chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased heartrate; Excruciating pain though the finger tips.; Rash; Tiredness; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Increased heartrate), PAIN IN EXTREMITY (Excruciating pain though the finger tips.), RASH (Rash), FATIGUE (Tiredness) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced TACHYCARDIA (Increased heartrate), PAIN IN EXTREMITY (Excruciating pain though the finger tips.), RASH (Rash), FATIGUE (Tiredness), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). On 28-Mar-2021, TACHYCARDIA (Increased heartrate) and RASH (Rash) had resolved. On 31-Mar-2021, PAIN IN EXTREMITY (Excruciating pain though the finger tips.), FATIGUE (Tiredness), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included asthma medication. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUNE-2021 - NNI
Mom and Dad reported on 12-3-08 that infant ran 103 degree temp for 3 days starting the following day after 7-28-08 vaccinations. Also reported some vomiting. Parents took infant to see Doctor at clinic the next day and then saw Doctor in clinic 2 weeks later and both thought it was related to vaccine.
This spontaneous report as received from a nurse refers to an infant patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB injection, intramuscularly (lot # and dose were not provided), on 08-JUL-2016 with the second dose and third dose on 08-SEP-2016. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received her first Pfizer vaccine on 3/19/21 and her second on 4/8/21. Starting on 5/31/21 she developed increasing shortness of air, a productive cough, and persistent chest congestion. Her chest felt heavy during this time and she first went to see her PCP mid June 2021 after taking over the counter cold medications without relief.  Over the next 6-8 weeks she was given various steroids and antibiotics by her primary care provider. She was also given inhalers for possible asthma treatment without consistent relief.  Her symptoms progressed to include orthopnea and paroxysmal nocturnal dyspnea with a 15 pound weight gain. She next presented to the ER on 8/3/21 and was found to have significant volume overload with pleural effusions, ascites, cardiomegaly, and pulmonary edema. She was discharged on PO diuretics and was referred to Dr. as an OP for cardiovascular examination.  On 8/4/21 after meeting Dr. she was admitted to Hospital for acute heart failure. She has since been aggressively diuresed and started on heart failure guideline directed medical therapy with improvement of symptoms. Ultimately she has been diagnosed with acute myocarditis and acute heart failure and has been referred for heart transplant.
Alk Phos raised; ALT High; AST High; Feeling bad with nerve pain; feeling bad; tiredness; Felt weak; Low BP; Felt like passing out; bad headache; Headache kept on getting worse; temp of 99 that went to 101, rose to 102.6; nausea; achiness; sore arm; A spontaneous report was received from a 69-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore arm, achiness, feeling badly, tiredness, weakness, nerve pain, elevated liver enzymes of ALT, AST and ALK Phos, a temperature of 99 that went to 101, rose to 102.6, headache, nausea, low blood pressure, and felt like passing out.  The patient's medical history included anxiety. Products known to have been used by the patient, within two weeks prior to the event, included clonazepam and progesterone/estrogen.  On 06 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, the patient experienced a sore arm. On 08 Feb 2021, the patient developed achiness. On 09 Feb 2021, the patient's temperature went from 99 to 101, she had a bad headache, nausea, low blood pressure, felt like passing out, and felt weak. On 11 Feb 2021, the patient started feeling bad with nerve pain and tiredness. On 13 Feb 2021, the patient took ibuprofen to help with her headache and ended up going to the emergency room (ER). At the ER, the patient was given fluids. A blood test was performed and showed elevated liver enzymes- ALK Phos 188, ALT 249, and AST 110. A sonogram on the liver was performed, but came back as normal. A COVID-19 test was performed and was negative. The patient was released on 13 Feb 2021 with prescribed medications of Toradol and Benadryl. On 15 Feb 2021, the patient's headache was worse and her temperature rose to 102.6. She took the Toradol and Benadryl with no relief. That evening, the patient went to the ER again. Another blood test was completed and showed her liver enzymes elevated- ALK Phos 207, ALT 302, and AST 158. The patient was given fluids and a "migraine cocktail". A computerized tomogram head scan was performed and came out normal. Another COVID-19 test was performed and was negative. On 15 Feb 2021, the patient reported that she was still feeling bad, still had a headache, and temperature keeps coming back to 101.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, headache, feeling bad, and body temperature increased, were considered not recovered/ not resolved. The outcomes of the events, sore arm, achiness, tired, nerve pain, nausea, low blood pressure, felt like passing out, and felt weak, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Per patient report: diagnosed as PVC (premature ventricular contraction) by cardiologist on 9/2/21. Started on 8/20/21 to present.
Patient was given Flu vaccine has a 3" x 1 1/2" reddened, hot, swollen, painful area on left deltoid.
Pt was given a COVID vaccine which was prepared about 72 hours ago and the vaccine was in the room temperature for that length.  Mom reported patient had headache and fever for about 24 hours following the vaccine but then he was fine and asymptomatic.
Patient c/o right arm deltoid pain post vaccination for Pneumovax. Pt c/o of lack of mobility, swelling, severe to extreme pain, on pain scale 1-10, 10 being worse. He verbally says: " pain is an eleven". Pt denies fever or chills. Has been taking 2 tab Vicodin 5/500 mg yesterday this did not relief the pain. Negative for HA, nausea. Pt was seen by Dr and a venous duplex of his UE was ordered.
