chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All start around 5:00 am (caused early wake up) - Fever of 100.1 (broke about 5:00 PM) - Chills (stopped about 3:00 PM) - Body aches (entire body, stopped about 7:30 PM) - Nausea (stopped about 2:00 PM) - Headache (stopped about 2:30 PM) - Body warm (started 10:00 PM stopped 9:00 am following day, 04/12)
This spontaneous report as received from a registered nurse refers to a patient of unknown age. It was reported that an expired dose of 0.5 ml PNEUMOVAX 23 (lot # 667914/1067Z, expired on 28-FEB-2012) was intramuscularly administered to a patient on 10-AUG-2012. No adverse effect was reported. The outcome of patient was unknown. Additional information is not expected.
Lunch time on 10/19/99, had headache, itchy injection site. Wed. a.m. not feeling great, headache. Wed. p.m. size of orange at site, wheezing & headache. Thursday, seen by PA & tx'd with ice to sight & Benadryl.
Patient may have received dose after the expiration date of 31Jan2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The registered nurse (RN) reported that, the patient might had received Kinrix after the expiration date of 31st January 2022., which led to expired vaccine used. The reporter consented to follow up via email. The Vaccine Administration Facility is the same as Primary Reporter. This case has been linked to US2022046885, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046885:Same reporter.
This spontaneous report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no pertinent medical history and no know drug allergies who on 26-MAR-2012 was vaccinated IM with a dose of GARDASIL (dose, route and lot# not reported). Other suspect therapy included ENGERIX-B. The patient's last menstrual period was note as 28-MAR-2012 in the patient's chart, but the nurse practitioner was not sure if that was correct. The patient came to the physician's office on 11-APR-2012 for a normal annual  exam. During the visit, it was discovered that she was pregnant, via urine pregnancy test. The patient was still pregnant. The estimated delivery date would be 02-JAN-2013. Follow up information has been received from a registered nurse who was able to access the clinic records for information concerning this pregnancy registry patient. The registered nurse stated that the patient had a prenatal appointment scheduled for 14-MAY-2012 and the patient never came in for the appointment. The registered nurse stated that the patient had been lost to follow up and they have no information to share. Additional information has been requested.
3 mon old recv dose 2 Hib-Titer, DTP(MFR unk) & OPV(MFR unk) on 18-Nov-99, devel anaphylaxis. Pt pale, shutdown & wheezy. Treated w/ ephinephrine and recovered w/in 80 mins. MFR comment: lot #PO946, however not valid Lederle lot #
Urticaria -macular papular rash on extremities (arms and legs), sides, back, face, very itchy. The rash started at 5pm on 4/17/2021, one week after receiving the vaccine. Urticaria got progressively worse. was given 50mg of Benadryl PO at 6:45pm. At 7:45pm the urticaria is gradually subsiding but is still present. I also contacted Janssen and spoke with a Pharmacist. I also reported this to Premier to the on call physician which is his PCP group. The on-call physician suggested I also administer Pepcid which I gave him 20mg. did have a sore arm several days after the injection. He is not having chills or an elevated temperature.
Post vax, the pt was seen in ER with large, red, warm area around injection site. He also complained of mild pain originally thought of as cellulitis. Pt started on Keflex and Motrin. Symptoms worsened-redness and subcutaneous nodules.
"Blood shot eyes, throat feels like it is closing up". Daughter called Nurse Practitioner to inform of symptoms, instructed to call #911, needs to go to ER.
Approx 2 hours following vaccine stated with headache to back of head - traveled down spine and shoulders- then felt achy all over- not relieved with 600 mg of Advil.
