chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine, waited 5-10 minutes, and returned to desk. Soon after patient reported being sick to stomach. Patient walked to bathroom and passed out. Patient awoke with BP 100/70.  0.5cc, 1:1000, epinephrine injection to right deltoid. Patient came around. Emergency response arrived and took patient to hospital.
After more than a week on March 25, 2021, I woke up with the injection site swollen, red, hot, and itchy. It subsided throughout the day. It has recurred now on Tuesday March 30, 2021, but closer to the inner arm and more itchy.
Pt vaccinated w/DTP and OPV experienced unilateral cranial nerve palsy.
Shaky, flushing, dry mouth, Benadryl 50mg IM x1.
Itchiness; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and PAIN IN EXTREMITY (Arm pain) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 03-May-2021, the patient experienced PRURITUS (Itchiness). At the time of the report, PRURITUS (Itchiness) and PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ?No treatment information was provided.
PT RECEIVED HIVES ON RIGHT ARM WHERE VACCINE WAS GIVEN AND SPREAD TO RIGH LEG. PT ALSO COMPLAINED OF ITCHINESS.
Headache the next day after the shot for 4 days, dizzy spells on and of for 3 weeks, almost fainting 3 times, fever 99.9, muscle aches, fatigue for 3 weeks, racing heart for two weeks, nausea on and off and one episode of hand numbness.
administered dose after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   On 8th February 2022, the patient received FluLaval Quadrivalent 2021-2022 season. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter administered a dose of FluLaval to the patient after a temperature excursion exceeding stability information, which led to incorrect storage of drug. The reporter did not have patient information available for the adverse event. The reporter consented to follow up. Healthcare professional gave permission for the safety team to follow up.
No Adverse event; administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022 at 2:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022 at 2:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture).    No concomitant medications were reported. The vials were Individual. Vial size was 2.5 ml. Vial was initially stored in the refrigerator on 06-Oct-2022 at 10:56 AM Date and time of the vial first punctured : 09-Oct-2022 10 AM Date and time of vaccine administration : 10-Oct-2022 2:30 PM The vial was stored in the fridge post puncture. The vial was not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree C equals to 46 to 77 degree F): 30 minutes out of the Fridge. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-658091 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2022: Live Follow-up  Significant information accepted. Added patient details, reporter details and date of administration of vaccine.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658091:MOD-2022-658091 (patient case)
Feelings of dizziness and tiredness about 1 hr after. Massive headache, very sore arm, and general physical tiredness about 5 hrs later. The next day, self-medicated with multiple doses of 400 mg of Advil. It helped with the symptoms
Got a pretty significant headache within minutes of injection (Friday) Experienced extreme fatigue day after the vaccine (Saturday) The next day started to feel okay and then got intense stomach pains and bad nausea (Sunday) Now on this Monday, I am still fatigued, nauseous, and feeling like the flu  Not sure if this has to do with the vaccine, just wanted to report.
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K003422 with expiration date 06-MAR-2016; dose, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd a dose of Engerix-B on 17OCT90 @ 9AM & on 17NOV90 as part of vax program; Pt did not exp any events following 1st dose but on the day p/2nd dose lymph nodes were swollen & pt exp general malaise; Pt refused 3rd dose in the series;
I took tylenol for fever and headache and rested, left side lymph nodes were swollen on 12/16/20 which was the worst day, and has gotten better today 12/17/2020. Did not go to the doctor.
(R) arm hot, red, swollen & painful (no nausea, vomiting or diarrhea).
Patient has significant swelling, redness and pain at injection site.  Also reports headache, chills, fatigue, muscle aches
A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 29-Nov-2013. Reporter reported that they administered expired FLUMIST/one of my staff members accidentally administered expired FLUMIST which started on 29-Nov-2013. The outcome of the event of administered expired FLUMIST/one of my staff members accidentally administered expired FLUMIST is unknown. The report was considered to be non-serious.
Arm pain at injection site; F/C/night sweats; malaise; mylagias.
