chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect; M-M-R II administered by intramuscular rather than subcutaneous route; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant therapy included sterile diluent(STERILE DILUENT).  On 14-AUG-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection (dose and frequency was not reported) (lot # R030809, expiry date: 24-OCT-2020) via intramuscular route rather than subcutaneous route for prophylaxis. It was reported that, the reporter wanted to vaccinate at 45 degree angle, but the patient moved which may have caused the injection to be administered by intramuscular route (incorrect route of product administration). No adverse effects were reported. No product quality complaint was involved.
NO ADVERSE EFFECT; The patient was inadvertently administered a dose ofVAQTA which was expired; This spontaneous report was received from a Medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 06-OCT-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # S017739 with expiration date of 29-AUG-2020 for prophylaxis(strength, dose, frequency, route were not provided).No adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S017739; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Symptoms developed the morning of 11/20/04 and lasted until 11/23/04.  Pt c/o congestion, earache, muscle aches and low grade fever.  Pt developed hives on Saturday afternoon.  Pt reports taking Benadryl and the hives subsided 1 hour later.  Pt reports hives reoccurred on Sunday am 11/21/04 and again subsided after taking Benadryl.  Pt reports feeling "heat" behind knees and on elbows which lasted approx. 2 hours.  Pt reports that symptoms
I am not sleeping due to the pain in my upper arm, chronic musle aching, reduced range of motion of my right arm, dull ache.
hearing loss Left ear. tinnitus in both ears.  Facial numbness (resolved now) Hearing loss left ear improved. Still high pitched tone tinnitus in both ears persistent shoulder pains.
New onset of gastroparesis and flare of her RA; Inflammation with high inflammatory markers il-6 and hs-crp
Rash-cleared on own early Nov. 07.  12-31-07, 1-8-08, 1-9-08 seen for abscess on L leg, red, swollen nodule.
NOT SLEEPING WELL; ITCHING ALL OVER BODY; BROKE OUT INTO HIVES; FLU-LIKE SYMPTOMS (COLD CHILLS, ACHES); SWEATING QUITE A BIT; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy experienced it as a childhood reaction, alcohol user 2-3 beers every night around supper time, and cigarette smoker 10 cigarettes per day, and other pre-existing medical conditions included no 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: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-JUL-2021, the subject experienced flu-like symptoms (cold chills, aches). On 16-JUL-2021, the subject experienced sweating quite a bit. On 19-JUL-2021, the subject experienced not sleeping well. On 19-JUL-2021, the subject experienced itching all over body. On 19-JUL-2021, the subject experienced broke out into hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (cold chills, aches), and sweating quite a bit on 17-JUL-2021, had not recovered from broke out into hives, and itching all over body, and the outcome of not sleeping well was not reported. This report was non-serious.
This spontaneous report was received from office manager refers to a male patient of unknown age. The patient's pertinent medical history and concomitant medications were unknown. He had no known drug reactions/allergies. On 03-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L035687 and expiry date 16-FEB-2017) intramuscular. On an unknown date in November 2016, he experienced abscess at the injection site and went to unspecified hospital overnight during which he received 2 different antibiotics. The outcome of injection site abscess was unknown. The reporter did not provide relatedness of the event with PNEUMOVAX 23. Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 7:02 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 7:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
swelling under the armpit/only swelling under the armpit on the same arm the injection was given; This is a spontaneous report from a contactable consumer (patient) from medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in arm, on an unspecified date, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced swelling under the armpit; there is no swelling at the site of the injection, only swelling under the armpit on the same arm on the injection was given, and it was continuing. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021353914 Same reporter/drug, different patient/events
after the shot, red swollen line going down elbow and around my arm about 8 inches wide. went to the  ER on the next day, and was diagnosed with  cellulites and the spot is infected both ER and the Physician said the same thing. Advised to get the second Shot on the other arm and to take one hr before Zyrtec and famotidine and again 4 hrs later. The inflammation is still spreading as of today.
Allergic local reaction (L) thigh swollen leg - difficulty ambulating, no fever.
10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is abnormal for me because my normal is 96.5-97.  I called my employer  and had COVID test on  1-2-21 negative. Employer instructed me to go to  get flu A and B test and strep test which were all negative on 1-3-21. On 1-5-21 had second covid test that was negative. On 1-6-21 video visit at PCP  since I wanted to be released to go back to work. Had CXR(negative) and started doxycyline 100mg for possible sinus infection. Flushing sensation stopped on 1-9-21. No flushing sensation until 1-22-21(10 days after 2nd vaccine) but temp 98.5 at highest and I continue to have today. I continued to work through this second episode since I believe it was my body's reaction to the virus.
