chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received shot about 2:45pm, sat done a couple minutes and was ok.  He got up to come to register to ring up vaccine. I was at the register and was signing for Rx and remarked, "Now I'm starting to feel" and said something like light-headed or funny, and in a couple seconds collapsed.  I tried to grab him through the plexiglass covid window, but was unable.  He fell straight back and hit the back of his head on the vinyl covered concrete floor.  We immediately called 911, I went around the counter and within seconds he was regaining consciousness.  He does not recall falling, but remembers signing for his prescription.  His pulse was slow, about 40.  He felt better, but was a little pale.  His head began to hurt and was very swollen in the back and there appeared to be a break in the skin but bleeding was not noticeable. We had him hold a cold pack on the spot until the ambulance arrived..  The  ambulance crew arrived around 3:10, they took him out to the ambulance around 3:20, they left for the hospital around 3:30, without any further report to me.
took the Vacination before I had shingles/Suspected Vaccination failure; had shingles 2 times over about 10 months. I have it now; itches so bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. The patient was treated with steroids nos (Steroid Shot (Nos)), nystatin and benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the vaccination failure and pruritus were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient took Shingrix vaccination before he/she had shingles ever before. The patient had shingles 2 times over about 10 months and patient still had it now and it itches so bad it drives patient crazy. The patient just left doctor office and got the steroid shot and prescriptions for some steroid pills, a tube of something that must had nystatin in it because it burned him/her so  bad it was like a hot fire, so at the pharmacy the patient picked up some Benadryl cream and tablet which should help to him/her soon. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. For the tolerance of Nystatin refer case US2021AMR183383, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183383:Pharma case
SORE ARM; This spontaneous report received from a patient concerned an 8 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 73 years old. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20231055739.
When I gave the patient her 3rd vaccine (Menveo) she started swaying and then fell in my lap. I had given her Adacel (Tdap) and Havrix (Hep A) prior. She didn't completely pass out but she was able to set up in a chair and she had lost all color. She then started falling to the side but was still alert.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: Sweating, dizziness, shaking, chills, lasted 10 minutes after receiving vaccine. Recovered fully after reclining supine for a few minutes.
MODERATE PAIN STARTED IN LEFT ARM AT INJECTION SITE WITHIN 4.5 DAYS OF VACCINE BEING ADMINISTERED. PAIN PROGRESSIVELY WORSENED OVER THE NEXT TWO DAYS, TRAVELLING UP THE ARM TO THE LEFT SHOULDER AREA AND UP TO THE BASE OF THE NECK. BY APRIL 26, 2021 (ONE WEEK AFTER VACCINE ADMINISTRATION), I COULD NO LONGER MOVE MY LEFT ARM, MY RANGE OF MOTION WAS SEVERELY IMPACTED AND PAIN WAS INTENSE (I COULD NOT SLEEP OR FUNCTION NORMALLY). I VISITED DR. ON TUESDAY, APRIL 27, AND SHE PRESCRIBED CYCLOBENZAPRINE, A MUSCLE RELAXANT FOR THE PAIN. X-RAYS WERE TAKEN OF MY LEFT SHOULDER AND CERVICAL SPINE. THE PAIN PERSISTED FOR ANOTHER WEEK, UNTIL APPROX. MONDAY MAY 3, 2021 (WHILE STILL TAKING CYCLOBENZAPRINE).
Hibrix  expired 10/24/2021. Kinrix was given to a 4 month old baby. Manufacturer notified, patient has not experienced symptoms for side effects, Hibrix was not counted & will re-administer, Kinrix was ok to be counted as vaccine.
Swollen lymph nodes (armpit), extreme fatigue, acute onset of shingles - like symptoms.
Janssen COVID -19 Vaccine. 9 hours after the shot I woke up freezing cold, all my joints hurt, my muscles were stiff, and I felt disoriented. I stayed in bed for a couple of hours. At 5am I got up with all the same symptoms and took my temp which was 101.4. My head hurt like there was too much pressure in my skull. I ate toast and took some ibuprofen and went back to bed. These symptoms lasted for 10 hours. Then for the next 5 hours I just had a fever off and on and fatigue. 3 days after the shot the gland in my left armpit became swollen. It has gone down in size but still sore 5 days later. I still feel tired too.
Vomiting for 48 hours, nausea, headache, chills, fever 102 for two days; period started and bleeding increases daily.  Vaginal bleeding still heavy with dime size clots.
Awoke with hives on legs. Hives were very itchy. The hives increased in number and size. At 24 hours into the event were on all parts of the body. Treated with Benadryl p.o. with improvement. When Benadryl stopped hives reappeared. Swelling of both hands and feet noted. No respiratory distress at anytime. All symptoms resolved as of December 9, 2006.