approximately 30 minutes after receiving the vaccine, patient reported development of symptoms including increased HR, chest tightness and mild shortness of breath.  She presented to the ED and was evaluated.  She was given diphenhydramine 25 mg IV x 1 1629, famotidine 40 mg iv x 1 @ 1630, methylprednisolone 125 mg iv x 1 at 1629.  patient was observed for 90 minutes. She was without further symptoms, VSS and she was discharge to home in stable condition at 1800
received Boostrix instead of Infanrix; 15-month-old received Boostrix.; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57GJ2, expiry date 29th May 2023) for prophylaxis.   On 24th January 2022, the patient received Boostrix. On 24th January 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient inadvertently received dose of Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The patient was fine, had no side effects. No further information reported. The reporter consented to follow-up. Notes:as reported dose 4 can't be kept as we don't know about previous doses were boostrix or infanrix.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 77 year old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In September 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy (strength, dose, frequency, lot # and expiration date were not reported). As a result of her receipt of zoster vaccine live (ZOSTAVAX) on 28-SEP-2016, the patient was caused to suffer shingles, including any and all of its sequelae. On or about 08-May-2016, the patient was treated at the hospital by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a result of her receipt of zoster vaccine live (ZOSTAVAX) the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Pt states that 36 hrs after receiving her Pfizer COVID booster, she felt cold, weak, and had tinnitus.  The cold and weakness lasted for 3 days. The tinnitus remains.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 23-JUN-2016, the patient was vaccinated with ZOSTAVAX intramuscularly rather than subcutaneously (dose, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
rash after receiving VARlVAX / she first developed chest pain / was diagnosed with Shingles in ER / continued pain and worsening rash; Route of Administration: intramuscular; This spontaneous report was received from a 53 years old female, not pregnant patient, who was referring to herself. The patient did not take any concomitant medications and had no known drug reactions/allergies. No information regarding the patient's pertinent medical history was provided.     On 09-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), intramuscularly for indication of vaccination (dose, lot# and expiration date were not reported). On 20-APR-2021, she developed rash and chest pain and was seen at urgent care. On 23-APR-2021, the patient went to Emergency Room (ER) and was diagnosed with shingles. She has been back on urgent care on 02-MAY-2021 for continued pain and worsening rash. The patient received treatment: acyclovir. The adverse events were not a cancer events and no overdose occurred. The outcome of the event was reported as not recovered/not resolved.  The causality assessment between the event and the suspect therapy was not provided.
I started to break out in the hives and I still do every single day; I have been getting the severe allergic reaction with the food that I have been okay with eating; When probed for the event is worsened, improved or persisting, Consumer stated, " Worse, but it's kind of goes up and down, like sometimes it's better and sometimes it's bad."; This is a spontaneous report from a contactable consumer. This contactable 18-year-old female consumer (patient) reported that: An 18-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in Arm Right on 11May2021 (at the age of 18-year-old) as single dose for covid-19 immunisation. Patient medical history reported as none. Medical condition related to adverse event reported as none. Family history related to adverse event It's kind of unknown because I am adopted. There were no concomitant medications. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Left arm on 20Apr2021 (at the age of 18-year-old) as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination. Patient reported I was told to call if I had like lingering side effect of the vaccine (Covid-19 Vaccine). I got my first dose on 20Apr and second on 11May. Two weeks after on unspecified date in May2021, my second dose I started to break out in the hives and I still do every single day and I have been getting the severe allergic reaction with the food that I have been okay with eating. Patient reported when probed for the event is worsened, improved or persisting, patient stated, it was worse, but it's kind of goes up and down, like sometimes it's better and sometimes it's bad. Still experiencing the problem. Therapeutic measures were taken as a result of the events with Prednisone and Hydroxyzine. The outcome of the events was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Extreme fatigue, weakness, moderate lightheadedness, persistent headache, mild nausea, intermittent low-grade fever alternating with moderate chills, increased nasal and lung congestion, persistent muscle ache.  Lasted about 48 hours.
Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 10-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Day 8 at injection site noticed a 2-3in circle in diameter, warm, itchy and elevated.; Day 8 at injection site noticed a 2-3in circle in diameter, warm, itchy and elevated.; Day 8 at injection site noticed a 2-3in circle in diameter, warm, itchy and elevated.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 16:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and had allergy to the antibiotic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), rizatriptan benzoate (MAXALT) and paracetamol (TYLENOL); all on unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 22Apr2021 at 18:00, on day 8, the patient noticed at the injection site, a 2-3in circle in diameter, warm, itchy and elevated. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken for the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a 2-3incircle in diameter, warm and itchy was not recovered at the time of this report.  The clinical outcome of the events 2-3in circle in diameter, warm, itchy and elevated was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema and injection site lump. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injection site erythema and injection site lump were recovered/resolved. The reporter considered the pain in arm, injection site erythema and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The age vaccination was not reported. The patient stated that his arm hurt and he experienced redness around injection site and had a lump around injection site. The patient reported that it did not need for medical intervention and no need for hospitalization. The patient believed it related to vaccination with SHINGRIX. All injection site reactions were resolved within few days.
