chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spontaneous hives that began after the injection; itching in the face that began after the injection; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:00 as dose 4 (booster), single (Lot number: 59267030402) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 3 (1st booster), Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 22Sep2022, outcome "not recovered", described as "Spontaneous hives that began after the injection"; PRURITUS (non-serious) with onset 22Sep2022, outcome "not recovered", described as "itching in the face that began after the injection". The events "spontaneous hives that began after the injection" and "itching in the face that began after the injection" required physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus. Additional information: the patient did not have covid prior to vaccination and has not been tested for covid post vaccination. The patient has no known allergies and other medical history. The treatment received by the patient is an antihistamine therapy.
Pt. c/o throat closing, raspy voice, some dizziness, and SHOB.  Pt. given Benadryl 50mg/mL IM to right gluteal and Oxygen 2.5 lpm nasal canula.  Epi pen on call if needed. Twenty to Twenty-Five minutes after Benadryl administered, patient reports resolution of symptoms. Pt. Dc' d home with ER precautions given.
blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction; fever; headaches; body was in a weakened state; pain in arm; swelling up her arm/swelling in hands; had a severe reaction; swelling at injection site; hot; A spontaneous report  was received from a consumer who was also a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction (vaccination site reaction), swelling and warmth at vaccination site, pain in the arm, swelling up her arm/left hand swelling (peripheral swelling), inflammation, rapid heartbeat (heart rate increased), blood pressure was 286/89/blood pressure was so high (hypertension), fever (pyrexia), headache and weakened body state (asthenia).   The patient's medical history, as provided by the reporter, pneumonia (had from Dec 2020 to Feb 2021 and had "compromised lungs"), allergies to penicillin and sulfa drugs, vitamin D deficiency, pseudobulbar effect, and traumatic brain injury (with swelling on back of brain stem, memory loss, problems with speech). Concomitant medications included levothyroxine sodium, vitamin C, vitamin D, fish oil, tizanidine, and fluvoxamine.     On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:029L20A) in the left arm for prophylaxis of COVID-19 infection.    On 18 Feb 2021, after receiving mRNA-1273 the patient reported to have a severe reaction to the vaccination. The patient had swelling at injection site which looked like a bee sting and felt hot.   On 19 Feb 2021, the patient reported to experience swelling and very bad pain in left hand. The patient took Benadryl as a treatment.   On 20 Feb 2021, terrible pain in arm was reported along with swelling. She went urgent care and they sent her to the hospital, where she stayed for about 8 hours.  Test showed a severe inflammatory reaction.  She also had headaches, her body was in a weakened state, pain went up her arm, she had a rapid heartbeat and a fever.  The patient's blood pressure was 289/89 and they "thought she was going to have a stroke or a heart attack" because her blood pressure was so high.    Treatment for the events included steroids and unspecified painkillers.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events peripheral swelling was considered to be not resolved at the time of reporting.  The outcome of the events of  severe reaction,  swelling and warmth at vaccination site, pain in the arm, inflammation, rapid heartbeat, blood pressure was 286/89/blood pressure was so high, fever, headache, and weakened body state was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
april 12th had chest pains, very high blood pressure, slight headache. but since vaccine been having more constant headaches.
On 06/30/2023 patient was given Dtap instead of Tdap by mistake. Staff was made aware of mistake by the immunization coordinator after they reviewed the immunizations. Patient's PCP and parent were notified and it has been documented.
hives; This is a spontaneous report from a contactable physician reported for a patient.  A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer product, lot number unknown), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced hives that began 24 hours post the first dose of the BNT162B2 vaccine. It resolved with one dose of Claritin. No other symptoms at all. The outcome of the event was resolved. Information on the lot/batch number has been requested.
