chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a child "under 5 year old" with fever and an ear infection at the time of vaccination, who on an unknown date was vaccinated with 0.5 ml of a dose of MMR II intramuscularly.  In approximately May 2009 (reported as "recently, within the last month"), the patient experienced seizure.  Subsequently, the patient recovered from seizure.  Upon internal review, seizure was considered to be an Other Important Medical Event.  Additional information has been requested.
Day 1 (1 hour after shot) - nausea, vomiting, fatigue, body shaking, general feeling unwell and needing to rest, injection site soreness. Day 2 (at night before bed) - some shortness of breath (not sure if due to anxiety), joint pains, muscle aches, injection site soreness, chills. Day 3 - abdominal spasming (contractions every couple of minutes) early morning to early evening 4pm, fatigue, waves of heat, throat closure sensation without issue eating/drinking/breathing, anxiety over symptoms.  Day 4 - less symptoms during day, occasional feelings of not being able to take deep breath.  Week and half after first vaccine - muscle twitching of legs only, achiness present before bed.
This spontaneous report was received from a medical assistant regarding a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 19-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot #L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Death, from vaccine induced heart swelling and failure.  Died on the evening of December 16th, 2021.
Sedation, Myalgia, Chills, pain and redness at injection site Narrative:
Case number PHHY2011US60072 is a combined initial and follow-up spontaneous report received from a nurse on 08 Jul 2011 and 13 Jul 2011. This report refers to a 17 years old female patient. She was given only the CYW-135 liquid component of MENVEO (batch number: M10034) intramuscularly on 27 Jun 2011. She was also vaccinated with GARDASIL (batch number: 15692, other manufacturer) intramuscularly on the same day. No other adverse reaction was reported.
pt recv vax 15DEC97 & 16DEC97 pt to MD office w/vomiting & fever of 104.7;
slight cold/feeling a cold; slight cold/feeling a cold; This is a spontaneous report from a Pfizer-sponsored program A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had slight cold/ feeling a cold. He asked whether he should get the second dose the next day and did the vaccine contain live virus. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Moderna doses had been administered previously on 01/28/21 and 02/25/21.  Instead of receiving a Moderna booster dose, she received a Pfizer dose 0.3ml.  No symptoms were noted.
Immediately after the dose headache and fatigue for 2-3 days. 7 days after I have swollen supraclavicular lymph nodes. They are still ther.
shoulder pain in area where shot was given; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional via consumer.  This case involves a 67 year old male patient who experienced shoulder pain in area where shot was given (vaccination site pain), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 03-Sep-2020, the patient developed a non-serious shoulder pain in area where shot was given (vaccination site pain), six days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Joint & muscle pain, fatigue, weakness, headache, nausea 1 full day Fatigue, loss of appetite 1 full day
Pt reports after receiving vaccine (HBV #1). Pt had swelling of right arm and side of face right side. She felt right leg also swollen but not sure. She went to ER.
Cough  Shortness of Breath  Sore throat  Congestion or running nose
suspected delayed onset systemic allergic response to the Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ALLERGY TO VACCINE (suspected delayed onset systemic allergic response to the Moderna booster) 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 ALLERGY TO VACCINE (suspected delayed onset systemic allergic response to the Moderna booster). At the time of the report, ALLERGY TO VACCINE (suspected delayed onset systemic allergic response to the Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
She had rapid heart rate; fear of being alone; sore throat; shallow breathing and loss of appetite. I took her to the doctor and she saw the nurse. She said her heart rate was 129 and blood pressure was high for kid. She was like this for 5-6 days. Symptoms getting a little better.
Received vaccine 30 m later became SOB, itchy and face swelled, 911 called transported to ER received BENADRYL and Prednisone. She is ok per TC 10/24/12.
There was no adverse event.  An expired pre-filled syringe of last years flu vaccine was squirted up a patients nose.  Our Pharmacist is directing us to fill out a report.
This spontaneous report as received from an other health professional refers to a 6 year old patient. On 10-JUL-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (lot # reported as J014229, EXP 08-NOV-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
PATIENT REPORTS MOUTH DRYNESS, NAUSEA, VOMITING, PAIN NEAR RIGHT HIP, BLOOD PRESSURE DROPPED.
Flu like symptoms started happening approximately 19-20 hours after shot was administered. Started with low grade fever, tiredness. Moved on to mix of chills and high fever, sweating, aching joints/muscles. No nausea occurred. Fever started to wear off 32 hours (after injection) and by 40 hours after injection I appeared to be back to normal for the most part.