Urinary tract infection 48-72 hours after vaccine. Hematuria, with WBC's. Given course if Macrobid for 7 days.
dizziness; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), HCTZ and LISINOPRIL for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache). On 19-Mar-2021, the patient experienced DIZZINESS (dizziness). On 17-Mar-2021, PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, DIZZINESS (dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (abnormal) Fever.         No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Pt received V-vax booster 8/15/07 - redness approx 3 in wide and tender to left arm after V-vax booster. No fever, lesions, or blisters. Tylenol or Motrin PRN pain and warm compress - Benadryl every 6 hours PRN itch, swelling. Call with further concerns.
Child is age 3 and recommended vaccine is Dtap.  She was given Tdap. State response when reported is that if dose 4 or 5-it can be considered valid and does not need to be repeated. (if dose 1,2, or 3-it would not count and need to be repeated) She has already received 4 doses of Dtap and this is dose #5. It  is a valid dose and the child is protected. It will count as 5th dose and is now completed.
around 9hr p/vax pt noticed a rash on rt arm neck, chest & shoulder;some itching;MD told pt to take 2 DPH-rash soon disappeared;
14-groggy, deep chest cough. 18th fever. 20 went to doctor, fever 103, eyes swelled shut, red splotches over eyes, sick, coughing. Goes back to doctor 10/22/09. 3 day steroid started 10/20/09 with amoxicillin.
Information has been received from a registered nurse concerning a 20 year old female with chronic fatigue syndrome, and temporomandibular joint syndrome and a medical history of hyperrigidity of the right shoulder, who on 03-JUL-2007 was vaccinated with the first dose of Gardasil, and on 30-OCT-2007 and 27-FEB-2008 was vaccinated intramuscularly in the left arm with the second and third 0.5 mL doses of Gardasil, respectively.  Concomitant therapy included herbal supplements (unspecified).  On 27-FEB-2008 immediately after receiving the third dose, the patient felt lightheaded and experienced left arm pain.  The patient sought unspecified medical attention.  No diagnostic laboratory studies were done.  As of 03-MAR-2008 the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/7/2008. On 15-APR-2008 the nurse reported that the left arm pain has resolved (specific date not given). No product quality complaint was involved. Additional information has been requested.
pt recv vax 20OCT98 pt ran fever next day 2 days p/vax rt arm exp large amount of swelling;pt did not see MD but family observed reaction;
Information has been received from a nurse via a company representative concerning a female (age not reported) with an allergy to bakers yeast and on a gluten free diet who, on an unspecified date, was vaccinated with a second dose of Gardasil and passed out (dates not reported). It was reported that the patient received the first dose with "no problem". At the time of the report, recovery status of the patient was unspecified. Additional information has been requested.
Patient developed severe pain throughout her body on June 10 2021 this was approximately one month after her second COVID vaccine (second done 5/7/2021, same vaccine site)   We don?t know what caused this pain. It is ongoing. We don?t have any idea why it is happening or how it can be treated and or resolved.
same reaction as the initial reporter; spasms in the chest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (same reaction as the initial reporter) and MUSCLE SPASMS (spasms in the chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (same reaction as the initial reporter) and MUSCLE SPASMS (spasms in the chest). At the time of the report, VACCINATION COMPLICATION (same reaction as the initial reporter) and MUSCLE SPASMS (spasms in the chest) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.  Caller stated that he joined a social media group called 'Chronic Spontaneous Urticaria after COVID- 19 vaccine Support Group' where there are group of people with the same type of reactions. Reporter stated that a doctor he knows had a same reaction and spasms in the chest after the 2nd dose in a similar time frame as he did (10-14 days).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 19-SEP-2016 the patient was vaccinated with an expired dose of M-M-R II (lot # M001200, expiration date 28-AUG-2016). No adverse event reported. Additional information has been requested.
