chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling ran down arm to fingers; Chills; Headache; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 47-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE, Lot number: Unknown, Anatomical site: Left arm), for COVID-19 immunisation, reaction(s): "Tingling". The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling ran down arm to fingers"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; CHILLS (non-serious), outcome "recovered", described as "Chills". Therapeutic measures were taken as a result of headache. Additional Information: It was unknown if the patient received any other medications within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unknown date the patient experienced tingling ran down arm to fingers that lasted 2 seconds in injection arm, occurred after both vaccines. On an unknown date at 02:00, day after the vaccine, the patient awoke with severe headache that lasted 2 days. The patient experienced chills for days 3-5 post vaccine. The patient received ibuprofen and acetaminophen for the event headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021327146 same patient, different event, different dose of vaccine
Felt a little achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Felt a little achy). At the time of the report, PAIN (Felt a little achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-335365.
This spontaneous report has been received from a physician and a medical student, and refers to a 17 months old patient. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with VARIVAX lot number: N025935 and expiration date: 19-SEP-2019 for prophylaxis (route of administration was not provided), which was diluted with sterile diluent (MERCK STERILE DILUENT) lot number 00006430900. On 17-AUG-2018 (reported as "4 days ago"), the patient developed shingles, for which he was hospitalized on an unspecified date in August 2018. The physician was requesting PCR testing. At the time of reporting, it was unknown if the patient had recovered from the event. The causal relationship between shingles and the suspect therapies was not provided.
Urticaria, facial flushing, teary eyes, sensation of throat swelling, pruritus of arms. Tx: epinephrine, prednisone, O2.
really bad diarrhea all day; Splitting headache; Cold Sweats; shaking real bad; didn't feel too great; tired; Sluggish; Had a little bit of body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP7534) at the age of 37 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "unknown", described as "didn't feel too great"; FATIGUE (non-serious) with onset 25Mar2021, outcome "unknown", described as "tired"; SLUGGISHNESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Sluggish"; PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "Had a little bit of body aches"; DIARRHOEA (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "really bad diarrhea all day"; HEADACHE (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "Splitting headache"; COLD SWEAT (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "Cold Sweats"; TREMOR (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "shaking real bad".  Additional information: The patient was not visit to Emergency Room and Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Mother called office 8-3-07 -  low grade fever, joints hurt, dizzy - chills, headache on 8-2-07. Irritable
Pt. passed out, face turned white - fainted off exam table bumping forehead - ice applied with small red spot, O2 at 3L NC, Sats 95-98% Roomair after O2 off - came to within approximate 1 min. - at baseline before leaving.
Day after injection, arm started to swell and burn. Swelling moved to extremities and she was seen by P.A.
Had Fever around 100; Coughing up small amount of blood and this is not good; Worst Pain; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. When probed for the concern, consumer stated, patient got second vaccine (unspecified vaccine) yesterday and patient had fever around 100, patient woke up from sleeping today and temperature was 101.7, patient was coughing up small amount of blood, patient have heard this was not good, but nobody seems to agree with me. It's not about that patient just want to know, what was going on. This was the worst pain patient ever felt. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected. Information on the lot/batch number has been requested.
I am scared; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that he had his COVID vaccine and would get second shot on 05Mar2021, but he was scared. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
No AE/PQC reported; VARIVAX accidentally administered to a patient /; This spontaneous report has been received from a healthcare professional concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 30-MAY-2023, the patient was vaccinated accidentally with one expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis, lot number U015686 with expiration date 18-MAY-2023 (dosage regimen and route of administration was not provided) (Expired product administered). No adverse event reported (No adverse event).
Extreme shortness of breath that led to hyperventilating, chest pain, and heart pain.
This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subject to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning an 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 06-Dec-2010. On 07-Dec-2010, the patient received the expired FLUMIST vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
lt arm became swollen & blotchy red about 24 hr p/vax given; went to ER; advised pt could have DPH, but took none;
Erythema from shoulder to elbow on side of injection, no fever, chills, began to resolve prior to office visit.
