chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient returned to pharmacy on 06/07/2021 with a red rash on left arm at injection site and left arm was swollen.
Covid arm  Slight rash about 4" under vaccination site lasting 3 days. Some pain. Easily treatable with Benadryl cream.
Patient fainted at 10.15 when she was waiting in the waiting area after the vaccine. She quickly came about. PA and EMT treated for Vasovagal Episode. Patient mentioned she fainted previously at a flu shot y ears ago and that she hadn't eaten all day. Pulse ox and blood pressure was ok, blood sugar was low. She was given 15 mg liquid glucose.
swelling went away after injection 1/13/2021 swelling started coming back 1/18/2021 with light to touch pain and itchiness
Patient admitted with Covid Pneumonia when fully vaccinated.  PMH significant for parkinson's, RA, HTN, Asthma, chronic hypoxia on 3L at baseline , PE/DVT who was admitted to HCF on 5/14/21 for evaluation of symptoms of right neck swelling of 2 day duration. Work up in the ED was significant for large pneumomediastinum; large subcutaneous emphysema. She was also Covid -19 positive ( was positive in January and has received both her Pfizer vaccine doses). CTS was consulted. CTS attributed the findings to Covid 19 and associated cough
her patients who did receive the vaccine were already pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (her patients who did receive the vaccine were already pregnant) in a female patient of an unknown age 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (her patients who did receive the vaccine were already pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (her patients who did receive the vaccine were already pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported . No treatment medication reported . The nurse stated that pregnancy is not a side effect of the vaccine.  This case concerns a female patient of unknown age who experienced vaccine exposure during pregnancy after the a dose of the vaccine.  Last menstrual period and estimated date of delivery were not provided. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a female patient of unknown age who experienced vaccine exposure during pregnancy after the a dose of the vaccine.  Last menstrual period and estimated date of delivery were not provided. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report
First it was itchy, and then started scratched it a little.  Lifted up shirt sleeve and noticed big red blotches going  from mid arm down to close to the  elbow.  Arm is sore where the red blotches are.  No pain or blotches at the injection site, but lower on the arm
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a currently 14 years old, male patient with no pertinent medical history reported. On 01-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
female patient received 2 doses of GARDASIL 9 six days apart (3/9/2023 and 3/15/2023); no additional AEs; This spontaneous report was received from a field employee on behalf of a nurse and refers to a 25-year-old female patient. Concurrent conditions, medical history, concomitant medications were not reported.  On 09-MAR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.   On 15-MAR-2023, 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) injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided). Therefore, she received 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) six days apart (Inappropriate schedule of product administration). No further information provided. No additional adverse event (AE) reported. No product quality complaint (PQC) reported.
Information has been received from a certified medical assistant concerning her daughter with no known drug allergies and no previous medical history who was vaccinated with her first dose of GARDASIL (lot# unspecified). There was no concomitant medication. Subsequently the patient experienced headache dizziness, fever and nausea. She took OTC Tylenol and the symptoms resolved within 24 hours. No other information was available. Additional information has been requested.
Symptoms of her arthritis relapsed and flared up.; She experienced fever; She experienced headache.; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms of her arthritis relapsed and flared up.), HEADACHE (She experienced headache.) and PYREXIA (She experienced fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (She experienced headache.). On 27-Jan-2021, the patient experienced PYREXIA (She experienced fever). On 30-Mar-2021, the patient experienced CONDITION AGGRAVATED (Symptoms of her arthritis relapsed and flared up.). The patient was treated with IBUPROFEN for Arthritis, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Symptoms of her arthritis relapsed and flared up.), HEADACHE (She experienced headache.) and PYREXIA (She experienced fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068568 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068568:CROSSLINKED WITH DOSE 1
Information has been received from a nurse concerning a 55 day old patient who on 16-MAY-2008 was vaccinated into the thigh with a dose of VARIVAX vaccine (Oka) (Lot# 659425/1916U). The nurse reported that on 16-MAY-2008 the patient was administered a dose of VARIVAX vaccine (Oka) instead of PREVNAR vaccine. This event was a result of human error, not product confusion. No adverse effect was reported. The patient sought unspecified medical attention. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male 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 1:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.92. No concomitant medications were reported. Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range of 29, 32 degrees Fahrenheit. This vial was moved to fridge on 29-Sep-2021, 05-Oct-2021 and beyond use date for the vial was reported as 29-Oct-2021, 04-Nov-2021. Product moved to clinic on 27-Oct-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Lazy (Half closed) right eye, blurred vision - 2 days numbness right side of face from corner of mouth to outside right eye area about the width of index finger - 5 days. (Symptoms possibility included in paperwork provided).
