chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This patient was given 0.2ml of UNDILUTED vaccine.  It was not realized until 3/29/22 at about 4:00 PM.  An attempt was made to contact her parents on 3/29, but no answer and no return of the message left.  Her mother was contacted on 3/30 at about noon.  She stated that patient had a little tenderness at the injection for about one day, but no other adverse reactions.
This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old unk patient who received BOOSTRIX (batch number UNK, expiry date unknown). Previously administered products included Tdap. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: 12 year old mistakenly given BOOSTRIX after previously receiving another Tdap vaccine within the last year.
Patient was given pneumococcal vaccine in right deltoid. Within 5 minutes he developed severe itching and redness at the injection site.  Redness spread to upper arm, neck and face.  Denies SOB/tongue or throat swelling.  Patient was given 50mg oral diphenhydramine and observed in clinic. Symptoms began to resolve in 30 minutes.
Pain to shoulder of injection site approximately 15 min post vaccination. Pain radiate to neck and feels numbness and as if swelling. Md in for assessment observation Vitals obtained, monitored an additional 15 mins. Symptom improved and discharged with post vaccination instructions and EC precautions.
Extreme injected arm pain, fever (101.9), severe headache, body aches and chills.  Severe for approx. 36 hours, then decreasing until gone 4 days after injection.
as before with shot number 2, I have a rash that looks like a hot water scald under my breast across my chest
Was out in the sun for 45 minutes burned extensively and after 3 weeks still red.; Was out in the sun for 45 minutes burned extensively and after 3 weeks still red.; Skin was scaley; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that when she was out in the sun for 45 minutes burned extensively and after 3 weeks she was still red. she peeled but her skin was scaley, it was not the usual sunburn she get. The outcome of all events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021894278 same reporter, drug and event, different patient
warm arm; swollen arm; rash is itchy at times; red arm; "horseshoe" shaped rash around site of administration; "bad" headache, is unsure if headache is related to vaccination; "hard nodule" below injection site; not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE ("hard nodule" below injection site), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm) and RASH PRURITIC (rash is itchy at times) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder). On 01-Apr-2021, the patient experienced INJECTION SITE NODULE ("hard nodule" below injection site), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm), RASH PRURITIC (rash is itchy at times), ERYTHEMA (red arm), RASH ("horseshoe" shaped rash around site of administration) and HEADACHE ("bad" headache, is unsure if headache is related to vaccination). On 26-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder) had resolved. On 08-Apr-2021, HEADACHE ("bad" headache, is unsure if headache is related to vaccination) had resolved. At the time of the report, INJECTION SITE NODULE ("hard nodule" below injection site), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm), RASH PRURITIC (rash is itchy at times), ERYTHEMA (red arm) and RASH ("horseshoe" shaped rash around site of administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Patient treated her symptoms with diphenhydramine(oral), hydrocortisone (topical) per recommendation of her local pharmacist. patient also took acetaminophen to relieve headache. Patient reports the rash has diminished in severity, but is still present. Patient reports headache has resolved as of 8Apr2021
his arms were "killing him"; having discomfort at the injection sites; This spontaneous report was received from a consumer, referring to her husband, a 50-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 04-MAR-2021, the patient received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (strengths, vaccination schemes, routes of administration, lot numbers and expiration dates were not reported) vaccines in different arms.  On the same date, the patient's arms were "killing him" (ill-defined disorder) and he was having discomfort at the injection sites (vaccination site discomfort).  The outcome of ill-defined disorder and vaccination site discomfort, and the causal relationship between the aforementioned events and the suspect therapies were not reported.
6:30pm, riding home in car, coughed a little. 6:50pm, "blotches" of swelling inside of cheeks & inside of bottom lip which lasted until 10:00am, 12/2/99. Thought throat felt constricted a little; gone by next am. Felt hot, cold/achey/sore/
Loss of taste; Loss of smell; Felt very weak; Chills; Fever; Body aches; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
10 yr old client received 5 immunizations per documentation. The child was quiet and calm when she received the immunizations. RN accompanied the child, who was alert and awake, from the immunization room to the reception area of the clinic. Approximately 10 minutes after the immunizations were given, the RN (and coworkers) witnessed the child having a syncopal episode. She fell from a standing position and hit the occiput of her head on the carpeted floor. No bleeding, circumoral or facial edema, cyanosis or difficulty breathing was observed. No incontinence or vomiting was noted. Syncopal episode lasted approximately 5-10 seconds and the child woke up screaming. A second RN brought the immunization anaphylaxis kit which was not needed. The 911 system was activated. The child was assessed by ambulance personnel and was transported to the Emergency Dept. by private vehicle.
