chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 53-year-old female patient with hypertension. The patient had no drug reactions or allergies. On 31-MAY-2016, the patient received an expired dose of PNEUMOVAX 23 injected intramuscularly (lot # K020214 with expiration date at 25-MAR-2016; dose and anatomical location were not reported), for prophylaxis. The patient was taking concomitantly carvedilol (COREG), furosemide (LASIX), lisinopril (manufacturer unknown), dabigatran etexilate mesylate (PRADAXA), pantoprazole sodium (PROTONIX), nitroglycerin (manufacturer unknown), fluoxetine hydrochloride (PROZAC) and amlodipine besylate (NORVASC). On 30-AUG-2016, the patient received her second dose PNEUMOVAX 23 injected intramuscularly in the left arm (lot # L005563 with expiration date at 03-NOV-2016; dose was not reported), also for prophylaxis. On 31-AUG-2016, the patient's entire left arm swelled and was warm to the touch. Additionally, the patient was nauseous. She sought medical attention and on the same date she was seen at the clinic in regards to the reaction. No laboratory diagnostic studies were performed. The patient was prescribed promethazine hydrochloride (PHENERGAN) as a treatment for the nausea and cephalexin (KEFLEX) as a treatment in case of infection. On 03-SEP-2016, the patient felt better. On 06-SEP-2016, when the patient was seen at the office, she was recovered. The causality assessment between aforementioned events and the vaccination with PNEUMOVAX 23 was not assessed. Additional information is not expected since the reporter did not wish further contact.
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; The patients have not reported any adverse reactions; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    This case considered of 4th patient out of 16 patients. Concomitant product use was not provided by the reporter. Patient received additional booster. It has been reported that 26 patients received bivalent vaccines from 2 different Bivalent lot numbers on 09-Jan-2023 they were lot numbers: 061F22A and AS7170B. For all 26 patients vaccine cards lot number has been written as AS7170B. For 16 patients Vaccination Cards reflected the wrong lot numbers. Additionally, it has been reported that all patients received the correct vaccine and bivalent dose and the error only involved in documentation. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:Master case
PATIENT WAS TO RECEIVE HPV DOSE #2 & HEP A DOSE #1. HOWEVER, WHILE GETTING THE VACCINES OUT APPARENTLY 2 HPV VACCINES WERE TAKEN OUT & GIVEN TO THE PATIENT IN SEPARATE SITES. THIS WAS NOTED WHEN THE OFFICE DID THE VACCINE COUNT AT THE END OF THE MONTH (7/29/22) & IT WAS OFF. AFTER FURTHER INVESTIGATION IT WAS CONCLUDED THAT THE PATIENT ABOVE RECEIVED 2 HPV VACCINES INSTEAD OF ONE HPV & ONE HEP A.  A PHONE CALL WAS PLACED TO THE LOCAL HEALTH DEPARTMENT (8/1/22) TO SEE IF THERE WAS ANYTHING SPECIFICALLY THAT NEEDED TO BE LOOKED FOR & PER THE STATE NURSE THE MOST LIKELY ISSUE WOULD BE AN INCREASED RISK OF A LOCALIZED SYSTEMIC REACTION. THERE WAS NO PHONE CALL FROM MOM REGARDING ANY IMMEDIATE REACTIONS BY THE PATIENT.  WHEN THE SITUATION WAS DISCUSSED WITH THE MOM (8/5/22), SHE STATED THAT THE PATIENT ONLY HAD MILD SWELLING & MUSCLE SORENESS BUT WAS OTHERWISE FINE.
Pt reported symptoms of weakness, headache, fever, nausea, soreness at injection site.
38 year old female received the Pfizer-BioNTech Covid-19 Vaccine and subsequently developed DVT.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 38-year-old female patient received bnt162b2 (BNT162B2) (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: DEEP VEIN THROMBOSIS (medically significant), outcome recovered (2021), described as 38-year-old female received the Pfizer-BioNTech Covid-19 Vaccine and subsequently developed DVT.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Deep vein thrombosis cannot be established. 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.
Patient had both vaccines. No immediate adverse effects. Was also having venipuncture for routine labs. Required two venipunctures. During the second venipuncture attempt, he stated he was "woozy" and briefly lost consciousness. Had stable pulse and respirations throughout. Walked out of clinic without any complaints. Both vaccines injections sites were stable.