rash devel 2 days later @ site of vax on thighs & arms; fever of 103 w/stiffness & c/o pain in both legs; low grade fever & rash cont thru 18DEC92;
seen in ER 11JUN96 per MD;4-5 hr p/vax pt became very irritable then slept was difficult to arouse;pt also had shaking episode;tx APAP & observation
After 1st shot : Platelets down to 140k; splenic discomfort /pain; This is a spontaneous report from a contactable nurse (patient herself). This  68-year old female patient receive her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL 9262, via unspecified route of administration on the left arm on 05Feb2021 at 3:30 PM (at the age of 68-year old) at single dose for COVID-19 immunization. Relevant medical history included allergy to NSAIDs, cephalosporin and bee stings, Epstein-Barr virus infection (EBV), chronic obstructive pulmonary disease (COPD), drug induced immune thrombocytopenia (ITP) with NSAIDs and Rebetrol/Interferon), "T&A", tubal ligation, cholecystectomy and osteoporosis. Concomitant medications included zinc, Vit D3, probiotics and calcium. After first shot, on an unspecified date in Feb2021, the patient experienced platelets down to 140k, (Hx of drug induced ITP), splenic discomfort/pain. No treatment was given to the patient for the events. The outcome was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Platelets decreased cannot be excluded. However, the medical history of drug induced immune thrombocytopenia (ITP) with NSAIDs may provide a plausible alternative explanation for the event.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021264907 same reporter/patient, different dose of COVID-19 vaccine/event
hand on her opposite arm/pins and needles sensation/numbness; Tingling in her hand up to her forearm; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route of administration left arm on 01Apr2021 at 13:15 (at the age of 37-years) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Family medical history relevant to AE was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced about 45 minutes after getting the vaccine, the hand on her opposite arm (right arm, she got injected on the left arm) experienced a pins and needles sensation, with accommodating numbness and tingling in her hand that went up to her forearm. It began only a few hours ago. It was in her hand and sometimes goes up a little bit. Patient stated that it's not awful, she was still able to do things. Otherwise she takes no medications. Patient did not visit to Emergency Room or Physician Office. She mentioned that it was not bad but enough to be noticeable. It had gone up to her forearm. She mentioned that it had been hours later that it was still not gone but it was not as bad. The outcome of the events was tingling in her hand up to her forearm was not resolved and other event was unknown.  No follow-up attempts are possible. No further information is expected.
Temp of 103 degrees for approx 7 days. Required Tylenol and tepid baths. Has had chronic joint and bone pain since.
Provider administered Tdap Boostrix to this adult client instead of Adacel Tdap.
Information has been received from a medical assistant, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with sulfa allergy and no pertinent medical history who was vaccinated IM with the first and second 0.5 ml doses of GARDASIL by different provider and was vaccinated IM with the third 0.5ml dose of GARDASIL (lot #: 659962/1740U) on 01-DEC-2008. Concomitant therapy included loratadine. The patient who received the three doses of GARDASIL was pregnant. The patient's last menstrual period was 29-NOV-2008 and estimated delivery date was 05-SEP-2009. The patient experienced vaginal bleeding and was hospitalized at an unspecified time period. Additional information has been requested.
2:50 C/o"dizzy and hot" 2:52 drank H2) and put feet up on chair for light headedness 2:58 Lips pink, nailbeds <3 sec cap refill, texting on phone no new c/o  3:03 unchanged 3:04 improved 3:05 VS 124/78, p 80, pO2 98% RA 3:20 reported symptoms resolved and comfortable to leave.  Advised if light headed in hall to sit and call for help.  Left with steady gate.
came to the ER w/fever & a fine maculopapular rash;fever reported to be 104;documented to be 101.6 in ER;
Severe and unusual headache all day on 04/04/2021, primarily in the sinus and lower forehead,  accompanied by nausea. Temp of 99.5 in the afternoon/evening, accompanied by high blood pressure (appx 150/90) and rapid heart rate and a feeling of faintness. Ibuprofen 400 mg and Ativan .05 mg taken around 4 or 5 pm and did not alleviate symptoms. About an hour later took an additional 400 mg Ibuprofen and did not alleviate symptoms. Around 6 pm took an additional .05 mg Ativan. Shortly thereafter all symptoms calmed down. The headache and nausea very atypical for me.
All these occurred the day after the vaccine:  Sore, itchy arm-no treatment-resolved after a week. Bone-crushing pain throughout whole body-slept and took Extra Strength Tylenol-resolved after 1 day.  Chills-slept, and wrapped myself in two blankets-resolved after 1 day. 101 degree fever-took Extra Strength Tylenol-resolved after 1 day.
Sore arm, chills, body aches, hot and cold spells, and weakness.
I want to know what location is vaccinating with GARD ASIL 9. I saw my ob/ gyn last year and she doesn't do it. I am 51 years old and I don't think I have had it.; I want to know what location is vaccinating with GARD ASIL 9. I saw my ob/ gyn last year and she doesn't do it. I am 51 years old and I don't think I have had it.; This spontaneous report was received from a 51-year-old female patient who referred to herself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  The patient was calling to inquire about locations where she could be vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). She saw her obstetrician/gynecologist (reported as ob/gyn) last year and the physician did not do it. The patient did not think she had had it (circumstance or information capable of leading to medication error and product administered to patient of inappropriate age). It was unknown if the patient missed a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Beginning the evening of the shot, patient had pain at the injection site followed by 5 days of headache, body ache, chills and nausea. On the sixth day a red blotchy rash was noted above and below the injection site. Patient was seen by her family practice doctor. He felt the symptoms were consistent with an adverse reaction and recommended that she does not get the second dose in the series.
Information has been received from a physician concerning a male who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient experienced a sore arm that lasted several weeks after vaccination. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Rash & ErythemaMultiform Narrative:  One week after vaccine, injection site is "itchy." Redness, pt has outlined.