Excruciating headache for 45 days, continuous hearing  heart beat in left ear
Patient received vaccine around 3PM CST and proceeded to waiting area for the recommended waiting time. Within a few minutes of receiving the vaccination, around 3:05PM CST, patient complained of feeling dizzy. Patient was carefully laid down on the floor, given a pillow to protect his head, and feet were elevated. Patient was extremely sweaty and lightheaded/dizzy. Patient maintained consciousness and expressed that he was beginning to feel a bit better once he was lying down. He was provided a cold bottle of water if needed. Patient refused dispatching an ambulance, which I believed to be an acceptable option as he was already improving and never lost consciousness. A blood pressure cuff was obtained and his blood pressure was 138/94 pulse 69 at approximately 3:15PM EST. He did not know what his BP typically is, but I felt comfortable that he wouldn't likely pass out with this BP. He wanted to set up due to feeling better, so we cautiously helped him do so. After having him remain seated on the ground out of caution, he requested to stand up. He stated he was feeling much better and expressed at that point he wanted to leave. His girlfriend was with him and would be driving him home. It seemed that his symptoms had fully resolved by the time he left the waiting area and assured me he felt okay.
Fatigue; Headache; Shivering; Fever; gastro intestinal (GI) symptom; flu; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included irritable bowel syndrome (had irritable bowel syndrome) and reflux gastritis (had reflux).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fatigue, headache, shivering, fever, gastrointestinal disorder and influenza. On an unknown date, the outcome of the fatigue, headache, shivering and fever were recovered/resolved and the outcome of the gastrointestinal disorder and influenza were unknown.   It was unknown if the reporter considered the fatigue, headache, shivering and fever to be related to Shingrix. The reporter considered the gastrointestinal disorder and influenza to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 62 or 63 years. The patient had medical history of irritable bowel syndrome and reflux. The reporter stated that, about 3 months ago, the patient received dose of Shingrix. After receiving Shingrix, the patient experienced fatigue, headache, shivering and fever. The patient stated that, right after that she experienced GI (gastro intestinal) symptoms, caught the flu from one of the relatives. The patient reported that, currently, and for about a month, had GI ((gastro intestinal)) symptoms again, but believed it was due to everything that was happening with the pandemic and not the Shingrix shot. The patient has not had the second dose yet. The patient consented to follow up.
No adverse events. Patient had already received a fluarix vaccination on  9/21/23.
