chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (barely sore arm) and FATIGUE (little tiredness/barely tired). At the time of the report, PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) outcome was unknown. The reporter informed that patient was over 70 years and not immunocompromised. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. This case was linked to MOD-2022-527276 (Patient Link).
My father was given his second dose of the Pfizer vaccine on Feb. 13, 2021.  He went downhill the following week.  He fell 9 times and was very confused.  He was taken to the hospital on Feb. 20 and admitted that day.  He spent a week there.  His condition continued to deteriorate.  He was totally bedridden for a week.  His mental status deteriorated.  By Feb. 22, he was unable to talk, he drooled, and had to be fed.  He made  slow improvement later in the week.  We were never given any reason for his condition.  There was no infection, no stroke, etc.  He was discharged and sent to rehab on Feb. 27.  He remained there until April 8.   He is currently doing fairly well.  He uses a walker and gait belt in the house and is receiving home therapy.  He is not as independent as he was before.  His short term memory seems to be more impaired than it was previously.
Fatigue, slight chills the same night starting around 9:00pm.  Bad headache at 7:00am the following day. Ibuprofen and rest eased the symptoms.
Awakened with joint pain, & nausea vomited 1 time - joint pain worsened thru the day, difficulty walking.  Next day less pain, still had nausea 3rd d. - better till later pm - joint pain again did not last long - appetite - better 4 + 5 d. - attended school - less achy.
RN gave booster Moderna in R deltoid and Influenza in L deltoid. Patient got up and walked to a chair with parents. She told her parents after a couple of minutes that she felt tired and soon after she passed out. RN saw something taking place. Got pulse ox, ice pack and BP cuff. Patient was arousing when nurse got to her. Put ice pack to neck. Pulse was 66 O2 sat 99% and BP was 88/50. Family later states she has passes out twice before. once when her dogs tale was cut off and another time when her ear was pierce with a needle. Patient place in recovery position. Face was pale she was clamy. Color soon returned after being put in recovery position. She was alert and oriented. She carried on a conversation. 12:20 vitals pulse 80 O2sat 99% 12:24 BP 98/60. Has her sit up after a time. Give sucker and some water. 12:49 before getting her in a wheelchair to leave BP 100/67, Pulse 75 O2sat 98%. Parent state his father is a doctor, They will contact him. She stated she was feeling fine.
No additional AE information provided; incorrect product storage; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 22-AUG-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Spinning vertigo and loss of balance for a few days.  Following by overwhelming fatigue, left foot drop, left hand weakness, diplopia.  In July 2010 I was diagnosed with Multiple Sclerosis.  3 other physicians in my hospital have had neurologic autoimmune disease within 2 months of onset.  I am currently being treated for Multiple Sclerosis and have residual left sided hemiplegia and ambulate with a cane.  On my second opinion in 10/2010 they recommended reporting this as an adverse event.
Still has pain; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that he or she would be getting 2nd Shingles shot next week from the date of reporting and that was something he or she did not want.  Because the reporter watched his or her mother go through it and still had pain almost 2 years later.
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from contactable physician. This physician reported similar events for 11 patients. This report is for 11th of 11 patients. This physician reported for a patient that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), dose 1 via an unspecified route of administration on 17Dec2020 and dose 2 via an unspecified route of administration in Jan2021 (Lot number: unknown), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after two weeks of second dose, the patient experienced unusually high number of COVID infections in fully vaccinated employees. The physician further stated they may need some kind of investigation here because they are seeing high viral loads in these individuals and symptoms. The patient was well after two weeks. The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available. ,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
About a week after my first shot i experienced the start of a rash on my lower back.Did not think much of it at the time,assumed contact dermatitis. Rash started to spread slowly,used hydrocortosone daily as needed.Contacted my PCP on 4/09 virtually and he told me to keep an eye on it.After my 2nd shot I experienced the usual fatigue and arm.pain but my rash got worse.,Contacted local urgent care provider on 4/18/2021 @11:25 AM.My provider was Doctor. By this time my rash was all over my back and had travelled to my front.After full mock up she diagnosed me with a pityriays-rosea condition .She prescribed me kenalog 0.1% predisone cream and Benadryl for itching.
Received  Moderna vaccine on Dec. 29 with just some muscle ache at injection site for about 3 days, then soreness disappeared. during night of Jan. 6th, I noticed  soreness again at site and in morning of January  7 I have some redness, and slight swelling with minor soreness at injection site.  The time frame is odd, since I received injection more than a week ago.
