chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 11:48 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 45.57 and 45.67. Concomitant products were not provided. On 14-Feb-2021, Excursion time was 09 AM, 10 AM and 11 AM, temperature was 32 respectively, Excursion time was 02 PM and 03 PM, temperature was 35 respectively, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021 (Batch: 031L20A). On 21-Mar-2021, Excursion time was 09 AM, 10 AM and 11 AM, temperature was 34, 32 and 34 respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine BUD date was 15-Apr-2021 (Batch: 003B21A). On 21-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 AM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41, 4 PM: 41 and 5 PM: 41 (Batch: 003B21A). The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Dizziness, Lightheadedness, Nausea, Vomiting.
TOOK TWO DOSES OF VIVOTIF WITH CIPROFLOXACIN; This spontaneous case report (PVX2019-2541) was received from a nurse on 10-Oct-2019. It described a female consumer who "took two doses of Vivotif with ciprofloxacin" (PT: Labelled drug-drug interaction medication error), while being on oral Vivotif (company suspect) for typhoid fever prophylaxis and ciprofloxacin (non-company suspect) for urinary tract infection (UTI).  Case report: The consumer took two doses of Vivotif with ciprofloxacin. She had a UTI prior to starting of Vivotif and she was prescribed with ciprofloxacin.    The consumer's medical history included UTI.  Action taken with Vivotif and ciprofloxacin with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses of Vivotif with ciprofloxacin" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses of Vivotif with ciprofloxacin" was considered as not applicable.
I had nausea and vomiting and severe diarrhea and a headache, a horrible headache. I had a cough as well, that was almost continuous. I went to my PCD on 2/7/2021. They gave me cough medicine, an antibiotic and I am trying to remember what else. Then I had the monoclonal antibody infusion. I had two COVID tests taken, 2/3/2021 and again on 2/7/2021. The treatment was okay, it made me feel a little bit better but not a whole lot because I got the antibody infusion on the tenth day and I went back to work on the 15th of February I believe.
Mother called and reported that son had hives on trunk and back of body approximately 4 hours after immunizations.  No other unusal exposures.  He had no swelling of lips no wheezing.  Bendryl given be mother.  Spoke with Dr. later in evening symptoms resolving.
12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was moved to a private location and EMS began assessment.  aprox 12:40pm EMS called for transport to a medical facility -  the patient experienced vomiting, neck swelling, facial swelling and inability to speak -  IV access was obtained by EMS and Benadryl was given IV - she was then given another IM injection of Epi by the EMS team  she agreed to transport and was then transported to the hospital around 1:30pm
Sore arm; Tired for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and IBANDRONATE SODIUM (BONIVA) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired for a couple of days). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired for a couple of days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Complained of rectal condyloma within 3 weeks of getting vaccine. No exposure there.
About an hour after I received the vaccine I got a headache and I felt really tired. Next day at work my heart rate was super high 130-150 bpm. My temp was 100.7. I felt lightheaded and dizzy and I had muscle aches.
Vaccine was potentially administered subcutaneously. Patient reports bubbling under the skin and a large bump at the injection site. She applied ice and took acetaminophen for the pain. We explained that while a subcutaneous injection is an error, her dose is still considered valid and does not need to be repeated.
expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)) and EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
Inconsolable screaming for 9 days, fever, eye swelling, small rash on left thigh, back arching,
Fever of 100.4 *F less than 24 hrs after vaccine, chills, headache, bodyaches
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 15-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L035124, expiration date (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock: Lot #L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: Lot #L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This case was reported by a physician and described the occurrence of vomiting in a 4-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included IPV (Sanofi) given on 10 August 2009. Concurrent medications included ZYRTEC given over 24 hours prior to this report. On 10 August 2009 at 18:00 the subject received unspecified dose of BOOSTRIX in the left thigh. This was the wrong vaccine for administration. BOOSTRIX is not indicated for use in children under the age of 10 years. The child was to have received her 5th dose of her DTaP series. Three days following vaccination with BOOSTRIX, the child experienced vomiting. At the time of reporting the vomiting was unresolved. The reporter did not know if the event was related to the maladministration.
