chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Covid 7 months prior. Same symptoms. Extreme body aches, chills,  fatigue and nausea.
This spontaneous report was received from a 45-year-old male patient referring to himself. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. The patient received his first dose of GARDASIL 9 in January 2022, and second dose in March 2022, but when he went to get his third dose on 25-JUL-2022, Pharmacy told him they were unable to do it due to his age and turned him away. The caller turned 46 on 10-APR-2022, which was the reason Pharmacy told him they were unable to provide him with his last dose of the third dose schedule (inappropriate schedule of product administration). The patient would have a visit with his healthcare provider on 29-JUL-2022 and the patient would speak to him regarding the third dose. No additional adverse event was reported (no adverse event).
orange urine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (orange urine) 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 CHROMATURIA (orange urine). At the time of the report, CHROMATURIA (orange urine) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Moderna COVID-19 Vaccine EUA - Developed a rash around the injection site on the left arm.  Also noticing some slight swelling in the area around the rash.  This rash developed 9 days after the vaccination.
Pt vaccinated /w Rubella vax immediately post-partum 12Aug89.14Aug89 pt exp petechial,blotchy,pruritic rash, on arms & thighs /w joint pain & swelling.Rash occurs X2 a mo.Aggravated by chocolate/tetracycline/colds.Episodes of rash cont.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (A booster dose was given today at about 12:15pm from a vial that was first punctured on 20Dec2021 at about 9:40am and that vial was left out at room temperature the entire time) and EXPIRED PRODUCT ADMINISTERED (A booster dose was given today at about 12:15pm from a vial that was first punctured on 20 Dec 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (A booster dose was given today at about 12:15pm from a vial that was first punctured on 20Dec2021 at about 9:40am and that vial was left out at room temperature the entire time) and EXPIRED PRODUCT ADMINISTERED (A booster dose was given today at about 12:15pm from a vial that was first punctured on 20 Dec 2021). On 21-Dec-2021, PRODUCT STORAGE ERROR (A booster dose was given today at about 12:15pm from a vial that was first punctured on 20Dec2021 at about 9:40am and that vial was left out at room temperature the entire time) and EXPIRED PRODUCT ADMINISTERED (A booster dose was given today at about 12:15pm from a vial that was first punctured on 20 Dec 2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Drug details were reported. No Treatment information was provided.
rash arm; itch; A Spontaneous report was received from consumer  concerning a 66-year-old, female patient , who received first dose of Modern's COVID-19 vaccine(mRNA 1273) and experienced itching and rash. The patient medical history was not provided by the reporter. Concomitant medications were not provided not provided by the reporter. On 13-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(042L20A) , via intramuscular  route and unknown anatomical location for prophylaxis of COVID-19 infection.  After receiving the first dose ,patient experienced itching and rash. Patient had taken Antiitch-lotion to treat itching. Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event rash ,itching were unknown.
Pt felt warm feet and numbness of lips and body. Treated with Benadryl only.
33 yo male s/p day 8 vaccination reports onset that date of approx 6 0.3-0.4 cm erythematous vesicles on his back; lesions non-tender, non-pruritic.  Pt otherwise reports (+) major take at vax site, occasional frontal HA relieved with Tylenol, mild generalized myalgias and mild (L) axillary tenderness.
next evening following vaccine, on January 27,  fever 101, chills, and nightsweat overnight. I was not sick, these were brief reactions to the Shingrix vaccine. On January 28, diarrhea once. My arm was so sore for 5 nights that I could not lay on it at all.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were administered doses (Oka/Merck) VARIVAX (lot # K005428, expiration date: 15-APR-2016; lot# K007781, expiration date: 28-MAY-2016; lot # K007983, expiration date: 03-JUN-2016 and lot# L006386, expiration date: 25-FEB-2017) (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Painful swelling of the lymph nodes in the arm pit of the arm that received the shot. It lasted for a week and a half. Tired and weak for 3 days following shot. Soreness and lump at the injection spot lasted about a week.
Pain; Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD; Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), BONE DENSITY ABNORMAL (Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD) and VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), BONE DENSITY ABNORMAL (Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD) and VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE). At the time of the report, PAIN (Pain), BONE DENSITY ABNORMAL (Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD) and VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Unknown date: Bone density test was performed and result was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  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.
