chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the injection site; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site) and ABDOMINAL PAIN UPPER (Stomach ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the injection site) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not reported. No treatment information were reported
No other AE reported; Expired vaccine used; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medications, drug allergies, or reactions was not provided.     On 15-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscular for prophylaxis(lot # S026366, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as 17-SET-2020) (expired product administered). No other adverse event was reported.  This is one of three same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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-009507513-2010USA006882:
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19.  F/u on 11/24- Reports 3-inch red rash around injection site with mild itching starting Friday evening, states area just pink at this time. Denies other symptoms.  F/u 11/26 Per pt ?I?m feeling great, I?m feeling fine.?  No additional questions. F/u 12/01 Per pt she is ?feeling great.?  No additional questions.
Initial report received from a health care professional, on 13 November 2006.  A 21 year old female patient, received on 20 October 2006, intramuscular vaccination of Fluzone (lot number U2240AA) (multidose vial), into the left deltoid.  4 hours post vaccination, on 20 October 2006, the patient had pain in her left arm.  The patient was seen in the office, three days later, on 13 November 2006 and the pain continued.  The patient did not have swelling, redness or weakness.  The patient was prescribed Advil and heat.  No concomitant vaccines were reported.  The patient had no illnesses at the time of vaccination.  No concomitant medications were reported.  The patient received Fluzone previously.  No information on adverse events was reported.  Follow-up information received on 31 January 2007.  The patient received Fluzone previously in the fall of '05, '04 and '03.  She received 0.1ml of Tubersol (lot number C2079AA) subdermally in the left forearm on 19 September 2006.  She did not have any illness at the time of Fluzone vaccination, she was taking mirtazapine 7.5 mg daily.  On 13 November 2006, the patient complained of left arm pain.  She complained of weakness in the entire arm with an inability to lift arm completely above head.  The plan was a trial of ibuprofen 400 mg BID and heat 20 minutes two times daily.  On 14 November 2006, the patient complained the arm was numb.  On 27 November 2006, she visited a physician for the same complaints.  On 25 January 2007, the patient reported her arm was slowly getting better.  She almost has full range of motion, except for anything up high.  She still can't hold anything heavy using only that arm, and some days it will ache all day.  She still has some tenderness in the area of the shot.  She is not on any medication now or seeing a physician for her arm.  She has not had a doctors visit since November.  She did not have physical therapy.  Follow-up information received on 23 February 2007 from a health care professional.  Demographic information was received.  Per the reporter, the case was reviewed and no additional information is available at this time.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.26.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time were 09 AM and 10AM, temperature were 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly doses of M-M-R II (rHA, lot # M011666, expiration date 08-MAR-2018; dose and route unknown) for prophylaxis, which was exposed to temperature excursion of 33.2 degrees Fahrenheit(F) for 12 hours and 43 minutes and 54.3 F for 1 hour and 23 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect had been reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004258: US-009507513-1612USA004371.
On 05/05/2022 in the morning at around 8:00AM I had elevated fever along with headache. It lasted 24- 48 hours. I took a COVID-19 home test which came out to be positive. I took Tylenol for 2 days for fever. I called my PCP and told him the information. They only prescribed medication if there is a negative effect at night time I started to cough  (congested in my chest). I had cough, fever, headache. The next day on 05/06/2022 in the morning I called my doctor and he prescribed me Paxlovid for 5 days. I am still quarantine but getting better.
Injection site swollen, red, hot & itchy, getting larger and larger over first 24 hours of symptoms. Dizzy and nauseated also.
-- Some slight dizziness after dose (very, very light). -- About an hour after the dose I was holding a bag, probably around 3 pounds, and I noticed my right hand was spasming/twitching while holding it.  It wasn't especially severe and I figured it would go away.  It did. -- At 10 PM, just after dinner, I noticed my heart was racing, but I also felt tired at the same time.  Both hands were kind of numb feeling, but I'd been laying on the right: I figured it'd go away.  It didn't.  Heart racing and fatigue continued but right hand was noticeably pins & needles.  Took a very hot shower around 11 PM and felt better, but right hand continues to be 'cold.' -- Reporting this because I'd never heard of any neurological(?) effects.  Probably just vaccine doing its thing and interacting with my slightly odd biochemistry.  Hopefully will be better in the morning!  ~ Also, an older member of the household received same lot of vaccine at same time: 0 side effects.