SWELLING AND REDNESS ON THE SIDE OF THE SHOT, SWELLING AND REDNESS ON BOTH UNCLES, BENADRYL 50MG IM WERE GIVEN TO THE PT. IN OUR OFF.
severe left arm pain on injection site, unable to move arm properly, taking Ibuprofen for pain
Sore throat; Fever; Nausea; Muscle pain; Joint pain; Vomiting; This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a male patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and VOMITING (Vomiting). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use included drug for enlarged prostate and antibiotic. Treatment medication use was not provided by the reporter.
Tingling in Left arm  EMS notified. VS taken BP 128/97 P-90 RA 96%
'I' have been having episodes of severe vertigo shortly after the second dose.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 08Aug2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Jul2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, the patient had episodes of severe vertigo shortly after the second dose. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had episodes of severe vertigo shortly after the second dose was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Narrative:  Hospitalization, COVID positive and fully vaccinated upon admission, critical care admit for shortness of breath and COVID positive
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 17-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R018143 for prophylaxis (dose, strength, route of administration, and frequency were unknown). No adverse effects were reported. On an unknown date, the VARIVAX vaccines suffered from a temperature excursion of -9°C to 8°C during 2 Hours and 10 Minutes. No previous temperature excursions were reported. Digital data logger was involved.
At the Time of the vaccination I felt OK no symptoms but now I feel flushed my arm sore and I have a weird pain on my left upper chest and chills
1015  Patient administered initial dose of  Pfizer Covid-19 vaccine by pharmacist. Physician at  bedside.   1038   Patient  stated she her tongue felt  odd  stated "it felt  like it  didn't belong in my mouth " She  reported  difficulty swallowing  and  that  her mouth/throat  felt "sticky" Patient assessed  speech  pattern and  tone  were changed  from earlier. No  gross  edema observed in mouth tongue or lips. Patient  placed on bedside monitor.  Physician notified. 20 ga PIV started  right AC  patient  tolerated  well.  Dr  at  bedside  Physician administered Auvi-Q 0.3 mg Epipen  to  patients right outer  thigh. 25mg Benadryl , 125 mg Solumedrol, and  20 mg Pepcid  given  IV by nurse  1103 patients voice has returned  to normal  patient  denies  any respiratory  difficulty.  1140  Patient denies  respiratory distress/difficulty  states mouth is  back to  normal at this time.
Fever, NauseaVomiting, chills, swelling to left upper arm Narrative:
diffuse, maculopapular, nodular rash she reports started within days of the second vaccination.  Resolving at time of her annual wellness appointment with me on 6/25/21
Pt received ProQuad and Varicella at the same office visit along with the other 1 yr immunizations. Pt is doing well
After receiving Lymerix (dose and series not provided), the pt's symptoms "immediately and serverely worsened". The moste recent information received on 2/17/2000, indicates that the pt continues to experience joint  inflammation and fatigue. Additional information has been requested.
Pt reports child got a knot on his arm after they vaccine and she thought it was normal but it has continued to get bigger. She has tried giving TYLENOL the child has pain and itching. Pt has area on LD that is approx. 8 x 3 1/2 " bright red and warm to the touch.
3 days later my husband completely lost feeling on his left side and ended up with three strokes at once and three more we can have later has been since left after sit in a facility he spent 6 weeks in the hospital when it first happened and like I said it's paralyzed now and I'm not facility and I'm having a hard time getting insurance for him for long-term care
After my second immunization I experienced extreme fatigue lasting approximately 24-36 hours after the vaccination, a headache that lasted the same amount of time, and a mild-grade fever (100-101 degrees F) during the same timeframe.