Buzzing in left ear.  Visit to PCP - found water in both ears.  Treatment with Montelukast 10mg/90 days began 03/31/2022 and is ongoing.  Onset was insidious and worsened with time.  Exact start of event is uncertain but less than one year.   May be occupational hazard (retired airline pilot for 5 years).   I have received 2 doses and 2 boosters of Moderna.
fatigue 2-3 days; Red spot on inside of bicep, same arm but not on injection site, opposite side of the bone, against rib cage, size of palm print; Itching; A spontaneous report was received from a consumer concerning a 30 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced fatigue, pruritus and erythema.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) on 29 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   The consumer called to report she had received the Moderna COVID-19 vaccine on 29 Dec 2020. She stated she had fatigue for 2-3 days, unknown start date. Started itching on 04 Jan 2021. On 05 Jan 2021, she stated there was a red spot on the inside of her bicep, same arm but not on the injection site, opposite side of the bone, against her rib cage, the size of a palm print.   Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, fatigue, was considered resolved. The events, pruritus and erythema, were considered unknown.  The reporter did not provide an assessment of the events, fatigue, pruritus and erythema.; Reporter's Comments: This case concerns a 30-year-old female who experienced NS events of unexpected pruritus and erythema and expected fatigue.  Event onset occurred on day 7 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
devel erythema multiforme on 7JUN93 recvd vax 3JUN93;
After immunizations. Pt was in check out with her mother. Told her mother she felt sick and then laid down. Did not hit head. Staff who were present did not think child lost consciousness. Was able to talk and communicate. BP 90/58, Pulse 100, skin warm mildly clammy, BS 97. Declined drink. Was able to get up within a few minutes.
After leaving injection center (after waiting 15 min) while driving down the road started getting the feeling of my throat swelling.  This progressed and got very light headed and weak for about 2 minutes. Throat tightness continued for about 1 hour but did not cause trouble breathing.  At one point felt like I was unable to swallow.  Monitored by coworkers when arrived at work and chose not to go to ED unless symptoms worsened which they did not.
No adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not provided.   On 12-SEP-2019, the patient vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020(which lot was given to the patient was unknown); vaccine dosage detail was not reported) for prophylaxis(product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent. The storage temperatures of varicella virus vaccine live (Oka/Merck) (VARIVAX) were -14 Celsius degrees to -10 Celsius degrees (-9.74 Celsius degrees) for unknown duration. There was no previous temperature excursion. No adverse effects noted. Data logger was involved.
Headache, dizziness. BPs 156/88 (pulse 60), 142/86, O2 sats 100%. Given juice.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 51-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date 30th June 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th October 2015, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness, injection site swelling and contusion. On an unknown date, the outcome of the injection site redness, injection site swelling and contusion were recovering/resolving. The reporter considered the injection site redness, injection site swelling and contusion to be probably related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The reported injection site for FLULAVAL QIV vaccine was left arm. The patient experienced red, swollen arm (injection site) and bruising.
No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 03-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005629: US-009507513-1904USA005133: US-009507513-1904USA005631: US-009507513-1904USA005627:
Hives covered both lower arms; Extreme malaise; headaches; chills; body aches; Vomiting; diarrhea; Klein-Levin Syndrome episode was triggered; Klein-Levin Syndrome episode was triggered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:00 (at the age of 40-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included common variable immune deficiency, mannose binding lection deficiency, ongoing klein-levin syndrome, peptic ulcer, arthritis and was allergic to Keflex, Reglan and Prilosec. The patient did not receive any other vaccines within 4 weeks. Concomitant medications included pharmacy brand 50+ year old multivitamin (within two weeks). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: PAA156051) via an unspecified route of administration, administered in right arm on 27Jan2021 at 15:00 at a single dose for Covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021 at 22:00, the patient experienced hives covered both lower arms and on an unspecified date in Feb2021, the patient experienced extreme malaise, headaches, chills, and body aches began within 12 hours, vomiting and diarrhea occurred within 36 hours and persisted for approx 18 hours and A Klein- Levin Syndrome episode was triggered 72 hours later and persisted for 17 days. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse.  She is able to breathe without difficulty.  She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine.  She will call Dr. back later and may need note for work.  2/26 11:30 AM  Received text message from patient.  "I woke up with trouble breathing, hives on my neck and jaw and swollen face.  Nausea and diarrhea.  Trouble swallowing so I took Benadryl.  Swelling went down on face but still tight in throat.  . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday.  I asked her if her symptoms were not changed, worse, or improved.  She answered:  "They got worse this am from 5 to 10 and feeling better now.  As far as swelling and breathing feels better.  3/1 10:21 AM  Dr. Spoke with patient 10:21 am.  She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness.  She does still have nausea, with occasional vomiting, and diarrhea.  She felt well enough to return to work today.    3/3 11:09 AM  Dr. spoke with patient.  She stated that she is finally feeling "back to normal".  We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination.  She stated that at one point she was "close to going to the ER".
