chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product temperature excursion issue; There was an excursion from the freezer/administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.  No concomitant medication was provided.  No treatment medication was provided.
Chronic pain and limited range of motion in left arm and shoulder from Sept to present. Treatment: Chiropractic/orthopedics.
Per daughter, the day following the injection her arm was sore, but there were no visible defects on her arm.  She denied any weakness or tingling.  She says the pain has persisted for more than 3 weeks and her mother is still complaining about it.  She says Celebrex helps the pain during the day, but the pain interferes with sleep at night.  She has not sought medical attention yet but plans to call her PCP soon for advice.
COVID-19 Breakthrough Case with sore throat, head and body ache, fever, cough, 3 days then contacted my doctor via tele visit April 14.
Vertigo, nausea, vomiting, chills 7 days after vaccination with flu shot. Improving after time. Given Meclizine, Amoxicillin.
Patient reported decreasing Blood pressure, pain in arm, radiating across chest, achy, nausea.
This is a spontaneous report from a contactable nurse (patient's wife) from a Pfizer Sponsored Program Regulatory Authority. A 66-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and second dose via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. A 61-year-old registered nurse and her 66-year-old husband (patient) said they received both doses of the Pfizer-BioNTech Covid-19 Vaccine in March 2021. Yesterday, 5 months after their 2nd dose, they both tested positive for Covid. Patient was "pretty darn ill" and has a fever of 102. The outcome of event was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed if there is any new information available.
pt recv vax 29OCT96 & 20NOV96 pt devel one lesion on lt upper arm;pt was sent to MD who verified that it was pox;25NOV96 pt had over 35 lesions all over;many of them were in scalp;
Vaccine was incorrectly administered into fat (subcutaneous) and not in muscle; They want to give her the third dose; A spontaneous report  was received from a consumer, concerning a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in events, vaccine was incorrectly administered into fat (subcutaneous) and not in muscle/incorrect route of product administration and they want to give her the third dose/prescribed overdose.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of events, the patient received their first dose of mRNA-1273 (Lot number: unknown), subcutaneous in the back of her arm for prophylaxis of COVID-19 infection.  The nurse didn't administer the vaccine to the patient in her deltoid muscle but administered it in the back of her arm. The nurse at the clinic stated that it wasn't administered correctly and was administered into her fat (subcutaneous) and not in her muscle. The patient's arm was not sore, and they want to give her the third dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, "vaccine was incorrectly administered into fat (subcutaneous) and not in muscle and they want to give her the third dose", were reported as resolved on an unknown date.; Reporter's Comments: This report refers to a case of a female consumer who received Moderna's COVID 19 vaccine subcutaneously, (instead of intramuscularly (IM)), and they want to give her the third dose/prescribed overdose. The vaccine lot number was not reported.  There were no reported AEs associated with this case of female consumer who received Moderna's COVID-19 vaccine subcutaneously, and want to give her a third dose.
No treatment other than heat and elevation. Pt had heat redness and swelling below injection site extended down the arm down to the elbow, more noted on the inside of the arm.
Broke out with the chicken pox on 12-7-05.  Form completed as much as possible.  Vaccine not given in our office.
received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patients received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comment: Regional director reported that they found a Menveo diluent left in the box.  The reporter assumed that some patients received Menveo doses reconstituted with sterile water but they need to check this information. There were probably 5 patients involved as reported. The reporter given consented to follow up. Additional Supportive Information: The patients were administered Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
returned to MD p/blood drawn w/skin changes;definitive urticaria in 4 places;given epi & DPH;
In the days immediately following vaccination, Patient noticed joint pain/ tenderness while engaging in routine daily activities. First noticed in left elbow. Days to weeks later noticed in Left wrist. Weeks later in right elbow. Weeks later in right wrist. It has been over 6 months now. Pain is getting worse as time goes on.
