chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of conciousness; chills; fever of 102F; third dose; This is a spontaneous report from a non-contactable nurse (patient). A 55-year-old non-pregnant female patient received the third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: FF2590), via an unspecified route of administration on 18Oct2021 (at the age of 55-years-old) at dose 3 (booster), single in the left arm for COVID-19 immunization. The patient has no medical history and concomitant medications. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot No: EL0142) received on 29Dec2021 (at the age of 54-years-old),and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot No: EL1283) received on 15Jan2021 (at the age of 54-years-old); both for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient has no known allergies, did not receive any other vaccines within 4 weeks prior to the COVID-vaccine, and has no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Oct2021 at 22:00, the patient experienced loss of consciousness, chills, and fever of 102F. No treatment was received for the events. The patient underwent lab tests and procedures which included: Body temperature on 18Oct2021: 102 Fahrenheit; and COVID-19 nasal swab on 23Sep2021: negative. Outcome of the events was recovered on Oct2021.   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 available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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.
8/7/02 child rec'd immunizations listed below 2 days later 8/9/02 ret'd to PH office with marked area of inflammation on LAT 2" x 3" induration, warm area with addt'l 1-2" surrounding redness. No fever reported. Tender to touch. Referred to MD.
severe local reaction to DPT (Infarix) the whole right area from deltoids to elbow.
DTaP #5 given 6/1/04- left upper arm 24 hrs. Arm swollen & reddened from top to upper arm to elbow- Seen 6/7/04- swelling & redness decreased- Still approximately 1/2 way down upper arm. No treatment. On Zyrtec for allergies.
I had a sense of being high. euphoric and also giddy, feeling silly.    Some brain fog.   No medical treatment. After 24 to 48 hours the symptoms subsided
Pt. notes truncal pruritis (primarily B/L breasts).  Sx occurred 24-48 hours s/p vaccine (GARDASIL) # T and lasted approx. 4 wks.  Denies rash/ fever/ chills/ sob.
1/2 hr p/vax, pt devel stiffness & pain in both legs; had pain & stifness from bottom of back to middle of back; could not raise up;
"Patient" was given Varivax and Flu vaccine 1/15/08 about 9am. 1/16/08 mom called at noon stating arm red, hot to touch, swollen and bothering "patient"; 10cm Indurated area Noted
had fever and arm was sore on day of shot. Next day from elbow to shot area was very red/swollen down to mid arm with sack of fluid hanging from elbow to forearm; hot with fever.
Intussusception. Ran fever on 7-29-10 (102 degrees) and 7-30-10; started spitting up on 7-31-10 --> Progressed to projectile vomiting (1x) on 8-1-10 --> Projectile vomiting increased on 8-2-10 (took to ER).
Right axial lymph node swelling started one day after injection. 800mg of Advil controlled pain. On day 3, took 50mg benadryl and this lessened pain and swelling.
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     Patient had no allergy or disease listed. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medications were provided. No treatment medication was provided.
Has large cellulitis on left deltoid. Unknown sign and symptoms - sent to child's PCP.
On 9/6/06 had DTaP, MMR, IPV at doctor's office came to health department for Varicella that same day, next day 9/7/06 voice became squeaky could only whisper.  No problems breathing, no pain, no sore throat voice returned 9/10/06.
a patient received on 30/APR/2021 a dose/expired on 13/APR/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-month-old female patient who received HBV (Engerix B) (batch number CP275, expiry date 13th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Engerix B and Engerix B 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 information was provided as follows:  The nurse reported that  on 30th April 2021, the patient received Engerix B vaccine which was  already expired on 13th April 2021. The reporter consented to follow up.
Came to Employee Health on 11/19/19 and stated he had itching at site of vaccination as well as a rash and deep red coloration. Rash is gone now on 11/19/19, but still reddened in area of vaccination.  Not raised.  States not warm to touch, nor painful.
missed second dose (8 week duration between); A spontaneous report was received from a healthcare professional concerning a patient who missed second dose (8 week duration between) of mRNA-1273 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date the patient received their first of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient missed the second dose by an 8 weeks window.   Action taken with mRNA-1273 in response to the event was not provided.  The event missed second dose (8 week duration between), was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender wo experienced   missed second dose (8 week duration between) for mRNA-1273 (Inappropriate schedule of vaccine administered). There were no reported AEs associated with this case of Inappropriate schedule of vaccine administered.
Only injection side pain after first dose.  Second dose: injection side pain in 9 hours, chills, muscle pain, weakness, nausea 12:14 am 5/28-5/29:fever between 37.7-38.5 for 24 hours, severe headache. Took Tylenol at 8am on 5/28 and then again at 9pm. Went to bed and woke up with 35.8 in the morning.
pt recv vax 4JAN96 & pt devel swelling & pain @ the inj site;pt has recovered;this is one of two patients from this site & lot# to report adverse rxn;
The injection site started to itch and get bumpy, raised and red.  The rash was splotchy and covered an area of about 4" x 2". The rash stopped itching by the evening and slowly faded. The rash has calmed down by the next day (3-18-21) and only a pale pink area remained. No itching by the next day.