Child came in with emergency foster parent, they did not believe child had vaccinations and wanted them given that day.  Nothing was showing up in MIIC.  4 shots were administered.  Later found out that the name and date of birth were incorrect.  Once that was updated, we found that the children were completely up to date.  Foster parent reported the child had no adverse outcomes from additional vaccines.
Severe pain to arm throbbing, can't move up/down unrelieved by pain meds.
rash head to toe; maculo papular-pink & itchy; almost immediately p/2nd dose; resolved spontaneously w/o treatment by 6MAY92;
Pt recvd 3 Hepatitis-B vax 3AUG89, 6SEP89, & 25JAN90 following these titer=33; p/1yr titer=4; pt was given a 4th dose of vax 17APR91 following 4th dose titer=184;
Information has been received from a registered nurse concerning a 77 year old male who on 23-JAN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) and then on 29-APR-2008 was vaccinated with VARIVAX (Oka/Merck) inadvertently. No adverse effect reported. The nurse had no specific reason and/or recommendation for this medication error and was unable to provide the lot # for VARIVAX (Oka/Merck). Additional information from the R.N. indicated that the patient had forgotten that he had already received ZOSTAVAX (Oka/Merck) and come back to received the vaccine. It was a medication error that he received VARIVAX (Oka/Merck). The office followed their protocol and notified the doctor. The patient is fine and has no adverse experience. Additional information has been requested.
Severe headache, slurred speech. Involuntary body movement (tic, tremor muscle movements.) 2-21-12 severe movements every few mins to every hour or so sometimes when the nurse ck blood pressure it would start then as hours/days went by finally subsiding on the evening of 2-23-12.
Moderate nausea all day and evening for 3 weeks after second vaccination and continuing. Accompanied by burping, mild stomach upset. Stools are normal. No vomiting.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Dizziness, Headache, Diarrhea, dizziness after 10-15 min; then headache, diarrhea., arm soreness Narrative:
Covid-19 Vaccine: tested positive for Covid-19 after the booster dose; Covid-19 Vaccine: tested positive for Covid-19 after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 Vaccine: tested positive for Covid-19 after the booster dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Caller on the line who is concerned. She is 90 years old. She took Paxlovid yesterday. From yesterday until now, she is still tasting the medication. She mentioned that she is having diarrhea after taking the medication. She tested positive for Covid-19 after the booster dose of the Pfizer Covid -19 vaccine. Unable to clarify above details with caller. Caller is wanting to speak with a supervisor. She has been on the phone for over one hour. She wants a supervisor to call her back as soon as possible or her lawyer will call us. She cannot stay on this phone for over an hour. Caller disconnected abruptly after providing her phone number. Paxlovid: From taking the medication yesterday until now, she is still tasting the medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Symptoms I experienced that were not listed on the CDC website were: sore throat, heavy cough.
The soreness in my arm from the shot was about 1 hour in. Within 24-26 hours I started to have nausea and vomiting with chills.  30 hours in I was still vomiting, my joints are sore, and a throbbing headache.  Had to call off from work.  36 hours extreme fatigue and headache remained.  48 hours in fatigue and light headache. Still feel nauseated and arm soreness. Now have soreness in armpit.
Pt complained of tenderness noted at left deltoid arm. Noted mild induration at the injection site. No erythema or soft tissue swelling and no heat.
This spontaneous report was received from a Licensed Vocational Nurse (LVN) referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L012475, expiry date: 10-JUL-2016, route, dose and frequency unspecified). Other suspect and concomitant therapies were not reported. No adverse effects reported. No product quality complaint (PQC) reported. This is one of several reports from the same source. Additional information has been requested.
Hospitalization: 9/24/2022 - 10/10/2022  Presentation to the ED: AMS/stroke like symptoms. R sided weakness, unequal smile, slurred speech.  COVID-19 + date: 9/24/22. Treatment: high flow O2, Remdesivir, Decadrone and nebulizers. Discharge to: Hospice. Patient is deceased. She passed on 10/10/22.
had multiple vaccines at once: MMR, IPV, Hep A, Hep B, DTaP, Meningococcal. Erythema multiforme type rash on face primarily, multiple lesions.