This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored (Merck) VARIVAX (lot # K005427, expiration date: 15-APR-2016; lot # K018963, expiration date: 15-OCT-2106; lot # K015971, expiration date: 23-SEP-2016; lot # K005428, expiration date: 15-APR-2016) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of (Merck) VARIVAX experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
he couldn't stand up anymore; wasn't able to stand up with the muscle pain; couldn't support his legs any longer; fever; muscle pain; a stronger pain in his head; pain in his throat; heart beat was accelerated too much; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) reported for himself.   A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 07Jun2021 15:15 (at age of 33 years old) as single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot no: EW0177) on 17May2021 (at age of 33 years old) at left arm as single dose for COVID-19 Immunization and experienced a lot of congestion, body aches, cough. Caller stated he had side effects to the Pfizer COVID 19 vaccine and went to the ER (emergency room). The patient said he had to go to the emergency room because of side effects he was having to the COVID 19 vaccine. He is asking who will pay for his medical expenses. He experienced fever, muscle pain, a stronger pain in his head, pain in his throat and also his heartbeat was accelerated too much, all on 13Jun2021. Second dose received on 07Jun2021 in the left arm. After the second dose, it was 4 days starting on the 13Jun2021 with flu like symptoms. On the 16Jun2021, he couldn't stand up anymore so he went to the emergency room. He couldn't stand up anymore so he had to go to the emergency room on 16Jun2021. He was discharged from the emergency room. The emergency room ran some tests and told him to take some Tylenol. He had a COVID 19 test and he is expecting a call with the results and the staff at the hospital took his temperature. He explained to the hospital staff that he was having the symptoms that are on the COVID 19 vaccine paperwork and that was the reason for his visit, since he had the two COVID 19 vaccines. He would like to point out that he asked the nurse when he was going to have the second dose, since the first vaccine he was still having side effects, he asked her if he was in danger to have the second vaccine. The nurse told him he was ok to get the second vaccine. The nurse told him he might have some muscle pain but he shouldn't be worried about it. At the emergency room he also had some blood tests. And also they took his pulse and after that the doctor was reading something in English that the interpreter couldn't catch and read. He provided Pfizer with what happened so far since he had the vaccine. He wasn't able to stand up with the muscle pain and he couldn't support his legs any longer, all on 16Jun2021. He would like to know if he's going to get some help with the medical bills. The patient underwent lab tests and procedures which included Blood test: negative, COVID-19 virus test: negative on 16Jun2021. The outcome of the events was unknown.  information on the lot/batch number has been requested.
Swollen lymph node under my eye- pain and swelling.   Others- flu like, aches, chills, and headache
pale; diaphoretic; Seizure like arm movements for 3-5 seconds after. Opened eyes right after seizure like movement.; Seizure like arm movements for 3-5 seconds after. Opened eyes right after seizure like movement.; Became dizzy; fainted; This initial information has been received on request by the Company from the FDA under the Act (Health Authority # 6230533) on 25-SEP-2020, concerning a 17-year-old female patient. Concomitant therapy included ethinyl estradiol (+) norgestimate. Information about medical history and concurrent conditions was not provided.    On 20-SEP-2019 at 09:55, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028651, expiration date not reported, upon internal validation established as 27-JUL-2021, intramuscularly in the left arm; strength and dose were not reported) for prophylaxis.    On the same day at 09:58, the patient became dizzy, pale, diaphoretic and fainted within minutes of receiving injection. The patient experienced seizure like arm movements for 3-5 seconds after, opened eyes right after seizure like movement. The patient placed head between knees for 5 minutes, drank 2 glasses apple juice and ate crackers, then placed on stretcher to lie flat for 10 minutes. The patient gradually and incrementally raised hob to sitting position. The patient remained without further dizziness, vital signs (VS) remained stable throughout and she didn't eat breakfast. The outcome of the events was recovered. The causality assessment was not reported.  Follow up information was received on 07-DEC-2020 via an inbound call from a person of the general pediatrics. The reporter stated that a seizure convulsion letter was received addressed to a physician no longer at the practice and she could not identify the patient. After reviewing the case, the reporter stated that without additional patient identifiers and the physician information, the event could not be identified. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028651; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Vaccine given 12/30/2020, nausea.Worked my 3-11pm shift at hospital.  12/31/2020 around 1:00am woke up with swollen face, fast heart rate, heart palpitations, dizzy, lips and tongue tingling. Epi-pen given in Left thigh, Benadryl taken every 4 hours. Symptoms got better after several hours.
High fever, nausea, headache, extreme joint and muscle pain. Took 1000 mg of Tylenol twice daily for pain (slightly reduced pain). Symptoms lasted 48 hours.
period was about 8 days late after her first dose of the pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Feb2021 at 10:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included lyme disease. The patient had no COVID prior vaccination, no other vaccine in four weeks, not tested for COVID post vaccination. Concomitant medication included biotin and unspecified daily vitamins. It was reported that the patient's period was about 8 days late after her first dose of the pfizer vaccine. Event onset was reported as 17Feb2021 at 22:00. The patient did not receive treatment for the event. Outcome of the event was recovered.   Information about lot/batch number has been requested.
30 min after dose, thickening in back of throat, swelling of tongue, continued to worsen over the next 24 hours, then tightening of airway. Treated with Benadryl, albuterol, Pepcid and then required 4 days of oral steroids for airway inflammation
Pt began sweating, stated he had ringing in his ears, became very pale stated he was having difficulty breathing.