This case was reported by a healthcare professional (the subject's daughter) and described the occurrence of hypoglycemia in an 86-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included ALZHEIMER'S disease, anxiety depression, dementia, hyperlipidemia, OCD and tendency to fall. Previous and/or concurrent vaccination included FLULAVAL (GlaxoSmithKline; unknown; unknown) given on 3 October 2009. Concurrent medications included ARICEPT, ZOLOFT, PRILOSEC, WELLBUTRIN and Clonazepam. On 4 October 2009 the subject received 2nd dose of FLULAVAL (unknown, left arm), and experienced an extra dose administered. On an unspecified date (a few days) after administration of FLULAVAL, the subject experienced nasal congestion. On 12 October 2009, 8 days after vaccination with FLULAVAL, the subject experienced hypoglycemia and (some) seizure activity. A few days after administration of FLULAVAL. The subject was hospitalised and the healthcare professional considered the hypoglycemia, (some) seizure activity, strong nasal congestion and extra dose administered were disabling, life threatening and clinically significant (or requiring intervention). Relevant test results included blood glucose of 20 in October 2009, and Computed tomography scan ruled out a stroke in October 2009. At the time of reporting the outcome of the hypoglycemia, seizure activity, severe nasal congestion and extra dose administered were unspecified. The nurse reported that the subject received two doses of FLULAVAL (first dose on 3 October 2009 and the second dose on 4 October 2009). The subject developed severe nasal congestion a few days after administration of FLULAVAL. A week later (12 October 2009) the subject was hospitalized for hypoglycemia and some seizure activity. The subject's blood sugar dropped to 20 and had seizures. The reporter did not know if the extra dose administered was related to the subject's hospitalization nor was it known why the subject's blood sugar was low. A CT scan was done and ruled out a stroke. No further information was provided at the time of this reporting.
On 09/15/08 patient received immun: Pediarix, IPV, MMR, varicella. Scheduled immun are Dtap, IPV, MMR. and varicella. Patient received 2 doses of IPV as a result. Patient receive this risk of a serious adverse reaction but increase risk local reaction. Attempted to call parent 2 times and left message. No return call.
Patient seen in the ED on 7/19 for cough, fever, chills, lightheadedness, fatigue, chest pain, and body aches. COVID PCR swab taken in the ED was positive. Patient ultimately was admitted from 7/19-7/21 under observation status . Discharge diagnoses include probable left lower lobe bacterial CAP, COVID-19 infection, elevated 2 hours delta troponin, orthostatic hypotension, and AKI resolved. Patient has been vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Left shoulder 3 1/2 X 2 inch oval erythematous swollen lesion
Headache, Fever, NauseaVomiting, fatigue, chills, head congestion Narrative:
pt recv vax OCT96 & in NOV96 pt was found to have GBS:
No adverse event; 1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.) and NO ADVERSE EVENT (No adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 0215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.).    No concomitant information was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2023: Live follow up information received age group ,vaccination start date ,event start date and narrative was updated.
I developed stomach, intestinal pain, cramps. A continuous aching with a sharp pain about every 20 - 35 minutes. Lasting  36 hours. This was in my lower abdomen below belly button on the left side. Really quiet frightening, in that this was not in any material regarding side affects. I considered the emergency room  Saturday night but didn't t go. Began to subside Sunday afternoon, leaving me sore to the touch. Only a little tenderness remains in the area. I have seen no physicians. I cannot speak to any permanent damage.
Vasovagal Near Syncopal Episode. Good response to Ammonia inhalant and OJ. HR intially 56-76BPM oimety 100%RA.
In middle of night had strong headache, then day following vaccination was headache-y (mild), light-headed, tired and with body aches. Two days after had mild body aches and mild light headed-ness; day 3 I was clear.
She reported that she received her 1st dose "sometime January 2021" but never completed the entire dosage series. She mentioned that she started the dosage series over again and got another "1st dose'' in March 2022; she did not experience any adverse effects; This spontaneous report was received from consumer, referring herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in January 2021 (reported as "sometime" in January 2021"), the patient was vaccinated with the first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), but she never completed the entire dosage series (drug dose administration interval too long). She mentioned that she started the dosage series over again and got another "1st dose" in March 2022 and was on track to receiving the next 2 doses appropriately, however, she was wondering if she should consider the January 2021 dose as the "first dose", or if she should consider the March 2022 dose as the "first dose". The caller confirmed that she did not experience any adverse effects. No additional adverse effects or details reported.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient in her 60's. The patient's historical drugs included PREVNAR, received about a year prior to PNEUMOVAX23. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed cellulitis at the injection site. She was seen by her unspecified physician (unspecified date) for the cellulitis and was treated with unspecified antibiotics. The outcome of injection site cellulitis was reported as resolved on an unspecified date. The relatedness between the event and PNEUMOVAX23 was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA002353.