Pt had onset of vomiting, diarrhea, chills, approximately 3-4 hrs after administration. These lasted most of the night. She had a stiff neck the next morning which progressed to other joints later that day. By the 3rd day she was feeling better.
pt recvd vax; at time of vax T cell count was 460;approx 2 wks later devel childhood case of chicken pox according to md;at time of rpt pt was itching from head to toe w/ light recurring pox concentrated on hands, inner thighs & abd;
Myalgia chills, sweats Narrative:  Had to go home from work, stayed home next day
Soreness in shoulder as if I had been punched hard, rash oval/circle approx 5 inches in diameter, mild swelling under the rash, moderate fatigue, swelling of lymph node in arm pit opposite injection site like a squishy hand ball, severe sweats and chills, extreme urination, general body aches, general joint aches, aching of sports injuries less than 3 years old, mild nausea, mild dizziness, severe headache, swollen lymph nodes in both sides of neck, loss of taste, mild skin numbness around and above the rash. Most symptoms resolved after 4 days.
Sharp pain in left breast started 10 hours after the vaccine  Followed by flu like symptoms like sweating, chills, body aches and fever.
Psoriasis; Wound bleeding; Skin wound; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (Psoriasis), WOUND HAEMORRHAGE (Wound bleeding), SKIN WOUND (Skin wound) and FATIGUE (Tiredness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 09-Apr-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced PSORIASIS (Psoriasis), WOUND HAEMORRHAGE (Wound bleeding), SKIN WOUND (Skin wound) and FATIGUE (Tiredness). The patient was treated with Wound care for Wound haemorrhage. In June 2021, SKIN WOUND (Skin wound) and FATIGUE (Tiredness) had resolved. At the time of the report, PSORIASIS (Psoriasis) outcome was unknown and WOUND HAEMORRHAGE (Wound bleeding) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  It was reported that the in Jun-2021, the patient experienced felt very tired for a few days after second COVID Vaccine, she had an open wound, small open area on back of head that continued to bleed, patient felt it was due to psoriasis. She needed to be seen in urgent care for a small open area on the back of her head that continued to bleed, the area was cauterized without any further problems. She stated physician felt it was due to Psoriasis. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
When monthly cycle began (Sept 26), bleeding continued lightly and with spotting for 2 weeks.  Second dose was administered on October 4.  Next cycle started November 4 (40  days later) and was heavy, lasting 11 days.  November 21 (18 days after the last cycle started), bleeding began again.  Before the immunization, cycle was reliably 28 days in length with no abnormalities.
Daily headaches, extreme fatigue, elevated heart rate, 10 lb weight gain, mood swings
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Broke out in red papular bumps on face, back, labia and hand, was exposed to varicella 2 wks ago.
This spontaneous report was received from a nurse and refers to a 3 female patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot number N037533, expiration date: 17-MAY-2018 (exact dose, route of administration were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001644: US-009507513-1805USA001645: US-009507513-1805USA001646: US-009507513-1805USA001647: US-009507513-1805USA001642: US-009507513-1710USA011550.
Was in hot unairconditioned gym when baby cried unconsolably x 10-15min then went limp, pale and was unarousable. To ER. Observed in hosp.  8/31/07 Reviewed hospital medical records which reveal patient experienced unresponsive spell in a very warm room.  Patient began sweating profusely, intensely cried then fell asleep & could not be awakened.  Seen in ER 7/31/07 & was starting to awaken & cry.  Irritable.  Admitted overnight for observation & returned to baseline.   FINAL DX: possible heat stroke; possible reaction to immunization.
My stomach is cramping; Throwing up; Nauseous; Light headedness/Dizzy; This is a spontaneous report from a contactable consumer or other non hcp(patient). A patient of unspecified age and gender received first dose of  bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-not reported), via an unspecified route of administration on 22Aug2021earlier at 1:30 as DOSE 1, SINGLE for covid-19 immunisation .The patient's medical history and concomitant medications were not reported.It was reported that the patient received the first dose of Covid-19 vaccine today 22Aug2021 earlier at 1:30.On 22Aug2021 the patient experienced stomach cramping, throwing up ,nauseous, Light headedness,dizzy after patient took first dose of Covid-19 vaccine.The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
In May 2021 my menstrual was extremely heavy as if I was hemorrhaging. I'm scheduled to go to Gyn on 11/20/2021. I thought it was going to go away still awful feeling like I'm going to faint. I also had a lump on my left breast sent to have a diagnostic.