A consumer report has been received. The report concerns a 9 year old, Female consumer, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started during Oct-2014. The patient experienced ERYTHROMELALGIA which started on 02-Dec-2014. The outcome of the event of ERYTHROMELALGIA is unknown. The report was considered to be non-serious.
the patient was administered an improperly stored dose of Proquad; This spontaneous report was received from a Medical Assitant referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.  On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S013715, expiration date: 01-NOV-2020) route not reported for prophylaxis. The diluent (lot # S026378, expiration date 15-MAY-2022) used to reconstitute the vaccine was properly stored.   The call was because of a digital data logger. There was no previous temperature excursion. It was unknown if there were multiple temperature excursions involved or the time frame of the temperature excursion.
1st dose 12dec2022, 2nd 09Jan2023; 1st dose received  at  3 Months of age; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 12th December 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 12th December 2022, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 9th January 2023, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The Registered Nurse (RN) enquired on how to proceed, two doses of Infanrix were given 28 days apart to a patient. The reporter consented to follow-up. Additional Supportive Information: The patient received 1st dose at inappropriate age, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Infanrix earlier than recommended interval, which led to shortening of vaccination schedule.
Loss of hearing 11/24/16 (right ear) Rx with prednisone (11/25-12/1); resolved.
Patient came in with sepsis related to covid and metabolic encephalopathy. Treated with oxygen, steroids and remdesivir. Patient discharged to SNF.
I did not feel good after getting the shot. On 08/17/201 I started having a really bad headache. It was like a hammer was hitting my head. It made my blood pressure go up. I went to see my doctor and they said it might have been my body spiking. They did have much to tell me about it. I started feeling a little bit better because I was taking Tylenol. Then I started getting worse. I had to go to the ER. They did not tell me much either. They wanted to make sure it was not my heart because of my high blood pressure, so they did a test and it came back normal. They told me to take Tylenol. I have been having a sore throat. I have been getting tested for COVID, which have been coming back negative. Now, I am waiting for the results of a PCR. Last Saturday was the first day since I got the vaccine that I did not get the headache.
Admitted to hospital 8/2/2021 with COVID-19 Antigen +
soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided treatment was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-051618 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051618:Husband's case
Pts arm was sore and 24 hours later pt experienced fatigue and malaise. Two days post vax RU quadrant pain. the next day pt was seen in ER. Liver enlarged upon physical. Pt treated with Vicodan
Information has been received from a 16 year old female consumer regarding herself with a history of kidney problems when younger and no known allergies who 6 months ago was vaccinated with the first dose of GARDASIL and on 11-MAR-2008 was vaccinated with the third 0.5 ml dose of GARDASIL (no lot number provided). On 31-MAR-2008 the patient noticed a bruise at the injection site. Everytime the patient puts ice on the bruise it feels like her arm is "throbbing". There was no concomitant medication. Unknown medical attention was sought. Patient outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
Swelling soon after at site of injection yesterday. This a.m. mom noticed left arm swollen and pink at exam moderate edema, non-pithing and pink erythema, warm to touch, mildly tender from (L) elbow to (L) superior shoulder, 21 cm circumferential T 100.3. 4/4/13 improving gradually. 4/9/13 completely resolved.
Infant was running high temp of 103 very irritsble, lost mobility in left upper extremity, moaning in alot of pain and loss of appetite.
STAGE 5 KIDNEY FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose once total, 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 patient experienced stage 5 kidney failure. The action taken with covid-19 was not applicable. The outcome of stage 5 kidney failure was not reported. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to. Sender's Comments: COVID-19 VACCINE  stage 5 kidney failure. This event(s) is considered unassessable. The event(s) 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(s).