Severe Rash; Swollen Lymph node under left Armpit; This is a spontaneous report from a contactable consumer (patient wife).  A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included tooth extraction from 10May2021 to 10May2021.  The patient's concomitant medications were not reported.  The patient experienced severe rash and swollen lymph node under left armpit on 16May2021 at 07:42. Outcome of the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
ITCH, RASH, HIVES  BEGINNING ON 05/23/2019 ENDING 05/28/2019  TREATED WITH BENADRYL 50MG PO AND PREDISONE  MAY 23 THROUGH MAY 27 2019
Child's father reported that the fever that developed post vaccination was as a result of vaccines given. Prior to vaccine administration, father stated that child has running nose but no fever! I went ahead and vaccinated. Child was brought back in with fever of 104 degree F; and some flu-like symptoms according to the health aides. Parent stated "I know my child, he reacted like this last time, I do not want him to get vaccines no more"
Lost little bit of hearing; Tinnitus in both his ears; Inflammation in his inner ear; eustachian tubes draining; Discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost little bit of hearing) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DEAFNESS (Lost little bit of hearing) (seriousness criterion medically significant), TINNITUS (Tinnitus in both his ears), INNER EAR INFLAMMATION (Inflammation in his inner ear), EUSTACHIAN TUBE DYSFUNCTION (eustachian tubes draining) and DISCOMFORT (Discomfort). At the time of the report, DEAFNESS (Lost little bit of hearing), TINNITUS (Tinnitus in both his ears), INNER EAR INFLAMMATION (Inflammation in his inner ear), EUSTACHIAN TUBE DYSFUNCTION (eustachian tubes draining) and DISCOMFORT (Discomfort) outcome was unknown.            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. However, Very limited information regarding these events has been provided at this time. Further information has been provided.; Sender'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. However, Very limited information regarding these events has been provided at this time. Further information has been provided.
Patient had a fall after a vaccine. Initially stated to be at end of December when she received her flu vaccine, but was insistent that fall happened on date of COVID vaccine. She later reported that she remembered fall to be in October when informed that COVID vaccine was received in October. Patient stated that she was experiencing dizziness on date of vaccine and fell twice on the date of her vaccine. She stated that she also fell in her kitchen the day after the vaccine. Patient reports that she continues to have pain in her elbow and neck after these falls.
The patient came into the doctor's office to receive the Pfizer Covid - 19 Bivalent vaccine. The regular Pfizer Covid-19 vaccine was administered in error.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Other- hand on same side as injection is very swollen - dbl in size-Medium;  symptoms  lasted 1 day
Diarrhea.  Slow at first then very heavy over the next three days.  Then tapering off till 10 days after onset.
Dizzy spell within 15 minutes of receiving shot, subsided and drove home; vertigo for next 6 hours.  Better today but still feeling shaky.
Unaware of pregnancy status when she got her vaccine on 4/14 on 5/21 she had a miscarriage at 7-9 weeks of pregnancy.
24 hrs after administration of DTaP and IPV in left thigh, pt developed a 7x6.5" area of induration with pain and warmth.
Flu like symptoms, fever, fatigue, muscle aches and pains, headache, tiredness, blocked sinuses, chills. Took pain relief and congestion tablets, slept. Chills, fever and headaches still persisting up to today 03/26/2017.
Information has been received from a registered nurse concerning a patient who on 02-JUL-2012, was vaccinated SQ with an expired 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669538/1390Z, exp date 19-JAN-2012). No adverse effects were reported. Additional information has been requested.
poss SIDS, bronchopneumonio, mild, respiratory, edema & endocarditis;
Information has been received via medical records through a Merck pregnancy registry concerning a premature female infant who on 23-APR-2007 was vaccinated at birth with a dose of RECOMBIVAX HB (lot 654745/0608F). After delivery , the infant had seizures x1 while in intensive care (WAES# 0705USA00475). The infant has seizures x1 with normal MRI, and extensive work-up revealed all normal studies. On 01-MAY-2007, the infant was discharged to home to follow-up at clinic in 1 week. On 07-MAY-2007, the infant presented at the clinic for 2 week well baby check. The family was concerned as the infant was experiencing frequent hiccups. On 30-MAY-2007, office note indicated that the infant was constipated and fussy. On 04-JUN-2007, the infant was seen for 6 week well baby check. The mother stated that the baby started to cry, get fussy, burped, and spit up after feeding. She stated that it occurred mostly at night, and the infant seemed to feed well during the day. It was noted that there was a change in formula from Similac to Enfamil the previous week. The plan was to change back to Similac formula for a few days, and if no improvement may change to soy formula, and also use simethicone drops. Additional information is not expected.
Mom reports pt was "acting strange" & having difficulty breathing while sleeping. Reported fever of 102.6 (R).
Myocarditis; Her son still has some inflammation; This is a spontaneous report from a contactable other hcp (Patients mother). A 14-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0180 and Expiry Date: 19Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jun2021 as single dose for covid-19 immunisation. Patient previously received dose 1 of bnt162b2 (BNT162B2, Lot number: EW0178 and Expiration Date : Unknown to caller ) via an unspecified route of administration on 29May2021 as single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 21Jun2021, The patient experienced myocarditis, About 2 days later, he was taken by ambulance to the ER, diagnosed with Myocarditis and admitted to the hospital, discharged on 23Jun2021. Caller states that she believes her son still has some inflammation, it is better but still ongoing, as he is still unable to exert himself at all. The claims are not in yet but it looks like they will be spending 5000  to 6000 dollar out of pocket. She is looking for some type of compensation for their expenses. Patient had no other vaccines on the same day as the suspect product. Myocarditis lead to Emergency Room. The outcome of the event myocarditis was recovering and inflammation was not recovered.; Sender's Comments: As per the information provided in the narrative, the causal association between the suspect drug and the event cannot be excluded. 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.
