chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2017US003197, is an initial spontaneous report received from a nurse on 24 Jan 2017. This report refers to a 48 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619701, expiration date: May 2017) at a dose of 3.0 ml intramuscularly on 24 Jan 2017. On 24 Jan 2017, patient received 3.0 ml dose in error instead of the intended 0.5 ml dose. It was reported that the patient did not have any symptoms. No adverse event was reported following this administration error (incorrect dose administered).
5 hours after receiving vaccine sore throat, pain of a "4-5", slight asthmatic episode after received vaccine at 4 p.m. and at 11 p.m. 99 degree temperature and shivered in bed for 2 hours, did not sleep for 3 hours, and felt better next morning, better after 1 week later malaise and nausea.
Injection 7/28 with ZOSTAVAX. 7/29 burning, tingling, pain at injection site. 7/30 presented to office - swollen, wamr >6 cm firm injection site, erythema, was given prednisone and cephalexin/no fever.
This spontaneous prospective pregnancy report was received from a patient's aunt and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patient pregnant at 34 weeks of gestation was inadvertently administered with a dose of unidentified Merck HPV vaccine (name, lot #, expiration date, exact dose and route of administration were not provided). It was unknown if the patient received GARDASIL or GARDASIL 9. No adverse events were reported. No PQC (product quality complaint) was involved. Based on the number of weeks of pregnancy at the time of report, the patient became pregnant with last menstrual period (LMP) date of 10-MAR-2015 and estimated delivery date (EDD) of 15-DEC-2015. It was unknown at which week the initial exposure to unidentified Merck HPV vaccine was. The pregnancy outcome was pending. Fetal outcome was unknown. The outcome of vaccine exposure during pregnancy was unknown. Additional information is not expected because of lack of the reporter's contact details.
(9/29/20210), Lab work done at Urgent Care, MRG dropped by 14 points. No other show of symptoms. Scheduled a appointment with Nephrologist on 10/01/2021. No treatment given other than diet and exercise.
April 16 low energy, laid low April 17 Morning:  Low energy.  Afternoon:  Very chilled.  No appetite.  Nausea. Brain fog and fatigue.  Evening:  Threw up 2-3 times.  Sick to stomach.  Neck ache.  Chilled.  Finally warmed up with heating pad and many blankets.  Restless sleep.  April 18 Coughing, low energy, low stamina and weak. April 19 Felt much better
Diarrhea; Nausea; Itching around vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Itching around vaccination site) and NAUSEA (Nausea) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around vaccination site). On 11-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Itching around vaccination site) and NAUSEA (Nausea) was resolving.            Relevant concomitant medications were not reported. Treatment information was not provided. Patient reported that he was doing well at the time of report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received and patient reported doing well now hence, events outcome were updated from unknown to recovering/resolving.
Thursday 12/29/20 : Started wheezing, I am using my nebulizer but the wheezing seems to be getting worse My throat also is swollen and red. Fatigue/sleeping a lot Headache
At midnight I woke up with uncontrollable shaky chills and teeth chattering. Was able to fall back asleep after an hour and woke up again at 4 am with a headache and sweats. Took Tylenol at this time and woke up next feeling better
Patient received 21/22 vaccine exp 6/30/2022- no adverse event occured
Reported to health system call center on 4/29/21 to report symptoms she had with both doses of vaccines.  She reported leg swelling and nausea during the 8th day of her dose 1 (1/13/21; moderna; lot#025L20A). Saw her outside PCP and cardiologist for further evaluation . Pt had discussion with MD prior to receiving 2nd dose on 2/9/21. Pt has known history of SOB and asthma. ED precautions were provided . pt decline ED go to at this time will follow-up with her outside providers.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On approxiamtely 17-OCT-2014 (reported as about 3 weeks ago), the patient was inadvertently administered a 2nd dose of VAQTA (Lot #, dose and route not reported), which was only 1 month after the 1st dose (applied on approximately 17-SEP-2014). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from health care worker referring to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, 0.5 ml, subcutaneously, which had lot # L043213 and expiry date: 28-AUG-2017. The vaccine had unspecified temperature excursion on 19-JUL-2016. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Additional Details: PHARMACIST GAVE HIM INJECTION ,HE WAS DIZZI,NOT FEELING WELL ,CALLED 911 ,THEY CAME AND CHECKED HIM OUT ,BP WAS NORMAL, THEN HE WALK OUT FROM THE PHCY
Pt complains of sore arm persisting today after flu shot about 5 weeks ago. Took Tylenol #4 for a dental abscess and had not noticed any improvement. Pharmacist recommended she see MD and may try Ibuprofen or Naproxen in the meantime to help with pain and inflammation. Patient has MD appointment in approximately 2 weeks (around 11/13/08).
