chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in arm; swollen arm; discomfort in arm; A spontaneous report (United States) was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in arm, swollen arm, discomfort in arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) pain in arm . On 13 Feb 2021, the patient experienced the event(s) swollen arm . On 13 Feb 2021, the patient experienced the event(s) discomfort in arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in arm was unknown.The outcome of event(s), swollen arm was unknown.The outcome of event(s), discomfort in arm was unknown..
Pt received his 2nd pfizer covid 19 vaccine on March 11 (the lot number was not written on the card unfortunately) and was hospitalized from 5/21-6/4 with new onset profound hypotension and new onset atrial fibrillation with a bradycardic rate.,requiring ICU admission and pressor support. He presented with a fall and was found to be profoundly hypotensive. Sepsis was ruled out and the cause was unclear. He was eventually started on midodrine . He did not require any rate controlling medication. His daughter did not want anticoagulation ordered due to risk outweighing benefit. He was diagnosed with new autonomic dysfunction and new atrial fibrillation and discharged home on 6/4/21
06/28/2021 went for annual check with my primary doctor and he found my liver functions were elevated and recommended an ultrasound. I went last Monday (7/19) for ultrasound and was referred to a gastroenterologist; my first visitation with him was on Thursday (7/22) and he recommended more blood tests and have been getting results but have not seen him as of yet but it appears that I have autoimmune hepatitis. This is the first time that happens - I have elevated liver.
Sore throat and nasal congestion first week. Second week went to PCP for right ear pain. PCP saw infection on both ears but right eardrum was Ruptured. Second Vaccine on 2/3/21 and my symptoms for two days where headaches, fever, chills, body aches. 4 days later left ear had discharged, next day saw PCP ear infection worse. Given stronger antibiotics to take for 10more days. The next day 2/9/21 my ear was starting to swell, went to the ER and was admitted for severe ear infection.  Was discharged from the hospital on 2/15/21 with a midline on my right arm to continue home health with the antibiotics through a syringe.
8/16/2022 5:30 pm: Difficulty breathing with O2 saturation room air 87%, 5L oxygen via N/C applied. Improved O2 saturation 93-95%.
The patient experienced no symptoms; a shipment of PNEUMOVAX 23 was due to be delivered on 26-FEB-2020 but was not delivered until 27-FEB-2020; This initial spontaneous report was received from a nurse, referring to a patient of unknown age and gender. This case concerns 1 patient and 1 combination product. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 05-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration and vaccination scheme were not reported; lot number S029542, expiration date 10-JUN-2021) as prophylaxis. The vaccine was supposed to be delivered on 26-FEB-2020, but was not delivered until 27-FEB-2020 (product distribution issue). The patient experienced no symptoms.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA004890:
Information has been received from manufacturer for hep B virus vaccine. This was originally reported by a RN concerning a 41 year old female with no past medical history and no known drug allergies who on 4/18/03 was vaccinated in the right arm with a first 20mcg dose of hep B virus vaccine (645173/1210M). Prior vaccination included the first series of hep B virus vaccine completed in 1995. The pt did not have antibodies when tested later so they decided to give another series. Concomitant therapy included Xanaflex, amitriptyline hydrochloride and a dose of tetanus toxoid administered on 4/9/03. On 4/19/03, the day after vaccination, the pt reportably began experiencing flu-like symptoms, described as general malaise, profuse sweating and chills, and joint pain. The pt also developed a rash on an unknown date that lasted about a week. The pt noted that the symptoms (other than the rash) lasted the whole month and were present on 5/21/03, when she received her fifth dose of the second series of hep B virus vaccine (637001/1032K). After receiving the second dose of the series, the symptoms" seemed to get a little worse." In late May, the pt saw her family doctor and was prescribed Wellbutrin for a diagnosis of "viral type illness and depression." After she started the Wellbutrin, the nurse practitioner stated that the symptoms went away. However, she also noted that the pt made a trip to the ER in early June for neck and joint pains. A workup at time only showed minimal lab abnormalities. The nurse noted that the pt is now "fine." The outcome of the flu-like symptoms and the rash are recovered. There were no adverse events following previous vaccinations. Information was received which pertained to events which occurred approximately 1 month after vaccination with hep B virus vaccine. This info contained the following adverse experience: viral type illness (late May) and depression (late May). Additional info is not expected.