dry heaves; dry cough; nauseated/she feels like throwing up; she experienced sore arm during approximately 3 day; This spontaneous case was reported by a patient and describes the occurrence of RETCHING (dry heaves), COUGH (dry cough), PAIN IN EXTREMITY (she experienced sore arm during approximately 3 day) and NAUSEA (nauseated/she feels like throwing up) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Blood cholesterol abnormal. Concurrent medical conditions included Type 2 diabetes mellitus and Blood pressure high. Concomitant products included METFORMIN, EMPAGLIFLOZIN (JARDIANCE), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), SPIRONOLACTONE, LISINOPRIL, HCTZ, ATORVASTATIN, AMLODIPINE BESYLATE and INSULIN GLARGINE (LANTUS SOLOSTAR) for an unknown indication.    On 02-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 12-Nov-2023, the patient experienced RETCHING (dry heaves), COUGH (dry cough) and NAUSEA (nauseated/she feels like throwing up). In November 2023, the patient experienced PAIN IN EXTREMITY (she experienced sore arm during approximately 3 day). In November 2023, PAIN IN EXTREMITY (she experienced sore arm during approximately 3 day) had resolved. At the time of the report, RETCHING (dry heaves), COUGH (dry cough) and NAUSEA (nauseated/she feels like throwing up) had not resolved.       Reported patient already received all her 3 or 4 Moderna shots but did not remember dates. For the previous vaccines she did not experience any adverse events. She received recent dose on 2-Nov-2023. she experienced sore arm during approximately 3 days and then it stopped, but on 12-Nov-2023 she started feeling nauseated dry cough, dry heaves, she feels like throwing up when she does not, and this was still ongoing, but patient did not know if this was related to the vaccine.  No treatment medications were reported.
Patient received moderna booster. He had pfizer primary series. Per technician at check in and vaccinator, and per our documentation,  patient wanted to switch to moderna booster.
Within 5 minutes, feeling soreness in arm, pulse 75 to 58,  sweaty
This spontaneous report as received from a pharmacist refers to an approximately 13 month old female patient. No medical history was reported. Drug allergies/reactions was reported as none. On 17-SEP-2014, the physician vaccinated the patient with VARIVAX (Merck) (dose, route and frequency unknown). No concomitant medication is reported. On 01-OCT-2014, the patient experienced non-febrile seizure. The patient sought medical attention and was hospitalized the same day. On 01-OCT-2014, the following lab test was performed blood culture, urine screen, CAT scan, lumbar puncture, electroencephalogram (EEG) which was all normal. Oxygen was administered as intervention (the event considered to be medically significant by reporter). No treatment was provided for event. The patient recovered from the event on 01-OCT-2014 and was discharged on 03-OCT-2014. There was no product quality complaint. The causality for the event was not reported. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced discomfort and pain. On an unknown date, the outcome of the discomfort and pain were recovered/resolved. It was unknown if the reporter considered the discomfort and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The physician casually reported that, everyone (not specified number of patients) complained of discomfort or pain which lasted for 2 to 3 days. The healthcare professional wondered the occurrence of systemic adverse events and provided general statements of what he had heard in terms of patient experiences but did not had an adverse event to directly report. This case has been linked with US2018176413, reported by the same reporter.
Reported arm and shoulder pain, swelling around the site, difficulty moving arm due to pain on same day as injection. Next day pain, swelling continued also with bruising and red spots. Pt took Advil and Benadryl. Also used cold compresses. Still with minimal swelling and bruising 5 days after.
