chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had allergic reaction due to beef or pork component within vaccine and ended up in the hospital; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional (office staff).  This case involves a male patient of unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that patient had allergic reaction due to beef or pork component within vaccine and ended up in the hospital (allergy to vaccine).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received 1 dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced allergic reaction due to beef or pork component within vaccine and ended up in the hospital (allergy to vaccine). The patient was hospitalized for this event.  (Other relevant tests included no lab data.)  Final diagnosis was allergy to vaccine.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.; Sender's Comments: This case involves a male patient of unknown age who experienced allergy to vaccine after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Stomach ache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache) and DIARRHOEA (Diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.
Joint pain; This is a spontaneous report from a Pfizer-sponsored program, received by a contactable consumer (patient herself).  This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 17Feb2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient was experiencing joint pain and she was wanting to know if she could take an acetylsalicylic acid (ASPIRIN) or a pain killer. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
01/17/22 presents to EC ED for "shortness of breath". PMHx of "positive for COVID on 1/3" "CKD s/p renal transplant, CAD s/p stent and Hypertension"
Around 7 A.M. developed extreme chills and nausea. By 8 A.M. violent vomiting any time not laying down and still. Around then, hearing was muffled, unable to walk, stand, or crawl without extreme nausea, dizziness, and feeling of about to pass out. Numbness and no feeling from mid-forearm through fingertips. Hands were ashen white. Numbness and minimal to no feeling from mid calf down. Unable to stand or grip anything. By then, fully at rest pulse was 136 (normal is in 80s) with blood pressure 131/80. Unable to move or open eyes without feeling of passing out and/or vomiting. Continued chills with need for winter socks and gloves to try to keep hands and feet warm. Was only able to keep a teaspoon of liquid every half hour down for the first 5 hours and resorted to 1-2 ml of liquid Tylenol to try to improve symptoms.  This continued until 2 pm at which point it seemed I?d gotted enough Tylenol down to slowly improve. By 2:30 was able to sit-up without falling over for the first time since onset of symptoms but it was not until about 8 pm that hearing started to return. By next day, blood pressure and pulse still elevated, but lower, full return of hearing. Visible muscle spasms in calves and arms throughout the following day with extremely painful lymph node in shot arm. Shooting pain from elbow down occasionally in shot arm
Following administration of the influenza and pneumococcal conjugate vaccine, patient did develop dizziness, muscle aches, chills, fever and soreness.
Rash on forearms developed 24hrs after shot. On the third day developed intense itching in various area around my body. Comes and goes through the day. Stronger at night. Rash has subsided  but itching continues.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 18-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
Likely generalized vaccinia at day 11 following small pox vaccination. Also with viral cellulitis/lymphangitis.
13 days after moderna booster I became extremely itchy with hives.  It has now been 15 days and have dermatographia.
Per clinical documentation upon hospice admission on 11-16-21:  FAMILY REPORTS AFTER 2 ND COVID VACCINE, ON NOV 4TH, PT HAS BEEN PROGRESSIVELY WEAKER, FEVERISH. PAST FRIDAY UNABLE TO BEAR WEIGHT, NO APPETITE, INCREASED SLEEPING, FAMILY HAS BEEN GIVING LIQ TYLENOL AND SIPS   Patient was previously under the care of primary care physician.
Pt was given the vaccine after the expiration date. Exp date 8/31/2022. Vaccine given on 9/9/2022
Shortly after I have tachycardia, high blood pressure, I went into convulsions. I was taken to the ER and was monitored for a few hours until my BP went down. 1 week later I went to a follow up appointment and I still felt all the symptoms but my BP had went down. From the first day of getting the vaccine I had muscle twitching for 2 months. I also was very winded for 2 months, I could barely walk up the stairs. I also had tingling in my legs and it continued for 2 months, after 1 week of taking the vaccine I also had sores in my mouth for about 10 days, with major fatigue. An overall feeling of not being well. My heart felt very labored like it was working very hard.
red and swollen arm; red and swollen arm; This is a spontaneous report from a contactable consumer.  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced red and swollen arm on 20Jan2021. The outcome was unknown.    Information on the lot/batch number has been requested.
pt was found deceased in bassinet;time of death called @ 1232; pt was alive @ 1130
Hives- Head to toe    Was treated in ER with a steroid.  They thought it was something else not the vaccine but are not sure.  Vaccine was 2 weeks previously  and was 2nd injection
12 hrs later experienced extensive itching, redness, left arm swelling at injection site. Right lower arm has 8" red rash w/extreme itching. Slight erythematous.
Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.; Itchy on the head; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.) and PRURITUS (Itchy on the head) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced URTICARIA (Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.) and PRURITUS (Itchy on the head). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and CORTISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives have been on and off since that time appearing first on knuckles and toes and subsequently moved on to the upper torso.) and PRURITUS (Itchy on the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.
Patient received FLUAD on 11/29 in L deltoid. Patient reports on 11/30 swelling of L deltoid area as well as tenderness to palpation and restriction of movement. No involvement of airway or any other s/sx of IgE mediated reaction. The symptoms are ongoing, it is day one post injection.
Arm was extremely swollen, red, and itchy beginning 2 days after vaccination and lasting a few days. She said it had resolved before calling us. She just wanted to report.
Right deltoid red, swollen and leaking. Starting the evening of 12-9-13 after administration. Relieved with TYLENOL. Started on antibiotics by PCP.