Pain & swelling at injection site for Covid vaccine, none noticed for flu. Started immediately on same day, still present as of Sept 28, 2023. No treatments.  Gastrointestinal bloating/discomfort on Sept 26, 2023, went away by next day. No treatments.  Headache on Sept 27, 2023, still present as of Sept 28, 2023. Took half dose of acetaminophen, no effect.
pt recv vax SEP95 & NOV97 broke out w/chickenpox consisting of approx 30 to 40 lesions or 50 to 100 lesions;
The first dose of Covid 19 vaccine was Moderna on 1/7/2021 I attended my sencond dose on 7/29/2021 at facility but they gave me Pfizer vaccine, they gave me two different vaccines. I did not get the necessary information about which vaccine they gave me, although I showed them my previous vaccination card that said the first dose of Moderna vaccine, they did not check my information good and I got the Pfizer vaccine. I realized that until I got the paper of my second vaccination and asked them why I got different vaccine. They told me I could take another vaccine from Pfizer in 21 days, I took information from another pharmacy and they told me this was not possible since facility had given me the necessary information and they did not.
pt recvd vax; exp inject site reaction soreness but no swelling ; also fever of 101; out of work 2 days
herpes zoster iridocyclitis; iritis; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 87-year-old male patient. His medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about December 2009, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot # and expiration date were not provided). On unknown dates, the patient suffered the following injuries as a result of zoster vaccine live (ZOSTAVAX): pain, rash, herpes zoster, iritis, and herpes zoster iridocyclitis. The outcome of the events was not provided.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of herpes zoster iridocyclitis was considered to be medically significant.
Information has been received from a license practical nurse concerning a 3 year old female consumer who in August 2007 was inadvertently vaccinated in the right deltoid with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The LPN indicated this was a staff error only. No adverse events reported post vaccination. Medical attention was sought in the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
A report has been received from a pharmacist concerning a 28 year old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received nasal FLUMIST QUADRIVALENT on 15-Feb-2014. The patient was administered entire dose of FLUMIST QUADRIVALENT in one nostril on 15-Feb-2014. The patient did not have any adverse events. The outcome of the event of administered entire ose of FLUMIST QUADRIVALENT in one nostril was unknown. The reporter considered the event to bee non-serious. Corrected report 06-May-2014. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
Localized pain at site, circular swelling also noted at site, tender to touch. Pt states she has also got this reaction from flu shot but will continue to get vaccines because of her medical condition. No systemic reaction. Advised ice and BENADRYL report back if any changes.
Patient reported that his throat started to feel as if his throat was swelling. He reports that this incident happened  20 minutes after he left the clinic. He reports taking 50 mg of Benadryl after incident.
did not get her second shot; lost weight since the surgery; she had surgery; had arm pain; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (she had surgery), PAIN IN EXTREMITY (had arm pain), WEIGHT DECREASED (lost weight since the surgery) and PRODUCT DOSE OMISSION ISSUE (did not get her second shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PAIN IN EXTREMITY (had arm pain). On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SURGERY (she had surgery) and WEIGHT DECREASED (lost weight since the surgery). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her second shot). The patient was treated with AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SURGERY (she had surgery), PAIN IN EXTREMITY (had arm pain), WEIGHT DECREASED (lost weight since the surgery) and PRODUCT DOSE OMISSION ISSUE (did not get her second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was unknown.  Company comment: This is a case of product dose omission issue for this 44-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of pain in extremity, surgery and weight decreased. The event pain in extremity occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine; the events surgery and weight decreased occurred 26 days after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of product dose omission issue for this 44-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of pain in extremity, surgery and weight decreased. The event pain in extremity occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine; the events surgery and weight decreased occurred 26 days after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
No additional AE reported.; patient received an extra dose of PROQUAD today (01/18/2023). Patient received 1st dose in 2018 and 2nd dose 2019.; This spontaneous report was received from a physician regarding an 8-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown day in 2018, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis.   On an unspecified day in 2019, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis.     On 18-JAN-2023 (reported as "today"), the patient was vaccinated with a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, product quantity 1, lot #W029543 and expiration date: 14-MAR-2024, (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Extra dose administered). No adverse events were reported.
Extreme fatigue, chills, nausea, body aches, head aches, joint pain  Took ibuprofen and Tylenol every 4 hours
Symptoms began 1-2 weeks after vaccine administered with some bilateral knee pain and swelling.  She took 2 ibuprofen TID.  She was seen 3/5/08 by me; obvious edema and knee effusion was noted.  She was treated with MEDROL DOSE PACK, 1/2 ayazide x 1 week.  Her CRP was 24.5, ESR was 6.5.  Symptoms resolved; a followup with rheumatologist suggested no other cause except for the vaccine because of proximity to symptoms.
Tired; Upset stomach; Sluggish; This case was reported by a consumer via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received Shingrix. On 24th October 2019, 1 days after receiving Shingrix, the patient experienced tiredness, upset stomach and sluggishness. On an unknown date, the outcome of the tiredness, upset stomach and sluggishness were unknown.   It was unknown if the reporter considered the tiredness and sluggishness to be related to Shingrix. The reporter considered the upset stomach to be possibly related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be between 84 or 85 years. The patient day after vaccination experienced slight upset stomach, tired and sluggishness. The GSK employee stated that the stomach issues are listed as possible side effects for Shingrix and refered the patient to the doctor for treatment recommendations for these side effects.
pt recv vax 30APR96 945AM & began crying 1015AM;slept for a few mins then crying & screaming would rest then resume screaming;subsided in the office @ 145PM;instructed to use warm, compress, APAP
swollen lymph nodes; fever; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 20May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Patient received his first dose of vaccine in the left arm without any issues.), for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "swollen lymph nodes"; PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "body aches".  Additional Information: 55-year-old male reported having had swollen lymph nodes, fever, chills, and body aches after receiving his second dose of COVID vaccine. Optional Information: Patient received his first dose of vaccine in the left arm without any issues. He received his second dose in the right arm and experienced the reported AEs. Second dose was received on 20May2021. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A mother reported that her 6-month-old daughter with a recent history of ear infection received injections of Prevnar (third dose), DTaP (manufacturer unknown), and Hib (manafacturer unkown vaccinees on 18-Feb-2002. On Feb 2002, she developed "severe" diarrhea. The reporter indicated that her daughter then developed "severe" diaper rash related to the diarrhea. As of 28-FEB-2002, the diarrhea had improved. FOLLoW-UP information received from the mother on 03/06/02 indicated that the infant continued to have diarrhea. She indicated that bulk has been added to the infants stools after a change of formula to Isomil DF. FOLLOW-UP information received on 04/16/02 indicated that stool studies were negative. she recovered approximately two weeks later.
severe pain in left arm (site of injection)- same day - pain continued and seen by Dr. on 10/30/19 dx: myositis pain continued and seen by second doctor Dr. on 12/2/19 dx: adhesive capsulitis
Muscles went taut and breathing stopped. Patient placed on floor and EpiPen administered into her left leg. Emergency services called and patient cleared by them.
Pt presented to ER with stroke like symptoms.  On routine admission test, pt tested positive for COVID-19, after previously having both doses of the COVID-19 vaccine on 2/3/2021 and 2/24/2021.  Notes from provider: "2. Covid 19 + despite Pfizer vaccination 2/2021 - possibly related to her MGUS and inadequate immune response, though her son (whom she lives with and has been homeless in the past) has not been vaccinated, so possibly either failure of immune response with true Covid19 infection vs false + due to exposure to son (he is planning on being tested). Continue dexamethasone and remdesivir given oxygen requirements and standard lab monitoring.  3. Acute hypoxic respiratory failure - continue Rx for Covid19 with dex/remdesivir and ceftri/azith for possible CAP, will also increase IV lasix given findings on TTE today. "
08/04/2017 at 09:40 AM mother called and spoke with RN. Mother stated child had an episode of shaking during sleep, appeared to partially wake up but was still partly asleep. Shaking lasted about 3 minutes. Mom stated she gave child MOTRIN after he received the vaccinations. Child had been running a slight temperature earlier in the evening and states he mentioned he felt cold; at this time she gave him more MOTRIN. Mother stated child does have a Hx of night terrors and does sometimes wake up in the middle of the night. She felt the shaking was different in this case. Client was told the temperature increase is a typical reaction but the other symptoms are not typical. Child seems okay today per parent. Let parent know report would be filed per RN on 08/04/2017. Client also had Hx febrile seizures as a toddler unrelated to vaccines per parent. Per parent, did not actually take child's temperature but stated he felt warm.
I had the vaccine on Thursday evening 3/25/2021 and symptoms started with plain body aches around 12 am. Around 4:45 am, I started to have severe chills and body aches were getting worse even when I took 800mg Ibuprofen. I left work and felt really cold and my body would not stop shaking and crying due to the body aches. My fever reached 103 degrees and when I took Ibuprofen the fever went down to 100 degrees and I had a sore throat.
24APR98 pt recv vax & devel T104.8 resulting in febrile sz;taken by amb to hosp;began @ 1050PM lasted approx 1/2hr sz;lost consciousness;released from hosp;appetite;no more fevers, etc;