Received second dose of moderna vaccine around 8 pm on Friday. No side effects or symptoms at the time. Next day, sore arm with swollen injection area. Around noon, fatigue and muscle pain started. By the evening headache. Took ibuprofen before bed and all good in the morning. Only painful arm stayed. In the evening of that day I noticed very red spot around injection area and painful swollen armpit on the right. As of today, painful arm and red, little itchy injection area.
A 65 year old female, who was scratched by a stray cat, received RabAvert, 1ml IM, and Human Rabies Immunoglobulin (HRIG) on 4/12/02 and 4/15/02. The patient developed severe headache and malaise after the second dose of the regimen. She had no significant past medical history. No other details were reported. The treating physician assessed the events as possibly related to the drugs administered.
pt recvd vax;returned to er on 9apr95 w/ lt arm swollen from shoulder to elbow;difficulty in moving arm; tx w/ steroids & dph;
The vaccine gave me a fever; some vomiting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: The vaccine gave me a fever) and vomiting (Verbatim: some vomiting). The outcome of the fever and vomiting were resolved.   The reporter considered the fever and vomiting to be related to Shingles vaccine.     The company considered the fever and vomiting to be related to Shingles vaccine.   Additional Information: GSK receipt date 21 Jul 2023: This case was reported by a consumer via interactive digital media. The vaccine gave him/her a fever and some vomiting one night but the patient would still get the vaccine again when it's time. It was still better then weeks of hell.
Redness occurred at site of administration within hours, spreading over the next day to a total size of approximately 3" by 5", accompanied by itching and tenderness.  No treatment administered.  Reaction was still present but diminished to approximately 1 square inch by 2/16/09.  Patient reported vaccine "burned" on administration.
Pt stated that about 1.5 hours after receiving second dose began feeling burning in leg, headache, burning and numbness in first finger all unilaterally.  He went to the hospital and was treated over the course of 2 days.  He identified as having symptoms of stroke though hospital staff stated it was a seizure.
A temperature excursion of unopened PENTACEL and ACT-HIB at 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes, the patient had been given ACTHIB post-excursion/ No AE; Initial information was received on 05-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via phone (under Global medical information (GMI) Inquiry Number: 00712270 and 00712270).  This case involves a 25 months old male patient.  This case involves a temperature excursion of unopened DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] lot UJ434ABA, expiry date: 08-MAR-2022 and HIB (PRP/T) VACCINE [ACT-HIB] at 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes that occurred 11-Jun-2021, and the patient had been given ACT-HIB vaccine post-excursion (product storage error).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  On 27-Jul-2021, the patient received a 0.5 ml third dose of suspect HIB (PRP/T) VACCINE lot UJ437ABB, expiry date: 03-MAY-2022, frequency: once, strength: standard via intramuscular route in the left thigh for prophylactic vaccination.  Emergency Room/ Doctor visit and date: 27-Jul-2021.  It was a case of an actual medication error due to product storage error temperature too low (latency: same day).  It was reported "Medical assistant reported temperature excursion for unopened: PENTACEL and ACTHIB reported several temperature excursions: first was 46.7 Fahrenheit for total excursion of 30 minutes, second was 46.5 Fahrenheit for total excursion of 30 minutes and third was 46.5 degrees Celsius for total excursion of 30 minutes cause of temperature excursions is unknown. Medical assistant asking for stability information. Caller reports she had called previously regarding a temperature excursion. Caller states that she needs to report another temperature excursion that occurred 11-Jun-2021, temperature excursion was for unopened: PENTACEL and ACTHIB temperature excursion was 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes. Caller does report that a patient has been given ACT-HIB post-excursion. Product used, First time product used: No".  At the time of reporting, 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 by the regulatory authority. 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.
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On 18-NOV-2015 these patients were vaccinated with unspecified number of improperly stored doses of PNEUMOVAX 23 (lot # reported as L029093, expiration date 19-APR-2017) (dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Information has been received from an administrator concerning a patient of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M017983 with expiration date of 30-MAY-2018 for prophylaxis (route and dose were not provided). It was reported that the vaccine had been stored for 15 minutes  in a temperature between 32 degrees Fahrenheit and 36 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effect was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Bump where injection was given. Swelling, redness tingling at injection site. Hurts to touch. Bump measures 2x1.5 cm when lifts up arm up.
It started out with an itchy throat. The next day I had a sore throat. The next day I had cough and congestion. The next day I developed diarrhea. Then I was riding up a storm for the like the next 3 days. After about a week I was feeling better.
A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional concerning a 39 year old female vaccinee who developed an injection site that was warm to touch. The vaccinee also experienced redness and itching after receiving Fluvirin on 10/14/03. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.
