chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiny red bumps on torso, buttock, chin, legs and arms.  Looks like he was poked with a needle all over.  Heat made rash worse, per mother. 03/23/15: Pediatric Exam: GENERAL APPEARANCE: alert, active, no distress, well hydrated. SKIN: macular papular eruption primarily trunk but evidence on face and extremities. No bruising. EARS: TMs pearly grey. NECK: no lymphadenopathy. No treatment.
Rash outbreak w/in 10 min of injection. No problems breathing at that time. Went to ER next day and c/o tightness in throat and itching all over body. Treated with Medrol and Decadron. Back to ER on 5-6-05 with only slight tightness in throat, but rash spread to palms and soles-papular rash with stinging, burning and sensitive skin to touch. Treated with EPO x2, Celestone and Zyrtec.
Six months "about JAN91" ago pt had a needlestick; @ that time titer was checked & the result was negative; 1 booster dose of Engerix-B was given six months ago; 3 months p/booster, titer still neg; MD suggested pt recvd vax again;
Rash, racing heart, fever 102.5 , headache, nausea,  for 3 days.
1520: Member sitting in chair during observation, post COVID-19 Pfizer vaccine.  Member c/o of dizziness and diaphoresis, pale. Never lost consciousness .  Vital signs stable.  Symptoms improved when lying down in stretcher.  Alert/oriented.
No known adverse effects.; On 09/17/2020, a patient received a dose of VARIVAX that was reconstituted with an expired diluent.; On 09/17/2020, a patient received a dose of VARIVAX that was reconstituted with an expired diluent.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions, or allergies and concomitant medications were not reported.   On 17-SEP-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S019461, which has been verified to be valid, expiration date reported and validated as 24-JUN-2021) as prophylaxis, however; it was reconstituted (medication dilution) with an expired sterile diluent(MERCK STERILE DILUENT) (formulation, strength, dose, frequency and route of administration were not reported; lot number N029881, which has been verified to be valid, expiration date reported and validated as 24-MAY-2020) (expired product administered and product preparation issue). It was not known any adverse effect.
FLU LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS). At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) outcome was unknown.     No concomitant medications were provided.  No treatments were provided,  This case was linked to MOD-2021-087587.
PATIENT WAS SITTING IN A CHAIR AFTER RECEIVING THE VACCINATION AND SLUMPED TO THE FLOOR.
pt recv vax 19OCT95 & c/o swelling, pain & warmth @ the inj site the following day;pt had recv vax prev yr (unk if a rxn occurred);
eyelids were swollen; whole eye area was very swollen; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 68 year-old female patient received pneumococcal 13-valent conjugated vaccine (diphteria crm197 protein) (PREVNAR 13), administered in arm left, administration date 2019 (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "thyroid problem" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased; PANTOPRAZOLE taken for gastrooesophageal reflux disease, start date: 2012; IRBESARTAN taken for blood pressure measurement, start date: 2010. The following information was reported: SWELLING OF EYELID (non-serious) with onset 2019, outcome "unknown", described as "eyelids were swollen"; EYE SWELLING (non-serious) with onset 2019, outcome "unknown", described as "whole eye area was very swollen". Additional information: In 2019 the patient received a Prevnar 13 vaccine and her eyelids and pretty much around her whole eye area were very swollen, though her eyelids were like whoa. She says it was very swollen like she had consumed a lot of salt, like eating gallons of Chinese food. She says her doctor said this could have been a possible side effect. She says she googled swollen eyelid without incidence and it said it could be a reaction to polyethylene glycol or polysorbate, and to see an allergist  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have been experiencing diarrhea, blood in my stools, mucus in my stools, a sense of urgency to use the bathroom, gas, and abdominal pain. I have been to see a doctor and they don't know for sure if I have either ulcerative colitis or Crohn's disease. They are still trying to run test so that they can diagnose me.
