chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14--NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054.
pt received first dose on 12/01/2021, second dose administered early inadvertently on 12/13/2021. CDC resources reviewed, pt rescheduled based on guidance documents to repeat too early 2nd dose in primary series
1.19.22 fever noted; respiratory status declined placed on High Flow Nasal Cannula then Vapotherm, tested Covid positive  Decadron ordered - 1.20 transitioned off Vapotherm to  6L HFNC  -1.21 continue on 6 L HFNC - 1.23=34.5 1.24 change in mental status upon return from CT Head developed respiratory distress - no response to bagging; patient intubated then developed PEA arrest; unable to recover with ACLS protocol
Fever over 24 hours, 101.6 at highest Muscle/body aches
This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 28-AUG-2014, the patient was vaccinated with M-M-R II (route, dose unspecified) lot # H015826, expiry date: 24-AUG-2014. No concomitant therapies were reported. ON 28-AUG-2014 the patient inadvertently received an expired dose of M-M-R II which was expired on 24-AUG-2014. No adverse event was reported. Additional information has been requested.
pain; fever of 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain) and PYREXIA (fever of 100 degrees) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided.).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain) and PYREXIA (fever of 100 degrees). At the time of the report, PAIN IN EXTREMITY (pain) and PYREXIA (fever of 100 degrees) outcome was unknown. Not Provided          No treatment information was provided.
Body aches, sore throat, hoarse, congestion, headache, generalized malaise.  Currently feeling all of these symptoms today 9/20/2010, called in sick to work.
Patient came to the pharmacy on 4/18/11 to report a reaction to ZOSTAVAX. Patient's left arm was very swollen, red, and irritated. It appeared to be forming a rash and discharge was coming from the injection site. Patient had contacted her primary care doctor and was taking Ibuprofen OTC. Patient was called 24 hrs later by pharmacist for follow-up. Patient said arm appeared to be getting better.
may have administered FLUBLOK to a 14 year old patient; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00837243) and transmitted to Sanofi on 01-Nov-2021.  This case involves a 14-year-old patient (unknown gender) who reportedly may have received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age)  The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On 31-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Inappropriate age at vaccine administration (latency same day)  It was reported "Pharmacist reports that her intern told her they may have administered FLUBLOK to a 14 year old patient yesterday, 31OCT2021; states she still has to verify that this event occurred. Pharmacist asks if there are any recommendations when FLUBLOK is administered to a patient younger than 18 years; asks if there are any side effects when FLUBLOK is administered to a patient younger than 18 years. Pharmacist states she will call back to complete adverse event (AE) report when she verifies that the event occurred and collects the information about the event; agent gave pharmacist case reference number. Pharmacist confirms that it would have been the standard 0.5 mL dose of FLUBLOK that was administered"  No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
FORGOT TO REFRIGERATE AND TOOK ALL FOUR DOSES; This spontaneous case report (PVX2019-2749) was received from a pharmacist on 06-Nov-2019. It described a 67-year-old elderly female consumer who "forgot to refrigerate and took all four doses" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case Report- The consumer took all the four doses of Vivotif which were unrefrigerated.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to refrigerate and took all four doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to refrigerate and took all four doses" was considered as not applicable.
When it first began, I had pain in the left side of my throat like glass was stabbing my throat and diarrhea. I went to the doctor for testing the next day, and they took cultures for testing for the influenza, strep throat and COVID-19 on 01/03/2022. They called me and told I had the flu, but three days later, they called again to say I had COVID-19 on 01/05/2022. She later prescribed me PAXLOVID for treatment; I'm currently on the third day of treatment with 2 days to go. I still have the cough and diarrhea as my symptoms, but I'm slowly getting better.
This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.
High temperature (39 oC, 102F) for 2 days after 1 day from the flu shot. Muscle and joint ache at whole body for 2 days after 1 day from the flu shot. Nausea and diarrhea for 3 days after 1 day from the flu shot. No appetite for 3 days after 1 day from the flu shot. I had slept for two days and cured.  I just want to report my case. These symptoms were so severe. I couldn't move and therefore couldn't go to a hospital.
Within (12) hours of injection:  Fatigue set in which is still occurring (9) days later.  Within (5) days of injection:  Left arm is showing a lot of discoloration & numerous black & blue within 6? of vaccination site.
