chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme stomachs pain, headache and nausea. Very sore arm at injection site. At 8:00 AM I started throwing up and getting sweaty and clammy.  I took a Zofran and laid down with saltine crackers...  The symptoms are ongoing at this time.
Patient woke up on 05/13/2023 with an almost all over body rash/hives.  She went to urgent care 3 times, visited her dermatologist and took the following medications over the course of the next month: adrenaline, Benadryl, steroids, prednisone, Xolair, fexofenadine.  Patient still currently on prednisone.
fever, chills, cough, sore throat, headache ×almost 2 days now.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Pt started with toe tingling around 4/3 - 4/7. Came to ER on 5/6 and had an US that was negative for DVT. Admitted to the hospital on 7/8/21 with an ischemic left foot. Underwent arteriogram LE, angiojet thrombectomy left pop artery, penumbra thrombectomy and thrombolysis catheter placement in the left PT/Pop artery. Back to OR on 7/10 for open thrombectomy tibio-peroneal trunk, patch angioplasty left TP trunk, open thrombectomy DP and distal PT arteries. Back to OR on 7/12 for an open thrombectomy left ATA and PTA, arteriogram left LE. Then again to the OR on 7/13 for a left BKA.
patient reported tingling in throat and hands 10 minutes after vaccine administration- physician notified -administered diphenhydramine 25 mg po and observed addition 30 minutes until symptoms resolved
no additional adverse event; he believes the child only got half dose; This spontaneous report has been received from a physician via company representative concerning a child patient of unknown gender. The patient's relevant medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 16-FEB-2021, a nurse vaccinated the child with Measles (+) Mumps (+) Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (MMR-II) (strength, dose, dose number, route of administration, anatomical location not provided) (lot number reported as T006165 and expiration date as 19-FEB-2022) for prophylaxis; however, she did not hold the child very well. Thus, the investigator believed the child only got half dose. There was no additional adverse event.
SM developed intermittent chest pain and SOB starting on the 19 of Nov with a very brief episode and then no recurrence until 25th Nov. Chest pain not related to exertion. SM is noting SOB with climbing stairs and during PT.
My vision was doubled and distorted  and then my face began going numb within a few minutes.  The numbness spread to the lower half of my face. Later on it spread to my cheeks. It felt much like dental anesthesia. The numbness slowly diminished and was gone in 6 days.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case included information of patient 60 out of 104 patients.  Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.
Continuous vomitting started Friday 4/2-went to Urgent Care Saturday 4/4. recieved  IV fluids-Vomiting continued at home, went to  Emergency room later that day Saturday, kept me overnight with IV/meds and went home Sunday 4/4
pt recvd 2nd dose of vax 23MAY88 & on 30MAY88 sx reappeared-fever, severe backache w/nausea & f/u MD reported pt devel arthralgia & arthritis following the 1st & wnd doses of vax; No further details were provided;
Patient says she has swollen arms and sore arms. She says she can't left up her arms.
first dose February 2022, second 28-JUL-2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix-B (received 1st dose in February 2022).   On 28th July 2022, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 28th July 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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: GSK receipt date: 29-Jul-2022 Reporter' comment: The patient received 2nd dose of Engerix-B later than the recommended interval. The patient had nothing else to report. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Engerix-B later than the recommended interval, which led to lengthening of vaccine schedule.
12 hours after vaccination patient states she "does not feel right" with extreme fatigue, changes in taste, body aches, and insomnia
Used to have psoriasis / started with an break out all over her body(arms, back, legs); This case was reported by a pharmacist via call center representative and described the occurrence of psoriasis aggravated in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number NR55Z, expiry date 22nd October 2022) for prophylaxis.   Concurrent medical conditions included psoriasis.   On 15th May 2021, the patient received the 1st dose of Shingrix. In May 2021, 2 weeks after receiving Shingrix, the patient experienced psoriasis aggravated. On an unknown date, the outcome of the psoriasis aggravated was unknown.   It was unknown if the reporter considered the psoriasis aggravated to be related to Shingrix.  Additional details were provided as follows: The reporter was looking for information about Shingrix common side effects after 1st dose because the patient that used to have psoriasis received Shingrix 1st dose and two weeks later started with a breakout all over her body (arms, back, legs).  The reporter consented to follow up by phone.
This spontaneous report as received from a nurse refers to a 13 month old female patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 06-FEB-2019, the patient was vaccinated with improperly stored dose of M-M-R II (frequency, route of administration was not reported; lot # N026273, expiration date 21-SEP-2019) and dose of VARIVAX (frequency, route of administration was not reported; lot # N035937, expiration date 19-DEC-2019 for prophylaxis. Concomitant therapies included sterile diluent which was stored appropriately. The temperature of excursion with M-M-R II was above 9 Celsius degrees for 1 hour and 36 minutes and with VARIVAX was -14 to -10 Celsius degrees for 1 hour and 8 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1902USA006504: US-009507513-1902USA007126.
