chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immed p/vax pt gagged, stopped crying, stopped breathing for approx 10 sec; then began breathing briefly then stopped again; eyes staring no movement of limbs for approx 10 sec; face was flushed & seemed sl lethargic;
late for the second dose / first dose was administrated on May 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient was late for the 2nd dose of Shingrix and till the time of reporting, she did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. No further information was reported.
Reported swelling in left arm and left neck with continued pain in left neck for 6 months afterward. Symptoms started within 24 hours of receiving shot in left arm.
My daughter fainted immediately after receiving the vaccine. I was not there so I do not know all the details. My daughter does not have needle anxiety and has never had problems with vaccines before.
Information has been received from a physician concerning a 66 year old male with coronary artery disease and lung disease who on approx 26Jan05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P). On 28Jan05 the pt was admitted to the hospital with local pain and swelling and hives. The pt was described as seriously ill and almost died as a result. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that another pt had an adverse experience (WAES0504USA01199). Additional information has been requested.
Information has been received from a medical assistant concerning a 12 month old male patient who on 13-JAN-2008 was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX (Merck) (Lot not reported) instead of VARIVAX (Merck). Not noted to be product confusion. No adverse events reported. Additional information has been requested.
I woke up the next morning with swelling under my eye. Within about an hour of noticing,  the swollen area increased in size and spread to the area between the bridge of my nose and eye, and above my eye up to my eyebrow. This was all on my right eye.
Covid arm. Swelling, pain, big rash, itchy, firmness under skin (knots)
Hot flash 5 minutes after shot. Due date april 26th 2021. No adverse reactions to baby known at this time. Nausea 40 minutes after shot
VERY LARGE CONTUSION - ABOUT THE SIZE OF A FIST - VERY SORE AND BLACK. SORENESS STARTED SEVERAL HOURS LATER, PT BECARE AWARE OF THE DISCOLORATION THE NEXT MORNING. AREA IS STILL HEALING AT THIS TIME.
My toes swelled, turned red, red spots and sores emerged on the bottom of all of my toes.  Lunula, moon shape on toenail, discolored turning bright red and continues to grow out red, and the rest of the toenail blanched white with red streaks.  It began mid January 2022 about three weeks after the third dose of vaccine, booster.  I consulted my primary care physician who didn't know what it was, but said I had sausage toes.  I went my dermatologist who didn't know what it was, and gave my antifungus cream because my nails were slightly thickened.  Both well regarded doctors.  I finally went to a podiatrist in another area who Dx chilblains and prescribed Betamethasone.  After three weeks of treatment the symptoms have diminished by 50%.
Difficulty breathing, wheezing, weak, paleness, rapid heartbeat, fluid in lungs, could not sleep.
Patient received a covid vaccine, and turned very pale 10 mins after. A customer and 2 pharmacy staffs assisted her. she said she felt dizzy, and had chest pains. She said she is type 1 diabetic, and history of seizure. She drank some water and Matcha Frapp, and we also offered patient some apple juice.  To be safe, we offered to call  an ambulance and she agreed.  She left the store with medical personnel.  I follow up with the patient the next morning, she said she's doing well.   She thinks the incident happened because she was nervous about the needle, and her blood sugar dropped from 300 to 80+.
Initial unsolicited case received from a consumer (office staff) on 21 Nov 2017. This case involves 12-year-old patient (gender not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed seizure. Relevant lab tests and corrective treatment were not reported. Outcome of the event was not reported. The case was reported as serious by the reporter due to medically significant event. List of documents held by sender: none. Sender's Comments: 12 year old Patient had a seizure after getting DAPTACEL. Time to onset compatibility is unknown. Further information including patient's medical history, concurrent medical condition, any seizure disorder, concomitant medications, previous vaccination, concurrent infection and tolerance would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Acute Parotitis. Pain and swelling right face (anterior to the ear) and submandibular region.  Pain on chewing. Malaise. My husband is a retired physician and made the diagnosis.
