chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 yo patient, his brother and mom all came for covid vaccines. 6 yo vaccine was completed (he was worked up over it, had anxiety and screamed/cried). He was finished and watching his mom receive her vaccine. Right after the moms vaccine was finished, the patient took 2 steps towards his mom, then fell backwards (we think he passed out), hitting his head on the pharmacy door very hard. We immediately opened the door and had him lay down, his face was pale and his eyes unfocused, looked like he passed out. He came to a few seconds later, was confused about what happened and started to cry. We called code white immediately. We got him a water and a push pop and it seemed to perk him back up. The mom sat with him in the booth for a while to make sure he was ok. I counseled her on signs/symptoms to watch for a concussion as this was my main concern after he hit his head. I told her to follow up with his PCP on this as well. I think the main factor was either he was so worked up about getting a vaccine he then crashed (adrenaline) after it was done or he possibly was needle squeamish and watching his mom receive a shot affected him.
Swollen arm, body aches, fever, nausea/vomiting and painful (Temp 101.8 deg)
Felt 'funny', slightly dizzy Initial Treatment: Arrived at clinic alone and riding bike. Gave water, juice, and snacks prior to vaccine.  4:20 Vitals: BP 110/80 HR 102 O2Sat 98  Skin Signs: Warm and dry  Follow up Treatment: Water, snacks, laying down  Doing well on discharge. Dad's friend came to get son (cleared upon phone call with Dad). Stable and no symptoms on discharge.
Moderna COVID-19 Vaccine EUA. Swollen lymph node on armpit of injection, started taken ibuprofen to limit pain, pain reduced two days after first noticing, haven't given enough time to see swelling reduce
Immunization given 15:00 01/13/04 @ 14:00 01/15/04, feeling weak.  Shaky and warm into studentt health, temperature 101.8F.  Left arm red and sore size of baseball urged to take fluid and Ibuprofen - rest- to see MD if condition gets worse.  01/15/04 to clinic to see MD weak fever, nausea, given IV fluids for dehydration to take fluids Tylenol and rest.  Possible viral syndrome.  Possible vaccine reaction.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 77.58   On 27-OCT-2021, Excursion time was 09 AM temperature was 29 and 10 AM temperature was 32 total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-SEP-2021 and 05-OCT-2021 respectively, vial was moved to clinic on 27-OCT-2021. 2 and 4 vials were sent to clinic respectively. Vaccine BUD date was 29-OCT-2021 and 04-NOV-2021respectively. On 27-OCT-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Patient received flu vaccine, and immediately following the administration of the vaccine, the patient experienced a syncopal event resulting in a fall. The patient sustained minor injuries from the fall and also experienced nausea accompanied by emesis. The patient recovered within 15 minutes of the event and needed no further treatment.
Patient presents with itchy red rash since 1/11/21.  Some relief with hydrocortisone.  She does not remember any trauma to the area.  No new meds/ soaps/ detergents.  No close contacts with similar symptoms.
Unrelated to pregnancy: Received Moderna booster and within weeks experienced first ever signs of Onychomadesis on toenails. Nail growth halted for several weeks, then the band of original growth fell off, leaving nail beds leading to chronic ingrown toenails.  Onychomadesis recurred in May 2022 a few weeks after being diagnosed with COVID-19 (strain unknown). As of July 2022, nail beds are still banded and misshapen.
mom states pt vomitted small amount approx 15 mins p/vax; pt slept for about 1 hr & when awoke began screaming unconsolably w/a very high-pitched scream for approx 1 1/2 hrs; reddened raised area on rt thigh about 1-2"; feverish & fussy;
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35°Fahrenheit degrees (F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1707USA006643:
2nd dose administered to a pregnant patient; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (2nd dose administered to a pregnant patient) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 042J21A and 066H21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 08-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Mar-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (2nd dose administered to a pregnant patient). On 08-Mar-2022, MATERNAL EXPOSURE DURING PREGNANCY (2nd dose administered to a pregnant patient) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No medical history was provided.  It was reported that it was unknown whether patient had any allergies, whether patient had any COVID positive diagnosis. Also It was unknown if patient had any Acute and Chronic illnesses at the time of vaccination. I t was unknown if patient was administered with any other vaccines within 1 month prior to Moderna COVID-19 vaccine. 2nd dose of vaccine was administrated after 28days since the storage. Last menstrual period or due date of the patient was unknown.