Red eyes, chills, temperature 101.5, rapid heart rate 120 with 10 PVC's per minute.
No additional AEs; expired dose of RECOMBIVAX was administered; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #U019135, expiration date: 22-NOV-2022, administered intramuscularly for prophylaxis (strength was not provided) (expired product administered). There was no adverse event reported.  This is one of the several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA008524:Same Reporter US-009507513-2302USA008289:Same Reporter
Patient reported in observation that she is having generalized redness and itchiness and some blotchiness on her legs. Patient denies any other symptoms. Vital sign check: BP 118/84, 100% oxygen sat, HR was within normal limit. Patient okay'd to give 25mg oral Benadryl per standing order. Patient continuously monitored by nurse. Patient after receiving the Benadryl was noticeably less  red and patient reported feeling less itchy.  Patient denies any new symptoms. Patient called provider office unable to speak to provider at the time. Patient monitored, patient reported feeling better and she reported she felt safe enough to drive. Patient was called in the evening, patient reported that providers office did call her back, and she told to take Benadryl 4 hours after last dose and was also prescribed another anti-allergy medication.  Patient reported she also had a telehealth with provider the next day, reminded patient to talk to provider about the event and seek medical help with any other symptoms.
This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced having problems. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having problems was not reported. This report was non-serious.
Redness over left arm which is spreading. Mild pain. CEFTRIAXONE 1 GRAM INJ RECON SOLN, LIDOCAINE HCL 10 MG/ML (1%) INJ SOLN, CEPHALEXIN 500 MG ORAL CAP.
This spontaneous report as received from a pharmacy student refers to an unknown number of patients (demographics not provided). On an unknown date the patients were vaccinated with unsupported PNEUMOVAX23 (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. No adverse effects reported. Additional information has been requested.
Symptoms would have been bruising, when I blew my nose, there was blood. Petechiae and I was getting tired which meant my numbers were getting low for the ITP, platelet levels were dropping. I contacted the doctor and got my numbers checked and he gave me an injection of N-Plate and given dexamethasone. And I went back a week later to see if my numbers would go up and this has been weekly ever since. And he suggests the dosage of N-Plate depending on where my numbers are. Recovery status depends on numbers of platelet count weekly.
Sore arm; super tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 32-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10May2021 (Lot number: EW0168) at the age of 32 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "not recovered", described as "Sore arm"; FATIGUE (non-serious) with onset 10May2021, outcome "unknown", described as "super tired".  Additional information: Patients Medical History (including any illness at time of vaccination) was none. Family Medical history was none. History of all previous immunization with the Pfizer vaccine was none. No additional vaccines were Administered on Same Date of the Pfizer Suspect. The patient did not receive any Prior Vaccinations (within 4 weeks). The patient received Vaccination on 10May2021 between at 9:40 am to 9:55 am. The patient took the nap and then woke up and fell back asleep at the same time. She confirmed that the tiredness and sore arm started yesterday. She explains the arm soreness did not happen right way after the vaccine, it started between 4 and 5 PM yesterday. No relevant tests were performed.  No follow-up attempts are needed. No further information is expected.
Generalized red pink maculo papular skin rashes all over the body; almost 2 days after immunizations;
Pt had localized reaction to MMR vaccination. Temperature 101.2 (ear probe) treating fever with Tylenol/Motrin initially treated site with ice and warm compresses.
Shingles along left-side of body. Severely painful blistered rash on left truck. Treatment: antivirals (Valtrex).
rash/skin eruption at the injection site. discussed benadryl and ointment for supportive care.