Female pt felt lightheaded and dizzy after receiving vaccine.  Did not alert staff and had a syncopal episode, falling out of her chair.  EMRs at pts side, pt regained consciousness.  She did have a small hematoma on her head measuring approx. 1 inch.  Pts vitals were HR 68, BP 116/70, RR12 , sats 100%.  Pt sts all symptoms have resolved.  She denies all further treatment and/or transport.
A physician reported that an adult male in his late 30's received an injection of Flu-Sheild (1999-2000 formula) in the fall of 1999. Within 1 week post-immunization, he developed cryoglobulinemia and vasculitis. He was hospitalized. Unspecified tissue biopsies are pending. No further information was available at the date of this report.
immunocompromised; This is a spontaneous report from a contactable consumer (patient caregiver). A 72-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported.  She had a kidney transplant 20 years ago, is immunocompromised after receiving the Pfizer covid vaccine. She has already had both of the COVID vaccines. The outcome of the event is unknown.   Information on the lot/batch number has been requested
Severe pain, aching at injection site, constant muscle pain across left shoulder to right shoulder. Muscle and joint pain. Myasthenia Gravis reaction had to have (5) session IVIG. Also having walking gait issues.
Patient was seen on 10/16/2012 and was diagnosed with pregnancy. She had been given a Varicella vaccine on 08/27/2012. She was asked at that time if any chance for pregnancy and was denied. Stated last menses was 08/22/2012.
Client c/o sensation of throat closing at 9:15AM, immediately after vaccine was administered. RN and MD notified. Assessed. 50MG IM Benadryl given at 09:25AM. BP 148/62, HR 64, Resp 18. MD/RN continued to monitor. ALS team contacted hospital to assess client and advised client to be transferred to hospital. Client stated she was feeling better and declined transport. AMA form signed with ALS transport team. Monitored for additional 30 minutes. Client left with husband (driver).
I was feeling well and in good health prior to injection. I received the SHINGRIX (1st treatment dose) at approximately 4pm. I was asked to sit in the waiting room for 20 minutes. Within 5 minutes of injection I began feeling weird and with the following symptoms: foggy vision,  racing heartbeat, dizziness, weakness, overall not feeling right, a significant increase in blood pressure, nausea, spacy feeling. I was taken into the back treatment area where clinical staff and my primary doctor began triage of my condition, especially focused on my blood pressure and heart. My blood pressure continued to rise to approximately 177/123 to my last recollection. I was placed on O2 Sat monitor, EKG measured, and glucose tested. Oxygen was placed. Dr gave orders to call 911 and paramedics arrived taking over the treatment of my adverse reaction to the injection. Paramedics continued triage of my reaction taking a picture of my heart, EKG, and continued BP monitoring. It was indicated I needed to go to the hospital via ambulance. I was placed in the ambulance and taken to Hospital.
Information has been received from a medical assistant referring to a currently 23 year old female patient. The patient's concomitant medication included Vitamin D3. The patient had penicillin allergy and SULFA allergy. The patient had no medical history. On 23-FEB-2018, the patient received the first dose of GARDASIL 9 (intramuscular; strength, lot# and expiration date were not reported) for prophylaxis. On 14-MAY-2018, the patient received the second dose of GARDASIL 9 (intramuscular; strength, lot# and expiration date were not reported) for prophylaxis. On 28-SEP-2018, the patient received the third dose of GARDASIL 9 (intramuscularly in left deltoid, lot# R002345, expiration date was 16-NOV-2020; strength was not reported) for prophylaxis. On an unknown date in 2018, the patient experienced pain at the injection site. On an unknown date in 2018, the patient developed a "bump or cyst" at the injection site. A physician saw the patient on 26-OCT-2018. On the same day, the patient reported she was feeling better and the bump was smaller but she continued with discomfort at the injection site when she slept on her left arm. On the same day, the physician reported there was a 1.5 cm cyst at the injection site and there was no real tenderness with pressure at the injection site. The physician prescribed an unspecified dose of ibuprofen and told the patient to massage the cyst. The physician was unsure if this was a cyst or reaction from the immunization. No lab test was performed. The patient had a follow up appointment on 09-NOV-2018. The outcome of the events was reported as recovering. The causality between the events and GARDASIL 9 was not reported.
This is a spontaneous report from a contactable consumer (patient). A 87-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 25, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced swelling, redness and pain in Mar 2021 (two weeks later). The patient did not receive treatment for the events. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. Outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.