chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE ERYTHEMA (Red arm at injection site for 2 inches wide) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sodium sulfate) and Drug allergy (Erythromycin). In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE PAIN (Tinder arm) and VACCINATION SITE ERYTHEMA (Red arm at injection site for 2 inches wide). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE ERYTHEMA (Red arm at injection site for 2 inches wide) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant medications were not reported. Treatment details were not reported. This case was linked to MOD-2021-353880 (Patient Link).
Pt recvd immun on 17SEP91 rt thigh inject site remained reddened; small pimple; area scabbed & starting weeping fluid; Taken to MD on 8NOV91 culture done; med prescribed; Seen by MD again 18NOV91 area healed;  med prescribed;
petechiae over torso. (number 11) do not recall date of onset post vax, sorry (number 12) still show signs of petechiae
Within 3hr started body aching; painful discomfort that hit fast. I stopped what I was doing & went home it hit so fast this time, the  2nd shot at least took 12hrs plus to hit.  Then Chills soon followed with freezing like ice hands then i would get very hot for short  minutes while followed by long chills again this cycle continues at least 29hrs after shot. Took Tylenol once & day quilt cold&flu meds twice, last dose 29hrs after shot. Highest temp 100.5 a degree less then 2nd shot. But the muscle joint pain was so bad & still hurts but much better.  Sun. Woke & said I felt alive again but cold sweets still 48hr after shot. Hope i get to feeling even better joint & cols sweets wise.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/10/2021 and 4/7/2021. Presented to ED on 9/4/2021 with new onset of altered mental status, and right sided facial asymmetry. Patient admitted, and diagnosed as COVID-19 positive, treated with remdesivir, dexamethasone, baricitinib. Patient began requiring oxygen (3L NC) on 9/6, escalating to 5 L NC on 9/7, to 9L on 9/9, 11 L Oximizer on 9/10. Patient transitioned to comfort measures on 9/11/2021. Patient expired on 9/15/2021
A physician reported the occurrence of an injection site reaction in a 4-year-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine (Infanrix).  There was no relevant medical history.  The vaccinee had no adverse experiences following receipt of prior immunizations.  On 04/24/2002, the vaccinee received his fifth injection of Infanrix.  On that date, he also received an injection of inactivated poliomyelitis virus vaccine (IPOL).  On 04/25/2002, the vaccinee developed an injection site reaction characterized by swelling, redness and warmth.  The vaccinee was seen by a physician.  The injection site reaction resolved on 04/28/2002.  The reporter considered the event to be probably related to Infanrix administration.
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of PNEUMOVAX 23 (doses, routes, lot numbers and expiration dates were not reported). On an unknown date the patients experienced injection site reactions. The patients sought medical attention via contacting the physician. The outcome of injection site reaction was unknown. Relatedness between the event and the therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
High blood pressure and shingles. Shingles has now caused nerve damage on the left side of my head, face, and neck.
Loss of hearing and vision, everything dizzy for about 15 minutes Fainted Lips turned grey
Vomiting, diarrhea, three days; muscle and joint pain and weakness still occurring 6 days later.
Looks a lot like Conjunctivitis; it is red and swollen and oozy; it is red and swollen and oozy; left eye hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. This consumer reported for a 05-year-old female patient (daughter).  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 10:00 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE].  The following information was reported: CONJUNCTIVITIS (non-serious) with onset 06Nov2021 19:00, outcome "not recovered", described as "Looks a lot like Conjunctivitis"; EYE SWELLING (non-serious), OCULAR HYPERAEMIA (non-serious) all with onset 06Nov2021 19:00, outcome "not recovered" and all described as "it is red and swollen and oozy"; EYE PAIN (non-serious) with onset 06Nov2021 19:00, outcome "not recovered", described as "left eye hurt". The events "looks a lot like conjunctivitis", "it is red and swollen and oozy", "it is red and swollen and oozy" and "left eye hurt" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of conjunctivitis, eye swelling, ocular hyperaemia, eye pain.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No COVID tested post vaccination. Adverse event: At 7 PM my daughter complained that her left eye hurt, I looked at it and it is red and swollen and oozy. Looks a lot like Conjunctivitis but she didn't have any issues before the vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit.  Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Woke up approximately 13 hours after receiving first injection of Shingrix with severe flu-like symptoms.  Fever 101 degrees, uncontrollable chills with severe shaking,  lethargy.  Fever and chills subsided about 6 to 8 hours later although still noticeable present.   Other flu-like symptoms, lethargy, body aches, mild fever continued throughout the next day and night.   It took about 2.5 days to feel normal again after the injection.   Can't wait for round number 2....