This spontaneous case, received on 15-Oct-2018 from a pharmacist (initial and follow-up 1 combinedly processed), concerns a 34-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804545 was linked to source case 201804533 due to same reporter.
5/8/07-Pt called c/o pain, warmth, and swelling at injection site. Also c/o fever, chills, nausea, and vomiting. Office appt-pt instructed to ice arm, red, Medrol dosepak, tylenol, and Phenergan
Information has been received from a LPN concerning a 12 month old male with milk allergies who on 06/08/2004 was vaccinated  in the RL with a first dose of varicella virus vaccine live. On 06/16/04 the pt developed a rash of 20-25 lesions that looked like bug bites and itching. Medical attention was sought. No Tx was recommended. No product quality complaint involved. Follow up information from a LPN indicated that the pt had a papular, non pruritic rash on his arms, legs, and back. His temperature was 99.8 degrees at times. He was seen by the doctor on 06/17/04 for probable viral exanthema. It was noted to last one week and the pt recovered 06/23/04. No additional information is expected.
5/3/06 mom calling to report swelling upper right arm from elbow to well into shoulder double the size. Skin hot to touch redness from shoulder to past elbow, tender to touch left arm shot site lump with redness.
The patient was given a Moderna booster 0.5ml IM instead of a full Moderna 1st dose COVID vaccine. The patient was called and given an explanation of the incident. He does not have a reaction to the vaccine at current this incident report is written. The patient cannot return today but will come back on Monday to receive his additional .05ml of the booster dose to complete his full dosing.
From telephone contact received at a manufacturer on 4/3/02, it was reported that a 40 y.o. female received Rabies Imovax series for post exposure prophylaxis. After 3rd and 4th dose of rabies Imovax series, PT reported sharp abdominal pains w/a burning sensation lasting 2 days after each dose. 3rd dose received on 3/22/02 and 4th dose received on 3/29/02. Signs and symptoms started w/in 24 hrs of receipt of dose. No other signs and symptoms noted.
patient became weak and shaky approximately 2 hours after shot. A cough and chills also developed.
feeling exhausted; nausea; fever; vomiting; diarrhea; Sick for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ILLNESS (Sick for 3 days), FATIGUE (feeling exhausted), NAUSEA (nausea) and PYREXIA (fever) in a 39-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 information was provided by the reporter.  Concomitant products included IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS] for Immune system disorder, ZOLEDRONIC ACID (RECLAST) for Osteoporosis, LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ILLNESS (Sick for 3 days), FATIGUE (feeling exhausted), NAUSEA (nausea), PYREXIA (fever) and VOMITING (vomiting). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ILLNESS (Sick for 3 days), FATIGUE (feeling exhausted), NAUSEA (nausea), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: increased (High) increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information was  received and concomitant medications, treatment medications, new events were updated.
Arm pain; Fever; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) had not resolved.            No concomitant information was reported. No treatment information was reported. Reporter has stated that patient was asked whether they could take Tylenol after the booster dose.
very slight pain at the injection site; This is a spontaneous report received from a contactable reporter (Consumer) from Agency. The reporter is the patient.  A 74-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumovax 23, administration date: 2013, for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "very slight pain at the injection site". Additional information: Reporter mentioned that he was 74 y/o and was injected with the Prevnar 20 five milliliters vaccine yesterday and said that he did not have any noticeable side effects. Just maybe for a half hour a very slight pain at the injection site but after a half hour it went away. Patient said that he was about to take Shingrix but he wants to know how long he should wait to get the Shingrix vaccine. Created a manual form because the patient mentioned that he experienced slight pain at the injection site after getting Prevnar vaccine.  Follow-up attempts are completed. No further information is expected.