PATIENT PRESENTED TO THE PHARAMCY ON 02/24/16 WITH REDNESS AND SWELLING FROM SHOULDER TO ELBOW ON LEFT ARM.  PATIENT SAID THAT HE WENT TO A REGULAR PHYSICIAN APPOINTMENT AND THE DOCTOR PRESCRIBED CLINDAMYCIN TO TREAT ON 2/24/2016.  HE TOLD THE PATIENT THAT IF THE ANTIBIOTIC DID NOT HELP, HE SHOULD FOLLOW UP.
patient noticed red bumps on the back of her tongue and also redness at the back of her throat and difficulty swallowing
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-OCT-2018, the patient was vaccinated with dose of M-M-R II lot # N008366 with expiration date 13-MAR-2019 (dose, dose number, site and route of administration were not reported) which was reconstituted with SHINGRIX sterile diluent for prophylaxis. No adverse effects was reported.
Extreme Head Ache,  Leg cramps in both legs, chills and fatigue
Vax 20JUN91; fever that night gave APAP; fever went down; slept cranky; Friday devd rash; bumps w/a red dot in middle; Sat bright red bumps x/arms & legs; Threw up X 1 w/"dry heaves"; Sun afternoon more chipper; 0 Temp; Mon still has rash;
Tested COVID positive, symptoms include fever, chills, shortness of breath, and cough.
Public Health Clinic for the patients/residents.   1/8 /21; 1st vaccine-Moderna (Lot # 025J202A).   1/9/21, ER for adverse effect--dizzy, elevated glucose, difficulty walking/talking.  Given IV solution and discharged with follow up with PCP.   2/1/21; PCP changed insulin dosing.   2/8/21; 2nd vaccination Moderna ( Lot # 031M20A) with signed consent from PCP required by health department due to prior administration and adverse effects.
This spontaneous report has been received from a licensed practical nurse referring to a unspecified patients of unknown ages and genders. Information regarding medical history, drug reactions, allergies, concomitant therapies and concurrent conditions was not provided. Since 03-JAN-2017, the unspecified patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # M031574 and expiration date 11-NOV-2018, lot# M032649 and expiration date 11-NOV-2018 (route of administration, strength, dose and frequency were unknown by the reporter), for prophylaxis. The reporter stated that the temperature excursion of the vaccine was 0 Celsius (C) to 2 Celsius (C) and the time frame was 10 hours, also she stated that a previous temperature excursion was not involved, this information was registered in a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA011537: US-009507513-1702USA011538.
arm pain after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain after previous doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Start Date: 25 to 30 years ago Stop Date: 30 years ago (Improvement).), Hypertension, Hypercholesterolemia, Allergy to chemicals (Nitrates) and Reaction to monosodium glutamate ).    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain after previous doses). At the time of the report, VACCINATION SITE PAIN (arm pain after previous doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had concomitant medications daily for high cholesterol and blood pressure. It was reported that patient was not immunocompromised. Patient neither diagnosed with COVID-19 nor tested positive. Treatment medications were not reported.   This case was linked to MOD-2022-559589, MOD-2022-559594, MOD-2022-559608 (Patient Link).
angioedema; swelling of the lips; This is a spontaneous report from a non-contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as COVID-19 vaccine. Medical history included angioedema 23 years ago. Concomitant medications were not reported. The caller wanted to report AE for the COVID-19 vaccine. AE reported that she took the COVID-19 vaccine and after 23 hours, she developed angioedemia on unspecified date. Additionally, she said that she woke up with swelling of the lips on an unspecified date. Given the AE from the first request, it was inquired if it was recommended to get a second dose. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of angioedemia with lip swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
"swollen, red, and achy" -10/2/19 numbness and tingling in fingers - 10/2/19 sweaty, dizziness - 10/2/19
sore throat; white dots on the back of throat; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and MUCOSAL DISCOLORATION (white dots on the back of throat) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 041B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and MUCOSAL DISCOLORATION (white dots on the back of throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and MUCOSAL DISCOLORATION (white dots on the back of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include escitalopram   Reporter did not allow further contact
7-23-10 10:00 AM Had TDAP vaccine on 7/21/10. (R) DT - Lot# U3035CA-AD. Came in Health Dept today to have a PPD skin test read and mentioned (R) arm being sore, red, knot. About 2" round red spot with about 1/2" round knot in middle, sore to touch.
HEADACHE; This spontaneous report received from a patient via a company representative concerned a female 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) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
5pm 10/14/22 Vaccination at pharmacy.  Went to bed at 10pm.  Woke up middle of the night and had blurry vision left eye. 10/15/22 In the morning, more blurry vision left eye. Called Dr. to report, was told to give it a day to see if it clears up.  10/16/22  I wake up and vision is even worse than before, go straight to ER.  No ophthalmologist  onsite, appointment scheduled for the next day.  10/17/22 Dr. Visit 9am,  large dense Cataract from insult.  Dr. can't see past it to rear eye, removal of lens scheduled.