Breakthrough case admission after 2 vaccines Moderna 10/25/21 lot# 012F21A;  Moderna 11/22/21 lot# 034F
Noted (L) upper arm very sore 8/26/09 - 8/28/09 without swelling or redness. 8/29/09 had migraine HA. Developed hives 8/30/09. (L) arm feels numb from mid-forearm down to hand with itching. Notes little red bumps around injection site today 9/1/09. PM HP (+) migraine, PCN/Amoxicillin allergy.
Acute Severe Vertigo  for 24 hours then Severe Vertigo for another 24 hours then Mild Vertigo for another 24 hours now only from rising  Blood pressure readings on the top number of 145 or more when all of the other 65 years of my life my top number of BP never rose above 130
patient who received a booster dose towards the end of October.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient who received a booster dose towards the end of October.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ACCIDENTAL UNDERDOSE (patient who received a booster dose towards the end of October.). In October 2021, ACCIDENTAL UNDERDOSE (patient who received a booster dose towards the end of October.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter informed patient was immunocompromised and should have received a third full dose instead of booster dose.Also wanted to know how to manage going forward at this point since it is 2 months later.
Left upper arm started out just sore. About 36 hours later on Sunday, it was still sore, bright red, swollen, hot to the touch. Slightly itchy, but no raised bumps. The redness and swelling was worse on Monday. The affected area was well defined, never got larger. Symptoms decreased on Tuesday and Wednesday, completely gone by Thursday.
Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.
Starting 03/2021 I had my first period cycle since becoming fully vaccinated. My normal cycle lasted with my IUD for about 3-5 days using light tampons and panty liners. I noticed more cramping and  a heavy period in March resulting in having my IUD removed in April. My period would last about 3 weeks with 1 week of spotting/blood clots and no flow.  I started Lostrin 24 birth control pills in May to alleviate cramping and stop bleeding. My period did not "stop" or regulate until November 2021.
The nurse stated that she reconstituted the 5-11 year old  Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Fever; chills; Body aches; Muscle aches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206) via an unspecified route of administration in her left arm on 12Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications included iron (MANUFACTURER UNKNOWN), vitamin-D (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) at a dose of 20 mg and mirtazapine (MANUFACTURER UNKNOWN) at a dose of 20 mg. The patient was allergic to medications penicillin, codeine, erythromycin and prednisone. Since the vaccination, the patient had not tested for COVID-19.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 12Mar2021, at 12:30, the patient experienced fever, chills, body aches, muscle aches and nausea. The patient did not receive any treatment for the events. The clinical outcome of fever, chills, body aches, muscle aches and nausea were recovering.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown ages and gender. On an unknown date the patients were vaccinated late with dose 2 or dose 3, GARDASIL (lot# and expiration date not reported) intramuscularly. No adverse effect reported. Additional information has been requested.
patient reported to feel "dizzy" and cold after receiving pfizer-biontech covid vaccine after 10 minutes of administration. hard time for patient to get up. vital signs taken by EMT stable. observed in designated area for 15 minutes, patient and family reported full recovery, vital signs still stable.
Headache  (4hrs post-injection through 32 hours post-injection) Elevated temperature, body-aches, chills, tiredness, dry throat  (8-hours post-injection through 32 hours post injection) Arm pain and redness at the injection site (from time of injection through 48-hours post-injection)
Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. On 13-Jan-2022, the vial was initially stored in the refrigerator.  It was reported that as per the healthcare provider, the vials were set to expire on 12-Feb-2022 based on the stickers put on them. The healthcare provider was not sure and did not have the exact expiration date of the vial itself. The healthcare provider asked if they are going to revaccinate the patient or not.
Information has been received from a registered pharmacist concerning a 63 year old female with blood pressure high, a history of depression and no known drug reactions/allergies who on 13-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#1657AA, dose and route not reported). Concomitant medication included: unspecified blood pressure medication and unspecified antidepressant medication. The pharmacist reported that the patient developed an injection site reaction following vaccination. The injection site reaction was described as a red area that was itchy with some bruising at the injection site that was about an inch and one half in diameter (no rash noted). The patient sought medical attention by contacting pharmacist. No treatment was given and no lab diagnostics were performed. At the time of reporting, the patient was recovering. Follow up information was received from the registered pharmacist regarding the patient which received a dose of ZOSTAVAX (Merck) (Lot#1657AA), administered subcutaneously in right arm. The reaction described as a round red rash about 3 cm in diameter at the injection site. Also there was some bruising at the injection site. Additional information has been requested.
Patient presented to the pharmacy on 7/25/17 a raised red lump on her right arm that was continuing to get bigger per the patient from the BOOSTRIX Immunization.