chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching all over body; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over body) and RASH (rash all over body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     No medical information was provided.     On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (itching all over body) and RASH (rash all over body). The patient was treated with CALAMINE for Itching and Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching all over body) and RASH (rash all over body) outcome was unknown.            concomitant medications include blood pressure medications. Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of the event updated from unknown to resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 at 15:00 as dose 3 (booster), single (Lot number: EL9264) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive; (08Jul2022) Negative; (10Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 02Jul2022 to 07Jul2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. After testing negative for Covid on 08Jul2022 and 10Jul2022.  On 11Jul2022 at 06:00 am, the patient woke up with a new sore throat and tested positive for Covid on a rapid test. The patient assumed she had "Paxlovid rebound". Product Quality Group provided investigational results on 12Jul2022 for bnt162b2: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9264 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
diagnosed with COVID-19 on 8/7/21, symptom onset on 8/5/21.  household contact
headache; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.     On 02-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient wanted to know if she could take something to help with the pain. Treatment medications were not reported.
Vaccine Administration Error (Invalid Dose; Off-Label Use); administration of the Moderna COVID-19 Vaccine to a 17 year old male; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine Administration Error (Invalid Dose; Off-Label Use)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of the Moderna COVID-19 Vaccine to a 17 year old male) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine Administration Error (Invalid Dose; Off-Label Use)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of the Moderna COVID-19 Vaccine to a 17 year old male). On 17-May-2021, PRODUCT ADMINISTRATION ERROR (Vaccine Administration Error (Invalid Dose; Off-Label Use)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of the Moderna COVID-19 Vaccine to a 17 year old male) had resolved.        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.   No concomitant products were reported. No treatment information was provided.
Patient recieved the pfizer.  Her 1st shot approximately 712p, She felt "heavy" shortly after shot. 732p 50mg of Benadryl was given as she describes tingly and swelling of throat.  The Benadryl appeared to relieve symptoms and patient asked to leave at 755pm.  Patient was Conscious and alert through reactions, and no outward symptom seen.
Fever, decrease range of motion right arm, fatigue, low back pain, 2.5 cm erythema lateral arm at sq. site. tender axillary- RX- Ibuprofen; Claritin B,D 2 pack;
The employee kind of tasted the vaccine then had tingling sensation on the sides of her tongue. After several minutes, her sides of tongue was numb. After 4 hours, she felt fine but had that tingling sensation on the side of her tongue still
VACCINE ALMOST KILLED ME; WARPED MY HEART; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine almost killed me, and warped my heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine almost killed me and warped my heart was not reported. This report was non-serious.
Throat swelled up; This is a spontaneous report received from a contactable consumer or other non hcp.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGEAL SWELLING (death), outcome "fatal", described as "Throat swelled up". Caller stated her first cousin died right after. Clarified that her cousin lived two weeks after, but they had to put her in hospice the day after she got the COVID vaccination. Her throat swelled up to the point it killed her. The patient date of death was unknown. The reported cause of death was throat swelled up. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Throat swelled up
pain in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 09Mar2021 (Lot number: EN6204) at the age of 39 years as dose 1, single and administration date 30Mar2021 (Lot number: ER8732) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered" (12Mar2021), described as "pain in right arm". The event "pain in right arm" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity. Additional information: Clinical course: The patient got his first vaccine on 09Mar2021 and had a side effect (pain) the following day (10Mar2021) in his right arm. It lasted for 48 hours and went away. Then a week later, it came back 10 times worse than the previous occurrence, and now it's never left/ it's not going away (event still present after dose 2 administration). The patient went to the urgent care and was given steroid to hopefully help with the pain, but it didn't do anything.  No follow-up attempts are possible. No further information is expected.
w/in 24hrs of vax pt lt arm,especially @ inj site reddened,hard,warm to touch & itching;hand was cramping;saw MD 13JUL95;dx as d/t TD-Duricef & Hydramine given
By the evening, the patient reported having a very sore arm, hives around the site of the injection, cold sweat that lasted into the next morning. There was continued redness/itchiness and rash on the left arm for approximately 4 days.
Patient was due for the Hep A vaccine. When I went to get the vaccine he was due to get I grabbed what I thought was Hep A from the fridge and prepared. I grabbed Tdap instead. I then administered to the patient in the left thigh. I realized afterwards when charting that this was the wrong vaccine. I immediately notified the provider who notified the parents. No treatment needed and no negative outcomes from this event.
This spontaneous report was received from a consumer refers to her daughter as 11 year old female patient. Medical history not reported. Current conditions included allergy to amoxicillin and mild asthma. On an unknown date in June 2016, the patient received her first dose of GARDASIL along with tetanus toxoid (Diphtheria toxoid (+) Pertussis acellular vaccine (unspecified) (+) TE and (unspecified). On an unknown date in June 2016, following the vaccines, the patient was sitting on the exam table and had her eyes roll back and her arm went across her chest and her mom eased her down from the sitting position and she fainted for about 10 seconds and was a little disoriented. On an unknown date in 2016, following the events, everything seemed to return to normal and she participated in dance class that evening. The reporter also mentioned that the patient was particularly anxious that day. The outcome of the events was reported as recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Pt complained of nausea, weakness, fatigue, shaky, cold sweat, headache, knot and some heat at injection sight. All symptoms appeared 1 day after injection given. Pt took b/p at home and reading was around 105/52. Denied Diabetes but did state she has history of hypoglycemia a couple of times in the past. Encouraged pt to see md if symptoms continue and discussed s/s of arm and when to seek medical attention.