First dose of shingrix / of twinrix / 12/2019. does she need to restart / has not gotten any other doses; First dose of shingrix / of twinrix / 12/2019. does she need to restart / has not gotten any other doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019) and Twinrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix, the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient got the 1st dose of Shingrix and Twinrix, but had not gotten any other doses. Till the time of reporting, the patient did not receive 2nd dose of Shingrix and Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Dose of 0.2mL Pfizer 12+ given instead of Pfizer peds. 6mo-4yrs dose
who missed a dose of GARDASIL 9; No additional AE reported; This spontaneous report was received from a pharmacy technician and refers to a 17-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, lot # 1621934, expiration date 29-JAN-2022 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. On an unknown date, the patient missed a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event was reported. The outcome of the event was unknown.  The relatedness between the suspect therapy and the event was not provided  This is one of 2 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Shirking for no known reason 5-7 days and diarrhea for 10 days.
Allergic to Booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic to Booster shot) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    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 ALLERGY TO VACCINE (Allergic to Booster shot). At the time of the report, ALLERGY TO VACCINE (Allergic to Booster shot) outcome was unknown. Not Provided          No Concomitant medications were reported. No Treatment details were reported. It was reported that patient required Medical attention.  Company comment: This is a spontaneous case concerning a 76-year-old patient of an unknown gender with no relevant medical history, who experienced event of allergy to vaccine. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient required medical attention but clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76-year-old patient of an unknown gender with no relevant medical history, who experienced event of allergy to vaccine. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient required medical attention but clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
2-12-21 Received HPV vaccine in the left deltoid. "A couple hours after vaccination, patient felt pain in the armpit/back area".  Eventually "achey upper arm". No intervention at this time. 2-17-21 Pick up book bag, etc. arm hurts. 2-21-21 Patient told mom of the discomfort. States pain has been continuing since the vaccine. Fever: no, redness: no, swelling: no, but warm to the touch in the left lateral area distal to scapula area. 2-22-21 Mom has not been updated on today's discomfort.
This spontaneous report was received from a medical assistant refers to a 4 week 4 day old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 25-SEP-2015, the patient was inadvertently given an unspecified dose of VAQTA, injection, lot number reported as L022259 and expiration date 06-APR-2017, (route of administration and anatomical location were not reported) instead of RECOMBIVAX HB. There were no concomitant medications reported. No adverse effects and no product confusion were reported. There was no product quality issue involved. Additional information has been requested.
Swelling, blistering at site. Muscle aches, dull headache, severe fatigue.
One hour after shots, eyes rolled up and she had clinic jerks for about 40 seconds. In ER fever of 38.7C noted.
joint pain at base of thumbs/joint pain in elbows; joint pain at base of thumbs; This is a spontaneous report received from a contactable Physician. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, in deltoid left, on an unknown date, two weeks ago on a friday (at the age of 67 years), as 2nd dose, single dose for COVID-19 immunisation. The patient family medical history included bit of arthritic things (His mother when she got to be 90 years old she started to get quite a bit of arthritic things). Concomitant medications included zinc (Tablet, MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 15 mg (4 in morning and 4 at night) for unspecified indication (started taking 4 weeks ago, stopped as soon as elbows started hurting which was a week following the second shot. The patient had been taking concomitant products more than normally recommended dose of zinc because zinc was supposed to be beneficial and kill the virus. So he started taking extra zinc. He doesn't know if the zinc did it or what. It is not a lifesaving deal, but they said if you get a side effect you should report it. It is not a big deal, but it is definitely present). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, in deltoid left, on an unknown date, as a single dose for COVID-19 immunisation. There was no other relevant Tests done. There was no history of previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines Administered on Same Date of the Pfizer Suspect. There was no prior vaccinations within 4 weeks. There was no adverse event reported prior vaccinations. He is healthy and did not miss a day of work for 31 years. Caller stated that he got the two shots and about one week after the second shot he got quite significant joint pain, pain in the base of his thumbs started about 7 days (Morning) after second injection. Not life threatening or disabling, but it hurts enough. He is picking up stones and he cant do that task as well as he would like to. The pain is exactly the same as it was the day that it started and his elbows started about 7 days (Morning) after second injection at the medial epicondyle of both arms. It is not a terrible pain, but he has not ever had joint pains or anything like that. The pain started about 4 weeks after first dose and 1 week after the second dose. Reporter seriousness for joint pain at base of thumbs, joint pain in elbows was reported as not serious. The clinical outcome of the events was reported as not recovered. The events relatedness for events joint pain at base of thumbs/ joint pain in elbows were related.  Information on the lot/batch number has been requested.
pt recvd vax; pt exp vomiting & diarrhea x one week;
At 1:10 PM states she received her second dose of the maternal COVID-19 vaccination.  Approximately 10 minutes later she began to develop a cough and a slight headache.  Then, 17 minutes after the vaccination injection she began to develop some slight "shortness of breath, throat tightness, and tongue heaviness."  She was administered epinephrine 0.3 mg IM injection as well as Benadryl to 50 mg PO.  Subsequently, she came to the ED for further evaluation.  She states her symptoms have been slowly resolving and currently only has a slight headache.  No difficulty breathing at this time during my interview.  No rash/hives.
