chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shot gave me shingles in my face; shingles in my face; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend.  The age at vaccination was not reported. The patient reported that getting the shot was not always the best idea.  After the shot the patient experienced shingles on face. Prior to getting the shot the physician guaranteed the patient about no side effects. After the shot and shingles, the physician said sometimes it happens. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation shingles was not reported. The case has been linked with the case US2021AMR174927 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174927:same reporter
woke up with red area near vaccine site, Small area on Saturday 16th. On the 17th I woke up with an additional inflammed site  On the night of the 17th, it had grown even more
Slight left facial droop with effect on lip movement on that side. Dysarthria while speaking. Particularly when speaking at a more rapid delivery. May  fall within mild Guillain- Barre syndrome.
had flu-like symptoms with first two doses /flu-like syndrome; feeling terrible for over a week with each shot; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu-like symptoms with first two doses /flu-like syndrome) and FEELING ABNORMAL (feeling terrible for over a week with each shot) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Ex-smoker (0.5 packs/day) and Ex-tobacco user (Pt quit 18 years ago). Previously administered products included for Product used for unknown indication: Influenza (Flu) Vaccine on 19-Sep-2019. Past adverse reactions to the above products included No adverse event with Influenza (Flu) Vaccine. Family history included CVA (Paternal Grandfather) and Type II diabetes mellitus (Father). Concurrent medical conditions included Hyperlipidemia (Improvement, under control with diet and medication) since 09-Jan-2002, Hypertension (Improvement, under control with diet and medication) since 01-Jan-2015, Anxiety (Improvement, under control with diet and medication) since 09-Jan-2006, GERD (Improvement, under control with diet and medication) since 01-Jan-2002, Post-traumatic stress disorder (Improvement, under control with diet and medication) since 09-Jan-2006, Alcohol use (1 standard drink = 0.6 oz pure alcohol,1-2 glasses every other week) and Marijuana use (3.0 times per week,Helps with anxiety, per pt, and he prefers it to Xanax). Concomitant products included OMEPRAZOLE from 01-Jan-2006 to an unknown date for GERD, ATORVASTATIN from 01-Jan-2015 to an unknown date for Hyperlipidemia, AMLODIPINE from 01-Jan-2015 to an unknown date for Hypertension, SERTRALINE from 06-Jan-2019 to an unknown date for Post-traumatic stress disorder, ALPRAZOLAM from 06-Jan-2019 to an unknown date for Post-traumatic stress disorder and Anxiety.    On 19-Mar-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 INFLUENZA LIKE ILLNESS (had flu-like symptoms with first two doses /flu-like syndrome) and FEELING ABNORMAL (feeling terrible for over a week with each shot). At the time of the report, INFLUENZA LIKE ILLNESS (had flu-like symptoms with first two doses /flu-like syndrome) outcome was unknown and FEELING ABNORMAL (feeling terrible for over a week with each shot) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient received vaccine on right shoulder.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-445640, MOD-2022-498346.
initial vaccine 2/10/21, booster 3/10/21. on 3/16 patient had large hemorrhagic stroke with left sided deficits requiring craniotomy and has residual deficits still
adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 16-year-old of male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 20-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in right deltoid (strength, exact dose and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Hospitalization within 6 weeks of COVID vaccination for right total hip arthroplasty.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/17/2021 LEUKOCYTOSIS
pt recvd vax; pt marked induration, swelling at inject site for 3 days; tx w/ w/ ice & APAP;
Developed chills, threw up and has a 102.8 fever within 6 hours of getting the shot. Was feeling completely fine until then.
Rash-1 week after vaccination fever, body aches, sore throat and white spots in throat- 10 days after vaccination
ACUTE RESPIRATORY FAILURE 3/15/2023 POISONING BY OTHER OPIOIDS ACCIDENTAL INIT ENC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/13/2023 POISONING BY OTHER OPIOIDS ACCIDENTAL INIT ENC
Child sat in lobby after receiving vaccines, Tdap and MVC4. After about 5 minutes, mom said child looked pale and was weak in her arms. Upon assessing child. She was pale and said she felt a little dizzy and nauseated. Allow patient to lie down in nurse's office for 15 minutes, and gave her a Coke. BP 122/84, no signs of breathing difficultly. Pt sat back in waiting room for another 15 minutes. Mother took child home.