Starting around 22 hrs after injection, 3 episodes of vomiting over several hours (oddly, without much of the usual nausea) and inability to keep down food or drink for several hrs, and then only a tiny bite and sip if I stayed flat. By 36 hrs post injection, was able to eat and drink small portions. Sporadic clusters of contractions of tensor tympani muscle started maybe around 10 hrs after injection. Otherwise, common side effects (tender deltoid muscle, fever, malaise, fatigue, anorexia, mild headache, other muscle aches.) Felt mostly well, just fatigued, by hr 48, and well by hr 60 except that, oddly, now the tensor tympani muscle of the other ear is having sporadic clusters of contractions.
Ear fluid- ear pain, ear and head pressure, muffled and sensitivity to sound. Prescribed Methylprednisolone and recommended Claritin d. (Pain in the arm day following vaccine went away)
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 09-AUG-2017, a 74 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX 23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008715: US-009507513-1710USA008716: US-009507513-1710USA008717.
A non-serious spontaneous report of expired FLUMIST administered was received from a nurse concerning a six-year-old female. No medical history was provided. A nurse gave the patient FLUMIST that expired on 12-Nov-2008. There was no adverse event associated with this medication error therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up received on 02-Dec-2008 includes: patient was not re-dosed and no adverse events occurred. Additional information was received on 09-Apr-2009: Based on the results for the investigation, the root cause for the medication errors were caused by 1)customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.
Patient requested and was expecting to receive the Pfizer Covid Booster vaccine, but was mistakenly given the Moderna Covid Booster vaccine. Patient was immediately notified of the mistake and informed that per the agency and other agency it is okay to interchange the two if patient has a complete initial covid vaccination series. Patient did not have a reaction to the moderna and is doing well.
Event occurred after 2nd vaccine. First vaccine was on 3/15/21 and the second one on 4/5/21. Pt tested positive for COVID-19 on  11/28/21.
received expired dose of HAvrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix pediatric) (batch number Ep47e, expiry date 6th February 2023) for prophylaxis.   On 21st February 2023, the patient received Havrix pediatric. On 21st February 2023, unknown after receiving Havrix pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comments: The caller opted out of providing additional information The reporter did not consent to follow-up.  Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Large lump appeared in right breast suddenly, itching on right back, mess right side of breast area, itchy pimple rash right back atea
Day after the injection the area was very inflamed (red, swollen, hot, and painful) at site of injection and very painful.  Unable to raise arm overhead.  Day after the injection I felt nauseous, fatigued, had an elevated temperature of about 99.7 degrees F.   Two days after injection I still felt off and on nauseous, arm was still very inflamed at the site of injection.   Site appeared larger (8 cm in diameter), but not quite as sore or painful.  Still very red and hot to the touch.   Feel generally unwell still two days after the injection, but not quite as bad as the day after.  I treated the 1st day after with aleve and tylenol and zyrtec.  I also iced the injection site.  The 2nd day after I took aleve and have iced the injection site.
Patient called and scheduled to come in for 1st dose clinic at clinic.  He came in for appt, received his 1st dose Moderna vaccine, was monitored for side effects and scheduled for Dose 2.  During a QI audit by this nurse, it was discovered that he was previously seen at another clinic a month prior for his first dose of Pfizer.  Called patient, he was confused and thought that he was calling to schedule his 2nd doe of Pfizer.  He did not realize he had missed that appointment already.  Patient reported no adverse side effects from receiving 2 different medications.
No immediate side effects - approximately 9 hours after injection when trying to sleep got cold chills for 2-3 hours.
Patient reports pain, redness, swelling up the right shoulder and down the elbow, fever, lightheadedness, dizziness, shivering lasting 2-5 days after injection was given.
second dose of Shingrix has not been administered as of yet and is over the recommended 2nd dose schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 19th April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: second dose of Shingrix has not been administered as of yet and is over the recommended 2nd dose schedule). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Nov-2023 The patient has not been administered second dose of Shingrix yet and was over the recommended 2nd dose schedule. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
arm spasm; This spontaneous case was reported by an other caregiver and describes the occurrence of MUSCLE SPASMS (arm spasm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MUSCLE SPASMS (arm spasm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (arm spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other medication reported.     This case was linked to MOD-2021-063890 (E2B Linked Report).; Sender's Comments:  MOD-2021-063890:wife
sinus infection; bronchial infection; sore throat; coughing; post-nasal drip; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), BRONCHITIS (bronchial infection), OROPHARYNGEAL PAIN (sore throat), COUGH (coughing) and NASAL CONGESTION (post-nasal drip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced SINUSITIS (sinus infection), BRONCHITIS (bronchial infection), OROPHARYNGEAL PAIN (sore throat), COUGH (coughing) and NASAL CONGESTION (post-nasal drip). At the time of the report, SINUSITIS (sinus infection), BRONCHITIS (bronchial infection), OROPHARYNGEAL PAIN (sore throat), COUGH (coughing) and NASAL CONGESTION (post-nasal drip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I developed SVT two days after receiving the vaccine. I have had this before, but it always quit after two doses of metoprolol.
Given dose from vial that was opened from previous day and left in medication fridge in lab. Vial was opened 2:15pm on 10/13/22 and marked directly on label of vial. Patient was given  0.1ml Jynneos ID on left forearm 10/14/22 at 4:14pm. Expired dose administration caught at end of day vaccine reconciliation.  Dose was expired 18 hours due to opened vial.
This is a spontaneous report from a contactable consumer. A 44-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269) on her left arm, via an unspecified route of administration on 03Feb2021 12:30 at a single dose for covid-19 immunization. Medical history included PCN allergies. The patient's concomitant medications were not reported. It was reported that the patient's left arm and the left side of her left hand has felt weak since having her shot yesterday. She can close her hand, but it feels weak. Took place at 03Feb2021 01:15PM. No treatment was received for the event. The outcome of the event was not recovered.