chrisvoncsefalvay/vaers-outcomes huggingface dataset:
elevated Heart rate; he received a mishandled dose yesterday, an Expire batch of covid 19 vaccine; This is a spontaneous report from a contactable consumer. This (Age: 33, Unit: Unknown) male consumer (Patient) reported that:  A male patient of age 33 (Unit: not reported) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on a day prior to this report (stated as yesterday) as DOSE NUMBER UN-KNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A day prior to this report (stated as yesterday), the patient experienced elevated heart rate, he received a mishandled dose yesterday, an expire batch of covid 19 vaccine. Reporter said he got a call from the pharmacy today stating he received a "spoiled vaccine" and the Pharmacist wanted to get him a moderna vaccine today. Reporter further stated "I wasn't comfortable with mixing the two" and have a "elevated Heart rate for a few minutes yesterday". It was stated that the pharmacy said they would give another Pfizer dose tomorrow and asked for information about re-vaccination after an invalid/bad dose. Reporter was made aware if he has received Pfizer, he needed to continue with Pfizer for series. The patient underwent lab tests and procedures which included heart rate: elevated on an unspecified date. The outcome of events was unknown.  No follow-up attempts were possible; Information about lot/batch number could not be obtained.
Changes in menstrual cycle.  After 1st shot, period started 4 days later (5/25), which was a week early and last longer than usual (7 days vs 3-4 days normally).  Next month (June) my period never happened (I am not pregnant and I had not skipped a period in 14 years).   My next period didn?t start until  7/24 and lasted longer than usual again (12 days).  My next period started on 9/1 and lasted longer than usual again (15 days).  My most recent period started on 9/30 and still has not stopped (so going on 20 days of bleeding now).
Patient died due to Blood clots; This is a spontaneous report from a contactable nurse.  This nurse reported similar events for 3 patients. This is the 2nd of 3 reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient pass away recently due to blood clots.  The agency also stated that all 3 of these nurses had received the Pfizer vaccine. Document submitted for patient even though the event was outside of reporting timelines and deemed by the PI to be unrelated to study drug. It is not reported if autopsy was performed.   information about lot/batch number has been requested.; Sender's Comments: Based from current drug profile, the event thrombosis is assessed as unrelated to suspected drug  BNT162B2 . It is difficult to provide possible cause of the event due to limited patient medical  information or background.,Linked Report(s) : PFIZER INC-2021683252 same reporter, same drug, same event, different patient;PFIZER INC-2021688671 same reporter, same drug, same event, different patient; Reported Cause(s) of Death: Blood clots
p/vax pt had red splotches, vomiting & paleness;given APAP;
phlegm in his throat; This spontaneous case was reported by an other and describes the occurrence of PRODUCTIVE COUGH (phlegm in his throat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (phlegm in his throat). At the time of the report, PRODUCTIVE COUGH (phlegm in his throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Changed the outcome to resolved as patient is fine.
Itching - injection site and left side of body, throat, back and neck Slight soreness off & on - inj site. Sore body, tired, headache
24 hours at the shot, I got up and went to the bathroom, took my dog out, came inside, and was so nauseated, and weak, I passed out in my kitchen, for several minutes, crawled to my bed.  Had a fever 101 all day, very fatigued and weak, for almost 36 hours
a lot of pain; sweating; lymph nodes swelling around collar bone; joint pain; headache; fever on and off; Swelling and stiffness on left side; stiffness on left side; Reported at times unable to move left arm due to reported pain and stiffness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 03Mar2021 and on 29Mar2021 for Covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced a lot of pain, sweating, lymph nodes swelling around collar bone, joint pain headache, fever on and off and it was reported that, taking Tylenol for fever, swelling and stiffness on left side, loosens up during day and reported at times unable to move left arm due to reported pain and stiffness on an unspecified date. Outcome of the events was unknown.
first dose of Shingrix subcutaneously instead of intramuscularly; redness and swelling at site of injection; swelling at site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date unknown) and (batch number C7EX2, expiry date unknown) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 22nd September 2020, the 1st dose was an unknown dose. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 22nd September 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was updated from C7ET2 to C7EX2, as per sales data sheet. The reporter stated thjat, the patient receivced 1st dose of Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. After vaccination with Shingrix, the patient experienced redness and swelling at the site of injection. The reporter consented to follow up.