Diarrhea; Nausea; Had episode of severe vomiting; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiry Date: unknown) via an intramuscularly administered in arm on 26Jul2021 at 18:30 (at the age of 15-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive prior vaccination within 4 weeks. Reporter stated that patient received the first dose of the Pfizer vaccine about 2 weeks ago on wednesday and had an episode of severe vomiting on unspecified date in 2021. On 03Aug2021, he had diarrhea and nausea. On an unspecified date in 2021, he had another episode of vomiting. Later, there was an improvement compared to first vomiting episode. He took a Zofran. The reporter wanted to know if anyone else reported the same. For second dose due date, reporter did not know, it was most likely that he/she might not give it to the patient, but was not confirmed. Regarding causality, reporter thought a possibility but did not know for sure as reporter was not a vaccine professional. Reporter did not know about any laboratory test performed on patient or not. Therapeutic measures were taken for severe vomiting, diarrhea and nausea with zofran. The outcome of the event vomiting was recovering and other events outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Patient states she had a rash on her stomach that appeared one day later after her first covid vaccine and has been slowly improving. She also reports ankle and foot swelling and pain within an hour after getting vaccine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 27-SEP-2017, the patient was administered one dose of expired RECOMBIVAX HB injection, lot # M023892, expiration date: 15-SEP-2017, intramuscularly, (dose, dose number and injection site were not provided) for prophylaxis. There were no concomitant medications reported. No adverse effects were reported. Additional information is not expected because the reporter did not wish to be contacted.
After the booster shot, I developed itchy hives on my skin. It flares up and I get it all over my back, it goes away then my chest, go way then flare up on my face. I also went to an allergist. He diagnosed me with dermatographia and chronic hives. Whenever I touch my skin, it flares up.  the doctor prescribed over the counter allergy medication- clarendon and Zyrtec.
Covid19 breakthrough.  1st vaccine received on 03/02/2021.  88 y/o with PMHx HTN, HLD, Breast CA, Anxiety presents to ED with c/o SOB, Cough.  EMS states O2 sat 75% on 2.5L at home, on arrival to ED pt placed on BIPAP with O2 sats up to 100%.  CXR new small effusion and bibasilar infiltrates.  Started on IV ABX, steroids and Remdesivir.
pt recv 1st dose of vax; devel a rash;recv 2nd dose devel rash,became worse;
discolored area 4x5", swollen, tender to touch appeared bruised, became darker & almost black; still present 25OCT93; By late DEC93, area faintly discolored; other bruises present from B12 inject in different areas;
Sore throat that lasted 5 days  Cold sore lasted 7 days and still present Gum inflammation started after 2 days and still present and not getting better. I have been doing mouth washes regularly and taking ibuprofen
01/08/22 presents to ED for "generalized weakness x3 days". PMHx of "copd, afib (on eliquis), HTN"
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
The day after her vaccine she develop acute chest pain and mild hypoxia. Went to the ER on 2/4/22, no heart attack, no elevated troponin levels to suggest myocarditis. POx 88-92%. No wheeze, CT scan negative for PE. Given Duoneb with resolution of her symptoms and improvement of mild hypoxia. For a week after this Pox remained 85-93% unless it was right after using albuterol MDI.  Saw Pulmonology, started on Trelegy and now is fine.
approx 7days p/vax pt exp varicella rash. no crusting of lesions. used motrin for irritability & inflammation
, Additional Details: Patient passed out while RPh was signing his brother's immunization card. He fell on the chair but RPh got hold of him before he was on the ground. Patient remained conscious the whole time, immediately responsive, complained of dizziness and tiredness. Paramedics were called. All vitals were normal. Mother chose not to go to the ER as all seems well after about 5-10 mins. Patient was given some cold water by mother. He then regained full strength about 30 mins after the incident.
5 x 4 cm mildly erythematous, not war and tender, area around injection site, no skin breakdown.
Sore arm at injection site night of vaccine and next day. Then resolved (without taking any acetaminophen).
I had to go to the ER because I was having a severe reaction to the vaccine. I had fatigue, chills, headaches, weakness, tachycardia, shortness of breathe, muscle pain.
Redness, swelling and pain in left arm from shoulder to elbow. Was worse yesterday (12/09/17). Has gone down a little today (12/10/17).
