chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her chest) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 04-May-2021, the patient experienced RASH (Rash on her chest). At the time of the report, RASH (Rash on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment include steroid cream which has helped the patient with itching. No other medication reported.
soreness in the right upper arm since the Shingrix vaccine but also has some soreness down the arm and in the right axilla; also he says that he gets some tingling in the tips of the fingers of the right hand; no weakness; also says that recently he has a milder amount of soreness in the left axilla and some milder tingling in the left thigh, no weakness
Information has been received from a registered pharmacist concerning a 11 year old patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) instead of VARIVAX vaccine (Oka/Merck) (MSD). This happened within the past 24 hours at a hospital physician unknown. No adverse affects known. The pharmacist was not aware it was product confusion. The grandmother indicated human error. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. No further information is available.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 88-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had more than once). Concomitant products included Valacyclovir. In January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site discomfort and injection site pain. On an unknown date, the patient experienced shingles and weakness. On an unknown date, the outcome of the injection site erythema, injection site discomfort, shingles, weakness and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site discomfort, shingles, weakness and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient took valacyclovir to prevent shingles symptoms. The patient describes that he stopped taking the medication for three days prior to receiving the SHINGRIX vaccine. Approximately a little over a week ago from the date of reporting, the patient received SHINGRIX on left arm. The patient could not lay on his left arm. The patient experienced pain which resolved within two days and soon after the redness resolved. A few days after these symptoms resolved the patient began to have a shingles eruption on his backside and he felt weak.  These symptoms resolved after a few days. The reporter was difficult to follow and did not always answer the questions provided. Unable to obtain additional information. The reporter did not consent to follow-up.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The expiry date was reported as 09-Nov-2021.  Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up documents received included non-significant information
Severe Sinus drainage starting 2 days prior to second dose. Constantly fatigued. Brain fog, or delay in being able to respond to questions. Trembling of hand and of body at times. Anxiety also at times.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 13-year-old patient of unknown gender. On 03-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Pediatric 3yrs+ FLUZONE given to patient under the age of 2.
Narrative:  COVID infections following completion of COVID vaccine series 03/02/21 COVID vaccine dose #1 03/23/21 COVID vaccine dose #2 07/23/21 Pt reports close exposure to more than 3 people but is asymptomatic; COVID positive 07/25/21 Pt reports headache, denies any other symptoms 07/31/21 Pt reports headache, lightheadedness, muscle pain in legs/feet, tired eyes 08/03/21 Pt reports headache resolved and muscle pain has resolved; clinically resolved
had the first shingrix but not the second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had 1st dose of Shingrix shot but not the second dose till the time of reporting, which led incomplete course of vaccination. The question was asked did need to start over with the first shot of Shingrix. The follow-up would not possible as no contact details were available.
HYPERtension Hot flush Narrative: BP 148/109 HR 88, patient monitored for an additional 15 minutes, repeat BP 147/97 HR 72. Patient recovered and referred to PCP for follow up.
A little bit sore in the arm; This is a spontaneous report from a contactable other health care professional, the patient. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FA6780), intramuscular in the arm left on 14Jul2021 as dose 1, single (at the age of 58-years-old) for covid-19 immunization. Medical history included red circle and it was inflamed and painful and just around the injection site. The patient concomitant medications were not reported. The patient previously took flu shot. On an unknown date in 2021, the patient experienced a little bit sore in the arm. The outcome of the event was unknown.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13 via intramuscular route on 24Jul2015 at 0.5 ml single. Medical history and concomitant medications were not reported. The patient came back to her doctor's office after the injection site became very red and hot to the touch. The anatomical location of the injection site was unknown. The patient was given unknown antibiotics in the doctor's office on an unknown date and was then sent to the hospital on 30Jul2015 in response to the events. The outcome of the events was unknown. The patient's hospitalization was ongoing at the time of this report.
1st dose on 2/3/2020.  She has not received the 2nd dose yet.; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 16th April 2020, 73 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient was diagnosed with Shingles 73 days after receiving the 1st dose of Shingrix. The patient did not received 2nd dose till the time of reporting which led to incomplete course of vaccination. No other information was provided. The reporter consented to follow up.
Pt developed fever 102.4 F, lethargic, vomiting 2 hrs /p DTP was given.
All over rash and itch intermittently, started at site and spread to bilateral arms and bilateral legs
Had initial redness, pain and swelling that mostly went away within 24-48 hrs. Am reporting return of redness, swelling, tenderness and itchiness 8 days after vaccination administration. Then that also went away within 48 hours of reappearing.
This case was reported by a nurse via call center representative and described the occurrence of extremities hot feeling of in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extremities hot feeling of, fever, shivering, tiredness, erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the extremities hot feeling of, fever, shivering, tiredness, erythema, swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the extremities hot feeling of, fever, shivering, tiredness, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that a friend of her cousin's received SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The health care professional also stated that the patient experienced redness, hot arm, swelling, shivering, fever, and tiredness. This case has been linked with US2018144849, reported by the same reporter for herself.
