chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
Pt's mother called 8/4/03 stating pt has redness and swelling around the site where the varicella injection was given. Pt denies fever or pain.
ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 04-JUN-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915623, 20210915646, 20210915661, 20210915719, 20210915748, 20210915852, 20210916465, 20210916129, 20210916300, 20210916312, 20210913164, 20210913164, 20210916415, 20210913164, 20210916415, 20210916498, 20210913164, 20210916401, 20210916910, 20210916959, 20210916697, 20210916808 and 20210917160.
blood on his urine after he got the 1st dose; This is a spontaneous report received from contactable consumer (patient himself) via Pfizer sponsored program COVAX US Support. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: un-known, expiry date: unknown) via unspecified route of administration on 23Mar2021, as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. On an unspecified date, patient experienced blood on his urine after he got the 1st dose. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Have an hypersensitivity reaction to a pneumococcal vaccine; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunization.  Medical history included post splenectomy.  The patient's concomitant medications were not reported. The patient had a hypersensitivity reaction to a pneumococcal vaccine on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions and medical history were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced Bell's Palsy (VIIth nerve paralysis). The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the VIIth nerve paralysis was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information is not expected.
Temperature of 101. Peppery rash on trunk, hives on trunk, fussiness; all as reported by mother. Began 2/18/02, last 24 hours and then resolved.
Fully magnetic. Not just magnetic at site of injection. Very unpleasant periods/menstrual cycle. Furthermore, patient is fully magnetic, but has not received the Pfizer Biotech Injection. After patient had become magnetic, he has spoken to multiple doctors referring that he go to the ER or Urgent Care facility due to acute, chronic intestinal bleeding.
paralysis of my face for 2 days and severe migraines intermittent for the last 5 months that are invalidating
Extrememly high fever 104.5 was the highest recorded.  Broke out in "chicken pox" like marks...approximately 12-15.  Vomiting, diarrhea.
About 10 minutes after the injection I started feeling dizzy and hot. Then the headache started with pain moving up my head. Throat became dry. Started feeling nauseous. RN's started to check my vitals. Temperature was at 99.4. O2 was at 99%. Blood pressure was 135-92. Symptoms were not getting better and I started feeling worse. RN (House Supervisor) encouraged going to the ER. Was checked into ER where they gave me Benadryl, Tylenol, Zofran & steroids. Symptoms stayed about the same. Received second dose of Benadryl. Started to feel a little better about 30 minutes after. Spent about 3 hours total in ER. We home to sleep for about 7.5 hours. Woke up the next morning feeling very fatigued with a terrible headache. Continued to dose with Benadryl and Tylenol as needed.
Pt was found down at home, EMS brough patient to ED- pt continued to decline and died from respiratory failure, COVID, sepsis and pneumothorax.
Mom came to main clinic to address/notify Immunization Center that her child received a DTaP and not a Td as per age. Stated nurses gave shots and received sore throat, hives to upper chest (no fever) and pain to jaw when tried to speak. All on 10/1/10. Mom took child to PMD office. On bed rest x 3 days.
Information has been received from a company representative concerning a 17 year old male who at the age of five, in approximately 1995, was vaccinated with varicella virus vaccine live (Oka/Merck). On 09-JUN-2007 the patient developed chickenpox. The doctor performed a culture of the rash and sent it off to the lab where it was confirmed that the rash was chickenpox. The patient was treated with valacyclovir tablets (VALTREX). Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Employee received vaccination in right arm, went to have labs drawn after 15 minutes of observation was over without any concerns or symptoms.  Upon arriving at lab, noted slight rash around antecubital.  Phlebotomist attempted lab draw at this site and was unsuccessful.  Able to perform phlebotomy on left arm instead but advised employee to return to vaccination clinic for evaluation of right antecubital area.  Observed swelling to the anterolateral aspect of the antecubital site with noted tenderness and slight dry reddened areas.  Provided with warm pack to site and observed for an additional 30 minutes. No further worsening of swelling, advised to seek medical attention or contact employee health for any worsening or new symptoms.
After the shot, my arm was sore, and I had a bad cold. In July, I found my liver counts were high. The doctor retested my liver counts in December of 2021. They found I had thyroid issues, and my liver counts were still elevated. The doctor is monitoring my thyroid. I've retested every three months, and the counts were still high each time. They tested me for Hepatitis. The results were negative.
Information has been received from a physician concerning a female in her 20s who was vaccinated SC with a dose of varicella virus vaccine live. Concomitant medications included levothyroxine sodium (SYNTHROID), rabeprazol sodium (ACEPHEX), and ehinylestradiol + norgestimate (ORTHO TRI-CYCLEN). Subsequently, approximately 2 years ago, the patient broke out into hives on the injection area after administration. No additional treatment was incorporated to correct condition. Unspecified medical attention was sought. The outcome was reported as recovered. Follow up information indicated that on the evening of the injection the patient developed urticaria (diffuse) and significant erythema and induration at the injection site. The outcome was reported as recovered. No additional information is available.
Local injection site reaction: redness, swelling, itching, stinging, scaly feeling to touch, heat-producing.
Pt.'s girlfriend states after receiving the 1st dose of Phizer 03/31/2021, 24hrs after vaccination experienced a massive heart attack, emergency stent surgery preformed 04/01/2021. Has recovered from heart attack.
skin is still ashen/gray; This case was reported by a pharmacist via sales rep and described the occurrence of skin discoloration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix and after a couple weeks was still ashen/gray.