pt brought to hospital with AMS and weakness; given O2 supplementation; c/o diarrhea; pt too weak to go to dialysis today; found to be positive for COVID; after pt got to the hospital, she went to dialysis and her BP dropped; transferred to ICU where she was given empirical broad spectrum ABX and vasopressors; condition worsened; palliative care consulted; family transitioned pt to comfort care and she passed away in the hospital
Dose1: The evening of: nausea, muscle tension, headache, chills, point of injection pain, sore arm, restless sleep, alternating with burning up and chills, felt very dry, itchy throat.  Next morning: nausea, very tired.   Dose 2: (2/28/21 6pm, Lot 041L20A) arm sore, chills when getting ready for bed, a little restless sleep near morning, tired next day, but not as bad as first dose.
Sore Arm with pain, Patient felt abdominal pain , wobbling and un-steady
26 Year old female reported feeling itchiness, trembling and lightheaded approximately 40 minutes after receiving vaccine went to Emergency Dept. TX with Benadryl PO.
Shortly after receiving his COVID shot, patient began to feel nauseated and lightheaded.  He was standing up near the bleachers and an assistant initially brought a trash can over to him.  He was extremely pale and started to nod off as if he was going to pass out.  Chair placed so could sit down and instructed to breathe slowly and VSS obtained.  BP=122/70-98% spot oximeter-78 pulse.  He was able to drink some water and part of a cookie.  He fully recovered and was able to return to class after 25 minutes.
LAIV FluMist was administer to a lady who was pregnant.  CDC contacted, manufacturer's insert to FluMist was looked at.  Client notified of incident and encouraged to contact her MD about LAIV Flumist given.
one dose of undiluted vaccine, 0.2ml, was administered; one dose of undiluted vaccine, 0.2ml, was administered; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FL0007, Expiration Date: 21Feb2022) as dose number unknown, 0.2ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "one dose of undiluted vaccine, 0.2ml, was administered"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Arm pain".  No follow-up attempts are possible. No further information is expected.
Pt presented with rash around mouth area. Worsened to include itchy red rash down neck & swelling below jaw line. Pt took 25 mg BENADRYL, rash down neck disappeared & swelling below jawline went down.
Localized erythema, edema from site at triceps region to mid-forearm. Resolved with a prednisone 60 mg po x 5 days and Hydrocortisone topical applied with ice to left UE. Localized reaction resolved in few days w/meds.
31-JUL92 phoned said 1/2 hr p/Typhoid inject arm began to ache whole body ached all not; couldn't sleep took APAP; seen by MD who felt had allergic reaction; arm red & inflammed next to the inject site also sting & itches;
Sore to the touch on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore to the touch on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore to the touch on the injection site). At the time of the report, VACCINATION SITE PAIN (Sore to the touch on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
patient was given expired COVID-19 dose (from previous day) no adverse events. Notified patient. Asked to return for another dose per IC doctors recommendations
After 24 hrs of MMRV and DTaP-IPV patient with 8 cm diameter of erythema around injection sites.
Patient presented to the Health Department wanting a booster shot. Patient stated she last had her booster in September 2022. Secretary double checked and confirmed date. Bivalent Booster given on 01/20/2023, however it was then learned her last booster in September of 2022 was also a Bivalent so patient has received 2 bivalent boosters.  After learning this patient has not reported any adverse reactions
Pt. began to feel weak with palpitations about 8-10 minutes after vaccination,  her pulse was extremely fast, she then began to complain of lower mid-esophageal burning
Injection site warm to touch; Injection site itching; Injection site red; Injection site became raised; This is a spontaneous report from a contactable consumer, the patient. A 33-Year-old non-pregnant female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 22Mar2021 at 11:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lavandula angustifolia essential oil, mentha x piperita essential oil, citrus limon essential oil (DOTERRA TRIEASE) from unknown date for unspecified indication. The patient previously took nickel and experienced metal allergy and took kiwi and experienced fruit allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the Patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site raised on 23Mar2021 at 07:00 and  injection site red on 24Mar2021 (day 2) and  injection site warm to touch and itching on 25Mar2021 (day three). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for reported events. The clinical outcome of the injection site raised, injection site red, injection site warm and injection site itching was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.