Pfizer Bivalent booster vaccine was administered as the 1 dose in the Primary Series instead of the monovalent Comirnaty.  Patient was informed.  Per CDC recommendations, dose was not repeated and patient is scheduled to return in 21 days for the monovalent pfizer 2nd dose.  No adverse effects noted.
Pain at injection site; Not feeling well; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain and feeling unwell. On an unknown date, the outcome of the injection site pain and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix from her general patient population and had pain at injection site and not feeling well. It was a general observation but provided a small point of clarity stating that she has seen a greater of reaction from healthier patients as opposed to those whose immune system has declined.  No further information was provided.
Tachycardia; Palpitations; had a strong, whole body heat, and flushing; had a strong, whole body heat, and flushing; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 4th of 6 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. There is unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020.  Information on lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, feeling hot, tachycardia and palpitations. 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.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
My arm locked up on me frozen shoulder I got my shot over 2 years ago and I'm still experiencing the signs and symptoms
Redness ,swelling, burning and warm to touch at injection site. Pain spread to upper back and down left arm to hand . Chills and fatigue. First 24 hours.  Day 2 - Redness expanded and arm became swollen and hard at injection site.  Chills .  Day 3- Burning sensation  down entire left arm . Warm to touch and swollen. Fatigue and chills.
Red bumps, itching, redness and swelling down upper arm, looks like urticaria
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 664478/1191Y). Subsequently the patient experienced injection site reaction after vaccination, which consisted of the area of warmth, redness, and swollen. The patient called the office but did not come into the office. There were no lab studies were performed. At the time of the report, the patient had recovered (date unspecified). The reporter requested a lot check for lot # 664478/1191Y due to the patient's adverse experiences. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
large red area on arm; blotchy area on arm; didn't feel well; This case was reported by a other health professional via sales rep and described the occurrence of erythema of extremities in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose on an unknown date and experienced large, red, blotchy area on her arm and did not felt good after receiving vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities, blotchy and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the erythema of extremities, blotchy and feeling unwell were unknown.   It was unknown if the reporter considered the erythema of extremities, blotchy and feeling unwell to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The reporter stated that an acquaintance of hers experienced a large, red, blotchy area on her arm after the first dose of Shingrix. The patient was feeling unwell after getting the vaccine. This is 2 of the 2 cases reported by the same reporter.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "Hyperkalemia" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 11Oct2020; ROSUVASTATIN, start date: 25Aug2022, stop date: 23Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: COVID-19 treatment with Paxlovid from 24Dec2022 to 29Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hypo and hyperglycemia; Hypo and hyperglycemia; scalp and armpit acne; fatigue; sore arm; This is a spontaneous report from a contactable physician (Patient). A 69-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, in left arm on 01Feb2021 11:30, as 2nd single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1284 and Expiration date was not reported), via an unspecified route of administration, in left arm on 04Jan2021 01:00 PM, as 1st single dose for covid-19 immunisation. Medical history included diabetes 2, hypertension I, hyperlipidaemia and hypogonadism. Patient was allergies to Penicillin, Cipro and Bactrim. Concomitant medication(s) that patient received in two weeks included insulin (INSULIN); metformin (METFORMIN); terazosin (TERAZOSIN); finasteride (FINASTERIDE); hctz (HCTZ). Facility where COVID-19 vaccine was administered was at Public Health Clinic/Veterans Administration facility. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient not tested for COVID-19 prior vaccination. On 04Feb2021 10:30 AM, the patient experienced hypo and hyperglycaemia, scalp and armpit acne, fatigue, sore arm which continued at two-week mark after second dose. No treatment received for reported adverse events. Patient not tested for COVID-19 after the vaccination. The outcome of the events was reported as not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8732), at the age of 67, via an unspecified route of administration, left arm, on Mar 29, 2021, single dose, for COVID-19 immunisation. Medical history not available. The patient has no allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 29, 2021, patient experienced pain in upper left arm for three weeks. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of pain in upper left arm: not resolved. No follow-up attempts needed. No further information expected.
