chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). On 02-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved. Not Provided      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.   The  concomitant medications on use were not provided. No laboratory data was provided.  No treatment information was provided.  They had power outage on 01 Apr 2021 and vials were in freezer and refrigerator where temperature dropped to : Frozen vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered and she also received the dose.
This is a spontaneous report from a contactable consumer reporting for herself. This 21-year-old other ethnic group female patient received the fist single dose of TRUMENBA via an unspecified route of administration on 03MAR2015 around 4:30 PM. The patient medical history was not reported. Concomitant medication included KELNOR one capsule by mouth daily for birth control. On 03MAR2015 at 6:00 PMJ the patient experienced high temperature (100.7 degrees F) and a very intense body fatigue on her legs and her back. She administered ibuprofen for the high temperature and temperature was down to 100.3 degrees F on an unspecified date in MAR2015. It was reported that at the time of this report symptoms were still persisting. The consumer asked if it was normal to experience these events after the vaccination.  Follow-up (24MAR2015): Follow-up attempts completed. No further information expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 05-APR-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but instead contracted a persistent strain of shingles. On or about 11-MAY-2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as shingles. She was prescribed VALTREX for management of her painful symptoms. On or about 23-MAY-2016, the patient sought subsequent treatment from a physician for shingles. She was prescribed AVEENO ANTI-ITCH for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Nausea, Vomiting, Consistent Low grade fever, gaging, left side pain. Nausea is usually in the mornings. After 1st vaccine I was sick for about 7 days, but never completely went away, after the second shot it was bad for about 14 days and then still had remaining symptoms.
pt recv vax 8SEP97 & pt devel a local cellulitis @ the inj site;tx w/med;pt recovered;
Devel inc temp evening of inject; devel diffuse skin rash on body; taken to ER-cried prolonged period of time;
An hour after receiving the vaccine my chin became red, hot and itchy. It has continued  to be warm and itchy for the  16 days since I had the shot.
Redness, darkness size of quarter w/a knot in the middle. On the same day, a few blister, raised areas on wrist.
Fever, severe chills, body aches Gave Tylenol, covered with many blankets Lasted from 10:30pm 9/12/20 to about 4:30-5am 9/13/20 He did not sleep well at all during this Gave Tylenol again 5am He slept on/off about 5 hours until 10am Felt better and ate good breakfast  Laid back down about 1pm and currently still sleeping at 3pm now
Received wrong dosage for age 12 and up at age 11 on 6/16/21
Fever of 99.4° after 2 hours  After about 8 hours, developed vertigo, which lasted approx 3 hours  Slight jaw pain started sometime in the first 4 hours Arm pain at injection site after about 1-2 hours, worsened throughout day.
Information has been received from a physician concerning an approximately 16 year old female who on 19-JUL-2006 was vaccinated with HPV rLI 6 11 16 18 VLP vaccine (yeast).  It was reported that "immediately after the injection", on 19-JUL-2006, the patient experienced pain and stinging at the injection site that lasted about 2 minutes and radiated the arm.  The patient also reported feeling faint following the injection and experienced swelling.  It was reported that the swelling went down but the pain persisted.  Unspecified medical attention was sought.  Additional information has been requested.
Headache similar to headache when I had covid-19 in January 2021, nausea and dizziness that has persisted for the last 3 days with increasing severity.
Exhausted; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number unknown and expiry date not reported), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 56-year-old), as dose 1, single, for COVID-19 immunisation in Pharmacy or Drug Store. Medical history included gluten sensitivity and possible celiac. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown if patient had been tested for COVID-19 since the vaccination. After receiving the first dose (unspecified date in Mar2021), the patient went for a run (same day) but was so exhausted he needed to return home and sleep. The following day he had muscle and joint pain, but the subsequent day felt fine. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
third dose of Shingrix today inadvertently; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2019) and Shingrix (2nd dose received in December 2019).   On 10th September 2021, the patient received the 3rd dose of Shingrix. On 10th September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: Pharmacist reported that a patient experienced a 3rd dose of Shingrix inadvertently on the day of reporting which led to extra dose administered. The reporter did not consent to follow-up.
Dizziness, hypertension (BP 196/99) about 10 min after vaccine administration. Symptoms resolved within 20 min & BP came down to 162/92.