Client came to vaccine clinic, did not bring his previous card and was given Pfizer instead of Moderna. He just recently noticed the difference in vaccines when he found his first vaccine card. He denies having any illness, problems or complications after either vaccine.
Vomiting. Onset of symptoms under 1 hour from time of vaccination. No need for additional care or treatment.
Developed redness and swelling at the site of the injection.  Redness and warmth continued to spread down the arm, covering a large area of the left arm.  Seen in office, diagnosed with cellulitis and started on oral antibiotics.
Interaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male 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: DRUG INTERACTION (non-serious), outcome "unknown", described as "Interaction".  Additional information: The reporter wanted to know if there were any problems with diabetes medicine and COVID vaccine. The reporter clarified that the patient already had problems with interaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up with severe pain in right upper arm.   Eventually was diagnosed with PMR; the pain also going to both arms and hips.
severe joint pain w/weakness (loss of strength) involving multiple joints lasting 11 days; rest @ home; Advil 600mg 4+ times daily;
Chills: intermittent during a 12-hour period. Treatment: rest. Fever: low grade, during 12 hour period. Treatment: rest/fluids. Body aches: 24-48 hours. Treatment: rest, and took Aleve starting 36 hours after vaccine dose. Fatigue/weakness: 48-72 hours. Treatment: rest. Headache: 48-72 hours (turned into migraine with nausea/vomiting). Treatment: sumatriptan
SM. RECEIVED SMALLPOX ON 2OCT2008. SM. DID NOT KNOW AT THIS TIME HE WAS ALLERGIC TO LATEX. WAS ASKED PRIOR TO VACCINATION. SM. DEVELOPED HIVES ON ARMS, CHEST, STOMACH, AND ARMPITS.ALSO SWELLING OF THE THROAT 1 TO 2 DAYS AFTER VACCINATION.  SM. FOUND OUT ABOUT ALLERGY TO LATEX IN ANOTHER PROCEDURE BY A DIFFERENT CLINIC. WAS GIVEN ANTIBIOTICS, BENADRYL, AND NEW ALLERGY TAGS WITH LATEX ADDED TO THEM.
No additional adverse event; Caller reported expired dose of RECOMBIVAX was administered.; This spontaneous report was received from a medical assistant and refers to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 11-JAN-2023, the patient was vaccinated with an expired dose of with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, at a dose of 0.5 milliliter, lot #U019135, expiration date: 22-NOV-2022 who had been verified to be a valid number and established the same date, administered for prophylaxis (strength and anatomical site of injection were not provided) (expired product administered).
vomiting; flu like symptoms; bedridden; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced vomiting, influenza-like symptoms and bedridden. On an unknown date, the outcome of the vomiting, influenza-like symptoms and bedridden were recovered/resolved.   It was unknown if the reporter considered the vomiting, influenza-like symptoms and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per the vaccine indication. The patient experienced significant reactions after receiving Shingrix. The patient was bedridden with vomiting and flu like symptoms for 2 days. The reporter consented to follow up. This case was linked with the case US2019186076, reported by the same reporter.
27yr old patient with history of T1DM and other comorbidities presented to office for Pneumococcal Polysaccharide 23-Valent (Pneumovax-23) on 2/22. Patient previously received Pneumococcal Conjugate 13-Valent (Prevnar 13) on 12/20/21 with no issues.  RN administered Pneumococcal Polysaccharide 23-Valent (Pneumovax-23, LOT # U021995) IM in patient's left deltoid. On 2/23 0845, patient contacted office noting "overnight left arm swelling down to elbow, firmness/warmth to touch and redness". Pain 10/10, treated with ibuprofen and ice. In AM, swelling no mid-arm, pain 5/10 with continued warmth/redness and firmness. Virtual visit on 2/23 in which patient noted tingling on left side of face once overnight however, overal In AM, swelling no mid-arm, pain 5/10 with continued warmth/redness and firmness. Virtual visit on 2/23 in which patient noted tingling on left side of face once overnight however, overall swelling and pain improved. Provider recommended cetirizine (dosing not specified), diphenhydramine 25-50mg Q6H PRN itching, and OTC H2 blocker twice daily until symptoms resolved. No further documentation in chart regarding reaction.
Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling like when you get anesthesia from a dental procedure and it is thawing out.  It was just the left side of my face, same side I got the vaccine. Could feel a dividing line in the middle of my face.  It lasted with the same intensity for 3 days.  It then started to subside slowly for the next 3 days and then was totally gone.
05-Feb-2021: vomiting, nausea, dizziness 06-Feb-2021: fever, chills, body aches, fatigue, tiredness, vomiting, nausea, headache, pain at injection site, dizziness 07-Feb-2021: fever, body aches, fatigue, headache, pain at injection site, eye pain, eye swelling, night sweats 08-Feb-2021: pain at injection site, tiredness, fatigue, nausea, facial swelling, eye pain, eye swelling, tongue swelling and tingling, dizziness
onset of severe body ache;extremely severe diarrhea, hypovolemia & syncope;tachycardia & low BP, weakness;unsteady when first get up but able to walk normally;post vaccine synd;
itchy; red; hot; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash), PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included MERCAPTOPURINE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Rash). On 13-Mar-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot). The patient was treated with CLINDAMYCIN at an unspecified dose and frequency and CLOBETASOL PROPIONATE at an unspecified dose and frequency. At the time of the report, RASH (Rash) was resolving and PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a registered pharmacist concerning a patient who on 13-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). This was a human error. No adverse experience reported. The patient sought medical attention, consulted with pharmacist. There was no product quality complaint. Follow-up information has been received. The pharmacist was unable and could not provide details for the product confusion. A family practice office had called in to ask the pharmacist if there was a waiting period between the time VARIVAX (Merck) was given and the time ZOSTAVAX could be given to the patient. Additional information is expected.
pt recvd measles vax & laboratory evaluation in 1992 revealed that pt did not seroconvert; no further details were provided;
developed insomnia.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 74, Unit: Unknown) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 02Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient received his first Pfizer Covid vaccine on 02Mar2021. Immediately after the vaccine he developed insomnia. For the next 10 days he reported he would get about 1-2 hours of sleep. Patient is scheduled for the second Pfizer Covid vaccine on 30Mar2021 and he was asking if he should receive the second Pfizer Covid vaccine. Patient wanted to know if he should expect the same reaction with the second vaccine and if so how long. If same reaction is expected with second vaccine patient wanted to know what he can take for the Insomnia. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
RASH ON BACK OF NECK, ARMS, ABDOMEN, AND LOWER BACK AREA. PT STATES THE AREA ARE ITCHY AND RED. NO DISCHARGE FROM SITES. SELF TREATED WITH CORTISONE CREAM.
Form completed with dob 9/25/2008, per insurance 9/25/2009, tried to confirm with patient parents, left message but no call back
Patient's significant other reported to supervisor that patient fell ill later on that night and stated that he had a very bad reaction. The next morning, when she woke up, the patient was on the floor. She called emergency help and was hospitalized.