Day after vaccine, I was sick all day. Hard to breathe; heart rate would shoot up and then come down in one minutes sessions; I had body aches - all over. Doing anything felt painful. Eating was uncomfortable and sitting was uncomfortable. I had some fever. 238.5 Celsius and it got a little worse during the day (and that number is the end of the day). I had some pain in the chest, too - center of chest. I also had a headache throughout the day. I did a televisit (wednesday)  and she advised to take acetaminophen for fever. She said my blood pressure was fine and my heart rate was still under 100 most of the time. The next day, everything seemed fine - all symptoms seemed to go over night except heart rate - still was elevated and the difficulty breathing was still there. Even sitting - my breathing and heartrate felt like it was working. Friday, things were mostly similar - heart rate came mostly down. But end of day, difficulty breathing came worse and chest pain became worse and tightening of chest was more intense. No fever after Wed though. I went to see the Urgent Care doctor at Urgent Care. Friday, the second week after the vaccine, the symptoms received. Pain in left arm started (started Tuesday or Wed the second week)  and I had chest pain and tightness in the chest and slight difficulty breathing, nausea, dizziness and no fever.  ER - on Saturday - 11:30PM - they did more tests - everything heart related came back fine so they ruled out Heart attack; but didnt' know what it was; gave medication for nausea in case it would help. IV medication and then one medicine to drink on the spot. It didn't really help - the symptoms continued and slowly disappeared the next day (the second Sunday after the vaccine). Nothing new since then.
Approximately 15 hours after receiving the vaccine, I woke up with a fever of 103, drenched in sweat, body aches, extreme headache, and nausea.  I drank 16 oz of water and went back to sleep.  The symptoms continued into the morning.  At 0700, I took DayQuil and continued drinking water.  The symptoms continued throughout the day.  The medication eased the symptoms slightly, but they persisted until the following day at around 0700.
Fever so far up to 101.1; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 15Apr2021 at 17:15(at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included fluoxetine hydrochloride (PROZAC) from an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 14:00, the patient experienced fever so far up to 101.1. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 16Apr2021, the patient underwent body temperature and the test result was 101.1(unspecified units). The clinical outcome of the event fever so far up to 101.1 was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever, body aches and chills and loss of smell and taste. The treatment was just Tylenol and Motrin  and Soup I went to get Urgent Care - COVID test - positive result  - but didn't get an exam Those symptoms continued for about 12 days. I can taste most things now and I can smell about 1/2 of the things I should be able to smell.
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 19-APR-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 was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. 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.
Bloody diarrhea with mucus; has improved since 2/17/18. Pt seen in clinic 2/19/18.
Lot of pain; A spontaneous report was received from a consumer concerning a 85-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lot of pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the event of lot of pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event lot of pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Patient's mother wrote date of birth on both consent forms for each vaccine. We administered vaccination series as per Pfizer 5-11 year EUA. Unaware at the time that patient was born unknown. Patient is not within age limit for series. No adverse reactions reported during monitoring. Mother has not responded to communication requests for follow up.
expired ACT-HIB vaccine administered to 2 patients with no reported adverse event; Initial information received on 14-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an unknown age and unknown gender patients who had administered expired haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a standard expired dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total  (lot UJ644AA, expiry date- 02 -Apr-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  It was reported, The nurse can only provide lot number and expiration date and has no information regarding the patients and the health care provider. Nurse was also confirming regarding re-vaccination.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
tinnitus; exhausted; chills; diarrhea; felt absolutely terrible; The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible.; I had a really bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER8729) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "flu" (unspecified if ongoing), notes: I had the flu a couple years ago.; "tinnitus" (unspecified if ongoing), notes: I had tinnitus earlier in my life, about 15 years before this, but hadn't had it since. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Lot number: ER2613, Anatomical location: Arm Right), administration date: 19Mar2021, when the patient was 32 years old, for covid-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered", described as "The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible."; HEADACHE (non-serious) with onset Apr2021, outcome "recovered", described as "I had a really bad headache"; TINNITUS (non-serious) with onset 09Apr2021, outcome "recovered", described as "tinnitus"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "exhausted"; CHILLS (non-serious) with onset Apr2021, outcome "recovered", described as "chills"; DIARRHOEA (non-serious) with onset Apr2021, outcome "recovered", described as "diarrhea"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "recovered", described as "felt absolutely terrible". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, fatigue, chills, diarrhoea, feeling abnormal. Therapeutic measures were taken as a result of tinnitus.  Additional information: The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible. I could not get out of bed. I had a really bad headache. Was completely exhausted and couldn't stay awake. Had the chills and had diarrhea. I felt worse than I did when I had the flu a couple years ago. Immediately after the second shot I also started having bad tinnitus that lasted a few months. I had tinnitus earlier in my life, about 15 years before this, but hadn't had it since. After my booster shot (3rd dose) I felt the exact same way all over again. I can't take this vaccine anymore if it is going to make me feel this way every time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101625013 similar report from same reporter