VACCINE ADMINISTERED WAS STORED AT FREEZER TEMPERATURE FOR TOO LONG.  PATIENT IS BEING REVACCINATED.
Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2016566258) on 19 Dec 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE) (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient relevant medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient had swelling local and redness at injection site. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
On the morning of 02/19/2023, she woke up vomiting. On the next 2 days, she had a low grade fever and sore left ear. We went to the doctor on 02/22/2023, and she had an ear infection. She was prescribed amoxicillin. She went though that course and seemed to make a full recovery.
tightness when breathing, pt has history of anxiety and takes xanax. pt denies any other s/sx of ha and dizziness
hospitalized 9/8/21, SARS-CoV-2 positive 9/8, COVID pneumonia
B-cells were no longer functioning properly and somehow his immune system is compromised; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (B-cells were no longer functioning properly and somehow his immune system is compromised) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 IMMUNODEFICIENCY (B-cells were no longer functioning properly and somehow his immune system is compromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (B-cells were no longer functioning properly and somehow his immune system is compromised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Left arm where vaccine received was hard, swollen, hot, and could barely lift arm 1 day after receiving vaccine. Applied a cold compress and took BENADRYL.
Patient came in on 7/16/08 have rash all over his upper arm red.
Hives all over face that eventually spread through out the body within the next week. They were activated by touch to skin. Lasted 2 weeks. Used herbal remedies to cleanse system.
Reaction to vaccine/many problems; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to vaccine/many problems) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to vaccine/many problems). At the time of the report, VACCINATION COMPLICATION (Reaction to vaccine/many problems) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant medication reported. There was no treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received contains significant information, updated verbatim term to Reaction to vaccination/many problems.
TOOK TWO UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1570) report was received from a pharmacist on 17-Jun-2019. It describes a male child consumer who "took two unrefrigerated doses of Vivotif". He was receiving Vivotif for an unknown indication.  Case report: The consumer took two unrefrigerated doses of Vivotif on unknown dates.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.
Hives on a daily basis, itching, burning, crawling of skin. Chest pain, heartburn, stomach pain, feeling of something being lodged in throat. Hands, wrist & feet burn, itch, swell, have numbness & sharp shooting pains. Constant muscle spasms. Blurred vision & stabbing pains in eyes. Achy & throbbing of arms & legs. Canker sores in mouth. Joint & muscle pain. Swelling of lips, nose & chin. Skin is hot to touch along with hives. Brain fog & confusion, broken sleep, mind racing, headaches that last 3-4 days at times. Anxious & feelings of depression, withdrawal & general feeling of being ill.
Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The dose was administered to the patient after 30-day use by date or after manufacturer date of expiry.  The date on which the vial was initially stored in the refrigerator was unknown.  Number of doses/vials that were administered from that lot was reported as 102 doses.  The vial did not undergo any temperature excursion.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contain non significant information
This spontaneous prospective pregnancy report as received from a nurse refers to a 28 year old female patient. On 23-MAY-2014 the patient was vaccinated with VARIVAX (dose 1, subcutaneous, dosage and lot number unknown) for she has no titer. On 18-JUL-2014 the patient was vaccinated with VARIVAX (dose 2, subcutaneous, dosage and lot number unknown) for she had no titer. The patient reported that she was one month pregnant with LMP of 02-JUL-2014 and EDD of 08-APR-2015. Initial exposure to VARIVAX was at 2 week(s). The pregnancy outcome was outcome pending. The patient did not seek medical attention and did not receive treatment. Additional information has been requested.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.
Fainted in chair after receiving a PPD and GARDASIL vaccine. Hit back of head on floor. Father states patient "shake some as he fainted". Oriented to T-P-N. No bleeding or knot on head. Walked to car accompanied by both parents.