I had no real side effects for first two shots. Just pain at site for a couple of days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 11:00 (Lot number: SW6208) at the age of 56 years as dose 1, single and administered in arm left, administration date 09Apr2021 11:00 (Lot number: EN6208) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Scallops" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "I had no real side effects for first two shots. Just pain at site for a couple of days.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient told she had no real side effects for first two shots. Just pain at site for a couple of days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Rash on chest and body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on chest and body) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced RASH (Rash on chest and body). At the time of the report, RASH (Rash on chest and body) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up On 03-Aug-2021: TCR received - NNI FU and denied consent for FU
12hr p/vax pt devel fever, sweating & chills;pt recovered w/in 12hr;
Flu shot given 10/7/05 AM about 0800. About 12h later, pt rash developed on pt's neck and face that progressed to swelling of eyelids and lips. Pt treated with Benadryl and Relone.
The pt experienced chills, sweating, generalized achiness, loss of appetite, elevated temp. These symptoms started on 9/12/01. The pt reported them on 9/14/01. The pt recovered on 9/17/01.
2-3 weeks subsequent to receiving one dose of varicella virus vaccine live the pt developed 1-2 sores in his mouth with fever.  Several days later the pt was seen in a clinic with approximately 20 lesions covering his legs and back with a temperature of 103F. The pt was diagnosed with foot and mouth disease.
PT REPORTS ABOUT 1 1/2 HRS POST INJECTION HAVING DIFFICULTY BREATHING, COUGHING, CHILLS, AND FEVER (100.2). WENT TO ER AT HOSPITAL. WAITED 2 HRS TO BE SEEN. PT TOOK OWN TYLENOL THAT SHE BROUGHT WITH HER AND LEFT ER PRIOR TO BEING SEEN BY MD. PT STATES SHE FELT BETTER AFTER TYLENOL.
Swelling to the area (swollen from shoulder down arm), redness, hot to touch, skin tight.
Initial information regarding an unsolicited valid non-serious case received on 27-Sep-2018 from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274521, 2018SA274524, 2018SA274525, 2018SA274520 and 2018SA274523 (same reporter). This case involves a 80 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 10-Sep-2018. The patients past medical history, concomitant medication(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage (doses were not viable from shipping excursion, doses were given to nine patients). It was reported that vaccine took 3 days to deliver. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Mild twinge of soreness in arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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), outcome "unknown", described as "Mild twinge of soreness in arm"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The evening after receipt of vaccine I experienced extreme fatigue, fever of 101 and severe headache. After 2 days the fever abated however 6 weeks later I am still getting daily headaches that worsen as the day progresses and for at least 4 weeks after was experiencing daily vertigo. after 5 weeks I had office visit with my internist Dr who agreed that symptoms were likely triggered by the booster. I also saw a neurologist on October 26, 2021 and he agreed that symptoms were triggered by the Moderna booster. while I was given Trazasdone, various supplements and take xtra strength Tylenol, nothing as been effective
Moderna COVID-19 Vaccine EUA injection side pain, swelling and redness, fatigue, muscle and joint pain, chills, nausea. also some dizziness, and weakness, no energy. This is still ongoing on 3/12/2021,  10:00AM MST
Systemic: Chills-Medium, Systemic: BLOOD PRESSURE WAS AT LEAST 150/90, HEART RATE WAS UP TO 100 BY THE TIME PARAMEDIC SHOWED UP; symptoms lasted 1 day
Patient has "bubbles" at site of where the varicella vaccine was given on 6/24/2015.
Information has been received from a father concerning his 10 week old daughter with no medical history who on approximately 28-NOV-2007 was vaccinated into the leg with a first dose of PEDVAXHIB (OMPC).  Concomitant therapy included (therapy unspecified).  On approximately 05-DEC-2007 ("within a week of receiving vaccine") the patient experienced swelling at the injection site, respiratory virus and ear infection.  The patient's swelling at the injection site and respiratory virus and ear infection persisted.  Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies were reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: 7 days free of symptoms and negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Other medication in 2 weeks was reported as No. The patient received Anti-viral COVID 19 treatment Paxlovid from 08Jul2022 to 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt came to ER c/o chest pain, SOB, nausea, vomiting, syncope, and diarrhea.
BODY ACHES; REMAINED IN BED MOST OF THE TIME; FELT OFF; ILL; CHILLS; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, remained in bed most of the time, felt off, ill, chills, fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, fatigue, body aches, headache, remained in bed most of the time, felt off and ill was not reported. This report was non-serious.
No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 05-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005133: US-009507513-1904USA005629: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005627:
PATIENT GOT A SECOND DOSE OF JOHNSON AND JOHNSON COVID 19 VACCINE WHEN ITS ONLY SUPPOSED TO BE ONE DOSE. IT WAS EXPLAINED TO THE PATIENT THAT THIS VACCINE IS SINGLE DOSE ONLY BUT HE DID NOT SAY IT WAS HIS SECOND DOSE ALREADY. WE FOUND OUT WHILE BILLING THE SECOND DOSE.
Patient states to still suffer pain from the distal portion of her deltoid area and the upper portion of her tricep on the injection arm. She states that it was painful during injection and administration, but it has improved over the past few months.