chrisvoncsefalvay/vaers-outcomes huggingface dataset:
migraine headache; some flashes; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache) and FLUSHING (some flashes) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FLUSHING (some flashes). On 18-Feb-2021, the patient experienced MIGRAINE (migraine headache). The patient was treated with PARACETAMOL (TYLENOL) for Migraine headache, at an unspecified dose and frequency. On 17-Feb-2021, FLUSHING (some flashes) had resolved. At the time of the report, MIGRAINE (migraine headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products reported. It was reported that she was not going to take the second dose.
While administering vaccine, drops of vaccine noted on arm; hub of needle not tightened on syringe.
A report was received from a consumer on 11/22/03 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 11/22/03. On 11/22/03 the vaccinee inadvertently received Fluvirin. No adverse symptoms were exhibited at the time of reporting. Follow up pending.
On 11/24/2022 I started having back and chest pain that came and went for 2 days. On 11/28/2022 I again started having chest and back pain. I went to the ER and was diagnosed with a myocardial infarction. I had a stent placed in the mid LAD.
LEFT OUT OF FRIDGE BEYOND 6 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, intramuscular, batch number: 1821288, expiry: 01-AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced left out of fridge beyond 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of left out of fridge beyond 6 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210619240.
No additional AEs or PQC reported.; Caller is a medical assistant reporting a temperature excursion/ Patient administered improperly stored vaccine on 10/27/2020.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-OCT-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dosage form, lot # S031287, expiration date 08-APR-2022 (route of administration was not reported), for prophylaxis. There was no adverse effect reported.   Administered dose of vaccine experienced the temperature excursion of 47.7 degrees Fahrenheit for 20 minutes. Vaccines experienced previous excursion of 47.1 degrees Fahrenheit for 20 minutes. No digital data logger was involved.  This is one of two 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: S031287; expirationdate: 04-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA003238:
At 14:13 voiced complaints of Nausea, lightheadedness and dizziness. Then started vomiting. Attendee was pale and clammy. Assisted to the cot after she stopped vomiting. Elevated legs, when stated that she was no longer nauseated. HR: 84 BP 120/68 RR 16 O2sat 95. 14:20 - Attendee stated she felt better, a little pale, denied any dizziness, lightheadedness or nausea. Hr 82 BP 120/68 RR 18 O2Sat 97. 14:36 -No voiced complaints- skin warm and dry.  HR 69 BP 118/64 RR 20 O2Sat 98. 14:43 - Care Practitioner educated on home discharge/adverse reaction instructions and she was discharged to home with her mother.
Neck pain; Pain in extremity/ Pain with right arm left foot; Shoulder pain; Vaccination site reaction; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), VACCINATION SITE REACTION (Vaccination site reaction), PAIN IN EXTREMITY (Pain in extremity/ Pain with right arm left foot) and ARTHRALGIA (Shoulder pain) in an 89-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In March 2022, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction). On an unknown date, the patient experienced NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity/ Pain with right arm left foot) and ARTHRALGIA (Shoulder pain). At the time of the report, NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain) outcome was unknown, VACCINATION SITE REACTION (Vaccination site reaction) had resolved and PAIN IN EXTREMITY (Pain in extremity/ Pain with right arm left foot) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was unknown if the patient was enrolled in clinical trail.  Concomitant medications were not reported.  The daily dose of Humira was reported as Citrate free.   The stop date for event vaccination adverse reaction was reported as 2022.  Treatment information was not reported.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes), LYMPHADENOPATHY (lymph nodes R side of the neck swollen), SWELLING (little ball on the L side of neck), PRURITUS (neck hot and itchy) and PAIN (body pain) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes) and SWELLING (little ball on the L side of neck). On 25-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes R side of the neck swollen). On an unknown date, the patient experienced PRURITUS (neck hot and itchy), PAIN (body pain) and INJECTION SITE PAIN (pain at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DEXAMETHASONE at a dose of 1 dosage form and ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (lymph nodes), LYMPHADENOPATHY (lymph nodes R side of the neck swollen), SWELLING (little ball on the L side of neck), PRURITUS (neck hot and itchy), PAIN (body pain) and INJECTION SITE PAIN (pain at the site of injection) outcome was unknown.            This case was linked to MOD-2021-053380 (Patient Link).   Reporter did not allow further contact
COVOID vaccine breakthrough case. Moderna 4/24/21 016B21A, 5/22/21 033C21A, and boosted 12/2/21 013F21A
, Additional Details: Pt to prescribed dose of valium for autoimmune flare and nitroglycerin due to chest tightness/shortness of breath
Nausea and vomiting for 3-4 days post vaccination. Rested.
3 inch red raised indurated non-tender area around inoculation site.  Benadryl PRN left arm SQ injection site.
Got vac on Sat. By Tues, chest pain. Probably a 6/10. Heart "beating of chest". Generally seemed like myocarditis. Worse on Wednesday. By Wed night, above symptoms + felt really weak / feverish. Went to bed very early. Later that night it seemed to "break" like a fever breaks. Took Thurs off of work and just sat around. Felt better. Less severe / generally mild symptoms persisted for ~2 weeks. Had to take it easy on the workouts as well, cause that would cause it to flare up. As of writing, seem back to normal in all ways.