This is in follow up to report previously submitted on 5/14/99. Information has been received from a physician concerning a 4 year old female patient with asthma who on 9/13/96 was vaccinated with a first dose of varicella virus vaccine live SC in the right thigh. It was reported that the patient previously was taking loratadine 10mg half a tablet QD. On 1/28/99, the patient developed chicken pox located on her back and legs that consisted of approximately 25 lesions. The patient was treated with diphenhydramine HCl, acetaminophen, and calamine. Additional information has been requested.
Fatigue, body aches, headaches, chills, left arm soreness, low grade fever the day after vaccine administration. Symptoms lasted one day
Started having partial seizures on Dec 5, sometimes every 5 mins. Dec 10 return to doctor cause they are becoming more frequent, longer & more shaking.
Vaccine as labeled incorrectly with expiration date for frozen storage rather than refrigerated storage. The date should have reflected a date of 10/03/2021 rather than 11/01/2021 as it was labeled. Vaccine was administered the employee after it was expired
Fever, grunting, rocking, loss of fine motor skills, inconsolable crying.
pt recvd vax & 2-3 days post vax pt exp an enlarged lymph node the size of a ping pong ball on knee which was warm to touch,pain in legs;these sx were treated w/Advil,& persisted for 2-3wks;
Cluster of 5 cases out of an unspecified number of vaccines that received Decavac, lot number U1704CA and experienced hard nodule at injection site. Initial report received on 11 January 2007, form a healthcare professional in USA. 5 unidentifiable patients received in December 2006 and intramuscular dose of Decavac (lot number U1704CA), into the deltoid and experienced hard nodule at injection site after vaccination. B-D needle, 1 inch was used to administrate the vaccine. At the time of the report (11 January 2007), the patients had not recovered. No other information was provided. The reporter is the same as in case 2007-00091
Hep A administered at 9m of age. Protocol is to start series at 1 yr.
The day following receiving his immunizations, mom noticed a small red bump on his leg, near where he received his immunizations. Over the course of the day, the affected area increased in size, and developed redness and slight warmth. He otherwise was acting well and at baseline besides that. He was diagnosed with cellulitis, and started on cephalexin two days after his immunizations.
Positive nausea, tachycardia the evening vaccine was given (? 4 hours later) - vomited. Positive swelling, tenderness erythema of arm - given Keflex next day.
Breakthrough case admission/oservation after three vaccines Pfizer 3/9/21 Lot# EN6199;  Pfizer 3/30/21Lot# ER8733;  Pfizer 10/20/21 LOt# 301258A
Tired with slight chills.  No headache.  Just felt spacey and weak.  Similar to having a glass of wine.  Slight sweats at night of 3/29/21.  Was fine the next day (3/30/21).
Fever, pounding headache, sensitivity to noise, upset stomach. Fever 101.4 morning after vaccine.  Normal temperature by evening. At the time of this report (one day after the injection) she is still suffering from severe headache. The first shot was a miserable experience for her as well.
fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported fever 99.9 to 100 degrees F, duration from recollection was days. The reporter did not had additional details and would be try and get more details. This case has been linked with case US2019AMR097312, US2019AMR097190 reported by the same reporter.      Lab Comments: On unknown date, body temperature was measured.
This spontaneous report as received from a pharmacist refers to a patient (age and gender of patient unspecified). Patients medical history was unspecified. On 05-FEB-2014, the patient was vaccinated with expired dose of ZOSTAVAX subcutaneous injection, 0.65 ml, (Lot number unspecified, expiry date 20-OCT-2013. Concomitant medications were unspecified. No adverse effect reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash around the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (rash around the injection site). At the time of the report, VACCINATION SITE RASH (rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was not feeling better), SOMNOLENCE (sleepy), FATIGUE (Fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (was not feeling better) and SOMNOLENCE (sleepy). On 11-Mar-2021 at 2:30 AM, the patient experienced FATIGUE (Fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (Chills) and NAUSEA (little nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (was not feeling better), SOMNOLENCE (sleepy), FATIGUE (Fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (Chills) and NAUSEA (little nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided  by the reporter. Reportedly, the patient had no symptoms of fever or vomiting.
Subsequent to receiving vax the pt experienced a diffuse rash over her entire body. The most recent information received, reports the symptoms as resolved.
Swelling & redness of hands & arms & feet & legs followed by desquamation of skin. Pt did not contact us re sx until all had resolved & seen for his routine appt.
Local reaction, swelling, tenderness, itchy, redness.  BENADRYL.
Tachycardia for 30 min after 1 dose shot. It went away on its own
PATIENT STATED DIZZINEES, COMPLAINED ABOUT INCREAsed heart rate, he went to restoom twice, he stated he was feeling worse and about to faint, so called 911.
Last 2 menstrual periods extremely heavy, longer in duration than usual, and very painful cramping.