Patient reported 1.5 month history of daily, intermittent hot flashes that started 1 week after receiving the first Pfizer COVID-19 vaccine. She was having regular menses every 25 days, but did not have a period for 3 months after the vaccine.
she "does not do well with vaccines"; This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 53-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient did not do well with vaccines. The patient also received Shingrix in March 2019. For the tolerance of dose, refer linked case US2020AMR175126.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR175126:Same reporter, same patient
RUA-deltoid area red, swollen, warm to touch, no drainage. Child says kinda hurts when I squeeze it. Also noted a small scratch in same area. Temp 97.6 took child to ER and was given Amox-Trxk for a secondary reaction to shots. phone call 4-21-03
An 18 year old received the adult dose of Hep A vaccine versus the pediatric dose.
Woke up with pin-head size blisters on arm, (localized), raised, hot. Inj site has remained heat sensitive for 3 days already. If out in sun, more blisters developed. Localized burning at injection site. Feels like a knot, deep, localized muscle ache (like feeling when get a tetanus shot, low grade fever.
Shot was administered at 10:20AM on March 23.  Woke at 2:20AM on March 24 with extreme aches all over.  Also had shivering chills and slight headache.  Was running a low level fever of 99.1  Took Advil and tried to go back to sleep  Got up around 8:00AM and felt much better.  Fever was gone and as the day wore on I felt fine again except for minor soreness at the vaccination site.
Donor was vomiting an extreme amount. She then called the paramedics to take her to the hospital.
Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; This is a spontaneous case, reported by health professional to Agency [reference number: SEQ19-05870] and initially received on 30-Oct-2019, concerning a 7-year-old female patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 29-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 259808, expiration date: 31-May-2020] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced injection site redness, itchiness, puffiness, swilling and the injection site was warm to the touch. The patient was treated with Benadryl cream (diphenhydramine). The patient was advised to apply cold compress.   On an unknown date in Nov-2019, four and five after experienced events, the patient recovered.  The case was assessed as non-serious.  The reporter did not provide causality assessment.   This case is linked to case 201905789 (same reporter).  Follow-up received from other health professional via Agency (reference number: SEQ19-06730) on 20-Nov-2019: Age of the patient added. Stop date for the events added and the outcome changed from not reported to resolved. Benadryl added as a treatment medication. Additional numbers added.The narrative was amended accordingly.   Company comment: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.; Sender's Comments: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.
Nurse reported pt was upset/crying & fighting against vax being given; 1210PM c/o shakiness, h/a, nausea, pulse rapid/reg 100; 15JAN92 mom reported seeing pt approx 1230 same day reported pt pasty white color, nauseated, skin cool;
Next morning upon awakening, patient reports left ear hearing loss and tinnitus. Also reports increased pressure. Still present today
This is a spontaneous report from a contactable physician calling on behalf of his wife (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. About 5 days after the injection she started getting pain which had a trigger point, it was a headache and it was a trigger point on the side of her face, on her scalp. The reporter stated that in reading about on the web regarding side effect, headache is fairly common side effect, she was having severe lancinating pain on an unspecified date. The outcome of the event was unknown. The reporter stated that next step was to go to a neurologist.
About 5pm on 8/17/20, I noticed my left ankle was very itchy and red. After, I went to be the same day, I woke up shivering, cold and feverish. The next day, 8/18/20, my stomach hurt, very bad headache, very tired/fatigued, nausea, loss of appetite, dizziness. This lasted the entire day on 8/18/20. I was not able to eat anything, just drink water and a little bit of juice. Today, is much better, but still have a slight headache. I took ibuprofen both days, but not sure it helped.
Pt was given 0.3mL of Moderna (second dose) instead of the recommended dosage 0.5mL of Moderna
SOB; Chest pain (especially when inhaling); Numbness in left arm; Pain/feeling sore in extremities; Tiredness; Headache; Vomiting (once); This is a spontaneous report from a non-contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Aug2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines with aura, allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 31Aug2021, the patient experienced shortness of breath (SOB), chest pain (especially when inhaling), numbness in left arm, tiredness, pain/feeling sore in extremities, headache and vomiting (once). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events shortness of breath (SOB), chest pain (especially when inhaling), numbness in left arm, tiredness, pain/feeling sore in extremities, headache and vomiting (once) were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.