He woke up with nausea, headache, very sore injection site, fever of 101. He couldn't move his left arm up higher than his waist. He took Ibuprofen OTC, rested, felt ok by evening. Next day, no side effects remained.
vomiting; fever of 99.9; diarrhea; nausea; weakness; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting, fever of 99.9, diarrhea, nausea and weakness on 09Feb2021 (reported as 2 days after receiving the vaccine). The outcome of the events was unknown. The patient would like to known whether he can get his second dose.   No follow-up attempts are possible. No further information is expected. Information about batch/lot number already obtained.
Rash for 2-3 days Rash on various areas of body. He got dry itchy patches on whole body, more on limbs the day after vaccination.
Information has been received from a physician concerning a 37 month old female who on 11-APR-1996 was vaccinated SC with one dose of VARIVAX vaccine. On 09-MAR-1998 the patient had exposure to a sibling who was not vaccinated and infected with a natural strain. On 24-MAR-1998 the patient developed bypical varicella. Subsequently the patient recovered. The patient's sister was also reported (WAERS 99032232). No further information is available.
Developed flu after vaccine in spring. Patient received DTaP (IM), lot U0321AC/unknown manufacturer, IPV(SQ),  lot number X0711-2/unknown manufacturer and Merck MMR (SQ), lot number 0949N on 09/08/04.
Approximately one hour after receiving the flu shot, my daughter had red blotches/bumps all over her body.  She began tugging her ears and they became swollen as well. 3/7/06 Received ER medical records which revealed patient experienced acute allergic reaction w/hives, rash & facial edema/ss
Marked increase in incidents of short term memory loss with inability to retrieve lost information for approxxmately  6 days
At 11:15 -11:30 am the resident received her initial dose of Pfizer COVID -19 vaccine  in the front of the facility so that her daughter could encourage her to receive the vaccination  she was then returned to  the her neighborhood at approximately 1:15 pm the circulating Pharmacist administered a second dose of the vaccine.
Received dose #1 at 12:04, at 1228 reported "feeling very itchy" and made a comment "its like if someone has a cat in here or something."  "My throat is now feeling tight."  Rapid Response called and the patient was transported to the ED for further evaluation.
PT. RECEIVED VACC. ON 11-18-03, AT THAT TIME NO ADVERSE EVENTS WERE NOTED. SHE CALLED 2   DAYS LATER AND STATED THAT SHE WAS GETTING SOME REDNESS AND A LITTLE SWELLING AROUND THE INJECTION SITE AND IT WAS WARM TO TOUCH. WE ADVISED HER ON HOW TO CARE FOR THE SITE AND MONITOR, IF THINGS SHOULD GET WORSE, TO SEE SEE HER PHYSICIAN. WE INFORMED HER THAT WE WOULD REPORT THIS INCIDENT TO VAERS AND WHY WE HAVE TO DO THIS AND TOLD HER THAT WE WOULD FOLLOW UP WITH A PHONE CALL IN A COUPLE OF DAYS.
Patient developed swelling, itching, and redness the day of the injection.  She went to urgent care 4 days following shot.  She was given Dexamethasone 10mg IM injection.  Then prescribed medrol 4mg dose pak and Keflex 500mg BIDx10days.  On 11/10, she returned to urgent care and reported the itching and swelling resolved, but she then developed a constant pain in her left back arm.  Patient stated that she had been taken ibuprofen and Tylenol with no relief. and not "feeling sick".   She was given cyclobenzaprine 5mg TID for 10 days
Pt describes rash as bruising, and burst blood vessel on the top of the feet Rash is located on the; top of the feet without trauma
multiple (>200) varicella lesions w/extensive involvement of OP & inj site necessitating IVF as pt becomes acidotic quickly if won't take PO
18 hours after injection - light fever, headache, and minor muscle aches in back of thighs. Patient has had similar reactions to other vaccines previously. Taking bed rest with increased protein and fluid intake.
12/23 first dose: 12 minutes after injection, racing heart 130 pulse for less than 2 minutes, feeling of impending doom. Repeat episodes ocurred at 1 hr post  injection and 12 hrs post injection 1/19/2023 second dose: 5 minutes after injection, racing heart 130 pulse for less than 2 minutes, feeling of impending doom.  Mild flu like symptoms at around 12 hrs post injection that lasted for 24 hrs.  Around 48 hrs post injection, chest pain, feeling of impending doom 5-10 minutes and presented to urgent care for evaluation.
p/vax pt devel 3x5'' oval; red; swollen; warm area around inj site; no treatment given
inadvertently administered doses from a vial that was in refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (inadvertently administered doses from a vial that was in refrigerator for more than 30 days) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (inadvertently administered doses from a vial that was in refrigerator for more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (inadvertently administered doses from a vial that was in refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-017961 (Patient Link).; Sender's Comments: This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
Shingles on right C3 & C4 dermatome. Currently being treated with Valtrex 1g TID x7 days. Tingling/burning prodromal symptoms began Tuesday 4/06/21 around 9:30pm. An erythematous burning rash appeared the following day Wednesday 4/07/21. I was diagnosed with Shingles on Friday 4/09/21 at 3:30pm and stared first dose of Valtrex at 7:30pm that same evening 4/09. Rash and pain is still present  as of today 4/14/21.
