chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DID NOT HAVE MENSTRUAL CYCLE FOR A PERIOD OF 6 MONTHS; DIZZINESS; FEVER; DIARRHEA; SWOLLEN LYMPH NODES; WEAKNESS; EXTREME HEADACHE; This spontaneous report received from a patient concerned a female 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced did not have menstrual cycle for a period of 6 months, dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache, and the outcome of did not have menstrual cycle for a period of 6 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211236008.
Bad cough; Awful fatigue; Muscle soreness; Pain came back; some soreness in the muscles throughout her body; It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes; pain from her arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough), THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes), PAIN IN EXTREMITY (pain from her arm), PAIN (Pain came back) and FATIGUE (Awful fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone marrow transplant (Bone marrow donor procedure) in 1990. Concurrent medical conditions included Asthma and Chronic pain (Experienced chronic pain in both her legs and her lower back like she was being stabbed every day since the bone marrow donor procedure in 1990. Her pain was in both legs, but mostly in her left and also in her lower back).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes), PAIN IN EXTREMITY (pain from her arm) and MYALGIA (some soreness in the muscles throughout her body). In August 2021, the patient experienced PAIN (Pain came back). In September 2021, the patient experienced COUGH (Bad cough), FATIGUE (Awful fatigue) and MYALGIA (Muscle soreness). On 18-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes) had resolved. In August 2021, PAIN (Pain came back) had resolved. At the time of the report, COUGH (Bad cough), FATIGUE (Awful fatigue) and MYALGIA (Muscle soreness) was resolving and PAIN IN EXTREMITY (pain from her arm) and MYALGIA (some soreness in the muscles throughout her body) had resolved.            No concomitant medication reported. No treatment medication reported. One day following the first dose of the Moderna vaccine her long term pain went away. Patient also had experienced some soreness in the muscles throughout her body and pain from her arm, but those have resolved later. Patient reported that in September 2021, she did not have a positive COVID-19 test but the symptoms were present. She stayed home for 15 days and her symptoms were improved.
This spontaneous prospective pregnancy report as received from a 31 year old female consumer reporting herself with nauseous and morning sickness. The patient had no pertinent medical history or drug reactions/allergies. The patient became pregnant with last menstruation period of appropriate February 2014 and Estimate Delivery Date of November 2014. Initial exposure to GARDASIL was at 28 week(s) ("about 7 months"). The pregnancy outcome was unknown. On 15-SEP-2014, the patient was "about 7 months" pregnant and accidentally vaccinated with a dose of GARDASIL, 0.5 ml, (lot number not provided) intramuscular. Concomitant therapies included ZOFRAN. The patient also reported that she "for the last couple days on 15-SEP-2014, she felt more nauseous than her usual morning sickness after being administered GARDASIL". The patient also reported that her "nausea has started to get better in the last few days". The patient also provided her Date of Birth which placed her outside of the recommended indications for GARDASIL. No treatment was given for event and no lab diagnostics were performed. She just visited to the office for help. Additional information has been requested.
syncope (very brief) while learning exam room p/shots; dx vasovagal rxn;
SLIGHT HEADACHE; CHEST PAIN DUE TO DIFFICULTY IN BREATHING; DIFFICULTY BREATHING; SLOW TO MOVE/LACK ENERGY; SORE ON LEFT SHOULDER FELT LIKE HE WAS PUNCHED IN THE SHOULDER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced chest pain due to difficulty in breathing. On 19-APR-2021, the subject experienced difficulty breathing. On 19-APR-2021, the subject experienced slow to move/lack energy. On 19-APR-2021, the subject experienced sore on left shoulder felt like he was punched in the shoulder. Laboratory data included: Normal pulse rate (NR: not provided) normal at around 60. On an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain due to difficulty in breathing, difficulty breathing, sore on left shoulder felt like he was punched in the shoulder, and slow to move/lack energy, and had not recovered from slight headache. This report was non-serious.
Client received the influenza, pneumococcal (PPV23), Tdap, MMR, Hepatitis A, Hepatitis B, and shingles Vaccine at 10:10 a.m. at clinic. Client then went to another clinic to get the influenza Vaccine at 2:15p.m. She was consequently also administered the Varicella Vaccine at 2:15 p.m.  Client noticed that she began having wheals (hives) on the left side of abdomen on Sunday, April 26, 2009 at 9:00 a.m. Client had itching (4 on a scale from 0-10). Pain level report at 2-3 on scale 0-10. The lesions were in a area four inches in diameter. On April 28, 2009 the hives spread to over 12 inches in diameter, somewhat confluent fashion. The lesions appear mainly on the left side of abdomen. There are no lesions on the back or any other area of the body except the abdomen area. Client used body lotion on the lesions and it helped with the itching. Client also took warm baths and it appeared to stop the itching. Client referred to medical provider for consultation.
fussy w/in 1hr p/vax, lethargic, had to wake pt for feedings;screamed high pitched cry, even when sleeping for 24hr;pale, lo grade temp, dec appetite;no local rxn @ inj site;
Had an AFib 3 weeks after the 2nd vaccination and now my heart is enlarged  was wondering if this is a major side effect to the vaccination  my heart rate was reaching 190 and skipping the night before I got admitted to the hospital
Pt presented 48 hrs after immunization with redness, soreness, and irritation at injection site. Lower left arm/triceps area was warm to touch. Instructed patient to apply ice and call MD. Became worse over period of 2 days.