Per consulting rheumatology provider most likely diagnosis was immune-mediated post-vaccine myofasciitis. Initially patient described muscle and back pain in the hips/groin/lower back. Symptoms started within one week post-vaccination and increased despite supportive measures (Tylenol). Patient was treated with 10 mg of steroids for 3 days with no improvement. Approximately 2 weeks after vaccination patient was admitted for increased pain, laboratory evidence of rhabdomyolysis and hypercalcemia and initiated on 1mg/kg of methylprednisolone and given 4 mg of Zoledronic acid. Patient clinically improved over the next 4 days and was discharged 6 days after hospitalization having fully recovered.
Received FLUMIST later that night spiked fever of 102.5 and chest pain.
Late in the afternoon of 2021-07-18, I noticed a (unilateral) loss of hearing in my left ear. It got a little better around bedtime, but was worse the next morning. That night (Monday), I was nearly deaf in that ear (I could barely hear the grandfather clock striking when my right ear was obstructed by my pillow). Wednesday, I consulted my doctor and was started on a 10-day course of prednisone (50mg q1d). The symptoms subsided within 8 days, but have recurred one time since then, but cleared without further treatment.
At site of administration, area became increasingly red, swollen, and hot to the touch.  Painful with light touch as well.
About 10 minutes after the shot, the patient was itchy from head to toe. Administered 10ml of Benadryl.
Pt vaccinated w/1st dose of vax developed generalized itching & redness of the extremities w/a hot sensation in her chest; tx Celestone & DPH;
pt recvd vax;very fine rash on face,stomach,legs;fever 20mar95;was not active or as hungry as usual;approx 5pm v&d;to hosp;MD felt rash,swelling of rt leg are a local rxn to dtp;felt v,d related to virus that started @same time;cont w/ shot
This spontaneous report as received from a healthcare worker refers to multiple unknown patients of unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patient received improperly stored PNEUMOVAX 23 (lot # L024129, expiry date: 21-JAN-2017; lot # M00386, expiry date: 17-AUG-2017; lot # M005287, expiry date: 08-OCT-2017 and lot # M020521, expiry date: 17-NOV-2017). She mentioned that it could not be ruled out that the vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same reporter. Additional information has been requested.
child taken to ER for hives/fine rash over body;mom gave PO DPH;@ hosp recv 2 inj DPH & pred;not admitted;next day less rash & aching;on pred x 2 days;mom stated PMD did not feel rxn was d/t immun;
FIRST DAY - ONLY SLIGHT PAIN IN MY LEFT ARM. SECOND DAY-BEING AT WORK STARTED WITH VOMITING, VERTIGO, BLOOD PRESSURE DROPPED DOWN TO 70/40 (NORMAL 120/90 WITH BENICAR 5 MLG DAILY MEDICATION).
Anaphalaxis (throat swelling), took 2 BENADRYL, took care of reaction.
This spontaneous report was received from the patient's wife and the 78 year old male patient with high blood pressure, reporting on himself. The patient had no pertinent drug reactions/allergies. On an unspecified date in 2008 the patient was vaccinated with ZOSTAVAX, injection (dose and lot number were not provided). Concomitant medications included an unspecified blood pressure medicine. Reporter stated that the patient received the ZOSTAVAX vaccine 2008, and he came down with shingles on 12-SEP-2014. Reporter stated that he was in the third week of a wicked case of shingles. The outcome of wicked case of shingles was reported as not recovered/not resolved. Patient was prescribed steroids and pain killers as treatment. The relationship between ZOSTAVAX and the event was not reported. No lab diagnostics studies were performed. Patient had an doctor office visit. Additional information has been requested.