Cx came on Mon 8/3/15 claimed that after walked the dog to the park, he got itchy and start crashed his feet (L); he didn't know that from the shingle vaccine he got on Sat. 8/1/15 or not. Red dots rash.
AFTER ADMINISTERING THE INJECTION I IMMEDIATELY SAW A RAISED AREA ABOUT THE SIZE OF A QUARTER WHERE THE INJECTION WAS GIVEN.  THE PATIENT STATED THAT HIS ARM WAS NUMB IN THE INJECTION ARM.  HOWEVER, HE STATED THAT THIS HAD OCCURED WITH THE FIRST VACCINE AND IT LASTED TWO DAYS.
Vaccine was expired for 46 days. Given inadvertently due to confusion in extended dates. vaccine stored in refrigerator and not ultra-cold. Used ultra-cold extended date instead of 10 week expiration date.
Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063H021A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .58 milliliter. On 19-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine). On 19-Jan-2022, ACCIDENTAL OVERDOSE (Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.
Hurt bad until switched to citrate free pen; COVID-19; COVID-19; Rash that got filled with liquid COVID vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4311957-00 (AbbVie).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single, intramuscular, administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at single (unk (citrate free)) for psoriasis, psoriatic arthropathy, rheumatoid arthritis. Relevant medical history included: "Cigarette smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" (2022) and all described as "COVID-19"; INJECTION SITE PAIN (non-serious), outcome "recovered", described as "Hurt bad until switched to citrate free pen"; RASH VESICULAR (non-serious) with onset 20Mar2021, outcome "recovered", described as "Rash that got filled with liquid COVID vaccine". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of suspected covid-19, injection site pain, rash vesicular with prednisone.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of when started HUMIRA it used to hurt bad until switched to citrate free pen, rash that got filled with liquid with covid vaccine, COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for Pfizer biontech COVID-19: The reporter causality for the events "Rash that got filled with liquid COVID vaccine" was reported as possible, for "Hurt bad until switched to citrate free pen", COVID-19 Pfizer biontech COVID-19 were not reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective(LOE) and  cannot be ruled out. Event "Hurt bad until switched to citrate free pen' is assessed unrelated to suspect vaccine BNT162B2, since its possibly related to concomitant drug humira.   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.
3:00PM - patient reported throat felt tingly, somewhat constrictive and his right eye was twitching 3:07PM - 25mg of benadryl given 3:13-3:20 - throat symptoms improving but still feeling somewhat constrictive, eye still twitching 3:23PM - blood pressure 137/97 3:34PM - blood pressure 135/87 3:37PM - patient feeling well enough and comfortable to leave with wife as a driver due to benadryl  Called the patient at 7:00PM to check in.  Symptoms had resolved completely and the patient required no further interventions
Fever the day after, chills, headache, tiredness. Hot flashes lasted a few days. Menstrual cycle delayed over a week. First dose was within first week of cycle.
Patient falsified DOB when registering for vaccination,. Guardian,consented to the vaccination.  Department of Health verified with statistical records that the patients which made the vaccine a contraindication. No known adverse reactions noted.
arm be sore and red and itchy / Arm is itchy; arm be sore / Arm is itchy sore; arm be sore and red / Arm is itchy sore red; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itchy upper limbs, pain in arm and erythema. On an unknown date, the outcome of the itchy upper limbs, pain in arm and erythema were unknown.   It was unknown if the reporter considered the itchy upper limbs, pain in arm and erythema to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and arm became sore, red and itchy. The reporter asked how long would arm be sore, red and itchy.
Information has been received from a pharmacist referring to a 70 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On 02-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (subcutaneous; dose was unknown) by the pharmacist. The patient came back to the pharmacy on 09-SEP-2016 (reported as a week later), stated that he had to go to an unknown urgent care facility (unspecified date), due to his arm began feeling as though it was dislocated and he was in severe pain. The patient informed the pharmacist that, at the unknown urgent care facility, he was given MOTRIN and told to put ice on his arm. The outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Within a few minutes after administration,there was profound swelling  left deltoid.  Ice pack applied Benadryl 50mg po given at 10:30am. She returned to work.  I called her at 2:15pm she felt well though deltoid was still swollen. Her plan is to call her MD which she had done that day.  She has a allergy to mangoes.
tightness in chest, possible side-effect from minoxidil.  Discontinued minoxidil and symptoms are improving.
The caregiver came back to Employee Health about a half hour after receiving her Flu shot. Her face looked flushed. But other than that she looked fine. Insertion site looked normal, no skin issues like rash or hives. She was complaining of itching all over. "Even my toes itch" Caregiver took 50 mg of Benadryl and watched  for signs of respiratory distress. No report of other symptoms.
exhausted; chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced chills and exhaustion. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the exhaustion was unknown.   It was unknown if the reporter considered the chills and exhaustion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's comments: This case was reported by a patient via interactive digital media.  The patient got the chills for a day, no amounts of blankets helped, and was exhausted the day after the second shot of Shingles vaccine.  The patient would do it again in a heartbeat.