chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports that since she had her covid vaccine she has had morning headings and intermittent dizziness which she never had before her vaccine.  The headaches do improve with Ibuprofen.  She is also reporting severe muscle cramps that are random that never occurred before the vaccine. She has back spasms.  She reports that 2 days after the vaccine she felt horrible and had to call in (fever and chills and fatigue) and since that time she has also had random chest pain, she is more short of breathe walking up the stairs.     Patient reports that the joint pains are mostly in her hands and she will randomly have her fingers contract.  She also has random cramps in her calves.
Hives, swelling, itching. Visited Baystate Clinic, Westfield, MA approximately two days into symptoms.  Prednisone, Hydroxyzine, Famotidine, Loratadine prescribed.  2 days later, increase in hives, swelling, itching, and wheezing. Further swelling of lips, face, neck and throat.  Prednisone, Benedryl injection, Epinephrine injection.
Left arm swollen and hot 3x arm on right side. Started about fist size and moved about 2inches up and down arm.  Took to emergency room Sunday and doctor said it was an infection.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M045653 with expiration date of 03-JUL-2019 and lot# N002913 with expiration date of 23-FEB-2019, for prophylaxis (dose, route and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger". This one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000697: US-009507513-1707USA000698: US-009507513-1707USA000699.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 14-NOV-"2018" (after the date of this report), a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 23-FEB-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX) vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Dizziness, Diaphoretic. Patient left on way to car and felt light headed and came back to clinic. Patient VS monitored and discharged.
Mom states 3-4 hours after vax child developed fever of 104. He then developed hypersomnolence, slept from 4pm-11pm, then had unconsolable crying >3 hours.
I have experienced the extreme exhaustion, nausea without vomiting, and COVID-19 arm. Also concerning my top lip went numb within minutes of the shot each time, however it did not swell and went away by the next day. The concerning symptoms include dizziness, difficulties to concentrate, my bp is averaging 155/145 with a heart rate from 106 to 139 at full resting or sleeping. It gets worse sitting, or standing.  The fever has been 100.6 to 102.9 and uncontrollable. I have not been able to knock it down since the shot.
body aches; felt tired; week of joint pain; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (body aches), FATIGUE (felt tired) and ARTHRALGIA (week of joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Thyroidectomy. Concomitant products included VITAMINS NOS, VITAMIN D [VITAMIN D NOS] and LEVOTHYROXINE for an unknown indication.   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 27-Feb-2021, the patient experienced MYALGIA (body aches), FATIGUE (felt tired) and ARTHRALGIA (week of joint pain). On 06-Mar-2021, ARTHRALGIA (week of joint pain) had resolved. At the time of the report, MYALGIA (body aches) and FATIGUE (felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.
9-21-05 Td was given subcutaneously. CCD information line contacted no TX advised. 9-23-05 Pt had slight swelling at injection site. 9-21-05 Warm pack and Tylenol suggested  if needed. 11-04-05 No known adverse reactions.
severe joint and muscle pain as well as pain in sciatic nerve (left leg), chills, lethargy
Pt called reporting bruise and welt. Also having headache and joint pain heart palpitations. Chills till Sunday.
Patient given influenza vaccine and 2 days later, parent reported had raised red edematous area to injection site
Information has been received from a physician concerning a 16 year old female who on 06-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 659182/1757U) and when she walked to the front desk afterwards she fainted.  Concomitant suspect therapy included VARIVAX.  Other concomitant therapy included LOESTRIN.  The patient was given some unspecified fluids in the office and recovered from the event.  No further information provided.  Additional information has been requested.
pt recvd vax & w/in 15mins p/vax exp resp distress,diff breathing,fullness in throat,& was panicky;pt treated w/epi in ER;sx resolved;
No AE/ PQC reported at this time.; Improper storage of product in use; This spontaneous report was received from other health care professional and refers to a 6-week-old patient of unknown gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 24-MAY-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1741376, which has been verified to be valid, the expiration date was reported and validated 06-MAR-2022), as prophylaxis (product storage error) (strength, dose, dose number, and route of administration were not provided).    The suspect vaccine was exposed to a temperature of 36 to 46 degrees Fahrenheit (F) (48.2 degrees F) for a time frame of 0 hours 15 minutes 0 seconds, as recorded by digital data logger. There was a previous temperature excursion reported of 36 to 46 degrees Fahrenheit (F) (46.2 degrees F) for a time frame of 0 hours 15 minutes 0 seconds. No additional adverse event were reported.  This is one of several report received from the same reporter.; Sender's Comments:  US-009507513-2106USA000988:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. In May 2016, the patient was vaccinated with a dose of an improperly store ROTATEQ, orally, lot number K020181, expiration date 24-JUN-2016 (dose and frequency were not reported) before this lot of ROTATEQ expired. There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
DIAGNOSED WITH BELLS PALSY ON DISCHARGE FROM HOSPITAL ON 06 OCT 2021.  ON 05 OCT 2021, PRESENTED TO E.R. WITH ONSET OF L SIDED FACIAL WEAKNESS/PARALYSIS THAT STARTED ON 03 OCT 2021.  GIVEN RX PREDNISONE 60 MG X 7 DAYS.  AS OF THIS WRITING (31 OCT 2021) SIGNS / SX'S HAVE RESOLVED ABOUT 70%..  ***NOTE. THE MODERNA DOSE ABOVE WAS ADDITIONAL DOSE AFTER COMPLETION OF 2 DOSE PFIZER REGIMEN ADMINISTERED 02 FEB / 24 FEB 2021 RESPECTIVELY.    *** ADDITIONALLY, I ALSO RECEIVED 1ST DOSE OF SHINGRIX ZOSTER RECOMBINANT ON 23 JUN 2021 AND QUADRIVALENT INFLUENZA ON 15 SEP 2021.
bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pfizer! I received your booster shot in the middle of December, my first doses being in Moderna" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1), for COVID-19 immunization; Moderna (DOSE 2), for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset Jan2022, outcome "unknown", described as "bleeding". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
My son was given an extra covid vaccine when he does not need it and is not approved to get a 3rd shot. He had 2 moderna shots this summer and today I was told he needed another one and they gave him Pfizer
Sore arm. Pain is still there after 3 months. Hurts to raise my arm, reach behind me, or to lean on arm.
Received only influenza vaccine 11/16/06. Awoke with mild-moderate ataxia within 24 hours. Otherwise well. No evidence of weakness but DTR's 1+ equal bilaterally. No nystagmus. EOMs normal.
impacted tooth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TOOTH IMPACTED (non-serious), outcome "unknown", described as "impacted tooth". Additional information: The patient asked if it was okay for him to get his second dose of the COVID-19 vaccine on 03Mar2021 instead of 02Mar2021. The patient had just been to his dentist due to impacted tooth and his dentist wanted to put him to an antibiotic which is Penicillin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after the shot, strange pains shot down the arm, but they went away after a few minutes. about 4-5 hours after the shot felt dizzy, nauseous, extreme arm pain, fatigue. All have subsided except for the extreme arm pain.  (We were given a paper that said to report all side effects here)
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, and other pre-existing medical conditions included: Patient was healthy, did not have any chronic conditions and medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-SEP-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, in the morning the patient had bad fever. On 17-SEP-2021, the patient had a tele-visit with his doctor who suggested patient to take a COVID-19 PCR (coronavirus 19 polymerase chain reaction) test, which came back to positive (confirmed covid-19 infection) with symptoms of cough, headache, fatigue and fever. On 19-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 103.8 F. Treatment medications included: ibuprofen, and paracetamol (given every 4-6 hours to keep fever down) and fever went at 9 to 10. On 20-SEP-2021, the patient went to hospital/clinic where patient received antibiotics, inhaler, CIPAP (continuous positive airway pressure therapy), and a monoclonal infusion as corrective treatment. On the same day, Laboratory data included: Body temperature (NR: not provided) 102 F. The patient was not hospitalized, just stayed at the clinic located in the hospital for a few hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958723.; Sender's Comments: V0: 20210958772-COVID-19 VACCINE AD26.COV2.S-Confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient called pharmacy at 10:00 am and stated she had rash from inj. site down to elbow. Her arm was sore, swollen, red, and itchy. Pt. was advised to take BENADRYL and contact Dr. or pharmacy if no improvement after several hours. Patient called back around 12:35 pm stating that she did take 2 reg. strength BENADRYL and the swelling did go down slightly but an hour after taking them she said the itching and pain was starting to return. Advised her to take BENADRYL every 4-6 hours and if it does not continue to improve later in the day then call Dr.
Pt received vaccine at clinic at work (3rd shift). She received shot and immediately felt pain. It throbbed throughout the night. She could barely lift arm next morning. RPh told her to take TYLENOL or Ibuprofen and use ice pack and watch for next few hours.
Possible cellulitis. 4x6" red, warm, tender superficial area (L) lateral arm approx. 2" from injection site. No open wounds noted.
Not positive what type of hep b but it was first shot of hep b. The whole experience was weird and I believe she did the shot too high on my arm. A 25 gauge needle doesn?t hurt and it didn?t hurt going in but afterwards it felt like a nerve was hit and I know what that feels like due to nerve pain I?ve experienced for years. when she pulled the needle out I was bleeding a lot and that has also never happened with a shot before. Nothing was prepared (bandaid, cotton ball, wipe) anything at all. Very very painful as of now and it?s been 2 and a half hours.
Severe reaction in feet and knees that I have had osteoarthritis....could not walk 24 hours after vaccine was given.  Quite certain vaccine caused this reaction, I was able to get around with a manual walker before the reaction....