On Sunday, July 22, had chills, low grade fever, body aches. Notice 1 small pustule on R wrist (inner aspect), very lethargic. Monday, July 23 approx 12 scattered pustules, temp 100.2, lethargic. Tuesday, July 24, numerous pustules have arisen over night, on my scalp, face, BLE's, back, etc..., temp 99.3. Headache x 3 days, little relief with Tylenol. Called PCP 7/23 Rx for Acyclovir 800 mg began (qid)
Pt contacted this RN and described a rash that extended from right side of abdomen to left side of abdomen with 2 raised patches on each side.
Patient was given vaccine and told do to history of seizures needed to wait in waiting area for 30 minutes.  Patient stated she walked to the bathroom and started feeling dizzy.  She came back to the consultation  window  about 6 minutes later  and reported that she was feeling dizzy.  she sat down on floor in front of pharmacy.  I went and sat with her.  she started complaining that her arms were numb and tingling.  She said her right arm was tingling more than her left.  She then reported her face was feeling numb and her lips looked slightly swollen.  Dialed 911 she then reported increase in heart rate and trouble swallowing.  Went to get EMTS.  They said her blood pressure was up and then guided her out of the store.  Spoke with Patient on 10/02 and she stated that reaction had resolved and she was only feeling fatigue and headache from vaccine.  Does not plan on getting 2nd dose.
arm pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain". Additional information: Patient received his 1st shot on 28Apr2021 and experienced arm pain after the 1st dose. Patient would like to reschedule his appointment from 18May2021 to 21May2021.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Fever began around 11:55am the day after initial vaccination. Chills and fever were reduced by 1:00pm after taking 1000mg Tylenol at 12:10pm. No appetite all day.
Info has been received from an MD concerning a 12 y.o. female who on 9/18/01 was vax'd w/a first dose of Hep B vax recombinant. Subsequently, 10 mins post vax, the PT developed numbness and stiffness in her arms and legs as well as fatigue. According to the reporter, the inject site was mildly swollen and warm. Medical attention was sought and the PT was given ibuprofen (Motrin). On 9/20/02, the PT was reported as doing "better today". Add'l info has been requested.
I63.9 - Stroke (CMS/HCC) I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness
eight or nine days after first vaccine, large red area developed around injection site.  it's about 2.5 inches in diameter, roundish, and red.  the skin is hardened and there is a firm lump under the skin.  mild itching occasionally (i noticed itching first, about six days after injection).  the skin on its surface is warmer than the surrounding area, and feels slightly numb, which is weird.
Soreness on entire right arm and right leg.  Unsure if coincidental or if sciatic nerve bothering. Not interfering with daily activities but noticeable.
At roughly 11:00 p.m., the day after receiving the vaccine, I began vomiting. I tried to drink a glass of water but vomited that up shortly afterward. I vomited a third time maybe an hour or so later. At 2:00 a.m. I got up again and vomited up bile, and then had quite a bit of diarrhea. I don't think it was something I ate within the past day or so because several other people ate the same meals and did not feel sick. It's now 11:00 a.m. the following day and I'm taking it slow and drinking some water that I've so far been able to keep down.
10:00PM Saturday, 4/17/21 Sudden chest pain. Tried to sleep it off, pain lingered all day Sunday 4/18/21. 8:00PM went to local ER with same chest pain, had not gotten better. ER took blood draw, my troponin was 4.6 and doctors thought it was an error since I am 38 years old and otherwise health with no history of chest pain or family history of heat trouble. Second blood draw showed troponin at 5.0 getting worse. They called an ambulance and took me to the hospital nearby. Third blood draw showed 6.0 and I spiked at 10.0 overnight. I had several EKGs, a CT scan, and an angiogram. None of these showed any obstructions or blockages in the heart or blood vessels that could have caused the heart trauma. I had an echocardiogram which showed that my heart is only pumping at 50% which is low for a healthy young person who is a runner. I was diagnosed with myocarditis and with having had a Non-ST Segment Elevation Heart Attack. Again, I have no family history of this, I am otherwise healthy, I do not use drugs and I did not have any trauma to my chest, such as a car accident, that could have caused this. The only explanation is that it was related to the COVID shot, which I had roughly 48 hours before my sudden chest pain
really sick; fever (100.7 ºF); a really bad headache (kind of like a migraine); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), PYREXIA (fever (100.7 ºF)) and HEADACHE (a really bad headache (kind of like a migraine)) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (a really bad headache (kind of like a migraine)). On 15-Feb-2021, the patient experienced PYREXIA (fever (100.7 ºF)). On an unknown date, the patient experienced ILLNESS (really sick). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (really sick), PYREXIA (fever (100.7 ºF)) and HEADACHE (a really bad headache (kind of like a migraine)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100.7 (High) 100.7 degree Fahrenheit.         Action taken with mRNA-1273 in response to the events was not applicable.