COMPLAINS OF RIGHT SIDED FACIAL WEAKNESS.  PROBLEMS CLOSING RIGHT EYE. TREATED WITH VISINE AND PREDNISONE 20 MG 2 TABLETS DAILY.  SENT TO EMERGENCY ROOM FOR FURTHER EVALUATION
Hepatitis B antibody titers were low; Off-label use (5 year old); On 19-OCT-2022, a spontaneous report was received from a consumer regarding a 5-year-old female who was potentially administered PREHEVBRIO (hepatitis B vaccine, recombinant; unknown manufacturer of hepatitis B vaccine administered and PREHEVBRIO cannot be excluded).  Medical history and concomitant products were not reported. On an unspecified date, the patient started hepatitis B vaccine series, potentially, of PREHEVBRIO (unknown manufacturer) at an unknown dose, route, and frequency for an unreported indication.   On an unspecified date, after completing the hepatitis B vaccine series, the patient experienced low hepatitis B antibody titers and was subsequently administered a hepatitis B vaccine booster (unknown manufacturer [PREHEVBRIO cannot be excluded] and dose; off-label use due to age). The reporter queried if the patient contracted hepatitis B because she was not immune (her antibodies were low) or was it because she was possibly sexually assaulted and contracted it (hepatitis B) from an infected person. Additionally, the reporter did not know what manufacturer of hepatitis B vaccine the patient received as her primary series nor her booster; and they read information on hepatitis B on the CDC (Center for Disease Control) website and found it's (PREHEVBRIO) contact number on a hepatitis B website. As of 19-OCT-2022, the event outcomes of low hepatitis B antibody titers and off-label use were unknown. No additional information was provided and the reporter declined follow-up.; Sender's Comments: Company comment: A 5-year-old female completed the hepatitis B vaccine series. She had low hepatitis B antibody titers and received a hepatitis B vaccine booster (manufacturers unknown for both). The child's mother queried if the patient contracted hepatitis B because her antibodies were low or a possible sexual assault by an infected person. The outcomes of low hepatitis B antibody titers and off-label use were unknown. Based on the information provided, a causal relationship cannot be determined. As per product labeling, the safety and effectiveness of PREHEVBRIO have not been established in individuals less than 18 years of age.
Swelling, pain, itching, hot to touch, and redness at site of COVID vaccine injection (left deltoid). No treatment, cold compress used once. Aches in lower back and hips lasting one day after vaccine administration.
cough; sore throat; very nauseated; fatigue; dizzy; sick; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ILLNESS (sick), COUGH (cough), OROPHARYNGEAL PAIN (sore throat) and NAUSEA (very nauseated) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (dizzy) and ILLNESS (sick). On an unknown date, the patient experienced COUGH (cough), OROPHARYNGEAL PAIN (sore throat), NAUSEA (very nauseated) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizzy), ILLNESS (sick), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), NAUSEA (very nauseated) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-1 test: positive (Positive) positive [rapid antigen test for COVID].     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 medication provided. There is no treatment taken.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, Based on the mechanism of action of mRNA -1273, causal association between the event of SAR-COV-2 test positive and mRNA-1273 is assessed as not applicable.
Vaqta expired on 5/4/22, administered exp vaccine on 5/12/22.
Side effect of moderna some what more pronounced; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effect of moderna some what more pronounced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   In June 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In July 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced IMMUNISATION REACTION (Side effect of moderna some what more pronounced). At the time of the report, IMMUNISATION REACTION (Side effect of moderna some what more pronounced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that side effects of moderna somewhat more pronounced but over after 3 days and no problems since, no infection, despite multiple warnings from the  app.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Within hours of receiving second dose of Lymerix, the pt developed a faint red rash with annular lesions over the trunk and arms. The pt reported to the dermatologist that the rash was sometimes papular if he were warm and perspiring. At some time pt developed acute tenderness over the entire affected region and the pt reported that it was painful to put any clothing over the area. The rash was treated with triamcinolone cream and oral methylprednisolone, starting in June, 2000 with little relief according to the pt. On 08/09/2000 the lesion was biopsied and the pt was placed on prednisone for 10 days. The preliminary biopsy results were consistent with a gyrate erythema or Lyme disease. A stain for spirochetes to rule out active Lyme disease is at this time still pending. The prednisone had not helped the pts pain much. The prednisone has already caused the unwanted side effect of weight gain. According to the pt the dermatologist was absolutely sure that the reaction was related to Lymerix. The pt stated that she has seen two dermatologists without relief. As of 09/13/2000 the outcome of the event is ongoing.