headache; lightheaded and getting worse; lightheaded and getting worse; my lips were tingling; my cheeks, then my tongue, my checks got red and a bit swollen; breathing started to feel weird; breathing started to feel weird; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 (at the age of 45-years-old) (Batch/Lot Number: EN6208) as Dose 1, Single for Covid-19 immunisation. Medical history included fibromyalgia, hypertension, vertigo, food allergy allergies tamiflu, meloxicam, coke, chocolate, food allergy from an unknown date. Concomitant medications included Montelukast, fexofenadine hydrochloride (ALLEGRA), Olmesartan, zinc taken for an unspecified indication, start and stop date were not reported. The patient previously took tamiflu and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity.Treatment medication includes benadryl, methylprednisolone IV, Pepcid, metoclopr. On 17Mar2021 15:15 the patient experienced after 10 min, got a headache, then felt lightheaded and getting worse every minute, then my lips were tingling, then my cheeks, then my tongue, my checks got red and a bit swollen, then my breathing started to feel weird. At this point I agreed to go on rescued. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of headache (headache), lightheaded and getting worse (dizziness), lightheaded and getting worse (condition aggravated), my lips were tingling (paraesthesia oral), my cheeks, then my tongue, my checks got red and a bit swollen (swelling), breathing started to feel weird (respiration abnormal), breathing started to feel weird (feeling abnormal). Events were considered as medically significant. Outcome of events were resolved on unspecified date in 2021 with no sequels.    Follow-up attempts are completed. No further information is expected.
I felt a sudden jolt of severe chest pain 2 days after receiving my second vaccine dose. It happened three times, the third time was so intense that I nearly fell on my knees. The pain lasted for about 45 minutes and it hurt to breathe the entire time. I also experienced shortness of breath and fatigue. I felt another jolt in my chest this morning, which was mild and only occurred once so far.
12/30/2021: Event occurred after 2nd vaccine.  Patient is an 81-year-old male with a history of hypertension who presented to emergency department after sustaining a fall more than 24 hours ago. also complain of generalized weakness in the upper or lower extremities denies any fever chills headaches patient also stated that he did not lose consciousness. Currently  01/06/2022: remains in hospital .  on mid flow 10 to 15 L.  Continue dexamethasone and remdesivir
The pt developed fever of greater than or equal to 105 deg. F at 1 1/2 days post vaccination.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the local authority to staff and then to our facility and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout our facility was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
This patient received his booster dose too soon. It had not been 5 months since he completed his primary 2 dose series. Administered a Pfizer booster to him today.
Developed "itchy"rash on "both arms, chest and stomach"    Unsure of when rash started...but sure it was not within 4 hours of vaccination and did have the rash by 12/25/20 Describes rash as red, raised, "scaby" Rash is much improved but still present Did not go to Dr. Did use OTC Hydrocortisone cream
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and  concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient got hot and had side effects. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from got hot and side effects.
L leg with rash, redness and swelling. 15cmx13cm area of redness and swelling on left thigh.
Subsequent to receiving varicella virus vaccine live the pts husband developed itching on the back of his neck. There were no reported bumps or lesions.
My arm  has been swollen and red in the injection site for 11 days now.  It itches too. No other side effects. It has been a constant.  Clinic recommended  heat pack and benadryl today. I talked with someone and he explained it is a continued reaction to the shot. I then called the clinic and they gave me the above suggestions.
Pt with mom states she feels dizzy and faint.  While with EMS on site, pt states her chest felt tight.  Mom at beside with pt.
Patient vaccinated with Pfizer covid vaccine on 7/13/22, 8/10/2022 and with Moderna bivalent on 9/23/2022
Inflamed rotator cuff, extreme pain and restricted range of motion in left arm. Symptoms began day of injection and increasingly got worse to present day.
received only the diluent portion; received only the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported. The patient had received only the diluent portion of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine. Patient data was not available at the moment. HCP reported it was administered without the powder. No further clarifications were made. The reporter consent to follow up.
Very painful, swollen (L) upper arm. Covered approx 2/3 upper arm. Pt unable to work x 3 d.
Information has been received from a physician concerning a 4 year old patient who on 26-APRI-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. The physician reported that the practice ordered Varivax and Zostavax was sent by the pharmacy. The vaccine was put in the freezer where Varivax is normally kept and the medical assistant administered the vaccine assuming it was Varivax. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        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.
This  patient was admitted to Hospital on 12/29/2021 for COVID related symptoms. This is considered a breakthrough case.