Pain in sterum area that radiated through my right breast and to my shoulder blade, all on the right side, pin so severe at times that had it been on my left side we would have ben off to the hospital. Almost intolerable!!! The pain has lasted, it gets better and then flares up sometimes so bad that I have thought ER.
Appx 14 hours after shot began the 101?F fever.  Following fever was body chills and aches. The chills subsided and a sever migraine began and last approximately 18hours.   I then had chronic fatigue, elevated heart rate and shortness of breath that lasted approximately 11 months before I had to receive an blood work, X-Ray and EKG.   Chronic fatigue did not subside until a week after testing positive for COVID-19 on January 4, 2022. Once catching COVID-19 my energy seemed to return to prior vaccination levels.
Patient wanted a 1st dose Pfizer but received his 1 dose J&J Janssen vaccine. Pt was informed. Given information on J&J. No adverse events at time of vaccine. Given number for clinic and asked to contact us if he has questions or concerns.
4 hours after inj, achy at inj site.18 hour after inj, pain mark increase in deltoid, fatigue, malaise,, general body aches, felt chilly, sob ( PO 98%,HR 90), mild nausea, loss of appetite.  side effects ended 48 hours after inj.  of note: i had covid illness 3-20-20.covid test positive 3-24-20.  antibody positive 2 months later
Patient noted to have bilateral upper extremity weakness on 2/15/21 (received first dose of covid vaccine on 1/29/21) requiring hospitalization. As of today 2/16. On MRI found to have central cord syndrome of cervical spine -  Working up for transverse myelitis vs thromembolic central cord ischemic event. Care team interested in guidance about if second dose of vaccine would be appropriate at this time (due for second dose of vaccine 2/19)
Patient reports feeling warm on the right side of the head and itching in arms, hands, and legs. Patient did not show or refer respiratory difficulty. Benadryl was suggested orally and the paramedics indicated they could administer it intramuscularly but they would have to transport her to ER. Patient reported being transported. Dr. was notified and approved intervention and indicated to do a report.
Upon giving the vaccine the pt bleed some but then a raised welt appeard that was hard to the touch. The pt did not complain of any pain or signs of an allergic reaction. However the raised pimple like bump appeared very quickly. He had no pain to his arm and had no problems with range of motion. As the patient waited the necessary 15 minutes for a allergic reaction the welt did diminsh slightly. However because of the time frame of the reaction I sent the pt to urgent care to ensure it is not an allergic reaction.
Dizziness started that day, ringing in right ear started that day, pressure began to build in right ear (noticed the next day).  Pressure continued to build in right ear over the 2 days. Pt. reported need to see ENT by Friday morning due to pressure in right ear and hearing loss.   Saw Dr. Office on Tuesday 4/27/21
PATIENT COMPLAINED OF TINGLING TO HER TONGUE AND MOUTH.  BENDRYL  50MG PO GIVEN.
Consumer answered "Yes" to having side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided
This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bruise on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, NauseaVomiting, arm pain, chills Narrative:
Myalgia & Diarrhea Narrative: going home early from work, likely will be out tomorrow
Mild pain, tenderness of ipsilateral ( left ) breast and single tender lymph node beginning 1 day after vaccine and  mostly resolving 1 week later. No treatment
Extensive macular rash started 2 days after vaccine was given & a fever of ? degree was reported by his mother. He had no fever when seen 6/19/09.
Fluzone administered on 11/07/08.  On 11/14, patient reported that her arm was achy and she has difficulty in lifting the affected arm, especially early in the AM.  No tenderness upon palpation, no induration or swelling at site.  Writer recommended hot packing, acet/ibuprofen and report back to our office in several days.  On 11/19, patient reported still having weakness.  She will consult a physician.
Inside of nose, hard palate, and surface of tongue feel abnormally cold. Like after drinking cold water or being outside in winter. Breathing in feels cold even in 80 degree weather. It started out of the blue 2 weeks after my first shot. Happens every day, varies in degree of feeling