chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling hot, with no temperature / events have not resolved; Sniffles and runny nose / events have not resolved; Stomach discomfort / events have not resolved; Experienced chills and shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, 12 hrs after receiving Shingrix, the patient experienced chills. On 13th January 2021, the patient experienced feeling hot, sniffles and stomach discomfort. On 29th December 2020, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the feeling hot, sniffles and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the chills, feeling hot, sniffles and stomach discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that there were no events after 1st dose.  The patient received the 2nd dose and about 12 hours after the patient experienced chills and shivering, which resolved on the next day.  The patient reported that 2 weeks later, she began to experience feeling hot, with no temperature.  The patient reported sniffles and runny nose.  The patient also experienced stomach discomfort.  These events were not resolved.  The reporter did not consent to followup.
no further AE; Patient was administed PREVNAR 13 followed by PNEUMOVAX 23 before the recommended 8 week administration spacing interval.; This spontaneous report was received from a nurse and refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions included human immunodeficiency virus (HIV) infection. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 11-MAR-2021, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (exact dose, injection site, route of administration, lot # and expiration date were not reported). On 29-MAR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vial, 0.5 milliliter, lot # S028602, expiration date 28-JUN-2021 (injection site and route of administration were not reported) for prophylaxis.  The reporter stated it was sooner than the recommended spacing of 8 weeks between the 2 vaccines for immunocompromised patients. There was not further adverse events.
These are the events that happened to the best of my recollection. None of the areas with pain have had swelling, discoloration, or were made worse by touching. Day1-2 - Sore arm at injection site. Day2 - Runny nose. Day3 - Pain in left lower back and left side of jaw at joint by ear. Day4-5 - Burning sensation on top of right hand occurring a couple of times each day for a short duration less than a minute. Day6-11 - Dull pain in back of left leg around knee height. Pain is relatively constant. Day8 - Stabbing pain in right big toe. Very painful and most painful of all events thus far. Pain was short in duration less than a minute. Pain repeated every 15 minutes or so for a couple of hours. Day9 - Tingling in all the toes of left foot. Occurred once and short in duration. Called PCP to make appointment to discuss.  Day9-11 - Dull pain in both calves. Longer in duration.  Day10-11 - Dull pain in the middle of left upper arm on the rib cage side. Longer in duration.
Approx. 2 minutes after vaccines were completed- syncope event, ammonia placed in front of nose and patient regained consciousness. Became clammy, pale. Within 5 minutes patient was back to baseline.
Initial case retrieved from the scientific literature on 25 April 2011.  It pertains to 1 of 4 patients who experienced adverse events following exposure to a military service member who had recently received the ACAM2000 vaccine.  The other 3 patients are captured in case numbers 2010-04089, 2010-04090, 2011-02468; the case for the military service member is captured in 2011-02465.  On 23 February 2010, a military service member received ACAM2000 (lot not reported) in preparation for deployment.  On 27 February 2010 he wrestled 2 persons in a semi-professional wrestling match, during which the dressing covering the vaccination site was detached.  One of the 2 persons was a 24-year-old male, with no underlying risk factors, who was exposed to the service member on 27 February 2010 during the wrestling match.  On 01 March 2010 he developed lesions on his face, neck, chin, and left eye which were associated with substantial pruritis, exudate, and erythema.  He was contacted by the state department of health on 11 March 2010, and notified of his exposure to the vaccinee.  On 12 March 2010 he was evaluated by the public health physician, and at that time was noted to have numerous papular lesions that were umbilicated with overlying vesicles, several of which were draining serous fluid.  He was also noted to have involvement of the left lower eyelid with substantial erythema and early blepharitis.  Vaccinia virus (VAVC) was clinically diagnosed at that time.  He subsequently received slit-lamp examination by a local ophthalmologist, who treated him with trifluridine ophthalmic solution.  The blepharitis and eyelid erythema resolved within 48 hours of beginning treatment.  The patient was followed until he had complete lesion resolution, approximately 3 weeks.  Documents held by sender: None.
Pt received vaccine Sunday. Pt said slept all day Monday, came in called us Tuesday, said feels hot and itchy. Site was clear on all vaccines. Pt received Flu, Pneumonia on right arm separated, left arm received Zostavax. Pt. described pain in Flu/Pneumonia only on 1st day, 3rd day was taking Benadryl for itching. No hives just itching. Today is 4th day much better.
Pt received Booster dose of Pfizer in left deltoid after receiving two doses of the Moderna vaccine previously.  The next day she developed a large bruise on her upper left arm and it became very swollen and red.  Twelve days later she now has a small scab at the vaccination site that bleeds periodically.  The area is not infected and there is no residual swelling.  She denies any pain.
pt got a rash on his chest about 15 minutes after the vaccination. His skin was a bit red but the rash subsided after a few minutes. It doesn't bother him.