Around 10 pm, I first felt weak and tired with a bit of a nauseous stomach. I struggled to sleep, having chills and feeling feverish. Then around 2 am I woke up and vomited. About 20 minutes later I vomited again. The next day I woke up and was fatigued, weak, and nauseous the rest of the day. I fell asleep multiple times and napped by accident. By 10pm,  almost exactly 24 hours later, I felt fine again.
extreme restlessness & all noc screaming; t100; to MD 2x's to assess pts status; no eating following this by extreme lethargy;
pt was vax w/one dose on 15aug98 & on 15sep98 pt sought medical attention & lab tests revealed ``vax failure for measles only w/immunity to mumps and rubella
This spontaneous report was received from a medical assistant, concerning a 17 year-old female patient. There were no concurrent conditions, drug reactions or allergies reported for the patient. She did not have any medical history and her concomitant therapies included unspecified vitamins. On 19-MAR-2001 and 02-APR-2007, the patient was vaccinated with the first and second dose of VARIVAX (dose, frequency, route, lot # and expiration date were not reported), for prophylaxis. On an unspecified date in 2017 (reported as "last week"), the patient developed shingles like rash on her arm (rash vesicular), so, she was seen on the medical assistance's office on 29-MAR-2017 and was prescribed valacyclovir (VALTREX) as treatment and no laboratories were done. At the time of the report the patient was recovering from the adverse event. No product quality complaint (PQC) was involved. The causality between the adverse event and VARIVAX was unknown. Additional information has been requested.
My father was vaccinated yet still got shingles/Suspected vaccination failure; My father was vaccinated yet still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 82-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
fever; chills; muscle aches; where I had the shot (arm) it's really really sore; one lymph node under my arm is swollen; body aches; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN5318; Expiration date: Unknown) via an unspecified route of administration (age at vaccination 39-year) in arm on either 11Feb or 12Feb2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever, chills, muscle aches, where she had the shot (arm) it's really really sore, one lymph node under her arm was swollen, body aches. Caller reported her experience after first dose of Pfizer-BioNTech COVID-19 Vaccine: "woke up with severe symptoms; having fever, chills, muscle aches, one lymph node under her arm was swollen, body aches, fever, chills, and where she had the shot (arm) it's really really sore. She asked if she should get tested for COVID-19." The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive on an unspecified date in Jan2021. It was reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198; Expiration date: Unknown) on 08 MAR 2021 for COVID-19 immunization. Description of product complaint: Caller had her second shot of the COVID-19 Vaccine yesterday. Caller states that she woke up at 3AM this morning and she had every symptom. Caller was wondering what the chances are that she could have COVID-19 again, or if these symptoms were all from the shot. Caller previously had COVID-19 in Jan2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273646 similar report from same reporter
Unknown.  Mother will not return multiple phone calls.  She said patient had "reaction to it and nearly ended up in hospital"
Pt devel inc temp day of immun w/tender area rt leg; temp then normal 2 days p/immun; inc temp 4 days p/immun, rash on cheeks, arms, legs;
The vaccine (brand name Adacel) was admistered at 8:30 on Friday June 9th. I felt arm pain throughout the day, but have experienced that in the past and felt that was normal. I could not fall asleep on Friday night. I had severe chills, a fever, heart palpitations and pain throughout my entire body including my neck and terrible headache. On Saturday morning my pain had escalated and I could barely complete normal tasks. I was exhausted after minimal exertion such as walking to my car. On a scale of 1 - 10, my pain was an 8. I took ibuprofen and spent the day in bed. My  injection site was swollen, but not red. In the afternoon I felt a  little better, but as I started doing things, the symptoms came back. Again I have a low grade fever, chills and was very pale. I was lightheaded and still had the same terribel headache. My throat was swollen and it hurt to swallow, but did not cause wheezing. This persisted through the day. On Sunday I felt less pain throighout my entire body, but the neck pain and severe headache still were present. My arm was less painful and I was able to move it to 90 degrees. Again I took ibuprofen. On Monday the same symptoms existed, again less severe, except for the headache and neck pain. Again I took ibuprofen and slept a lot.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of unknown age (between 16-18) and ethnicity received third dose of TRUMENBA for Immunization at single dose on unknown date. On unknown date the patient experienced chills, dizzy, pain at the injection site that was unlike prior 2 immunizations. The outcome of the events were unknown.
Client reported dizziness in post-vaccination observation. Client also reported feeling sweaty. Obtained vital signs on the client (below). Client was given water and observed by MD in post-vaccination area. Client reported feeling better after resting for approximately 15 minutes. No need for EMS at this time, client recovered and was able to leave of own volition.