Fever of 102.6 degrees, chills, body aches arose the morning after the vaccine and resolved by 4 am the following morning.
after 2nd dose had extreme flu like sx; nausea/body aches/fatigue/headache/chills had blood work done by my Rheumatologist and my WBC dropped down to 2.3; repeat testing 4 weeks later WBC went back up to 5; Rheumatologist assumed it was Methotrexate that I take; but previous numbers were normal; He wanted me to stop Methotrexate but I didn't ; asked to have lab checked again since I felt soo bad with 2nd dose.
passed out; feeling strange; started sweating; sore arm; A spontaneous report was received from a consumer concerning a 78-year-old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and tender right arm, feeling strange, started sweating and passed out.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 16-MAR-2021 the patient received their second dose of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 16-MAR-2021 patient had a sore and tender right arm. On 19-MAR-2021, she started feeling strange, started sweating and passed out. The adverse event of passed out was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  Outcome of the events of sore and tender right arm, feeling strange, started sweating and passed out was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
tested positive for covid on binax rapid antigen test 1/18/22 fully vax w/ Pfizer- no booster
Right arm swelling noted about 40 hours after MMR vaccine administered subcutaneously.  Patient alsot received DTap and IPV in left (unaffected) arm.  Had fever to 102 day after vaccines, but now gone on day of evaluation.  Right upper extremity between antecub fossa and deltoid muscle noted to be red, warm, indurated, and slightly tender to touch.  No clear edge of erythema, no crust or exudate.  Patient with full range of motion of arm.  Clinically well appearing and playful.  Treated with Keflex liquid 375 mg TID for 7 days.
Chills, body aches, fatigue...large area of redness, soreness at injection site up to 4 days after. Became 5 inches in diameter with swollen, dark purple spot in the center around the size of a dime.  Now 8 days later, area of injection remains sore, swollen and red.  Small dime size hard lump where injected.  Concerned for vaccination error because the area of injection is lower on the arm than an intramuscular injection into the deltoid typically is.
Child developed Henoch Schonlein Purpura 22 hours after vaccine administration - rash, (R) knee arthritis.
patient claims the swelling and pain have not gone away, seven months after being administered the vacination.  The arm she showed me was the left arm, claims it is tender about a two inch diameter around injection site, and swollen., i did not oberve a rash or any irritaion to the skin.  The documentation, however, shows patient had injection in right arm, and patient is complaining in left arm
My symptom began on April 17, 2023.  I rolled over in bed, and I felt dizzy.  I went to urgent care.  I was diagnosed with vertigo-pi-natl.  I was given treatment plan for Eppley maneuver.  I have learned it is ear crystals in my ear canal that have moved to the wrong spot.  I am also taking Zyrtec in case it is allergy related.  I was prescribed Meclizine for dizzyness.
This spontaneous report was received from a physician referring to a 70 year old female patient. The patient's relevant history, preexisting medical conditions and concomitant medications were reported unknown. On 07-NOV-2017 at 19:30, the patient was vaccinated with PNEUMOVAX 23 (reported as unknown if it was her first or a subsequent dose) (lot # N025656 expiry date 19-APR-2019) in the right deltoid for prophylaxis (dosing details unknown). On 08-NOV-2017, an hour ago, the patient woke from sleep and noted significant discomfort in her upper arm and her arm felt numb and heavy. She went to the emergency room where the physician noted the small red puncture mark on her deltoid and the entire area surrounding it is indurated for 10 centimeters all around so it's about 20 centimeters in diameter. Her shoulder is probably 3 centimeters thickened. There was no bruising or discoloration, no erythema, just tissue edema. As of 08-NOV-2017, it was unknown if she will continue to take PNEUMOVAX 23. The patient's events were considered as localized events. The patient was prescribed with BENADRYL and was told to check in with her primary care physician. The outcome of was reported as ongoing (not recovered). Causality assessment was not reported. The reporter considered the events to be serious (medically significant).