Approximately 4 minutes after receiving the vaccine patient  appeared to have a absent seizure. We immediately contacted 911. Patient seem to become coherent shortly after.  She remained diaphoretic. EMS arrived and further evaluated patent. Spoke  to patient at 3:00 pm and she was home doing fine.
shingles; This is a spontaneous report from a Pfizer sponsored program, Pfizer . A contactable consumer (patient) of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 vaccination. The medical history and concomitant medications were not reported. Two weeks after receiving my 2nd dose of your vaccine I developed shingles. I know 6 other people in my age group (50s - 60s) that also developed shingles as well, 14 days after your vaccine. I had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in my body. This has been an extremely painful experience, but I still would have gotten the C19 vaccine. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.
Developed tinnitus the day I got first Pfizer COVID vaccine. Never had any known tinnitus nor hearing concerns nor hearing problems prior. Tinnitus is bilateral has been constant and continues now day 9 post vaccine. Did a hearing test that is showing mild sensorineural hearing loss in the high frequencies
Fever,  swollen armpit, shortness of breath, heartbeat 110-160  per minute
At midnight Pt woke up screaming in bed hallucinating.  She proceeded to hallucinate all night long in sheer terror that snakes were biting her.  She had a fever of 103 so we treated it with Motrin but that didn?t take it fully down so three hours later we gave Tylenol.  Her fever finally resolved with the Tylenol but the hallucinations continued all night and into the morning.  She had a low grade fever again after all the meds wore off and continued to talk about biting on her feet.  Finally into late morning after another dose of Motrin, she seemed to perk up more and hasn?t talked about snakes since.
I went to the Health Department to get both doses of my monkey pox vaccine. First dose went in the fatty area behind my bicep, but I was told on my second dose, that in order to conserve more of the vaccine because of shortages, injecting the forearm allows them to save ? of the normal dose while still maintaining full efficacy. Shortly after receiving the second dose in the forearm I noticed it was much more painful than the first dose in the back of the upper arm. Within the first day I had a noticeable amount of swelling and the injection site felt like a bruise. It was warm to the touch and also slightly itchy. The swelling is worse on day two with redness around two inches in diameter and the bruise feeling and itchiness persist. I contacted the health department and they told me to keep an eye on it and if it worsens any further or is proceeded with fevers to go to an urgent care clinic. So far I have yet to get any fevers or flu like symptoms but they told me to report my interactions here for the CDC.
Dizziness and twitching and felt head heavy. Patient reports this happen after last vaccination for Pfizer.
Woke up with cold sweat and severe dry mouth, and sore throat, as well as having a moderately hard time to breathe.
DTAP given per parent request to complete series as needed for school, DTAP at clinic for age 6weeks-7 years. No TDAP for under 10 years available at clinic. Phone call made to parent, voicemail left, waiting for parent to call back.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (lot # M022373, expiration date 20-FEB-2018; dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit for 36 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
48hr SOB, enlarged heart, tachycardia;dx viral myocarditis;ventilated, intubated, paralyzed; poss cardiac trans;MD feel events temp related;
when lifting something or having arm in certain position a stinging sensation at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on 17Mar2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. No known allergies were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 09Apr2021, the patient noticed when lifting something or having arm in certain position a stinging sensation at the injection site. The patient did not notice this until approximately one month after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event when lifting something or having arm in certain position a stinging sensation at the injection site was not recovered at the time of this report.     No follow-up attempts are needed. No further information is expected.
09/02/22 presents to ED for "sharp chest pain". PMHx of "HTN, former smoker"
Is a temp a side effect; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Is a temp a side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Is a temp a side effect). At the time of the report, ADVERSE EVENT (Is a temp a side effect) outcome was unknown.        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.   No concomitant medications reported. No treatment reported
heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M2A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], FENOFIBRATE, ATORVASTATIN CALCIUM (LIPITOR) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL at a dose of 25 mg; CLOPIDOGREL BISULFATE (PLAVIX) at a dose of 75 mg and DILTIAZEM (CARDIZEM [DILTIAZEM]) at a dose of 120 mg. At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's age, and comorbidities may be confounding factors to the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's age, and comorbidities may be confounding factors to the event.
Sedation, Myalgia Chills, Sore Throat, hoarseness Narrative:  Received 2nd dose on 1/26/21. Noted significant arm pain, chills, felt feverish and diarrhea at 48 hours after his dose. At 72 hours after injection noted increased fatigue, significant sore throat and hoarseness. Symptoms abruptly stopped the evening of 1/29/21. Missed work x 1 day. No known prior COVID infection.  Other Relevant History:
Cellulitis from covid vaccine injection site; I developed injection site pain and swelling post 6 days of vaccination; I developed injection site pain and swelling post 6 days of vaccination; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (COVID 19, Pfizer Covid Vaccine, Solution for injection, Lot number: EL9263), via an unspecified route of administration on left arm on 22Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine, aspirin [acetylsalicylic acid], pregabalin (LYRICA), gelatine hydrolysate (GENACOL), collagen, ginkgo biloba, vitamin D3, vitamin b complex, vit C [ascorbic acid], vit E [tocopherol], fish oil, zinc (Tablet), magnesium (Tablet). On 28Jan2021 at 20:00, the patient developed injection site pain and swelling post 6 days of vaccination and her PCP put her on Keflex for Cellulitis from covid vaccine injection site. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of cellulitis from covid vaccine injection site and Keflex was prescribed. Prior to vaccination the patient was not diagnosed with COVID-19. Outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Syncope episode, fever, arm pain, neck pain, nausea, vomiting Still not feeling well
In the weeks following my second dose, my legs and feet cramp daily. At times my feet are in a constant battle to NOT be in a cramp. The cramps move up my calves and cause extreme amounts of pain. I have been hydrating up to a gallon of water a day and that does not stop the cramps. I have started taking magnesium and all other vitamins to help but nothing has helped so far.