Enlarged lymp node; Lump on her neck; activities of daily living impaired; had a sore arm; reports having a brief, short-lived cold; causing stuffiness; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. In January 2020, the patient experienced cold and nasal congestion. On 17th January 2020, the patient experienced activities of daily living impaired. On 22nd January 2020, the patient experienced enlargement of lymph nodes and mass. On 3rd January 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the enlargement of lymph nodes and mass were not recovered/not resolved and the outcome of the cold and nasal congestion were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, cold, nasal congestion, mass and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had a sore arm the next day that only lasted for that day. Less than 2 weeks after vaccination, the patient was having a brief, short-lived cold. It takes as taking 4 days to decide it was going to become something other than causing stuffiness, and cold kept her from doing activities on 17th January 2020 and 18th January 2020. On 19th January 2020, the patient was up and going. On 22nd January 2020, 20 days after vaccination, the patient discovered a lump on her neck and lymphadenopathy scheduled a doctor's appointment. A few days later at the appointment, the physician discovered another lump that was an enlarged lymph node. The patient was having a full blood work up with no significant findings, next, an ultrasound will be scheduled to evaluate neck/ lymph nodes. The reporter consented to follow up.
Patient called in on Sunday Feb 25,2018 and said her arm had a small red area about 2 inches in size. I told her to draw a mark around it and if the red started going outside the mark she should call her doctor or go to ER. She came in the next morning and I looked it was much larger and going down her arm. She went to physician assistant and she was given BENADRYL 25mg capsules and CIPRO 500 mg twice a day. It is now clearing up.
Muscle and joint pain; Muscle and joint pain; fever; severe chills; nausea; vomiting; fatigue; severe headache; injection site pain; severe feeling of sickness; This is a spontaneous report from a contactable nurse reported for himself that:  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) form LOT# EJ1685 on left arm on 22Dec2020 10:00 at SINGLE DOSE for covid-19 immunization.Age at vaccination: 69 Years Medical history included flu (almost 43 years ago).  The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced  muscle and joint pain, fever, severe chills, severe shivering, nausea, vomiting, fatigue, severe headache, injection site pain and a severe feeling of sickness. This severe feeling of sickness was the worst feeling of sickness that I have had in my life, only equal to the most sick I have felt in my life, which was the last time I had the flu, which was almost 43 years ago. This began about 9 hours after I got my second vaccine shot. This lasted about 36 hours, the worst of it about 4 hours. Lab data sars-cov-2 test (unknown date): negative. No treatment received. Events were reported as non-serious. Outcome of the events was recovered.
Pt received PREVNAR on 2/9 and the next day pt noted redness and swelling on the right arm the next day. per RN note, arm is warm to touch. Spoke with provider in ER who states cellulitis of (R) arm may be due to local site injection reaction. Writer noted that injection site was not particularly more erythematous.  Erythema multiform and edema, warm to touch. Ceftriaxone 1 gm once, sulfamethizole/trimethoprim 1 tab BID, cephalexin 500 mg tid.
5 hours after injection - rapid heart rate increasing to 118bpm, dropping to 70bpm, increasing again to 120 bpm.  Chest and lower throat tightness was felt.  Continued this way for 2 hours.  No other symptoms.
When I went to get the shot, I had a  firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.
Information has been received from a physician concerning a 1.2 year old pt who on 06/25/2001 was vaccinated with varicella virus vaccine. Subsequently, the pt developed chicken pox lesions. On 06/27/2001, the pt presented to the physician's office with about 40 lesions. Additional info has been requested.
Ringing of my ears to the point I may have to quit my job. Rings 24 hrs a day never stops
I have been having burning sensations starting in my lower legs and now moving up above my knees, as well as in my hands.
100°F fever, entire body aches and pains, bad chills, headache, temporary loss of smell, fatigue and nausea
adult/ received a pediatric dose; adult/ received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 29-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 5th August 2021, the patient received Engerix B pediatric. On 5th August 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: Nurse reported that the adult patient was administered with Engerix B pediatric, which led to underdose and adult use of a child product. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
Pt. reported feeling light headed, after sitting experienced a syncopal episode.  BP 98/45 p 75.  Pt. was revivied after about 35 seconds and stated feeling better.  BP 112/72, p 76.  Pt.  stated has hx of syncope.  Pt and family refused to be transferred via squad.  Pt. states he will fu with PCP this week.
Everything was fine for a few days there than tiredness.  On Monday, 3 days after the vaccine, I experienced heartburn and gastrointestinal issues.  I went to a local urgent care because I was worried about the symptoms. Everything checked out, the doctor suggested it was a reaction to the vaccine.  That night, I nearly blacked out several times and broke out into a cold sweat.  I was a little better in the morning, but still have some lingering gastro issues.
None - pt found unresponsive and deceased 2/20/14 approximately 5 AM.
Patient noted sores in his mouth 4 days post vaccine. He mentioned it to a pharmacist who brought it to my attention. No other changes or events happened prior to or after received the COVID-19 vaccine.