Vomiting; fatigue; feeling ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 12:45 (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VOMITING (non-serious) with onset 14Dec2021 14:30, outcome "not recovered", described as "Vomiting"; FATIGUE (non-serious) with onset 14Dec2021 14:30, outcome "not recovered", described as "fatigue"; MALAISE (non-serious) with onset 14Dec2021 14:30, outcome "not recovered", described as "feeling ill". Therapeutic measures were taken as a result of vomiting, fatigue, malaise.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was None. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 14Dec2021. Reported Events: Vomiting, fatigue, feeling ill. The patient received the treatment for the adverse events with Ibuprofen and rest.  Follow-up attempts are completed. No further information is expected.
Resident reports that her arm is swollen a lot from vaccine. Pain also present.  No treatment at this time.
Patient received both doses of a approved vaccine (SinoVac). No known adverse reactions occurred.
Body aches ,Injection site upper arm sore and swollen under arm pit. Narrative:  Other Relevant History:
STABLE ANGINA 3/24/2022 SYNCOPE STABLE ANGINA 3/24/2022 ATRIAL FIBRILLATION, PAROXYSMAL
Initial soreness under left armpit, followed by itchiness at the injection site the next day (the 29th). Noticed that I had hives around the injection site on the 30th, which then developed into a large, raised, circular rash around the injection site. Used hydrocortisone cream to treat the itchiness. The rash slowly dissipated over the course of the next 5-6 days.
stools that appear to be what she described as "coffee grounds; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age also reported 71 (unit of measurement not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 24Mar2021, as SINGLE DOSE for covid-19 immunisation; apixaban (ELIQUIS), via an unspecified route of administration, from Sep2020 and ongoing, at 5 mg, 2x/day for an unspecified indication; iron via an unspecified route of administration, from an unspecified date, at unspecified dose and frequency, for an unspecified indication.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient was concerned about the information she received to report if she was taking a blood thinner. The patient didn't read the information prior to receiving the vaccine to inform the clinic. She has been taking ELIQUIS 5mg twice daily since Sep2020. The patient experienced stools that appear to be what she described as "coffee grounds" on 25Mar2021 (the next day). Action taken with apixaban and iron was unknown. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
flu like symptoms/ tired/ aches; weak; This is a spontaneous report from a contactable consumer (patient) received via . An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E19269), via an unspecified route of administration, administered in the right arm on 04Feb2021, at 15:30 as dose 1, single for COVID-19 immunisation. Medical history included known allergies: penicillin, etc. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. She did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Feb2021, at 07:00, the patient experienced flu like symptoms next two days; weak, tired, and ache. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient recovered from the events on 07Feb2021.  No follow-up attempts are possible. No further information is expected.
Rash along waistline two days following his first vaccine and then occurred again three days following his second vaccine. Rash was raised, itchy, warm to touch, and uncomfortable. Lasted about three days. Gave Benadryl and that helped.
2 days of widespread symmetrical pink maculopapular eruption w/ pruritus and burning; started on ankles and has spread to feet, lower legs, hands, wrists, forearms, and sparsely on back and abdomen; includes palms and soles
soreness at injection site; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2022116441).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:US2022116441   Additional Information: GSK Receipt Date: 08-AUG-2022. Reporter's Comments: The case was reported by the patient. In 2018, the patient received Shingrix. The patient experienced soreness at injection site and fatigue after 2nd dose. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022116441:Same reporter,same patient
Achy Chills Headaches  Cold Runny nose  Sneezy Fever Cough
immunized 1968, experienced developmental delay, dysmorphism, hypertelorism, thick tongue, asymptomatic pulmonary stenosis, possible Turner's Noonan's syndrome & heart murmur, child last seen by reporter 1971