Felt body needed to defecate but could not; Severe lower abdominal cramping on day 3 post vaccination. Intermittent pains throughout day but increased at night.; Intermittent pains; Some nausea; This is a spontaneous report from a contactable consumer, the patient.  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 10Dec2020 at 10:45 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. The patient previously received clindamycin and experienced allergy. The patient had no other relevant medical history or concurrent conditions. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. On 05Dec2020 (as reported) at 16:30, the patient experienced severe lower abdominal cramping on day 3 post vaccination. The patient experienced intermittent pains throughout day but increased at night. The patient experienced some nausea. The patient felt her body needed to defecate but could not and pain persisted. The pain improved on day 4. Therapeutic measures were taken as a result of the events and included the patient received Pepto Bismol. The clinical outcome of the events severe lower abdominal cramping, intermittent pains and felt body needed to defecate but could not was recovering. The outcome of the nausea was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Developed red warm raised rash around injection site 1 week after injection. Site itchy and irritated for three days
SOB, Palpitations, tachycardia and diarrhea started on 6/2/21
Patient under age 18 was vaccinated with Johnson and Johnson, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away. Parent validated age as 18. Unreported as error, found in data mining.
Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 27-OCT-2017, the patient received an improperly dose of VARIVAX lot # N017397, expiration date 07-JUN-2019 for prophylaxis (dose, anatomical location and route of administration were not reported) reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 3 hours and 41 minutes. The vaccine underwent a previous temperature excursion between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 1 hour and 40 minutes. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter; the additional report was considered as non-valid as there were no patient identifiers.; Sender's Comments: US-009507513-1711USA010765:
Progressive redness, swelling, itching at the injection site: @24hrs 4x3.5in @ 36hrs size doubled @ 48hrs. Redness & swelling had consumed arm from shoulder to elbow. Dizziness/lightheaded, nausea, very weak and feeling of exhaustion (slept 14hrs). Seen PCP at 36hrs Rx Cephalexin 500mg and steroid injection. Symptoms began to subside after 48hrs and returned to normal (except for itching and 'bruising' affect) after 72hrs.
Patient tested positive for COVID on 8/4/22 with sx of cough and SOB. Treatment includes oxygen and IV medication.
24 hours later developed a fist sized whelp at administration site along with itching and heat
Started as a few small pimple like bumps and some mild redness the size of a quarter. Redness turned purplish and grew to the size of a golf ball with hard bumps underneath. Measured 4.5cm by 2.5cm by physician.
FEVER, INFLAMMATION, RIGORS, AND SWELLING/REDNESS AT INJECTION SITE
SPASMS TO LEFT HAND AND FINGERS; BUMP SIZE, PENNY SIZE TO LEFT  UPPER ARM (INJECTION SITE); TENDENTIOUS/ LEFT ARM WITH RADIATING PAIN TO LEFT HAND AND FINGERS/ LEFT HAND THROB; SOME FATIGUE; HEADACHE RADIATING TO NECK, FRONT HEAD AND LEFT SHOULDER; UNABLE TO WORK; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 175 pounds, and height was 63 inches. The patient's concurrent conditions included fatty liver disease, blood pressure, alcoholic, non smoker, and muscular skeletal pain in left arm, and other pre-existing medical conditions included the patient had no known drug allergy and did not have history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included valsartan for blood pressure, and tizanidine for muscular skeletal pain in left arm. On APR-2021, the subject experienced unable to work. On 09-APR-2021, the subject experienced tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb. On 09-APR-2021, the subject experienced some fatigue. On 09-APR-2021, the subject experienced headache radiating to neck, front head and left shoulder. On 11-APR-2021, the subject experienced bump size, penny size to left upper arm (injection site). On 19-APR-2021, the subject experienced spasms to left hand and fingers. On 20-APR-2021, treatment medications included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some fatigue, had not recovered from headache radiating to neck, front head and left shoulder, bump size, penny size to left upper arm (injection site), and tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb, and the outcome of spasms to left hand and fingers and unable to work was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
pt grandmother states pt c/o lt hand numbness & hand is swollen;pt grandmother states hand is discolored-denies any injury to hand;recommended pt be exam by MD;
1st day after: fatigued. 2nd day after: nausea upon eating breakfast, tightness in neck, shoulders & headache. Take Tylenol.  Symptoms lessen by mid-afternoon or dinner time.  No symptoms first thing next day.  The issue has happened for 5 days in a row.  Eating oatmeal with no milk or sugar and hot tea. How long can this last???
Bumpy rash on shoulder around site of vaccination.  Not warm, red, or itchy.  A palm-sized area of raised small bumps - persistent at least 1 week after vaccination.  Not yet resolved.
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with VAQTA (lot # L015460, expiration date 20-JUL-2017). The vaccines were improperly stored the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
48 hrs p/DT booster got swollen, red, hot rt arm (site of inject) & t99.6, signif, malaise, vomiting;