INTENSE CHILLS; JOINT PAIN; MUSCLE PAIN; INTENSE HEADACHE ON LEFT SIDE OF HEAD; FEVER; This spontaneous report received from a patient concerned a 51 year old female. 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced hurts in the back when breaths deeply. On 02-APR-2021, the subject experienced chest pain on left side. On 02-APR-2021, the subject experienced black bruise on right hand (vein became black). On 02-APR-2021, the subject experienced pain in entire body. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced difficulty breathing. On 02-APR-2021, the subject experienced pain in leg. On 02-APR-2021, the subject experienced intense chills. On 02-APR-2021, the subject experienced joint pain. On 02-APR-2021, the subject experienced muscle pain. On 02-APR-2021, the subject experienced intense headache on left side of head. On 02-APR-2021, the subject experienced fever. Laboratory data included: Pain scale (NR: not provided) Chest 10/10, headache10/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in leg, black bruise on right hand (vein became black), and joint pain, had not recovered from intense headache on left side of head, hurts in the back when breaths deeply, and chest pain on left side, and the outcome of muscle pain, fever, intense chills, sensitivity to light, difficulty breathing and pain in entire body was not reported. This report was non-serious. This case, from the same reporter is linked to.