Strong ache in right deltoid (injection site); Pain in right deltoid preventing motion of deltoid; Flu-like fatigue; 102F-103F fever for 60 hours.
There was severe pain in my upper arm which over the days following was followed by pain going down my arm to my hand.It finally feels better this week .Since the injection up until today I had pain when I would twist or bend my arm certain days.I am diabetic as well and my fasting blood sugars were around the 200's which is not normal for me.I have been having a lot of stress but even with stress is usually not that high.I don't know if there is any relation or if it is purely coincidence .
Pt was awakened by grandson at 4 AM, with uncontrolled shaking. Family members on her husband's side of the family have seizure disorders, and she states that was what it was like. Reports she was "groggy" through Saturday and Sunday, more so on Saturday. Other symptoms, were injection site soreness and fatigue for a few days.
Headache, Myalgia, soreness at injection site Narrative:  Per supervisor report: "2nd shot 4/7/2021-sore arm, headache, body ache"  Other Relevant History:
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 27-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
slight fever 99.7 early evening 07Feb; lower abdomen pain thru to back; lower abdomen pain thru to back; then woke to cold and shivering lasting 2hours that night; then woke to cold and shivering lasting 2hours that night; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 06Feb2021 at 03:45 AM as single dose for COVID-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease. Allergies included shellfish allergy. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 07Feb2021 at 19:00, the patient experienced slight fever 99.7 early evening, lower abdomen pain thru to back, woke to cold and shivering lasting 2hours that night. The clinical outcome of the events slight fever 99.7 early evening, lower abdomen pain thru to back was unknown and the event woke to cold and shivering lasting 2hours was recovered. The patient underwent lab tests and procedures which included body temperature: 99.7 on 07Feb2021.  No follow-up attempts are possible and no further information is required.
Have a temperature; Chills; Achiness; Achiness and soreness and injection site; This case was reported by a consumer via interactive digital media and described the occurrence of high temperature in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date ,refer linked case US2020AMR199556).   On 2nd October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, less than a day after receiving Shingrix, the patient experienced high temperature, chills, pain and injection site pain. On an unknown date, the outcome of the high temperature, chills, pain and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the high temperature, chills, pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The reporter had received the second dose on the reporting date and had a temperature, chills, achiness and soreness and injection site. The reporter had also questioned if it was more normal with the second dose. For tolerance to the 1st dose of Shingrix, refer case US2020AMR199556.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199556:Same patient, same suspect, different dose
became nauseated about 24 hours after vaccine. She threw up around 1pm 1/14 then was sent home from work. She continued to have bad nausea and vomiting through out the night and into the morning of 1/15. She was again sent home from work.
Initial report received from a healthcare professional on 09 December 2013. A 68-year-old male patient, who had no medical history and concomitant medications, had received an intramuscular dose of FLUZONE HD, batch number: U4782AA on 08 November 2013 (dose number and anatomical site of vaccination was not reported). On 08 November 2013, the patient developed chills and body aches. The patient recovered from the events within 48 hours without physician evaluation or any medical intervention. Laboratory investigations were not done. Documents held by sender: none.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ, orally for prophylaxis (dose, lot# and expiration date were not reported). According to the reporter, the patient vomited some dose of an ROTATEQ after administration. The outcome of the event was not reported. Causality assessement was not provided.
Her symptoms started with dizziness, fatigue, then became worsened with fainting, The dizziness, brain fog, fatigue is a daily problem that happens every time she in upright position. She has fainted now a handful of times.
I received the vaccine in February and March 2021 with limited adverse reaction.  I had flu like symptoms the day after the 2nd dose.  On May 25, 2021 I noticed itching and discomfort in my left pinky toe.  When I looked at the toe a few days later, it had a cluster of purple rashes and was swollen.  It has remained this way for over 2 weeks.  I have seen 2 physicians this week (internal medicine and dermatology) and neither could identify what the issue was.  I now know of 3 other people who received vaccines around the same time as me and are having similar symptoms on their toes.  Based on what I've read, it sounds consistent with "Covid toes".  I never tested positive for Covid and I believe this is a delayed reaction to the vaccine.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022).    No concomitant medications were provided by the reporter.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. On 11-Jan-2021 at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. Product moved to clinic on 11-Jan-2021 and the vial was in not frozen condition at the administration.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medication was reported.
low grade fever; aches; This is a spontaneous report from a contactable consumer or other non hcp. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 09Mar2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether prior to vaccination, the patient diagnosed with COVID-19. It was also unknown whether since the vaccination patient had been tested for COVID-19. The patient experienced low grade fever and aches on 11Mar2021 09:00. Outcome of the events was unknown.   Follow up #1(18Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a male patient that: Email received - Wednesday, 10Mar2021 I reported it within 24 hours on the next business day". No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Achy across the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Achy across the shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 03-Feb-2021, the patient experienced ARTHRALGIA (Achy across the shoulder). At the time of the report, ARTHRALGIA (Achy across the shoulder) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Large red and swollen left upper arm that migrated down to elbow. Warm to touch and painful. Pt. applied BENADRYL cream and took oral BENADRYL. Swelling has gone down some. Still a little sore. C/O headache, flu symptoms but they are subsiding.
This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medication was reported.   No treatment information was reported.