Tested positive for Covid-19 on 8/4/2021.  Admitted to hospital 8/22/2021, not for Covid-19 s/s.
Runaway fever (105-106F) and metabolic encephalopathy 18 hours following Pfizer bivalent COVID booster. Fever did not respond to acetaminophen. Similar reaction in October to the Moderna bivalent COVID booster. Both events required hospitalization.
Did not have an adverse event to the vaccine. Started having symptoms on Jan 23rd, bad cough, head congestion and a running nose. Got Tested on Jan 24th and had a positive result for COVID 19.
feeling lightheaded; dizzy; nauseous; diarrhea; This is a spontaneous report from an Other Healthcare Professional, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose 1 , single dose via an unspecified route of administration in the left arm on 07Jan2021 at 03:45 PM (at the age of 23 years-old) for COVID-19 vaccination.  There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 05:00 AM, the patient woke up feeling lightheaded, dizzy, nauseous and experienced diarrhea. The report was reported as non-serious. The patient was not treated for feeling lightheaded, dizzy, nauseous and experienced diarrhea. The clinical outcome of feeling lightheaded, dizzy, nauseous and experienced diarrhea was recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on the Lot/Batch Number has been requested.
PNEUMOVAX 23 injection - arm is very sore with a red bump. Told to take TYLENOL and ice arm - confirmed w/Doctor.
BACK PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included dementia, and bad back. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 11:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021 21:00, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain. This report was non-serious.
Appx. 2 weeks following booster began to experience ongoing dizziness, disorientation, brain fog and eventually head/body rocking.  Primary doctor was unable to see me. Went to urgent care who indicated they were not equipped to assist aside from providing vertigo exercises and referred to ER if symptoms didn't subside. Saw ENT and he referred me to Neurologist  Diagnosed with vestibular hypofunction.
Information has been received from a registered nurse and a physician concerning a 31 year old normal healthy white female employee with quinine and seasonal allergies and no significant medical history (including no immunosuppression, no history of chicken pox, and no known recent varicella or shingles exposure) who on 3/6/03 at 2:00 PM was vaccinated SC in the left upper arm with a 0.5cc first dose of varicella virus vaccine live (lot 640553/0799M). There was no concomitant medication. There was no illness at the time of vaccination. It was also noted that no rash occurred at the site of injection post-vaccination. On 9/13/02, the patient had a negative varicella titer prior to vaccination with varicella virus vaccine live. Also on 9/13/03 a serum hepatitis B surface antigen test was negative. On 3/24/03 the patient had greater than 150 lesions, described as multiple discrete papules. The physician indicated that a lesion sample which they were attempting to grow was direct fluorescent antibody positive. At the time of the report, nothing had grown from the sample. Unspecified medical attention was sought. Follow up information from the registered nurse indicated that on 3/22/03 at 3:00 PM the patient developed a maximum oral temperature of 101.4 F. On Monday the patient went to the doctor's office after a rash developed. Chicken pox was diagnosed. The lesions were red and raised and some were pustular with small amounts of drainage. Itching was described. There were 15 lesions on each leg, 46 on the trunk, 46 on the back, 13 on the right arm, 10 on the left arm, 10 on the head, 10 on the face, and two to three on the neck. On 3/23/03 the patient was seen by an infectious disease/infection control medical doctor. Preliminary results of direct fluorescent antibody testing of the lesion showed no varicella zoster virus isolated to date. On 3/26/03 the final report of the direct fluorescent antibody testing was positive for varicella zoster virus antigen. The reporter indicated that the lesion cultures had not grown. It was noted that the patient recovered on 4/4/03. Additional information was received which indicated that on 3/26/03  a specimen was obtained from a papule lesion and on 5/6/03 (also reported as 3/26/03), was sent for varicella zoster virus identification. Follow up information was received from a physician indicating that the patient had a wide distribution of lesions that were pretty much healed at this point. Follow up information was received which indicated that it was an adequate specimen and a polymerase chain reaction test was negative for varicella zoster virus. It was noted that the specimen was retested and was still found to be negative. No further information is expected.
Shakiness, shivering, developed temperature of 102 at 6pm. Treated with Benadryl at hospital.
Chest tightness and wheezing. Spouse informed writer this lasted approx 5-10 min and that sx slowly resolved over evening. At onset felt hot, flushed followed by chest tightness and wheezing per pt.