I'm getting up and I feel like I was hit by a truck; the arm I got it in started hurting a lot, I can hardly move my arm; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (I'm getting up and I feel like I was hit by a truck) and PAIN IN EXTREMITY (the arm I got it in started hurting a lot, I can hardly move my arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 test positive (COVID positive) on 16-Jun-2021, Chronic bronchitis since 05-Jan-2017 and Type 2 diabetes mellitus since 07-Jan-2015. Concurrent medical conditions included Drug allergy (Percocet), Drug allergy (Tylenol with Codeine), Drug allergy (Oxycontin) and Drug allergy (Compazine). Concomitant products included LANSOPRAZOLE for Gastritis, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Herpes NOS, LISINOPRIL for Hypertension, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Major depressive disorder, BUPROPION for Smoking cessation therapy.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (I'm getting up and I feel like I was hit by a truck) and PAIN IN EXTREMITY (the arm I got it in started hurting a lot, I can hardly move my arm). At the time of the report, MALAISE (I'm getting up and I feel like I was hit by a truck) and PAIN IN EXTREMITY (the arm I got it in started hurting a lot, I can hardly move my arm) 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.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: added vaccination details, medical and drug history
Diffuse tenderness, redness with 1-2 plus edema. Sl. warm to touch T. 99.4 po. Increased cough with deep breathing. Tx with TYLENOL, antihistamines.
MD states pt shrieked when IPV given;pt cried for 1/2hr & was fussy that day;MD suspected pt had gross motor delay & social delay;report dated 16JAN97 from tricounties reg ctr states pt has delayed gross motor & cognitive per MD;
Began with lesion at the vaccination site. 1 cm crusted area. Centany cream TID x 7/10 days to lesion.
1st dose of the Pfizer Covid19 Vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose; 1st dose of the Pfizer Covid19 Vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history concomitant medications were not reported.  The patient experienced 1st dose of the Pfizer Covid19 Vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose on 2021. The events assessed as serious (Medically significant). The reporter also mentioned that she does not know why she needed to call back because she already received information for her query regarding the spacing of the 2nd dose and 1st dose of the Pfizer Covid19 vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose. They were referred to their HCP. She mentioned that she will be receiving the 2nd dose by next Monday. Reporter mentioned that patient already made a safety report, E-transferring to DSU, Possible AE Duplicate. The outcome of the events was unknown.  Information on lot/ batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be totally excluded,Linked Report(s) : US-PFIZER INC-2021329898 same reporter/ AE/ Drug, different pt.
In June following my vaccine, my menstrual cycle started unexpectedly and very heavy after several years (~3) of being gone. My doctor and I had determined I was though menopause. My period has continued for 2 more months and I don't know what next month will bring. I didn't think of this as a vaccine related event, however I've seen more and more discussion on menstrual issues in the news - including some reputable articles now. I decided to report this in the event you are trying to track these occurrences to see if there is any correlation to the vaccine.
hospitalized 1/1/21 with atrial fibrillation/myocarditis
Tinnitus; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the right arm on 27Mar2021(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as hypothyroid) and back pain. Concomitant medications taken within two weeks prior to vaccination included levothyroxine (MANUFACTURER UNKNOWN), pantoprazole sodium sesquihydrate (PROTONIX), vitamin d nos (VITAMIN D), ibuprofen (MOTRIN) and calcium (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: eng6198) via an unspecified route of administration in the right arm on 04Mar2021 at 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
he was noted to be hypoxic with oxygen saturations in the 80s, with associated fever and cough admitted to Hopsital from  Inpatient Rehab at clinic
Rash on his arm; Sweating; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th January 2021, 12 hrs after receiving Shingrix, the patient experienced sweating and vomiting. On 26th January 2021, the patient experienced rash. On an unknown date, the outcome of the sweating and vomiting were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the sweating, vomiting and rash to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient stated that, about 12 hours after vaccination, the patient had sweating and vomiting and were resolved. The patient stated that 3 days ago, the patient developed a rash on his arm and was not recovered. The patient did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021022953:same reporter US-GLAXOSMITHKLINE-US2021022954:same reporter
Inconsolable crying last evening (7-15-09) x 4 to 5 hours. Would not walk at that time.
On 12/12/14, I had the PNEUMOVAX 23 vial shot in my left arm. From that time on my arm has been in pain from the spot where I received the shot to my wrist. This pain is there 24/7. I have been seen by Dr's and all they can say is it will take all time to sometimes to heal.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date, the patient (reported as patient's sister) was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). No concomitant medications were reported. The patient developed polymyalgia after ZOSTAVAX administration on an unknown date. The patient sought medical attention (details unspecified). No product quality issue was involved. The outcome of polymyalgia was unknown. Additional information has been requested.
Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
VOMITING, FEVER RED AREA MOM STATED CHILD "BREATHING FUNNY. PLACED ON ORAPRED AND BENADRYL.