shortness of breath; felt warm in her arm; sweating; hot flash.; running nose; throat started to close up; wheezing; swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.) and RHINORRHOEA (running nose) in a 54-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.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.), RHINORRHOEA (running nose), OROPHARYNGEAL DISCOMFORT (throat started to close up), WHEEZING (wheezing) and SWOLLEN TONGUE (swollen tongue). At the time of the report, DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.), RHINORRHOEA (running nose), OROPHARYNGEAL DISCOMFORT (throat started to close up), WHEEZING (wheezing) and SWOLLEN TONGUE (swollen tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included EpiPen.
ABSCESS/ARM DRAINED; This spontaneous report received from a patient concerned a 39 year old white, Not Hispanic or Latino of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once total administered on 04-MAY-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient reported that ,saw a primary care and an orthopedic, sent back to the hospital to had the arm drained and was given antibiotics in the ER. 100 cc was removed and was still draining puss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abscess/arm drained. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210525721-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Abscess/arm drained. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by Reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-068226 (E2B Linked Report). This case was linked to MOD-2021-068321 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068226:SISTER
Lump at injection site; Red and Itchy rash at injection site; Red and Itchy rash at injection site; Red and Itchy rash at injection site; Slight Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Red and Itchy rash at injection site), HEADACHE (Slight Headache), VACCINATION SITE ERYTHEMA (Red and Itchy rash at injection site) and VACCINATION SITE RASH (Red and Itchy rash at injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (Slight Headache). On 14-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Red and Itchy rash at injection site), VACCINATION SITE ERYTHEMA (Red and Itchy rash at injection site) and VACCINATION SITE RASH (Red and Itchy rash at injection site). On 06-Jan-2021, HEADACHE (Slight Headache) had resolved. At the time of the report, VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Red and Itchy rash at injection site), VACCINATION SITE ERYTHEMA (Red and Itchy rash at injection site) and VACCINATION SITE RASH (Red and Itchy rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Ibuprofen  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.   Reporter did not allow further contact; 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.
1/12/05 2:30p onset of chills, 1/13/05 itching of arm, 1/14/05 Whelp with itching, 1/15/05 extended whelp severe itching, 1/16/05 arm throbbed during night, 1/17/05 went to urgent care center Motrin and Benadryl given, 1/20/05 Allegra per Dr.
Child was at health dept for appoint after immunization. Developed raspy wheeze and hives on trunk and legs approx 25 mins later. Epinepherine 0.13mg given Benadryl 0.3ml given IM. Breathing improved shortly after EMS arrived transported to local ER for evaluation. Mother stated no allergies prior to shot then after event stated allergic to Lasex.
On December 28th, 2021 I begin become sick (i.e., chest and nasal congestion, cough, chills,  fever for about 48 hours, and lost sense of smell) for about 4 to 5 days.
12/12/21 presents to EC ED for "worsening hallucinations". PMHx of "conversion disorder and schizophrenia"
rash was itchy; Red sensitive rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red sensitive rash) and RASH PRURITIC (rash was itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red sensitive rash) and RASH PRURITIC (rash was itchy). On 28-Mar-2021, RASH ERYTHEMATOUS (Red sensitive rash) and RASH PRURITIC (rash was itchy) 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 treatment was given.; 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.
Beginning approximately 12 hours after the vaccination administration: Chills, body aches, headache, severe dizziness and weakness, nausea, dry mouth, severe somnolence. Treatment: ibuprofen.  Partial resolution approximately 36 hours later.  Full resolution at 72 hours after vaccination administration. Noticed a red rash near injection site on day 3, unsure of when it appeared because too debilitated to have been able to see it.  Rash resolved by day 4.
Initial misuse report received from a healthcare professional (nurse) on 23 October 2013 and the case was received on 21 March 2014. It was reported that the patient (date of birth and gender was not provided) had subcutaneously received a dose of FLUZONE HD on an unspecified date. No adverse event was reported.