See initial presentation notes, patient collapsed out of hospital, and was diagnosed with left MCA stroke, diagnosed to be cardio-embolic in origin, from new onset atrial fibrillation.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 4:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 4:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 27-Feb-2021, Excursion time was 09 AM, 11 AM, 12 PM, 1 PM, 2 PM, 3 PM, 4 PM, 5 PM temperature was 33, 35, 35, 35, 35, 34, 34, 35 respectively total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 27-Mar-2021, Excursion time was 09 AM, 10 AM temperature was 35, 35 total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 PM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Awful chills that lasted for hours, headache that did not dissipate even taking Tylenol (it just lessened the headache) and slept so much and when not sleeping very fatigued. Loss of appetite too.
Severe underarm pain on right side.  Appears to be pain in a lymph node, continuing today for a second day.  Continuous pain and pain to the touch.  I also had a low-grade fever yesterday and joint pain.
patient received 2 doses of ActHIB vaccine on different days, no AE; Initial information was received on 06-May-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 72-year-old female patient who received two doses of HIB (PRP/T) VACCINE [ACT-HIB] vaccine on different days (extra dose administered).  AT the time of event, Patient had ongoing a cancer (Neoplasm malignant) and she thinks had a splenectomy.  Medical treatment, vaccination and family history were not provided.  On 14-Feb-2020, the patient received MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) as concomitant medication.  On 14-Feb-2020 and 05-May-2020, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot UJ180AAA, expiry date: 03-Jul-2021] via an intramuscular route at the left arm for prophylactic vaccination.  On 05-May-2020, patient received another dose of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).  It was a case of actual medication due extra dose administered. The patient who received two doses of HIB (PRP/T) VACCINE [ACT-HIB] vaccine on different days (extra dose administered).  At the time of report, no adverse event was reported.  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 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.
QUICK PULSE IN THROAT; NECK PAIN; LEFT SHOULDER PAIN; FEELING WEAK; HEADACHE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2022LA, and batch number: 2022LA expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced quick pulse in throat. On 11-APR-2021, the subject experienced neck pain. On 11-APR-2021, the subject experienced left shoulder pain. On 11-APR-2021, the subject experienced feeling weak. On 11-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling weak, quick pulse in throat, headache, left shoulder pain, and neck pain. This report was non-serious.
PT IS COMPLAINING OF DIZZINESS BEGINNING  5 DAYS AFTER RECIEVING VACCINE AND DIZZINESS IS STILL PRESENT,  DR HAS PT USING EAR WAX SOFTENER
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (On his left arm soreness), PERIPHERAL SWELLING (On his left arm swelling) and ERYTHEMA (On his left arm redness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (On his left arm soreness), PERIPHERAL SWELLING (On his left arm swelling) and ERYTHEMA (On his left arm redness). At the time of the report, PAIN IN EXTREMITY (On his left arm soreness), PERIPHERAL SWELLING (On his left arm swelling) and ERYTHEMA (On his left arm redness) outcome was unknown.            Treatment included none
On the Monday after the shot: Joints were sore, more than the normal; I had a doctor's appointment on Sat, sinus infection also.
migraine (~28hr~), fever (18~ hrs), chills (20~hrs), aches and pains (20hrs~), chronic fatigue (~28~ hrs
Patients states she was ok after staying in the immunization area for 15  minutes but begun having tingling in her lower lips and left side of her face when she got into her car. She had to go to the ER where she was told to make pharmacy aware of the event. She states  her blood pressure reading was 194/103 at the ER., and she s still experiencing tingling in her lower lips and face. She has a follow-up appointment with her PCP and will also be seeing a neurologist.
Pain in arm muscle where administered.  Headache (from an hour or two after administration to present--has not resolved and tylenol has not helped--will try ibuprofin). Low grade fever (99)/chills (first felt around 3:30 pm day after administration to present--perhaps didn't feel sooner because tylenol was working on fever, but not headache).  Other than the pain in the arm, which I expected from both shots, I've never experienced the other symptoms following a flu shot (and have had those most years over the last couple decades).