No Adverse event.  Mother came with a birth certificate to update daughters dob on 03/04/2022. Patients DOB was confirmed at least 7 times by the mother on 01/15/2022 and second shot day of 02/06/2022 in writing and verbally.  1 month after last contact with patient, mother updated patients dob revealing that she was 4 years old at the time of vaccination.
On 4-20-2022, I noticed that my left ear felt full. On 4-21-2022, I felt slight dizziness. Later that morning, I had extreme vertigo to the point that I was having to use nearby objects for steadiness. I fell but do not feel I had any injuries at that time. My daughter called the emergency number and I was taken to the ER at a local hospital. They ran some tests and they admitted me. I also had a migraine so they ordered an MRI, EKG, CT of brain, an Echo of my heart. I saw a Neurologist and an ENT doctor while in the hospital. After discharge from the hospital on 4-25, I made appointments for neurology and ENT followups. I did not go see the neurologist but I did go to an ENT and she gave me an tympanic injection on 5-23-2022. I started working with physical therapy clinic on 5-11-2022 and done that for 2 weeks. At this time, the only possible diagnosis by my PCP and one other physician was a possible viral infection. I am still experiencing white noise in my left ear and I do not hear anything at all in that ear. I still have dizziness every time I first rise out of bed as well.
Menstruation: I received my vaccine late night March 30 and was fatigued and slept most of the next afternoon and through the night. I began my period on April 1, which is around the usual time. Everything seemed fine for that first week (flow, discomfort levels, mood, etc.). but I still haven't stopped bleeding (as of April 15), which is completely abnormal; today marks two straight weeks of menstruating. Within this second week, there is significantly more cramping and back pain than usual, and my flow is very heavy with frequent large, thick clots passing in the blood, some globules the size of quarters or even half-dollars (though amorphously shaped). I go back for my second dose on April 22, and have a scheduled doctor's appointment on April 28.
Very sore arm at site of injection same day of vaccine. The 2nd day, whole right side of body (same as injection site) sore, achey, radiating to neck, back, and some numbness to right side of face, fatigue- this resolved same day. Arm pain persisted for a couple more days before resolving. Then after about a week, pain to joints in knees & both arms started. Significant pain to right arm again (injection site). Arm pain is now resolved, still having pain to knees.
child kicked the administrating medical assistant which resulted in a smaller than recommended dose of PROQUAD being administered; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-OCT-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot #, expiration date and route of administration were not provided) for prophylaxis. It was reported that a child kicked the medical assistant, which resulted in a smaller than recommended dose being administered (Accidental underdose).
37 y/o man with obesity with BMI of 34, former smoker, chronic HBV,  s/p J&J covid vaccine in April, HTN, HLP, exposure to his son who was covid positive on 12/27, symptoms of chills, fever, body ache started on 12/28, then diarrhea on 12/29, tested positive on 12/30, who presented to ED on 1/4  with c/o shortness of breath and cough. Patient is found to be hypoxic due to COVID PNA.   Hospital course:    COVID Pneumonia, Acute hypoxemic Respiratory failure: Symptom onset on 12/28 COVID positive on 12/30. Last fever on 12/28. Isolation until 1/17/2022. He had exertional hypoxemia on admission, therefore he was started on decadron and remdesivir ( RDV). He has completed 5 days of RDV on discharge. Exertional hypoxemia has resolved. No O2 requirements on discharge. Will prescribe decadron to complete a 10 day course. He had mild transaminitis most likely due to acute viral infection +/- remdesivir, please follow up as outpatient. Continue isolation at home per Regional/Local ID guidance. 20 days from start of symptoms which would be 1/17/22. Work activity status was provided. Please consider booster after you have completed isolation period.    HYPERTENSION: on PTA amlodipine 5 mg daily and lisinopril 10 mg daily.     Primary Procedures:  none   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Covid pneumonia with acute hypoxemic respiratory failure
Patient has a rash on both of his legs and hit buttocks. The rash started 6/8/19 in the AM.  It is a red lacy rash. It is not raised, not itchy or painful. Benadyl PRN if helps with the rash. Still present on 6/10/19 when evaluated in our office.