Next day after injection right upper arm rash present. Day three both arms joint pain and lower back. Having problems with walking.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 11:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022 at 11:40 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jan-2022 at 11:40 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. Reporter stated that the patient did not experience any adverse reaction after receiving the vaccine. Did the vial undergo any temperature excursions: No temperature excursions.
Pt administered meningitis vaccine, then walked to counter, fainted. In fainting, hit head on chair. Never lost consciousness. Vital signs stable entire time.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypertension-Mild, Additional Details: pt states heart rate increased, inside of lips swell, exhausted, tip of tongue tingling, taste of chemicals in mouth.  it is subsiding now. we were monitoring her for 30 minutes. may need follow up
Face begins to get hot, red, and welts appear. This causes my face to itch significantly. Happens weekly at least once but sometimes multiple times. Goes away within an hour.
Patient had done a form online and on that form asked for Janssen. When arrived the form was not found and our technician gave her another form unaware "Pfizer" was printed on the form. The vaccinator understood that patient wanted Pfizer based on the form and administered the vaccine. Patient was very upset she received Pfizer in place of Janssen. Checked on patient the next day and she reported normal expected side effects that she understand were normal and expected. She said she was alright. No further effects were reported to the Pharmacist
9:30AM recv vax & c/o stomach ache, several coughs, eyes watery;not in distress;lt clinic ambulatory;10:05 AM school nurse reported pt wheezing, eyes swollen shut, called 911;epi & nebulizer tx given;transported via amb to ER;
Fever (101 degrees F) since vaccine administered; extreme fatigue; nausea; swelling in left upper arm with pain in left shoulder, into neck, left armpit and chest and across left shoulder blade; body aches; on 8/9/13 - (2) episodes of near syncope with clammy skin.
weakness; myalgia; fatigue; joint/lower back pain; joint/lower back pain; This is a spontaneous report from a non-contactable consumer (patient) received via a sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced weakness, myalgia, fatigue and joint/lower back pain on 31Mar2021. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mental disturbances, psychotic like behavior which is VERY unusual for child.  Very fearful feelings of paranoia
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with an improperly stored dose of (Wistar ra 27-3) M-M-R II 0.5 ml (lot #L003856, expiration date 02-FEB-2017, therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time 96 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine were refrigerator (R)/ freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever & chills within 5 hours of second vaccine. 19 hours later fever of 103.5, chills, body aches, headache.  Following day (24-36 hours later) - fever of 101, body ache, headache, brain fog, large hive at injection site.    Two days later (48 - 72 hours later) - full body of hives, body aches, headache, brain fog Third day (72 - 96 hours later) full body of hives begins to fade, brain fog begins to lift, body aches and headache remain..
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 280 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccines received 12/20/2018, Fever developed on 12/30/2018 and lasted two days and then rash developed on 1/1/2019, started on face and spread down body including soles of feet, macular rash, no vesicles and no papules and non-urticarial. No Koplik spots, no conjuncitivitis, no cough and no coryza.
- Tylenol  -Advil I was sick after 1st 2 vaccine but developed Extremely bad headache after booster shot coupled with nausea.  It get bad sometime that I do not feel productive at all.
Seen in office 7/9/19 with Hand, Foot & Mouth Syndrome.  Seen 7/24 with extensive rash and Dx Gianotti-Crosti.
info recv from pt mom: pt had a sz @ home 15SEP96;pt taken to hosp by amb-CAT scan & lab work done;no tx;test results were WNL;instructed to f/u w/family MD 16SEP96;pt fell from bunk bed w/sz;twitching, lethargic;dx sz grand mal-petite mal
This spontaneous report as received from a physician (M.D.) refers to a male patient of unknown age who on unknown date was vaccinated with a series dose of hepatitis b vaccine (recombinant) (reporter was unsure whether the utilized vaccine RECOMBIVAX (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient did not respond to an unspecified hepatitis B vaccine series as the patient's titers were negative. Sought of medical attention was unknown. No treatment information was reported. The outcome was unknown. Additional information has been requested.