Received shot at 9:20 am.   Came home and went to bed.  Woke up at 3pm and felt worn out.  Then about 5:30pm I got super uncomfortable and then my skin got hypersensitive.   To the point I couldn't even touch it.  Then I felt like I had a fever but when I checked I did not.  Went to bed at 8pm still with the hypersensitive skin.  Could not get comfortable to sleep but when i eventually fell asleep I slept for 10 hours.  Thats about 5 more than I normally do.  The next day the hypersensitive skin was gone just felt a little wore out.
infrequent muscle spasm in shoulder, calf, groin.     Extreme testicular pain in left testicle, I thought it was a torsion, but that was ruled out after trip to ER. It's been four days and it still feels very sensitive, but I am no longer blacking out and vomiting from the pain.
Information was received on 03-MAR-2017 from a registered nurse regarding multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on  03-FEB-2017, 10-FEB-2017, and 16-FEB-2017 unspecified patients were administered an expired VAQTA vaccine (lot # L027735, expiration date 21-JAN-2017)(dose not specified). No adverse effects were reported. No further information was provided. The action taken with VAQTA was not applicable and the outcome of administered an expired VAQTA was unknown. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (around 15 to 16 years of age). Previously administered products included ZOSTAVAX (received around September 2017). On 9th February 2019, the patient received the 1st dose of SHINGRIX. On 9th February 2019, 4 hrs after receiving SHINGRIX, the patient experienced injection site swelling, shivering, feeling hot, pain in arm and malaise. On 10th February 2019, the patient experienced activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy. In February 2019, the patient experienced limbs stiffness. On an unknown date, the outcome of the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy were recovering/resolving and the outcome of the limbs stiffness was unknown. It was unknown if the reporter considered the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased, loss of energy and limbs stiffness to be related to SHINGRIX. Additional details were provided as follows: The patient never received chicken pox vaccine. On Friday around 2 pm, the patient received 1st dose of SHINGRIX on an unknown arm as recommended by physician. Six hours after receiving SHINGRIX, the patient experienced Shivering, feeling feverish and malaise. One day after receiving SHINGRIX, the patient was unable to perform normal functions (basically lay on the couch all day and evening) all day, experienced muscle weakness which led slow response to move legs to walk, extreme fatigue, extreme malaise, Pain (unable to lift injected arm above shoulder level as it was very painful to try to lift it) and no energy. The appetite of patient was normal. On 11th February 2019, the patient's condition was pretty much back to normal, injected arm still stiff, minimal pain raising arm fully up (which was unable to do yesterday). The patient asked are adverse events more pronounced or serious to response to 2nd shot or attenuated. Clarification raised to clarify discrepancy about GSK receipt date.
PATIENT REPORTED TACHYCARDIA AND CHEST PAIN STARTING AROUND 10 PM THAT NIGHT (~6 HOURS POST DOSE). CALLED 8/25 AM AND I DIRECTED HIM TO ER, WAS CLEARED WITH A CLEAN EKG. HAS FOLLOW UP APPOINTMENT THIS MONTH TO DETERMINE IF HE SHOULD GET DOSE 2.
On the night of the day I received my first and only dose of the vaccine, I noticed a racing and heavy heartbeat. For months my chest felt pressure and discomfort. It started to get better but when I started going to the gym the next year it came back again and much worse to the point of needing to visit the emergency room.
Was having headaches that I thought were sinus headaches. My blood pressure started running high. Went into doctor and she placed me on medication for blood pressure and I am supposed to follow up with my PCP tomorrow.
next day chills  fever 102.3 body aches. pain at injection site an  down the left arm  all day..
the billing of the second shot was misdated when processed making it appear that patient received her 2nd shot too early when in fact she rec'd it right on time.. date in billing 05/12/21 actual date 05/19/21
Left arm: painful, redness, swelling & inflammation. Hot to the touch around the site of injection. Swelling improve after 1 day. Treatment: BACTRIM DS.
My daughter is autistic. I have 3 other healthy daughters. Her younger sisters are not immunized because of her disability. I reported this to this site some time ago but never received a response. She showed immediate effects after this date wehre she was triple immunized. Stopped communicating verbally, no longer shoed eye contact or awareness, no longer recognized her name, forgot words previously learned, started 'side glancing'. I had lab testes ordered on her hair last year showing her to be a non excretorof mercury, meaning her body is not capable of ridding itself of Hg. After a few treatments of chelation her body started to excrete astronomical numbers of Hg. I have no doubt that the Thimerosol impaired her develepment. She has tons of social problems and other quirks but we are working with her.  7/02/2007 MR received from initial PCP from 9/26/2000-6/18/2002. Several normal WCCs.  making good eye contact and smiling at age 5 months. 7/05/2007 MR received from 2nd PCP from 1/3/2003 to 4/21/2006.  3 yr PE 1/20/2004 with concerns re: development, ? autism. Assessment: Suspect PDD/Autistic Disorder. 4/5 yr check with DX Autism. 1/5/10 She is moderately autistic, aspergers syndrome and according to hair samples does not secrete mercury at normal levels.