Patient stated could (taste) vaccine. I had patient wait awhile, but stated he was leaving after about 15 minutes. I counseled patient that if he was uncomfortable, or has any other side effects, to go to emergency room.
Injection Site Redness; Injection Site Swelling; Injection Site Pain; Rash underside of upper arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced rash, injection site erythema, injection site swelling and injection site pain. In April 2019, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: Approximately one week before the date of reporting, in the evening, the patient received Shingrix on an unknown deltoid. The next day, the patient got a rash on the underside of her upper arm. The rash had almost cleared up. Less than a week after receiving Shingrix, the patient experienced redness, swelling, and pain at the injection site for a couple of days. The reporter consented to follow up.  In core outcome of the events injection site erythema, injection site swelling and injection site pain were recovered/resolved, however in source document the outcome of this events were reported as recovered/resolved with sequel.
I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 fatigue, malaise. 12/31-1/4 Increased fatigue and malaise, migraines, body aches, intermittent dry cough, lightheadedness, photophoibia. 1/5-1/8 Intermittent lightheadedness, slowly improving body aches.
Fast heart rate and feeling like "heart is beating hard and fast". This was consistent for about 15 min. This started 45 min after administration. My child reported later that she felt it start on and off about 20 min after administration
Eight days post vax pt exhibited marked exacerbation of previously well controlled eczema. Onset occurred eight days post vax. Pt is afebrile, eats, plays, sleeps normally.
Bright red upper left arm and fever for 3 days when she came back on 12/19/16. Instructed to take Benadryl and see Dr right away.
On 5-3-04, four days after receiving the MMR vaccine (04-29-04), the patient experienced conjunctivitis. He was taken to the pediatrician listed above and was given Amoxicillin and Tobramycin. On 5-11-04 a confluent, generalized maculopapular rash appeared and patient was taken back to pediatrician on 5-12-04 where blood was drawn for the 3 tests listed below.
swelling eyelid; A spontaneous report was received from a consumer concerning a male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling eyelid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced  swelling eyelid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event swelling eyelid was unknown..
The patient was vaccinated with his 1st dose of the Pfizer vaccine.  Approximately 10 minutes after injection, it was witnessed that the patient was experiencing seizure like behavior that lasted for approximately 10 seconds.   After this incident, the patient was instructed to recline his seat.  The patient refused as he was more comfortable sitting up.  911 was called.  The patient's blood pressure was taken x 2 - 92/60.  The patient was given a water and ice pack that the patient applied to his neck.  The patient quickly recovered, within a few minutes of incident.  He was alert and oriented.  He was talking and joking with staff regarding the incident.  The patient was assessed by EMS.  The patient refused to be transported to the hospital..
This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition, drug allergies or concomitant medications were not reported. On 12-SEP-2016, ROTATEQ doses were exposed to the following temperature excursion (reported as 82): 73 degrees Fahrenheit (F) for 4 hours. On 06-JAN-2017, patients were vaccinated with improperly stored doses of ROTATEQ orally (strength and dose were not reported) (lot # L028645, expiration date 25-MAY-2017 (also reported as 06-APR-2016) for prophylaxis. According to the reporter, on 01-MAR-2017, ROTATEQ doses were exposed to the following temperature excursions (reported as 82): 32 degrees Fahrenheit (F) for 166 hours. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005263: US-009507513-1703USA010647: US-009507513-1704USA005262.
Patient presented a new rx for Prednisone on 10/21/07 and asked if I remembered giving her a flu shot on 10/17/07. She said the day after the shot she had bruising and tenderness at the site of injection. Two days after the shot the bruising worsened and the entire left arm was red. She was experiencing shortness of breath, light headness, and elevated blood pressure (178/91). Upon the urging of her daughter she went to the hospital ER on 7/19/07. The medical staff told her that I had hit a vein during the injection. She stayed in the hospital overnite and was treated with IV steroids.  11/09/2007 MR received for ER visit 10/19-20/2007 for c/o lightheadedness, nausea, and SOB and L arm pain.  Pt had been experiencing nausea r/t "nerves, weakness, SOB-taking increased nebs, and cough x 1 week.  Per pt sx worsened following flu shot.  BP noted to be elevated in ER.  Cardiac consult with impression: Nausea, SOB, lightheadedness. R/O 2' to HTN vs influenza vaccine reaction. CAD with previous angioplasty x2.  Cardiac status is stable and pt ok for D/C