This case was reported by a healthcare professional and described the occurrence of lethargy in a 72-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included lethargy which required previous hospitalization. Concurrent medical conditions included anemia, coronary artery disease, diabetes, dialysis, end stage renal disease, gout, hypertension and liver cirrhosis. The subject had 18 unspecified concomitant medications. No other vaccines were given on 10 May 2011. Initially, the healthcare professional reported that the subject received the second dose of ENGERIX B on 03 May 2011. The healthcare professional later reported that the subject received the second dose of ENGERIX B on 10 May 2011 at 18:08 (40 mcg, unknown, left arm). On 12 May 2011, 2 days after vaccination with ENGERIX B, the subject experienced lethargy. The subject had presented to the dialysis facility experiencing lethargy. The subject was hospitalised and the healthcare professional considered the event was disabling and clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jul2021 at 14:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment, Brand was Paxlovid. Treatment start date was 27Jul2022 and treatment stop date was 30Jul2022, Lot number: GD8744, Indication was Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored (Merck) VARIVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
Information has been received from a 52 year old female pharmacist who was also the patient. The patient had no pertinent medical history or drug reactions/allergies. On 24-MAR-2015 the patient was vaccinated with ZOSTAVAX, (lot# reported as 1003218, exp date 30-APR-2016), subcutaneously in the left arm to prevent shingle (dose and frequency were not reported). Concomitant therapy included naproxen which was used as needed. On 24-MAR-2015 (reported as "within 24 hours" of receiving ZOSTAVAX, the patient experienced stiffness in her left arm at the injection site. Between 01-APR-2015 and 04-APR-2015, she developed a rash that appeared as "pimples with whiteheads" that "break open" and "ooze out" on her left back, left ear, left insole of foot, left knee, right side of neck, down right arm and right leg, and 3 pustules on her face. The patient reported that had been very itchy since an unspecified date in April 2015. The patient sought medical attention and was seen by a physician on 23-APR-2015. The physician prescribed the patient ATARAX 50mg three times daily for ten days, prednisone 10mg once daily for 10 days, and CALAMINE LOTION and BENADRYL cream as needed for itching. No lab diagnostis studies were performed. The outcome of the events was reported as not recovered. This case was one of two cases from same reporter. Additional information has been requested.
Developed a bumpy rash with redness.  Parent stated this happened previously with both series of vaccines.  She didn't think much of it thinking it was a normal reaction.
This spontaneous report was received from a dentist referring to a 14-month-old Caucasian female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) 1 dosage form (route of administration, lot number and expiration date were not provided) for prophylaxis.       In December 2020 the patient experienced full body rash. On 16-DEC-2020 the patient experienced fussiness (irritability) and low-grade fever. The outcome of irritability and pyrexia was reported as recovered on that same day. The outcome of rash was unknown. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the events was reported as probably.
Patient's husband states that s/p getting vaccinated with the Moderna Booster at a local Pharmacy she developed lumps to her scalp about a week later, she then was seen at our clinic and referred to specialist who determined the lumps to be more than cysts, a CT scan  was ordered of her brain and it was found that she had metastatic lesions noted to her calvarium.
Don't feel okay; I feel super weak; My brain is working slow; bruise on her two arms; rash; a big bump and red; on both arms you see the bruises, left and right and she says they hurt; Both forearm, they got really sore; bruises on both arm, appearing the forearms; Feels dizzy; Fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, Expiration Date: was not reported) via an unspecified route of administration, administered anatomical location not reported, on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, she got her Covid-19 vaccine last Wednesday and she does not felt okay. The patient stated, she felt super week, her brain was working slow. The patient stated, on Monday she had like a bruise on her two arms and now a rash and have like a big bump and red. The patient mother stated that the patient's forearms, in both forearm they got really sore it looked like nothing was broken but you break a bone and started noticing bruises on both arms, left and right and she said they hurted and it was happened after vaccine. The patient's mother stated, she herself have not got the vaccine yet so she would not know but she was really preoccupied, and she was just translating. The patient's mother stated, the patient felt dizzy, fatigue too, ok symptoms are good but what about the bruises on both arms, appearing the forearm. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itchy, burning eyes, redness in the eyes, bumps forming around the eyes. Gave benadryl, didn't work.
Pts mom called on 4/16/09 & said 4/15/09 pt had red welt size nickel at inj site and then on 4/16  was size of a quarter. Pts mom will give benedryl & if not improved would call office back.
Extreme disorientation. Ambulance to hospital.  Did not know her own name. Disappeared after 14 hours.
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 14:00 (at the age of 59-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Mar2021 at 22:00, about 8 hours after administration of vaccine, the patient had shoulder pain and stiffness. The patient did not receive treatment for the events. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nausea, general body pain, headache and tiredness. On an unknown date, the outcome of the nausea, general body pain, headache and tiredness were unknown. It was unknown if the reporter considered the nausea, general body pain, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter know that folks were aware of these side effects of the SHINGRIX vaccine, but thought that the frequency of them occurring might be something track. So, the reporter would just like to report that got first shot on the day before reporting 5th June 2018. The patient usually suffered the stated side effects of vaccinations, but SHINGRIX seems to be hitting hard: nausea, aching all over (not sure if it was muscle or joint), headache and extremely tired.
at approximately 10 minutes post injection, pt complained of feeling dizzy.  BP was elevated at 200's/110's, pt was diaphoretic, c/o nausea and chest pain.  NP on site and Paramedic on site immediately evaluated and sent via ambulance to ER for further evaluation.
c/o pain, swelling at site of injection. Went to emergency room for evaluation. Tx: ice, IBUPROFEN, released.