Erythema multiforme; A spontaneous report was received from a consumer concerning a 27-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced Erythema multiforme .  The patient's medical history was not provided. No concomitant product use was reported. Family history included Steven Johnson syndrome (mother had a severe form).  On 05 Feb 2021, the patient received his first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, he noticed blistering on his arm, forearm and on his foot. He was diagnosed with Erythema multiforme (medically significant) following vaccination by his primary physician.   Treatment included topical steroids.  Action taken with mRNA-1273 with respect to the even Erythema multiforme was unknown.  The outcome of the event Erythema multiforme was resolving at the time of this report.; 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.
Patient jerked away from nurse as vaccine was being administered. As a result, the patient ended up with a superficial scratch on his upper right arm which bled slightly. He also as a result only received part of the dose of Hep B vaccine, and had to be revaccinated for Hep B that same office visit. A band-aid was placed on the scratch, and the patient was able to leave the clinic with no assistance.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (.65 ml, once, lot # L015414 and expiration date: 01-AUG-2016), (strength and route of administration were not reported). No adverse effects were reported and no product quality complain was involved. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 38-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 38, via an unspecified route of administration, left arm, on Mar 26, 2021, at 13:00, single dose, for COVID-19 immunisation. The patient has no reported medical history. The patient has no known allergies to medications, food or other products. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 26, 2021, at 15:00, patient experienced "pins and needles" feeling in hands, which started about an hour after she received the vaccine. It has not gone away and it has been over 3 weeks. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures not taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of "pins and needles" feeling in hands: not resolved (at the time of this report). No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Patient received Zostavax injection in her right arm on 7/9/16. On 7/12/16 she came into the pharmacy because the injection site where she received Zostavax had become slightly swollen, red, itchy and warm but did not hurt. She stated that she had been putting hydrocortisone on it and was feeling relief from that. She stated she would return to the pharmacy if symptoms progressed. Today 7/13/16 I called her to check in and she said that her symptoms had greatly reduced today after icing and hydrocortisone cream so she was relieved about that. She was not concerned nor upset and said that she did not need or want us to contact her prescriber about this.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication. One day after receiving the GARDASIL dose she had some swelling of her lip. No treatment was given, it resolved. The patient sought unspecified medical attention. Additional information has been requested.
11/28/22 I started with a headache, sore throat and earache. The next day, I had congestion, cough and some body aches, but did not seem too abnormal. I had severe fatigue. On 11/30/22, I began having severe body aches, fever around 100.3 in addition to the previous day symptoms. I tested with a home COVID test and it was positive. I called my doctor and was prescribed PAXLOVID and started taking it that day. 12/1/22 all my symptoms were the same. The next day, I started having diarrhea as well, but the other symptoms were going away except the fatigue. The next day, the symptoms basically all went away. I felt pretty good the following week and tested negative on 12/5. I only had a little bit of fatigue. 12/7, I tested negative. On 12/9, I felt completely normal. On 12/10 I woke up with severe coughing, nasal congestion, and sneezing. I tested positive for COVID again. On 12/12, I called my doctor, and she prescribed a Z-PAK. I still have some congestion, but the other symptoms are going away except the fatigue.
Myalgia sore throat, fatigue Narrative:  Epmloyee reported a sore throat, severe aches all over body, and headache; she was generally fatigued and aching for half the day on Sunday 1/10/21 and for the full day 1/11/2021
This spontaneous report as received from a physician assistant refers to a 11 years old female patient. The patient was vaccinated with the first dose of GARDASIL (lot # 673256/0629AE) 0.5 ml intramuscularly on 10-NOV-2012. Secondary suspect therapy included a dose of unspecified flu vaccine (manufacture unknown) given intramuscularly on 10-NOV-2012. Concomitant therapies included MENACTRA and TDaP given along with GARDASIL on 10-NOV-2012. Within a minute, the patient felt dizzy and had a feeling of impending doom. She appeared pale and was crying. She laid down and after a few minutes she started pacing. After about 30 minutes, the reporter was comfortable with her leaving because she seemed more calm. The reporter hadn't heard back from the patient since the adverse event happened, so he was assuming that she had recovered, but could not verify this. No lab tests were performed. No treatment was given. The patient had sought unspecified medical attention. Additional information has been requested.