I have had a significant amount of varicose veins in the thighs and calves of both legs (a condition noted in my mother) for many years.  Prior to the first dose of the Pfizer/BioNTech vaccine (second dose pending 5/4/2021 appointment) several of these veins in both legs were prominent and protruding above the skin level, including some bulges in places.  Upon arising the next morning and dressing I was shocked by a darkening of the veins on the top of my feet.  These had been evident previously, but were now much more so.  Likewise, the varicose veins in my thighs and calves had increased in prominence.  Some increase in the veins in both forearms was noted, but these have returned to their prior condition.  Those
Feeling yucky; Fever; When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Feeling yucky), PYREXIA (Fever) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9236B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (not hospitalized, Treatment received: At home ibuprofen) on 10-Jul-2022. Previously administered products included for COVID-19: Ibuprofen in July 2022. Past adverse reactions to the above products included No adverse event with Ibuprofen.   On 07-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling yucky), PYREXIA (Fever) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml). At the time of the report, FEELING ABNORMAL (Feeling yucky), PYREXIA (Fever) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 11-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         The patient had no allergies. The patient had no acute and chronic illnesses at the time of vaccination.The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.
The pharmacist injected the shot into my upper arm and directly into the bursa sac resulting in tremendous pain, inflammation. Resulting in medication, PT, and potential cortisone shots and other methods.
This spontaneous case was reported by a non-health professional and describes the occurrence of ECZEMA (Rash - Eczema Flair up), PRURITUS (Itchiness), DRY SKIN (extreme dryness of skin), SCAR (splitting of skin) and RASH MACULAR (Blotchy patches covering the body) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anemia and High cholesterol since an unknown date. Concurrent medical conditions included Hypertension. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ECZEMA (Rash - Eczema Flair up). On an unknown date, the patient experienced PRURITUS (Itchiness), DRY SKIN (extreme dryness of skin), SCAR (splitting of skin), RASH MACULAR (Blotchy patches covering the body), SKIN EXFOLIATION (scaling of skin), SCAB (1/4 inch scabs covering the bottom of feet), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (flaking skin), FEELING ABNORMAL (lessoning of feeling of touch), INSOMNIA (sleep loss), SWELLING (Swelling of hands and feet) and ERYTHEMA (redness of skin). On 26-Aug-2021, ECZEMA (Rash - Eczema Flair up) had resolved. At the time of the report, PRURITUS (Itchiness), DRY SKIN (extreme dryness of skin), SCAR (splitting of skin), RASH MACULAR (Blotchy patches covering the body), SKIN EXFOLIATION (scaling of skin), SCAB (1/4 inch scabs covering the bottom of feet), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (flaking skin), FEELING ABNORMAL (lessoning of feeling of touch), INSOMNIA (sleep loss), SWELLING (Swelling of hands and feet) and ERYTHEMA (redness of skin) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported.
A patient accidentally received a DT vaccine instead of the age appropriate Tdap vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00888053) and transmitted to Sanofi on 07-Dec-2021.  This case involves a 54 year old and unknown gender patient who was accidentally received a DIPHTHERIA AND TETANUS TOXOIDS (dt) vaccine instead of the age appropriate DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (tdap) (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 06-Dec-2021, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong product administered (latency same day).  It was reported "Caller states that a 54 year old patient accidentally received a DT vaccination in the office on 06DEC2021 instead of the age appropriate Tdap vaccine. Caller states that she must attend to a patient and asked for the phone number for Medical Information so that she could call back to provide more information related to this occurrence."  No other 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 the 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.  There will be no information available on the batch number for this case.
I received a Shingrix (Zoster) 50 mcg vaccination the afternoon of 2021-01-16. The usual sore arm was expected, however, I also developed a +4 deg fever with 24 hours. The elevated temperature began to subside about 10 hours after onset.
My son had convulsions, low fever. He used to coo at the sound of my voice and that night he seemed to slur and make very odd noises. His head was moving from side to side. He didn't seem to hear us when we tried to soothe him. He still doesn't respond to us, he doesn't seem to hear us. I called the doctors office and they saw him. They didn't think that they needed to file a complaint. They said that they would watch him closely next time. I said that I would not continue his immunizations.
1ST DAY NO EFFECTS. Day after: headache that won't go away, body aches, chills and fever of 102.8. Take advil cold and sinus (worked with prev dose) nothing, take tylenol: nothing. took Benedryl for the drainage and cough and nothing. Nothing worked at all, couldn't touch it. Continues until following morning, wake with bilateral flank pain and diarrhea but fever broke and only arm is hot and has pain.
Red feet; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-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 ERYTHEMA (Red feet). At the time of the report, ERYTHEMA (Red feet) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitants were provided no treatment medications were provided.   This case was linked to MOD21-0749404 (E2B Linked Report).; Sender's Comments:  MOD21-0749404: