chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 21-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 216 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
sleepiness; fever; chills; sweating; dizziness; fatigue; brain fog; vertigo; ear congestion; facial pressure/sensation on the right side; he has fluid in both of his ears and diagnosed him with allergic rhinitis; This is a spontaneous report from a contactable consumer (reported for himself).  The 23-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration as a single dose on 06Apr2021, for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, after vaccination, the patient experienced sleepiness, fever, chills, sweating, dizziness, fatigue, brain fog, vertigo. He had ear congestion, facial pressure/sensation on the right side, his doctor informed him that he had fluid in both of his ears and diagnosed him with allergic rhinitis. It was stated that most of it had gone but he still had vertigo and dizziness. The outcome of the events of sleepiness, fever, chills, sweating, fatigue, brain fog, ear congestion, facial pressure/sensation on the right side, fluid in both of his ears and diagnosed with allergic rhinitis was not reported, however outcome of the events of was vertigo and dizziness not recovered.   No follow-up attempts are needed. No further information is expected
Within 30 days: Hypoglycemia ( eventually subsided),  rapid, missed, irregular heartbeats ( all of 2021 & early 2022), calf pain  (checked for DVT..negative), inflammation in blood tests  (currently)., digestive issues ( had colon & endoscopy both ok), unexplained body aches that come & go.
Patient states on 2/23 she noticed itching but yesterday, 3/3 it started getting red and warm to the touch.  She has not done any treatment for reaction at this time.  I encouraged a cold compress and to call her physician Dr. as soon as she got home to discuss coming in for a visit to evaluate her.  Patient denied any other symptoms other than what was mentioned above.
stiffness/it feels like arthtritis; sore arm / pain in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness/it feels like arthtritis) and MYALGIA (sore arm / pain in the muscle) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Blood cholesterol abnormal.    On 14-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness/it feels like arthtritis) and MYALGIA (sore arm / pain in the muscle). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness/it feels like arthtritis) and MYALGIA (sore arm / pain in the muscle) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking medication for thyroid and cholesterol concomitantly. Treatment information was not provided. Patient asked whether she can take tylenol or use any pain cream for the sore arm. Patient experienced a similar event in the past.
Pfizer COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/14/2021 and 5/4/2021. Presented to ED on 1/5/2022 with complaints of generalized pain, fatigue, malaise, and shortness of breath for 6 days. Hypoxic on presentation, placed on HFNC and admitted for acute hypoxic respiratory failure due to Covid19 to ICU. Treated with dexamethasone, remdesivir, and baricitinib. Required intubation on 1/7 for worsening respiratory status. On 1/22/2022 experienced cardiac arrest, CPR was performed, patient expired.
SEVERE GAS STARTING ON JUNE 19 2021 TO CURRENT (JULY 15, 2021), SEVERE BLOATING, MINOR STOMACH CRAMPS. ONLY MINOR REMEDY IS EATING FRESH FRUITS EVERY TWO TO THREE HOURS.
Information has been received from a registered technician concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651330/1048P).  Subsequently the patient experienced red, hot sore arm at injection site within 48 hours post vaccination.  Treatment is unknown.  The registered technician had no other available information and placed a nurse practitioner on the phone.  The nurse practitioner stated that "she is not comfortable using this lot 1048P until a lot check is performed".  The records of testing prior to release of this lot have been checked by Quality Assurance an found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality control Quarantine/Rejection System revealed that there was no open Quarantines registered against this lot/fill.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with (Merck) VARIVAX injection (lot number and expiry date unknown) (Dose 0.5 ml, frequency unknown) subcutaneously which on an unknown date had undergone a temperature excursion (details unspecified). No adverse events were reported. No product quality issue was reported. The action taken with the (Merck) VARIVAX therapy and the outcome of the events was unknown. The relatedness of the events to the therapy with (Merck) VARIVAX was unknown. Additional information has been requested.
On Wednesday, 12/29/21, Patient came to Covid-19 Vaccination Site for her Moderna Covid-19 second dose. Client was vaccinated with Moderna Covid-19 vaccine (LOT #: 070H21A) in her left deltoid at 10:30 AM. After vaccination was given, LVN realized client was given a Moderna Covid-19 booster dose of 0.25 ml instead of a full Moderna second dose 0.5 ml. Lead RN was made aware of situation who elevated to Vaccine Operations Lead. Per Lead, client to be called and explained the situation as possible. Per CDC guidelines, client would need to be vaccinated with Moderna Covid-19 0.25 ml to equal a full second dose within 24 hours. Lead RN called and left a message for client to call back at 11 AM and again at 4 PM. No answer or call back from client. Per Lead, after the 24 hour window, Lead RN should attempt to make contact with client the next day and a consult would need to be made with County MD for further instruction.
No adverse side effects from vaccine. Just that after 5 days of receiving vaccine, I became infected with Covid-19. Started with symptoms Tuesday Dec. 29 2020 at 6am (Chills, severe body aches) I currently work in a jail setting with active covid-19 cases. Exposure to covid-19 at work high. Covid symptoms as of Jan. 3 2021 have been: mild headache, body aches, muscle stiffness, chills, sinus congestion/runny nose, mild cough, loss of taste/smell.
woke up vomiting non-stop for 4 days.  Husband finally took me to the emergency room.  Blood work taken at the emergency room and thyroid disorder (hyperthyroid) was detected.  Was NOT an issue before the covid vaccine.  My thyroid peroxidase antibody continues to be elevated and I have now been diagnosed with autoimmune thyroid disorder or hashimoto's thyroiditis.   My body has also snapped into a constant "fight or flight" mode with anxiety being a constant issue.  I DID NOT HAVE ANY OF THESE ISSUE BEFORE I RECEIVED THE JOHNSON&JOHNSON VACCINATION.
I had a scratchy throat and congestion along with a fever of 99.0. It went up to 100 degrees. I completed a COVID-19 home test on July 07, 2022, I called my doctor and he had me do a COVID-19 PCR test and prescribed PAXLOVID. I took TYLENOL for the fever. My fever was gone by the evening of July 8th. Over the next couple the congestion cleared up as well. I have completed recovered from all my symptoms.
Great Heaviness in chest, sweating and nausea. Waited a while to see if it would improve.  Got a little lighter but still painful so went to  ER.
PATIENT WOKE UP 9.26.2022 WITH AN ODD SENSATION IN HIS HEAD, FEELING DIZZING/LIGHT HEADED. 9.27.2022 SYMPTOMS CONTINUED BUT PATIENT ALSO DEVELOPED CHEST TIGHTNESS THAT EXTENDED DOWN HIS LEFT ARM AND NAUSEA AND VOMITING. PATIENT ALSO FOUND TO BE HYPONATREMIC.
On 10/12/13 patient noticed a rash on her stomach. It was red, blotchy and itchy. Patient took BENADRYL and a topical anti-itch cream. The rash persisted for 4 days and spread to the arms.
This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 58-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, extremities hot feeling of, swelling and pruritus. On an unknown date, the outcome of the erythema, extremities hot feeling of, swelling and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema, extremities hot feeling of, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by other healthcare professional via chat for herself. After receiving SHINGRIX, the patient experienced redness, swelling and her arm was hot which lasted a week.The patient also felt very itchy like she wanted to reach inside and scratch it. The itching lessened as time went on but it lasted a week. Toward the end it would just itch occasionally, all of a sudden. The patient had not answered if this was first time reporting or follow-up.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 66-year-old male subject who was vaccinated with Twinrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received an unspecified dose of Twinrix (unknown). At an unspecified time after vaccination with Twinrix, the subject experienced not responding to therapy ("lack of antibodies"). At the time of reporting the outcome of the event was unspecified. Follow-up information received on 06 July 2007 indicated that a titre drawn 7 months post completion of the Twinrix series showed no hepatitis B antibodies. No additional information was provided regarding outcome.
Tinnitus, sudden partial hearing loss in left ear. Tinnitus continued 10 + months, hearing loss is permanent. Treatment with oral dexamethasone, Steroid injections in middle ear, and steroid ear drops, Hearing aids.
Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: number, expiry date: unknown) via unspecified route of administration, in left arm on 08Mar2021 12:30 (age at vaccination: 79-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route on 15Feb2021 11:00 AM (Age at vaccination: 79-years) as dose 1, single for covid-19 immunisation. Patients medical history included cholesterol, gout and thyroid from an unspecified date and unknown if ongoing (Caller says she takes a medication for this, no details provided about this medication). Concomitant medications were not reported. She said after she got her vaccine it she was fine with no problems, no soreness or nothing, then the 11th she come down with diarrhea that she has had since then. She said the diarrhea was not severe or anything, but it doesn't seem to want to go away, and she would like to know is that a side effect of the shot. She said that the diarrhea started 11Mar2021, and had been staying the same, it doesn't seem to want to go away. As treatment for AE patient said she just start yesterday taking Kaopectate, which had not really done anything yet. She said she took it yesterday two times for her first dose and today she didn't take it at all, though she will probably take it in a little while. She said she doesn't know if it is going to help or not. She said she took one cap full of the liquid that you put in the plastic cap that comes on top of bottle, you drink that. The outcome of event was not recovered.   No follow up attempts are possible. No further information is expected.
This case was reported by a pharmacist and described the occurrence of a product complaint in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included PNEUMOVAX 23 (Merck) given on 28 October 2008. On 28 October 2008 the subject received a dose of FLULAVAL at 0.5 ml. Following administration of FLULAVAL, the pharmacist noted that there was a small piece of foreign matter in the vaccine vial. It was estimated that perhaps 5 subjects may have been injected with FLULAVAL from this vial. This was considered to be a product complaint. The pharmacist was not aware of any adverse events following this occurrence. The pharmacist did not have any specific information regarding the subjects involved. The pharmacist called back on 29 October 2008 to report that it was noted that a piece of the vial stopper was missing from the rim and that was the particulate that was floating in the vaccine solution. He was fairly certain that this was the particulate, but still has the vial for testing if necessary.
Chest pain and tightness. Racing heart and palpitations. Fever and lightheaded. All started within 24 hours of vaccine and lasted for week. The chest pain, tightness, and lightheadedness still occurs at times.
Missed menses. My cycle is like clockwork. I have a 24 day menstrual cycle. Since the second dose of Pfizer COVID vaccine, I have not menstruated. I am on day 35 of my cycle. I have no symptoms suggestive of menstruation. I have taken two pregnancy tests and I am not pregnant.
1:25pm: HA and diaphortic BP 176/88 P 94, reports HA d/t flourescent lights, feels "better"  1:45pm, Repeat BP 162/78 P 89 Glucose 137, ambulated to exit with staff
Injection Site:  Pain; inability to put any weight on arm and pain when moved; swelling; light redness General:  Fatigue; headache; muscle pain; joint pain; chills (constant day after injection); fever (101 degrees); weakness
Wheezing, Nausea, Vomiting, Chills, Fever. 6 hours. Took a tendril, and used inhaler. Thought a trip to the ER might be needed but not.
Presented with cough, diarrhea, fatigue x 5 days; Covid + ED ; admit 9/13 medical with Covid PNA; 9/13 maxipime,   zithromax, rocephin, LMWH, singulair, zinc started  9/14 remdesivir, Vit C, steroids started; O2: minimal supplemental O2 needed; 2 LPM down to RA at d/c
Shortly after receiving Dose 1 of Pfizer-BioNTech COVID-19 vaccine, patient reported feeling dizzy and nauseous. Patient was given water and apple juice. Patient educated on techniques to reduce symptoms/prevent fainting. Patient was then escorted to a room in the facility to lay down and elevate feet. Patient vomited a few times. Patient closely monitored for over 30 minutes by pharmacist and facility staff. Patient symptoms improved and did not require EMS.
Approximately 24hrs after vaccine administered - noted to have swollen & red area around injection site. Presented on 07/11/2010 and diagnosed with cellulitis.
BURN GOING IN AND FOR ABOUT 5 MINUTES AFTERWARDS; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced burn going in and for about 5 minutes afterwards, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and burn going in and for about 5 minutes afterwards was not reported. This report was non-serious.
tremors; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (tremors). At the time of the report, TREMOR (tremors) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported.   Concomitant medication not reported.
Received vaccine shot at 10:30, and by 14:00 was feeling sick-with fever, chills, headache, symptoms lasted several days.  No appetite for several days-lost weight.
Patient states vaccination site became sore in approx 1 hr. after administration - w/o red or swell. 10-27 to bed approx 10:30 pm. Slept late, until 7:30 am next day due to fatigue and sleepiness. Ran quick errand came home and went back to sleep until 5 pm. Ran quick errand (states felt sleepy even while driving) back home and to bed 6 pm sleeping until 6 am 10-29 when husband woke her. States she felt extremely fatigued and sleepy all of 10-28 % also of joint aches especially in her knees. 10-28 noted red bumpy rash 2 x 2 inches to mild sternum - w/o itchiness. 10-30 red bumps subsiding, redness remains. Extreme fatigue and sleepiness subsided on 10-29-14. Advised to make PMD aware.
Pt received the 1st Moderna COVID vaccine shot in the R arm without complication, sat down and felt well for ~ 15 mins and then began feeling dizzy without LOC, and approximately 5 mins later vomited x 1 in presence of the facility's Vaccine RNs. Pt was brought to the 2nd floor, andprovider called to evaluate the patient. Pt reports that he has had similar reaction in the past and that he felt very anxious about the vaccine due to his Hx of Sz activity.
This spontaneous report has been received from a patient's father concerning to a 17 year old female patient. Current conditions, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL, first dose, (dose, lot# and route not reported). Concomitant medication was not reported. On an unknown date, reported as after first GARDASIL dose, the patient experienced a scapular winging. The reporter stated that the patient was going to physical therapy. The outcome of a scapular winging was unknown. Additional information has been requested.
Stomach pain (bloat and diarrhea), dehydration, light-headedness, fatigue, headache, muscle pain and fever all occurred two (2) days post-shot.
Fully vaccinated on 12/30/2020 and 01/20/2021 with Pfizer vaccine, and tested positive for COVID on 08/21/2021
Customer called saying she had diarrhea x 2, felt sweaty called probably around 3 pm, she was asking if this could be related to the HIGH DOSE FLUZONE shot she had around 11 am that same day. The symptoms did not occur immediately, as customer, did some errands after the Flu shot.
Hospitalized 1/11/22-1/12/22 SOB, hives, lightheadedness, weakness, decreased urination, tingling in hands and feet, elevated D-dimer, hypotensive, bradycardia
Since getting my first dose of the Pfizer vaccine last Wednesday I am having episodes of paresthesia and burning pain in my hands and arms (occasionally my feet and around my shoulder blades). A few hours after the vaccine I noticed a hot, prickly feeling in my hands and wrists, but I am now noticing it in my arms/elbows (bilateral). It feels more like a true tingling now. I am not experiencing any weakness or other symptoms as this time. The pain is not severe (a 2/10) just uncomfortable. I was COVID positive in December and when I had COVID, I also experienced the same symptoms. At that time, the paresthesia lasted a few weeks before disappearing altogether.   Although I personally have never been diagnosed with an autoimmune disorder, my mother does have multiple sclerosis. Personally, I have no medical issues. I am currently breastfeeding.  I am unsure if I should still get my 2nd dose of the vaccine. Aside from the reaction mentioned above, I've had no issues. I just had the normal side effects otherwise (sore arm, fatigue, minor muscle aches).
The patient received VAQTA and GARDASIL 9 following a temperature excursion; no adverse effects; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (dosage schedule route of administration, anatomical location, lot number and expiration date were not reported) and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) (product storage error).  The administered doses of the vaccines experienced a temperature excursion below 36°F/2°C (35F) for 430 minutes. There was no previous temperature excursion. No adverse effects reported.
Severe gout attack on 4-20-21,  5 days after 2nd covid shot, big toe of right foot.  Treatment: hydration, nutrition, Colchicine, Ibuprofen; Colchicine:  0.6MG, 3 tablets per day for 3 days; Medication helped over 3 days pain reduced pain and swelling from severe to minor; 2nd Severe gout attack on 5-6-21, same place on big toe of right foot.  Same treatment and medication as before; Colchicine:  0.6MG, 3 tablets per day for 3 days. Medication, nutrition and hydration reduced pain and swelling from severe to minor.
improperly stored vaccine was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JUL-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, 0.5 ml, injected (not further specified) once lot # T003833 and expriation date 01-AUG-2021 (formulation, exact dose and route of administration were not reported) for prophylaxis. No additional adverse events were reported. A temperature excursion of -11.17 degrees Celsius (C) for 19 hours was noted. There was a previous temperature excursion of -11.17 degrees C for 2 hours. A data logger was used to capture the temperature excursions.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA010509: