chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On  06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Injection site became warm and swollen the next day after vaccination-lasted several days, lymph node in right armpit became swollen and tender about a day later, menstruation began 2 weeks early and was very heavy-began on 1/26, and then about 10 hours after injection there were chills, fever (102.7), fatigue, joint pain and soreness.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated intramuscular or subcutaneous with a first dose of PNEUMOVAX 23 in September, 2011. On an unspecified date the patient was receiving her second dose. In September, 2012 the patient experienced an injection-site reaction to PNEUMOVAX 23 (lot# not reported). The top of her shoulder to her elbow was raised and swollen. There was unspecified treatment given for the adverse event. The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
# 2 vaccine given 2/17/2021.  On April 10, 2021 noticed new onset of bilateral tinnitus.  Is fairly constant but waxes and wanes in intensity.   2 weeks prior to the onset I was started in Lisinopril 5mg for HTN and thought the Lisinopril might be the cause.  I stopped it and the Tinnitus has remained.   I question if the Vaccine was the cause.
fever, joint pain, swollen cervical nodes, & jaw pain 8 days post vax
This spontaneous report as received from a registered nurse refers to a 54 years old female patient with no relevant medical history or past drug history. The patient was vaccinated with left deltoid with a dose of ZOSTAVAX (dose and lot number was not reported) on 03-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 04-DEC-2012 (reported also as on "an unknown date in December 2012") after having ZOSTAVAX the patient experienced redness the size of a nickel and itching at the injection site. No treatment information was reported. No lab diagnostic studies were performed. It was also reported that as of 17-DEC-2012, the patient did not plan on having a ZOSTAVAX again. It was unknown if the patient sought medical attention. The redness lasted about 3 days and the itching lasted about 5 days and then resolved. The relatedness for the events was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information is not expected.
Headache, muscle aches, low fever. (lasted for 24 hours) Swelling and soreness at area of arm where vaccine was administered.  (it's been 3 days and still continues) Followed by a red spot/mark (measuring 2" x 4")  on arm below  injection site.   (it's been 3 days and still continues)
Sharp pain radiated pain up and down arm numbness. Pain in body and legs stiffness arm should back pain can't lift arm stabbing pain weak muscle. MRI pain med and muscle relaxers. Physical Therapy.
G-mom here today for the 4 month immunizations, hesitant to receive.  States @ 2 month immunizations on day of injections-fretful and crying all day--hard to console even after Tylenol given.  Redness/swelling @ site both thighs. Hot to touch, fever but did not take reading.  Dr. called but did not see. States swelling to both legs were complete thigh artea.  Immunizations held today per G-mom.  Has an appt with Dr tomorrow for well child visit and will discuss with Dr and let her decide to vaccinate or not.  At 2 month IZ visit was given VIS for each antigen a d was also told signs and symlptoms of reaction and to consult Dr. or hospital in event of reaction.  States infant was "OK" the next day.
I had a scratchy throat and runny nose. They were both mild and felt like hay fever. I took PAXLOVID for the normal dose days. I felt better in a day.
sore arm; arm swelled up; was hot; hot to the touch; chest was killing her/pain in her chest; glands swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch) and CHEST PAIN (chest was killing her/pain in her chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch), CHEST PAIN (chest was killing her/pain in her chest) and LYMPHADENOPATHY (glands swelled up). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch), CHEST PAIN (chest was killing her/pain in her chest) and LYMPHADENOPATHY (glands swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant product was reported
involving Tetanus toxoid (Allergy); Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a physician via other manufacturer Pfizer (under reference number: 2015087003).   This case involves a patient of an unknown age and gender who experienced tetanus toxoid allergy, while received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a booster dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number, expiry date, dose not reported) via unknown route in unknown administration site.  On 06-Jun-2019, he patient developed a non-serious involving tetanus toxoid (allergy) (allergy to vaccine) (unknown latency) following the administration of TETANUS TOXOID.  No lab data was reported.  Final diagnosis was involving tetanus toxoid (allergy).  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for involving tetanus toxoid (allergy).  Information on the batch number was requested.  Document held by the sender: none.
DARK FECES; LIGHT HEADACHE; BLOOD WHEN BRUSHING TEETH; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 73 kilograms, and height was 173 centimeters. The patient's past medical history included: broke his knee, residual bruising in left leg, and high cholesterol levels, and concurrent conditions included: developed veins in left leg that appear and disappear, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug usage. The patient noted that he has been eating a lot of yogurt, so his stool is usually more white in color. The patient experienced side effects when treated with rosuvastatin calcium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 7-MAR-2022) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient experienced blood when brushing teeth. On 26-SEP-2021, the patient experienced light headache. On 27-SEP-2021, the patient experienced dark feces. Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood when brushing teeth on 27-SEP-2021, and had not recovered from light headache, and dark feces. This report was non-serious.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant  medications were not reported. On 17-SEP-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Patient came to receive the first shingles vaccine. Patient also received a flu shot the same day as the shingles vaccine. Upon receiving the second vaccine patient reported that she felt ill with chills and shakes after receiving the first vaccine.
received a positive Covid 19 test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received a positive Covid 19 test) 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 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (received a positive Covid 19 test). At the time of the report, COVID-19 (received a positive Covid 19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Result-Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were provided.  No treatment drugs were provided.  Patient was asking if still second dose of the vaccine can get after the quarantine/isolation ends, or do have to wait 90 days.
This spontaneous report as received from a registered pharmacist refers to an approximately 75-year-old female patient. Current conditions included arthritis and allergy to penicillin. On 20-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J004266, expiration date 12-JUL-2014, route not reported). Concomitant therapies included Clopidogrel, Levothyroxine sodium, Lisinopril, Coal tar and Triamcinolone topical cream. Approximately on September 2013 (reported as after receiving ZOSTAVAX) the patient experienced redness at injections site. The event did not resolve at the time of this report. Treatment was not rendered for the events. Laboratory diagnostic test were not performed. Patient sought medical attention by contacting the pharmacist. Causality was not reported. Additional information is not expected.
This spontaneous report as received from a certified medical assistant refers to a 1 year old patient, gender was not reported. Medical history and concurrent conditions were not reported. On 27-OCT-2014, the patient was vaccinated with VARIVAX (Merck) (dose, strength, route and lot number were not reported) Secondary and concomitant therapies were not reported. Medical assistant reported that the patient was inadvertently administered two doses of VARIVAX (Merck) during the same office visit today. No adverse effect reported. Additional information has been requested.
Patient was contacted on 2/28/22 to make an appt. for his 2nd Shingrix vaccine.  He stated after approx. 12/3/21 he started to experience leg pain, cramps and stiffness so severe that he had to visit the ER.
fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received vaccine and 24 hours later experienced fever. The patient asked whether this event was expected after vaccination.
It was reported that a male pt was vaccinated with the hep b vaccine recombinant series. It was reported that approx. one month the first injection the pt started to slur his words, which turned out to be his first symptoms of multiple sclerosis. The pt, as well as his neurologist, were unsure whether the hep b vaccination series had anything to do with the multiple sclerosis. It was noted that the pt grew up in Europe so he may have been at risk but that this could never been determined. Follow-up information from the pt indicated that he received the first and second doses of the hep b vaccine. At the time he was a school bus driver at risk of hepatitis according to the school district. After the first dose he started slurring his words. He received the second dose on time. He was 46 years old. The pt retired in November 1990. He went to the hospital and indicated that the doctors were stumped. The following tests were performed: heavy metal tests, an EVP test, an MRI, lumbar puncture, CT scan and several other blood tests. None were conclusive for MS, but the pt indicated that they were leaning in that direction. Since that time the pt has had 8 MRIs and approx. the same number of other tests. He stated that he does not present clinically like a normal MS because his tests are not definitive by themselves. At no time did the doctors suggest that the hepatitis b vaccine was the trigger. The pt reported that they were adamant that it was not the MS trigger. The pt agreed with their conclusion given the research he has done. Upon internal review, multiple sclerosis was determined to be an other important medical event. Additional info has been requested.
crabby 2 hrs p/vax; arm stiff & somewhat immobile; vax site sore & hard to touch; area of vax swollen, tender & palm sized red w/irregular edges; arms still somewhat stiff; yelps @ sl brushes against vax area;
It felt like I had the flu.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (It felt like I had the flu.) in a 71-year-old female patient 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) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (It felt like I had the flu.). At the time of the report, INFLUENZA LIKE ILLNESS (It felt like I had the flu.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter denies side effects with 2nd dose & booster dose. No Treatment information was provided. No concomitant medication was provided.
Pt reports she felt hot and sweaty. Reports she took her jacket off and drank some water, States she cooled off to chilly put her jacker back on and felt better. O2 sat 96-97% RA. HR-82-88, pt remained stable with no further reaction noted. Pt instructed on post reaction symptoms and severe reactions and  what to do for either type of reaction. Pt verbalized understanding.
shingles; really tired; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), FATIGUE (really tired) and VACCINATION SITE PRURITUS (itching at the injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles), FATIGUE (really tired) and VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, HERPES ZOSTER (shingles), FATIGUE (really tired) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
NO ADVERSE EVENT. WE ARE JUST REPORTING ADMINISTRATION OF THE  VACCINE AFTER RECCOMMENDED  TIME  ROOM TEMPERATUE.  MODERNA MEDICAL TEAM VERIFIED THAT VACCINE WAS STILL EFFECTIVE , AND PT NOTIFIED  FOR OF POTENTIAL FOR SITE INFECTION.             NO ADVERSE EFFECT AT THIS TIME.
This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 63-year-old female patient who received SHINGRIX. Concomitant products included Aspirin. On 25th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved. The reporter considered the erythema and swelling arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician who himself was husband of the patient. The patient experienced arm redness and swelling after receiving SHINGRIX dose. The contact details of the physician were also provided.
Patient brought to the ED by EMS on 1/3/23 for evaluation of vomiting, dizziness, sore throat, and rhinorrhea that started the day prior. Patient reported he called 911 because he could not care for himself any longer.  A COVID PCR test performed in the ED resulted positive. Patient admitted 1/3/23 - 1/7/23. Discharge diagnoses included acute hypoxic respiratory failure due to COVID-19, among other diagnoses. Patient did require 3-4L supplemental O2 during his admission but was able to be weaned off. He has received the primary COVID vaccine series and 3 boosters.
4 days after injection ringing in the ears. As of 1/5/2022 (one month later), the tinnitus is unrelenting and so far no doctor has a clue what to do. I was my doctor's second patient with this issue.
Immediate hot flash I was so hot I was shedding clothes. I had a fan in my pocketbook and used that. I was extremely hot.  Fifteen minutes in I developed a metallic taste in my mouth. This lasted a total of 35 minutes with the hot flash. The metallic taste in my mouth I still have after 3 days of getting shot. My eyeballs were very hot I was given to ice pack, one of which I put on my eyes. I was so uncomfortable. Very scary...
pt devel h/a, nausea, malaise, slight fever p/receiving 1st dose of Typhoid; sx persisted for 2 or 3 days;
pt says she became very disoriented and dizzy.  She had to put her hand out to catch herself while she was sitting.  She kept getting these random episodes of dizziness.  She went to her PCP on 1/18/21.  She was told she had water behind her but she told him her ears were fine.  She was given antibiotic and steroid.  On 1/21/21 she started feeling a fullness with in her ear and began having tinnitus.  It started with the right ear but eventually moved to both ears.   On 1/25/21 she went back to her PCP and she was given another Medrol pack which did not help.  She was still having episodes of a high pitch sound and humming noise like a machine.  She went to ENT on 3/16/21.  They did a hearing test and she was sent for a VNG test. VNG was abnormal.  No DX was given.  She returned to ENT on 4/5/21 and was told she needed to try the epley maneuver.  Pts last visit was on 4/16/21 but does not seem to think this procedure helped any since she is still having symptoms.  Now on 5/26/21 she is still having episodes of dizziness but feels like they are less frequent.
Developed unusually high pitched cry which lasted about 1 hr; described as more irritable than high pitched; Also experienced pain upon touching, swelling, tiredness, & redness @ inject site;
Difficulty breathing due to large blood clot in each lung and a small clot in right femoral artery
Unable to move arm without severe pain in shoulder; waited 7 days with no improvement; went to clinic - diagnosis abscess cellulitis of axillary arm. Theorized serum went to joint.
I've had off and on hot and cold flashes, lost most usage of my arm, it had a deep aching pain that felt like it came from my bone, had a migraine, fever, lethargy, muscle aches.
Rash that appears at different spots on body and last approximate 1-2 days itchy, bumps and sometimes whelps.  Taking Benadryl to help with the discomfort and itchiness Rash started approx 1 week after vaccine was administered on 9/5/21 and 9/28/21
Lab worker - Smallpox placed 10/27/06; Read major reaction 11/2/06, on 11/5/06 Pt noted increased redness, tenderness at vaccine site. Afebrile. Seen 11/6/06 positive LA left axilla, 3" erythematous warm tender area left deltoid surrounding pusting, myalgia afebrile: 11/8/06 follow up redness now subsided after Levaqan 750 mg TPO qd x 5d - infection resolved 11/11/06.
quite ill; nausea; headache; fever; I felt weakness; pain in my upper thighs in the Back of my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization.  The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "quite ill"; NAUSEA (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; ASTHENIA (non-serious), outcome "recovered", described as "I felt weakness"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "pain in my upper thighs in the Back of my legs".  Additional information: Patient concerned about getting a second booster dose of the Pfizer Covid vaccine. Patient got quite ill with the booster with nausea headache fever. After about four or five days patient felt weakness and pain in my upper thighs in the Back of my legs. This did subside after a few days and I am fine now. Is this a normal reaction to the Pfizer vaccine or should I not get a booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.