This case was reported by a consumer via call center representative and described the occurrence of runny nose in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (administered 3 to 4 years ago). In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 1 day after receiving SHINGRIX, the patient experienced runny nose and injection site pain. On an unknown date, the outcome of the runny nose and injection site pain were recovered/resolved. It was unknown if the reporter considered the runny nose and injection site pain to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. In September 2018, approximately 2 weeks before the date of reporting, the patient was vaccinated with SHINGRIX. On the next morning of vaccination with SHINGRIX, the patient experienced runny nose. The injection site soreness and runny nose lasted for a period of 5 days. The patient stated that she already had a standing appointment with her doctor that was scheduled prior to the vaccination of SHINGRIX and so the patient went for her appointment and mentioned that the adverse events experienced by her to the doctor. The patient requested that she should not receive any additional correspondence that was any calls or letters regarding the events experienced by her as she was busy in taking care of her husband at the time of reporting. This case was linked to case US2018179127 reported by the same reporter.
Rash - whole body onset 3 d post vaccination. No tx at time of report.
Vial used for this dose was first punctured on 6/7/22. This patient received the vaccine on 6/10/22 around 72 hours since first puncture.   The vial had been stored in the fridge since 6/7/22. The pharmacist attempted to call the patient  but the phone number was not working at the time. We will continue to call her multiple times and possibly visit her house to gather more details regarding possible side effects.
Muscle pains, lethargy, lack of appetite, lack of energy, chills, slight fever at times.
Tachycardia, high blood pressure, elevated levels of troponin.  I was hospitalized with these conditions
Painful Swollen Lymph nodes; then Prednisone for six days (symptoms relieved), but symptoms returned two days after Prednisone course completed.  Symptoms persist still after 5 weeks;  now on 6th day of 7 day course of antibiotics (Augmentim) with no relief (as of 5/3)  Scheduled for ultrasound and soft tissue scans on 5/7.  This duration of swollen lymph nodes seems is longer in duration that what is reported on line.
received tetanus shot and was diagnosed with cellulitis 2 days later, being treated with cephalexin 500mg 3x a day for 5 days
In evening of vaccine administration patient developed flu-like symptoms, temp 104 degrees, chills, nausea, aches and SOB. Patient rested and took TYLENOL.
Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay
Stomach pain; Sorta hot; Muscle ache; mild headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), FEELING HOT (Sorta hot), MYALGIA (Muscle ache) and HEADACHE (mild headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), FEELING HOT (Sorta hot), MYALGIA (Muscle ache) and HEADACHE (mild headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), FEELING HOT (Sorta hot), MYALGIA (Muscle ache) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Treatment information included 2 pm pii.
Woke up in the middle of the night (approximately 13 hours after receiving vaccine) with chills and hot flashes. Was restless and unable to sleep.  Has a severe headache. Is feeling exhausted while trying to eat.  (Filling this out day after vaccine, side effects still exist).
Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 years old male patient who was vaccinated with a 0.5 ml dose of MENACTRA (Batch number: U5180AA; expiry date: 22-Jan-2017 dose in series were not reported) via intramuscular route in the left arm on 01-Apr-2014. It was also reported that the patient was vaccinated with a primary dose of MENACTRA when he was 13 years old on 01-Apr-2014. The patient's concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation (Batch number, expiry date, dose, dose in series, route and site of administration were not reported). It was a case of actual medication error due to extra dose administered. It was reported that No know reported symptoms or need for treatment. 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 Directive 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. List of documents held by sender: none.
Ringing in  right ear   now in august  ringing in both ears.  in trusive  and life changing
Patient complained of severe chest pain radiating to back within 5 minutes of vaccination. Significant language barrier but patient grimacing and clutching chest. Pain described as burning by family member. Evaluation by EMS, vital signs stable, Oxygen given and transported to Hospital ED  - disposition unknown.
Pt. seen on 6/6/17 for C/O inj. on 6/3/17. Pt. stated C/O grogginess/cloudiness hours after receiving inj. Pt. B/P 143/89. Pt. also stated C/O headache dizziness one possible fainting on 6/6/17 at 13:30 and believes it is R/T inj. No Tx performed. F/U with HCP.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course of the events: Other medication in 2 weeks: Yes. No known allergies. Historical vaccine: Yes. The patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Soreness in injection spot followed by fatigue and muscle ache all over body........forehead warm to the touch
First day was soreness. This is day 3 and still sore all down left arm into neck.  230am I had 103.2 fever aches and pains, lethargic and chills. Took ibuprofen 400 mg. Went back to sleep. Fever 100.7 at 615am so took 1000 mg Tylenol. Back to sleep until 11:15am and 99 fever with same symptoms. Now 106 pm and fever gone for moment but still have the other symptoms.