.5 ml Janssen COVID Vaccine lot # 043A21A  Exp 9-19-2021 was given  on 9-20-2021, one day after vaccine exp date.
arm hurt; Pyrexia; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PYREXIA (Pyrexia) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unk and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PYREXIA (Pyrexia) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt), PYREXIA (Pyrexia) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature increased: 100.5 f Inconclusive.         No treatment information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and muscle soreness. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the muscle soreness was unknown. It was unknown if the reporter considered the pain in arm and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient still experiencing muscle soreness with activity in her injected arm 6 months after dose 1 of SHINGRIX. The healthcare professional did not have vaccine lot number or expiry information, as the dose was not given at her pharmacy.
This spontaneous report was received from a pharmacy student referring to an unspecified number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M004890 (expiration date 10-NOV-2017), (dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complaint (PQC). This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
Pt. reported redness to (LT) deltoid area x 1 week post PREVNAR vaccine.
rash all over body suspect bullous pemphigoid worst under and around left arm ; started about a week after shot and is rapidly progressing; burning and itching especially sensitive to any contact, steriod cream adn doxy given; already taking oral steriods
Feeling mostly normal but tired fell asleep at 11PM day of second vaccine.  Woke up 1 hour later and got up to go to the bathroom but felt fine.  Went out to the hall bathroom so as not to wake husband in Master bath.   Urinited and  got up slowly as I always do and walked out to the hallway to go back to bed.   I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing.  I have no recollection of it  once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway.   I didn't feel any pain.  Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet  with sweat and I took a couple minutes to come to.  After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills.  No fever.  Slept most of the next day and night.   Headache and joint aches and swelled lymph nodes in neck..  Fatigue through 20th.  Mostly better by the 21st.  Still today on 22 I am being careful when going from  prone to standing.  I feel more head pressure getting up and maybe I notice a little  nausea  when rising.  I may just be worried about fainting again.  It has never happened to me before.  I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted.  Neck is sore.. Not sure if lymph nodes or something to do with fall.
Extreme Dizzyness, Fatigue, Double Vision/eyes not tracking, Headache on left side of head behind ear, burning left ear, Left ear fullness, Left eye pain, Wavy sensation in scalp, tingling on left side of face, left arm and leg,  Pain in left arm. Slight tinnitus, Neurologic symptoms in head
pt recv vax & exp a burning localized reaction (sl erythematous warm rash); sx resolved w/in 24hr;
High fever 101; Chills; Fatigue; Body joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain). At the time of the report, PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101 (High) Fever.     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.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain). At the time of the report, PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101 (High) Fever.     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.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
10 days after my first dose of Moderna a large red patch developed.  No itch but slightly sensitive.
Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous report from a contactable consumer, the patient.  A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration on 04Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disorder.  Concomitant medications included levothyroxine from an unknown date at 100 (units not provided) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on an unknown date (at the age of 74-years-old) as a single dose for COVID-19 vaccination. After the patient received the second BNT162B2 vaccine dose, overnight the patient got really sick, the patient experienced headache, chills, body aches, nausea, and joints hurt, all on unknown dates in Jan2021, per the patient it started during the night. The patient received ibuprofen (ADVIL) as treatment for the events. The clinical outcome of got really sick overnight and chills were unknown and the outcome of the events headache, body aches, nausea, and joints hurt was not recovered. It was also reported that the patient has been tested for COVID-19 with unknown results, the patient stated they get a COVID test every week at work.
Became itchy with rash and hives on arms, legs, body, shoulders 12/19. Took antihistamines with little relief. Face and head swelling and rash 12/20. Started Prednisone. ED visit 12/22 - breathing difficulties, general malaise. Vitals & CBC panel unremarkable. Prednisone taper began 12/25. Rash seems to be less every day.
arm soreness and stiffness; arm soreness and stiffness; This is a spontaneous report from a contactable consumer (patient's husband). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer Covid 19 vaccine yesterday (24Jan2021) and reports arm soreness and stiffness this morning on 25Jan2021 that has already resolved. The outcome of events was on recovered on 25Jan2021.  Information on the lot/batch number has been requested.
Information has been received from a physician assistant concerning about 5 patients. Starting on 18-AUG-2014, GARDASIL (lot: J006236; expiration: 25-FEB-2016), VAQTA (lot: K001792; expiration: 22-OCT-2015), RECOMBIVAX HB (lot: J005078; expiration: 20-SEP-2015), PNEUMOVAX 23 (an unsealed/opened multi-dose vial) (lot: K007773; expiration: 01-MAY-2015), and ROTATEQ (lot: J012954; expiration: 31-MAR-2015) were improperly exposed to 28F for 12 hours, and to 30-34 F over 10 separate occasions (on unspecified dates) for a cumulative of 24 hours. About 5 patients received at least one of the above vaccines on unspecified dates since 18-AUG-2014. No known adverse effects occurred. Additional information has been requested.
slight fever; diarrhea; sneezing; stuffy; feeling "yucky"; sores in mouth; swollen mouth; sore throat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 11Aug2021 at single dose for COVID-19 immunisation. Medical history included  had COVID-19 in 2020. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced slight fever, diarrhea, sneezing, stuffy, feeling yucky, sores in mouth, swollen mouth and sore throat. Event took place after use of product. The clinical outcome of events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I got my 2nd Covid vaccine 8/8/2021. I felt okay that day but the next day I started having headaches and have had headaches mostly every day until present. I would not label them migraines, but a 3-4 on the pain scale. I haven't had to miss work or anything because of them. But they're obnoxious. Again, no clue if this is associated but within a week of getting the vaccine, I started getting sores in my mouth, on my tongue and along the gum line. I went to my primary care office, dentist, and an oral surgeon and no one can figure out what's going on.  On 12/09/2021, I ended up getting a biopsy and we're waiting to get the final results of the biopsy. The pain is ongoing, and the sores are still there but we're trying to get to a solution.