9/22/09 red raised papular rashes on face trunk which progressed to papulo-vesicular the vesicular & crusting lesions.
This spontaneous report as received from a nurse refers to 6 unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition drug reactions/allergies and concomitant therapy was not provided. On unspecified dates, these patients were vaccinated with an improperly stored dose of (Oka/Merck) PROQUAD (lot # L041627, expiry date: 20-APR-2017). Reporting nurse stated that the mentioned vaccine was out of range for a total time frame of 198 hours and a maximum temperature reached was 0 degree Celsius. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
The patient has had soreness since the injection; This spontaneous report was received from a pharmacist referring to a 63 year old male patient. The patient's concurrent conditions included type 2 diabetes mellitus and hypertension. Information regarding medical history or concomitant medication was not provided. The patient did not have drug reactions or allergies.  On an unknown date in 2019 (also reported as 28-AUG-2019, conflicting information), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R016638, expiration date 28-JAN-2020) intramuscularly  in his dominant arm, for prophylaxis.  On approximately 07-AUG-2019 (reported as about 3 weeks ago), the patient had soreness since the injection and he spoke with the pharmacist to see how much longer the soreness would last. The patient had not complained of any other symptoms. It was also reported that laboratory diagnostics or studies were not performed.  At the reporting time, the outcome of pain was reported as not recovered. The causality assessment was not provided.
Left eye blurred vision, ASC. consulted Ophthalmologist on 1/8/2021, Provider stated to ASC. that vision appears to be impacted by viral infection and should resolve without intervention per ASC., also numbness surrounding orbit of left eye
On 14JAN92 fever 103 R day of immun cont w/fever; 17JAN92 seizures; 18JAN92 pt shaking-jerking turned blue dad applied CPR ambulance called; pt not taken to ER; 20JAN92 taken to ER-sp tap neg sl ear inf;
40 minutes post vax, the pt fell to the ground while walking home (knees buckled), but did not lose consciousness; felt dizzy, left leg twitched for 10 minutes. Felt dizzy the remainder of the day. Pt was examined on 8/30/00.
mom states pt had just recvd vax & were driving home & pt was in car seat & fell forward; mom noted very pale; states eyes were rolled back; pt was unresponsive; felt no respirations; episode lasted about 2 minutes; adm for observation;
Product storage error; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported
This is a spontaneous report from a non-contactable consumer (mother) reported for her baby. A 5-month-old male patient of an unspecified ethnicity received the 1st dose of PREVNAR 13 (Lot # S35324) at single dose on 29Aug2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took PREVNAR 13 for immunisation and experienced no adverse event. The patient received the 1st dose of PREVENAR 13 in June (year not clarified) for immunization and he didn't have any sort of reaction. On 29Aug2017 night the patient experienced high fever, rash all over his body, very irritable, unable to sleep, doesn't want to eat. The outcome of the events was unknown. Course of the events: The patient had his first vaccine of this (PREVNAR 13) back in June (Year not clarified) and he didn't have any sort of reaction, Then he had the vaccine on 30Aug2017 and the reaction was extreme, high fever, rash all over his body, very irritable, unable to sleep, doesn't want to eat. The reporter wanted to know, what's the difference between the two LOT numbers if they made any change to the formula, because he  had no reaction in June and now he had the bad reaction. No follow-up attempts are possible. No further information expected.
Pt started 1 Typhoid pill on 8/14/05. Awoke 8/16/05 with a fine red rash on lower arms only. Referred to manf, told ok to take #2 pill. Did so on 8/16/05, called on 8/18/05 reports same rash from head to toe some hives a few starting to blister and drain. States canker sore in mouth not sure when started is painful. Advised to get med care as soon as possible. She is in a wedding tomorrow.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long term-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, on an unknown date, the pt experienced shingles and was treated by a health care provider. As a direct and proximate result of use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain, medical care and treatment. Also, had significant medical and related expenses including but not limited to medical losses, and costs included care for hospitalization, physician care, monitoring treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages. At the reporting time, the pt was not recovered from shingles and it was considered related to zoster vaccine live (ZOSTAVAX).