Felt some of the vaccine dribble down my arm; A spontaneous report was received from a 65-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt some of the vaccine dribble down her arm.   There were no medical history and concomitant medications reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient reported that she felt some of the vaccine dribble down her arm. She was not sure if she received the full dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, "felt some of the vaccine dribble down her arm" was considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a 65-year-old female patient who received her first of two planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and after receiving the vaccine, she felt some of the vaccine dribble down her arm. There were no reported adverse events associated with the event after receiving the vaccine, she felt some of the vaccine dribble down her arm.
Hospitalization 01/28/22-01/31/22 for acute respiratory failure with hypoxia, COVID19. Treated with dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily.
Per patient, neck pain, fever of 100-101, hallucinations at night, leg wiggling, pain in the deep ear, jaw, and back, dizziness, and heart beat skipping
Patient received the 2nd Pfizer Covid-19 Injection on 4/27/2021. She began having severe stomach pain the following day that did not resolve. She went to the hospital and was admitted on 4/30/2019. She underwent CTs, Ultrasounds. Found that she had 1 blood clot in a mesenteric artery. A second CT performed 2 days later showed that she had a 2nd blood clot that formed in a mesenteric vein. She has a condition ITP where she does not clot very well, however, it was stable at this time. She was started on heparin drips which made no improvement to the clots. Lysis catheter inserted with a TPA drip. This resulted in hemorrhagic stroke. She was placed on palliative care and passed away on 05/11/2021.
patient requested bivalent covid vaccine, but in error received monovalent pfizer covid expired 9.22.2022
Missed dose; Loss of consciousness 3 times each one lasting 3-4 minutes; Vertigo; sweating; A spontaneous report was received from a consumer, concerning a 72-year-old male patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and Loss of consciousness 3 times each one lasting 3-4 minutes/loss of consciousness, vertigo, sweating/hyperhidrosis and missed dose/product dose omission issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient suffered from loss of consciousness every 3-4 days. The patient had  three episodes where he experienced loss of consciousness with each experience lasting 3-4 minutes. The patient also experienced vertigo and was sweating when he woke up from losing consciousness. Treatment for the event was unknown.  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, loss of consciousness 3 times each one lasting 3-4 minutes, was not resolved. The outcome of the events, vertigo, sweating, and missed dose, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This case was reported by a nurse via sales rep and described the occurrence of fever blister in a elderly patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown. The reporter considered the fever blister to be almost certainly related to SHINGRIX. Additional details were reported as follows: The case was reported by a Registered nurse. The age at vaccination was not reported. The patient received SHINGRIX on unknown arm. The patient experienced fever blisters on unknown site. Limited information was provided by the reporter.
Local swelling (LT) pain and redness x 5 days. 3 inch local swelling, heat and redness x 1 wk.
Patient has a softball sized area at the site of administration. Area is painful, red, swollen, and warm to touch.  Patient does not have a fever or other complaints.
This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX (batch number XC534, expiry date unknown). On 17th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, headache, pruritus and skin warm. On an unknown date, the outcome of the fatigue, headache, pruritus and skin warm were unknown. It was unknown if the reporter considered the fatigue, headache, pruritus and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient was a pharmacist and understood vaccines. The patient experienced crushing fatigue, headache and itching and her arm was still hot one week later. The reporter thought that this was vaccine related to worried that the non pharm D patient who experiences this will not return for dose 2.
After about 7-10 minutes I began to feel warm. The nurse asked me to remove my mask and I had a rash and hives on my neck, face and chest. I was taken to a room and given Benadryl and ice packs while my vitals were monitored. My ear turned bright read and burned so badly that they had to get ice for my ears as well. I was shaking and felt dizzy. After 15 minutes I was feeling worse and my ears were on fire. After listening to my chest the nurse called for an ambulance in case she needed to administer an epi pen. The ambulance arrived and I was taken out to be evaluated. This was around 40 minutes after being given Benadryl and it began to work. I was advised that being seen at the hospital would be a good idea but that all my vitals were back to normal but the rash and hives were still there. I decided not to go to the hospital and to see if the Benadryl continue to work. After about 1.5 hours after Benadryl my hives and rash have gone away mostly.
pt recvd vax; devel a 4cm itchy, erythematous, indurated patch at inject site w/ chicken pox blisters & a runny nose;to md & dx w/ cold;
Pt with history of MS who presented to hospital with witnessed cardiac arrest. Per family pt had tested positive for COVID a few days prior.
Sore shoulder; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore shoulder".  Additional information: Patient reported he had his first dose last Friday and second on 14May. Sore shoulder for a day but no side effects from first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.