Pt. reported per P.C. on 1/25/10 4:57 pm. Left arm very sore on Sat. 1/26/10 unable to move fever, redness, whelps & itching all over, red streaks & splotchy all over, including scalp pt. took BENADRYL 25 mg without relief. Inst. to take 50mg BENADRYL this PM & RTC in AM. Never RTC, phoned pt & reports better but had metallic taste in mouth right after injection also. Pt allergic to CODEINE, PCN pt. also reported URI symptoms.
full blown Covid symptoms for 1 day after her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown Covid symptoms for 1 day after her 2nd dose) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown Covid symptoms for 1 day after her 2nd dose). At the time of the report, SUSPECTED COVID-19 (full blown Covid symptoms for 1 day after her 2nd dose) outcome was unknown.            Concomitant medication of the patient was not reported. Patient states that she had full blown Covid symptoms for 2 days after her 1st dose of the Moderna Covid-19 Vaccine & for 1 day after her 2nd dose. No treatment information was provided by the reporter.  This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of Suspected COVID without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred after the second dose of mRNA- 1273 Moderna vaccine and had a duration of 1 day. The patient experienced COVID symptoms, which were not further specified. It is unknown if SARS-CoV-2 test was performed. COVID symptoms were also reported after the first dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395649 (Patient Link).
The day after the shot, the patient got the usual headaches, bodyaches, fatigue, arm soreness, such that it was difficult to raise his arm, nausea, dizziness and fatigue.  That all resolved after two days.  He then felt well for one week. Then, on May 29th, 9 days after vaccination, he got fever to 102, chills, fatigue, itchy vesicular whole body rash, headaches and bodyaches, such that, had he been working, he would have missed work for one week.  He was seen, and put on Valacyclovir 1 gram tid * 1 week for probable recurrent varicella illness.  Viral PCR was positive for VZV.  He recovered over the course of 7 days.
she had an auto immune condition - loefgren syndrome (erythema nodosum) and had no flare up in a few years. Within 1 week of receiving her 1st dose she had flare up, a bump under her skin; she had an auto immune condition - loefgren syndrome (erythema nodosum) and had no flare up in a few years. Within 1 week of receiving her 1st dose she had flare up, a bump under her skin; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number and Expiry date: was not reported) via an unspecified route of administration on an unspecified date (at the age of 72-year-old) as dose 1, single for covid-19 immunization. Medical history included Lofgren syndrome (erythema nodosum) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient stated that she had an auto immune condition - loefgren syndrome (erythema nodosum) and had no flare up in a few years. Within 1 week of receiving her 1st dose she had flare up, a bump under her skin before 10-15 days before the 2nd injection that's when she saw it came. She spoke with her physician who prescribed prednisone. However, she only took one dose stating that she stopped because she was scheduled to receive her 2nd dose of the vaccine at though she should not take prednisone in between the doses. As a result, her physician instead prescribed a Medrol dose pack, which she completed taking on 15Feb. She received her 2nd dose of the Covid vaccine on 16Feb. She is concerned that if she does not resume taking prednisone that she will have further flare ups and wants to know when it might be ok to resume taking medication for the treatment of her auto-immune condition. She is also concerned that the medicine might have affected the vaccine and would like to speak with someone concerning this. The clinical outcome of events was unknown. No follow-up attempts are possible, information about lot/batch number cannot been obtained.
male received a booster dose of Menactra  SC instead of IM in the Right arm, no advesre event; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 years old male patient who was vaccinated with a 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] )(lot U6016AA and Exp. Date 19-OCT-2019) via subcutaneous route instead of intramuscular route in the right arm on 24-Jun-2019.  The patient's medical history was not reported and concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (HPV VACCINE VLP RL1 9V (YEAST)) in the Left Deltoid for Immunisation.  It was an actual medication error case due to inappropriate route of vaccination.  No initial side effects reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
No adverse effect reported; Patient returned to the office and was administered additional doses of MMRII and VARlVAX simultaneously on 7/12/2019.; one unidentified patient was administered one dose of MMR II on 5/24/2019 and then one dose of VARlVAX on 6/7/2019; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 24-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1, 1 dosage form (dose number, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis and then on 07-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) dose 1, 1 dosage form (dose number, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. The reporter stated that the varicella virus vaccine live (oka/merck)(VARIVAX) was administered before the 28 day minimal interval between live vaccines. On 12-JUL-2019, the patient returned to the office and was administered simustaneusly measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 2 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis and varicella virus vaccine live (oka/merck)(VARIVAX) dose 2 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. No adverse effects reported.  This is a non-valid report due to lack of patient's identifiers.