Information has been received from a pharmacist referring to a newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 09-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning a patient who on 03-AUG-2007, was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The pharmacist stated that it was "staff error and not product confusion". The patient experienced no adverse experiences. A product quality complaint was not reported. No other information was available. Additional information is not expected.
The patient has a history of COPD and uses 3L O2 at baseline. He was seen in the ED on 7/26/23 for cough for the past week, along with chest pain and throat pain for the past few days. A COVID PCR test performed in the ED resulted positive. He was admitted 7/26/23 - 7/28/23 with discharge diagnoses including COVID infection and acute on chronic respiratory failure with hypoxemia, among other diagnoses. During admission, the patient did require supplemental oxygen to keep O2 sats above 90%. He was able to be weaned off.  He was placed on a 10 day course of Decadron. Of note, the patient has received the primary COVID vaccine series and one booster, which were all administered in 2021.
Patient complained she cannot raise her arm above her ear without a lot of pain, also arm feels bruised and she has pains going down the side of her body.
Headache, Fever, NauseaVomiting, chills, left arm tenderness, chills, tired Narrative:
VACCINATION ADMINISTERED TO PATIENT <18 YEARS OLD FOR MODERNA COVID VACCINE, OUTSIDE OF EUA. CONTACTED PATIENTS GUARDIAN, GRANDMA. GRANDMA REPORTED PT EXPERIENCED NO SIDE EFFECTED FROM THE VACCINE. SHE REPORTED THAT SHE IS NOT CONCERNED, AS HE IS A LARGER INDIVIDUAL. BASED ON GUIDANCE FROM LOCAL PUBLIC HEALTH, I INFORMED HER THAT HE COULD RECEIVE A SECOND DOSE OFF LABEL IN FOUR WEEKS, OR WAIT UNTIL HE IS 18 OR AN EUA IS AUTHORIZED FOR MODERNA FOR THOSE AGED <18 YEARS. SHE STATED THEY WOULD LIKE TO PROCEED WITH THE SECOND DOSE.
This report was received from the investigator on 07 June 2010. A 31 year-old male subject with no significant medical history received ACAM2000 (lot number not reported) on 23 February 2010. The subject previously received H1N1 (manufacturer unknown and lot number not reported) on 04 February 2010. Thirteen days after receiving ACAM2000, the subject was diagnosed with acute pericarditis, unspecified. On day 11 (06 March 2010), the subject had an abnormal electrocardiogram. On day 12 (07 March 2010), the subject had a Troponin I of 12.05 (abnormal) and on day 13 (08 March 2010) the subject had an abnormal echocardiogram. The outcome was not reported.  Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
local rxn to vax;rt leg red, swollen, warm to touch, child cranky;tx w/motrin & ice to site;
Limited mvmt of arm due to pain at injection site cont 7 days post immunization. Pt has taken occasional Advil no relief.
Vaccine registry was pulled and reviewed prior to administration. No bivalent was on patients record. After administration the registry was verified again to see if reporting for vaccine was successful. Upon the second time it was pulled a bivalent dose appeared.   Patient was notified of the event while he was still waiting at the pharmacy. He has had no adverse reaction and was not concerned about receiving the extra/unneeded dose.
Some doses that may have been administered past 30 days from being thawed; The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was reported by the reporter.
8.13.2021  3 days of cough, cold congestion with body aches and chills.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 11 years old female patient who had her face was red and swollen, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced redness facial and swelling face. (Other relevant tests included no lab data.) Final diagnosis was her face was red and swollen. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for both events. List of documents held by sender: none.
Change in taste. Metallic taste day after. Two days after Now everything tastes bad.; This is a spontaneous report from a contactable consumer reported himself that a 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown), via an unknown route of administration in left arm on 14Feb2021 at 13:45 (at the age of 70-years-old) as dose number unknown, single for COVID-19 immunization. Facility type vaccine was mentioned as other. The patient's medical history included cancer from an unknown date and unknown if ongoing. No known allergies. Concomitant medication was not reported. Other vaccine 4 weeks vaccine date was on 24Jan2021 (detail not provided). On an unknown date in Feb2021, the patient experienced change in taste. Metallic taste day after. Two days after Now everything tastes bad. No covid prior vaccination. No covid tested post vaccination. No treatment received. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
12.5 x 9.6 cm area of erythema, warmth and mild swelling. Erythematous papular rash noted on the outer edges.
09/08/22 presents to ED for "right arm numbness, bilateral blurred vision and abnormal gait". PMHx of "Neck pain s/p cervical Surgery on 08/30/22"
Pots (Postural Orthostatic Tachycardia Syndrome); Chronic fainting, fatigue, body pain, migraine, nausea, exercise intolerance, brain fog, difficulty concentrating - worsened after second dose.
At approx. 1:45pm vaccines administered.  Within fifteen minutes of receiving vaccines, baby was screaming and continued to do so the entire trip home (approx. 30 minutes).  Gave him a bottle and he fell asleep - slept longer than usual - I was holding him as he slept and he woke himself up at 5:00pm SCREAMING, NOT crying.  I attempted to console him and NOTHING worked.  His entire body was tight - his legs drawn up, his fists clenched, his face in an unrecognizable scowel.  The scream was unlike any he has EVER done before or since and he wouldn't stop.  I took him outside, I rocked him, I attempted to feed him and he refused though hungry.  I was so frantic I called my mother-in-law to come over and she was terrified also.  He sounded and acted like he was in terrible pain.  I gave him a second dose of Tylenol (he had one with the shots) and called the after hours emergency line at the hospital. She asked me all kinds of questions.  The one additional thing I noticed was a red, irregular shaped, patch under his skin on his leg.  It was not at the actual injection sight, but about an inch below it.  It was a little larger than 2" in diameter.  I put a warm compress on it, which he would hardly let me do.   Finally, after OVER a FULL HOUR of SCREAMING he was exhausted and fell asleep.  I held him for four hours that evening as he slept (he never sleeps that long at that time of day).  When he woke up he seemed better.  His eyes were swollen from all the screaming and he seemed lethargic and not his usual happy self.  But, thank God, he wasn't screaming anymore.  I continued with the Tylenol every four hours for twenty-four hours and as needed for irritability beyond that.
Fever of 103 for 3 days, extreme chills and muscle aches for 3 days
shot injured; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INJURY (non-serious) with onset Dec2020, outcome "unknown", described as "shot injured".  Additional information: It was reported that the reporter have received two packets requesting information on the passing of mother after her two Pfizer shots. Reporter refused to fill out these pages and it will be futile, in his opinion, to ask the nursing home she was in at the time to do so. The nursing homes, as well as most hospitals and doctors have been ordered, or maybe instructed, to administer treatment as directed by the CDC, the FDA, etc. and will not do anything outside of those boundaries at risk of licensing issues possibly loss of, as has been the case with many doctors that reporter now follow that have stepped outside this box created for them. Reporter wanted to give the name Of the nursing facility, as the reporter believe they will always believe they have done all they  have done in the good name of medical expediency and possibly to this day will never believe that the shots for covid did any harm (name withheld), (Address withheld). If Pfizer were truly interested in reporter's mother's case, Pfizer would start acknowledging all of the known cases of shot injured as with,(Name withheld) injured in trial in Dec2020 and as Of Jan2023, Pfizer has not acknowledged this girl in any way. One organization with just one report (organization Name withheld), press release dated 24Aug2022, in which several injured cases are listed Report Reveals Multiple Covid Shot Injuries. You can look that up if you want to take the initiative. This is just two reports you can research and acknowledge, there are so many many more. Reporter asked that Pfizer do the right thing Stop being part of a mandatory requirement for the shot, acknowledge the risks, acknowledge the injured and help them, stop the push for even further shots down to 6 month old babies stop your greed at the expense Of human lives. Bottom line, stop the deceit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300057978 same reporter/drug, different patient/AE;
Extreme swelling in area where the shot was administered, pain in arm everytime I would lift it or move it in general, the swelling lasted about 8 days, swelling has gone down but there is still a noticeable lump on my arm where the shot was given. Normal pregnancy, estimated due date is 3/22/2018.
R57.9 SHOCK, UNSPECIFIED 6/24/2022 CARDIOMYOPATHY, UNSPECIFIED
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 5 (booster), single (Lot number: CH9693) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FA7484) and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Dec2022 at 18:00, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Nov2022) Positive; (07Dec2022) Positive, notes: I got home antigen test and it went positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: On Monday, 05Nov2022 my husband tested positive for COVID-19. On Wednesday, 07Dec2022, I started having COVID-19 symptoms (fever, nasal congestion, sore throat, and cough). I got home antigen test and it went positive. On that same Wednesday at night, I started PAXLOVID. I finished treatment with PAXLOVID. The patient did not take other medication in 2 weeks. The patient was treated with Paxlovid (Lot number: 1923792A) from 07Dec2022 to 12Dec2022, indication: Treatment of COVID-19. Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
This spontaneous report was received from a 21 years old female Medical assistant reporting on herself who received all 3 doses of RECOMBIVAX HB intramuscularly between about "1993 and 1996". No other co-suspects were reported. No concomitant medications were reported. On 26-NOV-2012, a surface antibody test was performed that returned negative results for immunity to hepatitis B virus. The patient's present status was unchanged since 26-NOV-2012. No treatment was given. The relatedness for negative results to immunity to hepatitis b virus was unknown for RECOMBIVAX HB. Additional information has been requested.
Pt states she had a hard time breathing, felt shaky and had some dizziness. Ambulance came to her home but she did not go to the hospital when paramedics asked her to. This occurred 1.5 hrs after receiving the vaccine.