Approx. 12 hours after the vaccine: fever, chills, nausea, shortness of breath, and pain at the injection site. This lasted about nine hours. Took her to ER, blood work was negative and lungs clear.
Left ear has gone mostly numb. When he turn head to the right side, he feel a nerve shoot up his ear. Hasn't impacted hearing at all.; Left ear has gone mostly numb. When he turn head to the right side, he feel a nerve shoot up his ear. Hasn't impacted hearing at all.; This is a spontaneous report from a non-contactable pharmacist (patient). A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL9261) on 21Jan2021 11:45 at SINGLE DOSE in left arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. No Other medications in two weeks. Medical history included covid prior vaccination.  There were no concomitant medications.  On 24Jan2021, the patient experienced Left ear has gone mostly numb. When he turn head to the right side, he feel a nerve shoot up his ear. Hasn't impacted hearing at all. The outcome was Not recovered. No treatment for AE. No Covid tested post vaccination.
This is a 82-year-old female with past medical history of hypertension, advanced dementia, anxiety, depression, glaucoma, severe protein energy malnutrition, pre diabetes, resident of assisted living facility. She came to the hospital with a chief complaint of progressive worsening altered mental status since this morning.  According to the staff from the assisted living facility the patient was unresponsive and not acting like her usual self.  Usually the patient is aware regarding her surroundings and can behave accordingly.   This morning the patient was completely not responding to the verbal stimuli so the nursing staff was concerned and sent her to the hospital via ambulance. Tested positive on 8/27/2021. This is a 82-year-old female with past medical history of hypertension, advanced dementia, anxiety, depression, glaucoma, severe protein energy malnutrition, pre diabetes, resident of assisted living facility.  She came to the hospital with a chief complaint of progressive worsening altered mental status since this morning.  According to the staff from the assisted living facility the patient was unresponsive and not acting like her usual self.  Usually the patient is aware regarding her surroundings and can behave accordingly. This morning the patient was completely not responding to the verbal stimuli so the nursing staff was concerned and sent her to the hospital via ambulance.  The patient has been in the isolation unit in the assisted living facility due to COVID-19 positive status for the last 2 weeks.   She has been vaccinated with 2 doses of Pfizer.  The patient has not been reported to be having any other symptoms otherwise apart from diarrhea from the nursing home staff.  History taking was not possible from the patient due to metabolic encephalopathy.  Most of the history was obtained from the patient's daughter on the phone and the emergency room provider and previous medical records.
On 8/19/21 patient reported localized swelling, pain, itchiness and redness; as well as some minor fatigue. Advised patient to take benadryl, acetaminophen or ibuprofen and to apply an ice pack as needed.  Instructed patient to seek emergency medical treatment if reaction spread beyond arm, new symptoms developed or if it did not improve in 3-5 days.  On 8/21 patient sought assistance at an urgent care facility.  Was given a steroid injection (reported by the patient - steroid type unknown) and a topical steroid.  By 8/23 patient was reporting feeling much better, stating the swelling is almost completely gone.
Patient came for 3rd vaccine; verified with patient that he was here for 3rd dose of Pfizer and he verbally verified this. Gave Pfizer vaccine and on vaccine record patient had received 2 doses of Moderna vaccine. Patient was observed for 15 minutes post vaccination with no adverse reaction noted.
still be running a fever after 3 days/My fever is 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (still be running a fever after 3 days/My fever is 103) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (still be running a fever after 3 days/My fever is 103). At the time of the report, PYREXIA (still be running a fever after 3 days/My fever is 103) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
From date I got the vaccine, I had a quarter sized welt at the injection site for about four to five days and on the sixth day, it became half dollar size and increasingly and still red and hard. It itched very badly for about 12 days. After the 12th day, I could tell the site was more swollen, my skin was very tight, and my arm felt weak. That night, it was very uncomfortable for me to go to bed (aching, throbbing, and numbness). On the 13th day, I noticed the area was now the size of my hand, still very hot, and painful to the touch. The site also had a ring where my golf ball bump was and where it looked like whatever was causing the stress ?popped? under my arm and now it looks like I have a puddle on my upper arm.
Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The pharmacist reported that an underdose of Shingrix had been administered to a patient.  The date of administration was not specified by the healthcare professional.  The healthcare professional did not provide more information since they no longer worked in the facility where the vaccine was administered. The reporter asked to remain anonymous and did not consent to follow-up.