At 1550, RRT activated when client (28 y/o M) at the vaccination table after getting the shot started getting pale, slow to respond to stimuli, and in and out of consciousness for about 1-2 minutes. Vaccinated at 1549 on the R arm, with no previous medical history, no allergies, and not taking any medication. BP ? 82/42, HR ? 79, RR ? 18, Pain ? 0/0, O2 Sat ? 93% RA. Head to toe assessment completed. During monitoring period, client?s condition improved. Stated ?I pass out every time I get a shot or seeing blood;? ?this is normal for me.? After 5 minutes, stated feeling better and ?back to normal.? EMS arrived at the scene, but by that time, client is already well. Client declined to be transported to the ER. At the end of the monitoring period, client was not experiencing what was experienced initially. Client stated not to retake his BP as it causes him to be anxious all over again. Client remained in the post-vaccination area an extra 15 minutes. He left the vaccination clinic at 1625 ambulatory and in stable condition.
Extreme swelling & pain approx 3-4" above lt elbow on outer aspect of upper arm; Unable to lift forearm above elbow level; Began shortly p/inject, & cont now 2 mo later; Seen by MD;
Patient had said he didn't like shots when counseled to stay around. He felt light headed after the shots and was on the floor.  He sat on the floor for about 10 minutes, afterwards he got on the chair and after a couple of minutes slumped off the chair  and fainted for a couple of seconds. He came to  it after a couple of seconds.  Emergency services was called in and they checked his blood pressure, it was low. He didn't want to go with the service. We were advised to give him crackers and water, which was done.  He was advised not to drive home and he got a ride to take him home.
Patient received a booster dose of the Pfizer COVID vaccine (Comirnaty) in his left deltoid muscle. Within 30 seconds, patient reported feeling extreme chills, nausea, dizziness, and a sore arm where the injection site was. Patient was within sight of the pharmacist for nearly 30 minutes. Patient felt cool, but not cold to the touch while patient experienced chills. He reported feeling the chills eased up within 15 minutes of receiving the vaccine. He stated that this episode was not as intense as the first dose, but still appeared in distress (patient clenching hands into fists, eyes rolling in the patient's head, general paleness). He was able to answer simple questions about his symptoms throughout the episode. Patient has a history of this reaction to previous doses of the COVID vaccine. Besides general verbal comforting from his father and sitting down in the waiting area, no intervention was taken. Patient was taken home by father and his brother after about 30 minutes. Called father for update a few hours later and patient is resting and doing better at home. Patient reports feeling groggy and dizzy, but chills resolved about 60-90 minutes after leaving pharmacy. Father did not know whether patient took any acetaminophen to relieve chills. Patient was reported to be well enough to eat.
This is a spontaneous report from a contactable consumer. A female patient, of unspecified age,  received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: unknown), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2, via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Patient's medical history and concomitant medications not reported. Patient was going through a horrible experience since she her second dose of the Pfizer vaccine. She has seen more than 8 doctors so far. Her whole body was full of red dots that were extremely itchy. She gained over 40 pounds on prednisone. She was overly depressed. She tried all sorts of allergy medication. They even gave her ivermectin; she had no more itch for the first 9 days; then the effects came back. Taking all sort of medications was ruining her kidneys. She doesn't sleep and her mood was extremely bad. She was also getting very anxious and thus definitely affecting her daily life. The outcome of "her whole body is full of red dots that are extremely itchy:" not recovered; the rest: unknown. Follow-up attempts  completed. Batch/lot number not available for BNT162B2. No further information expected.
pt went to school c/o a tight throat, diff breathing, feel shaky;office staff able to calm pt down & call mom;MD office pt had same c/o as well as nausea & h/a;BP nl;
Pt's family stated that they did not have a booster Covid shot, in the Epic records of the clinic only 2 vaccines were shown. After the vaccine booster was ordered by the provider the nurse gave the vaccine. After the nurse was documenting the vaccine it was found in the local Immunization Information Connection that the pt had received at booster on 1/14/22 at a different facility.  Mom states that she didn't remember that they received a booster that day.  Therefore the vaccine given today would be the pt's 4th vaccine.
fever 105; soreness for 2 days, leg cramps; rash on legs;
PATIENT IS INFORMED THE PFIZER GIVEN WAS EXPIRED BY 2 DAYS.  NO ADVERSE EVENT AT THE TIME OF THIS REPORT.
Persisting weakness in her left arm; Metallic taste in mouth; Itchy left wrist/itchy right cheek; Numbness of the throat; "A little" difficulty breathing; Right lymph node(s) began to swell; Headache; Itchy throat; This spontaneous case was reported by a consumer and describes the occurrence of   in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Cedar allergy). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included diphenhydramine (Benadryl).   Reporter did not allow further contact
PT COMPLAIN OF SWELLING  AND NUMBNESS OF LIPS AND HAD TROUBLE BREATHING.  V/S B.P 154/99  HR 98 R-19 TRMP. 96.0  EPI PEN WAS ADMINISTERED AND STARTED ON O2 NC  PARAMEDICS WERE CALLED AND WAS TRANSPORTED TO THE HOSPITAL.
Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination related malaise) 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 COVID-19 on 15-Feb-2021.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination related malaise). At the time of the report, VACCINATION COMPLICATION (Vaccination related malaise) had not resolved.            The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was Not Applicable. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-239052 (Patient Link).
It started with migraine symptoms, a vice grip type of pain with nausea then approximately two weeks later I had flu like symptoms with Tinnitus, fatigue, muscle aches, vertigo, very sleepy, pressure in my ears and this continued for the next few weeks. Again this was a continuous issue with no break or letup in symptoms it has caused me to miss my work outs and work which had never happened previously. My doctor gave me an MRI which showed no result. My doctor prescribed dexamethasone (worked only while taking) and meclizine.
Patient received dose of Janssen at 4:37pm, apx 20 minutes later (he was on 15 min observation but was waiting on family member with 30 minute observation) pt states ?swelling in my left tonsil? pointing to left throat. RN Assessment does not note any swelling in airway or respiratory distress. Pt states this sometimes happens with seasonal allergies but this ?feels different.? Pt with continued observation, stable, talking with family, states feels ?the same? 10 minutes later, no visible distress, drinking water, speaking clearly/coherently. Pt asks to go outside to take mask off as pt states he rarely wears mask for extended period of time. RN accompanies pt outside where he states ?swelling is better? but now feels dizzy. RN takes vitals: 154/90 left arm, manual, 97%RA, RR18, clear lung sounds bilaterally, HR 70. Pt states dizziness resolved but now feels ?swelling? again, same as before, not worse, states ?just a little bit? swollen. RN does not note any visible airway compromise, pt denies CP, SOB, swallowing difficulty, appears comfortable but anxious. No hives on chest, back, pt ambulating freely around vaccination site. Patient offered EMS ride and safely of further medical evaluation. Education provided on delayed allergic reaction. Patient declines, stays on site until 5:31, signs AMA form and leaves with family. No distress on leaving, pt drinking water and speaking clearly, education provided on calling 911. Patient and family verbalize understanding.
Patient felt that her muscles in her shoulders seized up, started getting chills, and that her face was starting to swell in her lips, eyes, and cheeks 20 minutes after receiving her second dose. She was treated with 25 mg diphenhydramine and remained seated for 20 minutes further.  She went home after that and was going to take a second dose of diphenhydramine after eating dinner.
02/19/23 presents to ED for "fever/chills/profuse sweating/generalized body aches, shortness of breath". PMHx of "asthma, HTN, HLD, DM type 2, mood disorder, OSA (on CPAP) and GERD"
Information has been received from a registered nurse concerning a 26 day old male patient who was orally vaccinated with the first, second and third dose of ROTATEQ on 12-NOV-2009, 16-DEC-2009 and 12-FEB-2010, respectively. The patient sought medical attention by an office visit. There were no adverse effects reported. Additional information has been requested.
Fever up to 101.8 Joint aches Stiffness and Aches near injection site and underneath that armpit Headache lasting an entire day despite taking aspirin Tiredness By the morning of 3/28/21, all adverse events disappeared with the exception of the stiffness and aches near the injection site and underneath the armpit.  That lingers.
Tinnitus increased; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: HFH K-9) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history reported as many overtime, "fairly good immediate health otherwise now "and known allergy to poison ivy, to insect bites which gave a fairly large result. 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. The patient was taking unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: HFH K-9) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 17Mar2021, after second vaccination dose, the patient experienced tinnitus increased over time may be by approximately 50% to 70%. The patient was monitoring conditions that seemed to reduce problem and taking many individual actions tried to reduce tinnitus including sound input greatly reduced (example- closed captioning only on TV). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event tinnitus was recovering at the time of report.   No follow-up attempts are needed. No further information is expected
puffiness, itch, and redness 2 inches below the injection side which has lasted 10 days
2nd day soar arm, 3rd day fatigue no appitite nauseaus. By 9:30 pm vomiting and diarhia once.had 100.7 fever . Went to bed ,from12:30 am to 4:00 am , vomited every hour on the hour. Slept til 8:00am 4thday . Drank pedialyte, gatorade water  slowley. Ate a cracker toast 1/2 bannana. 9:00 pm diareaha again. Slept threw night. Fatigued on 5 th day. Today am monitoring. What should i expect after 2nd shot?,worried.
Red/swollen injection site on day 4 and 5 after immunization. On day 5 arm is warm to touch and itchy. Told to use ice pack and take BENADRYL. Suspect not vaccine related allergy issue but patient and I could find no potential cause.
Pt started at 1300 on March 4, 2021 with chin and lip swelling and tingling.  For the past 7 months, she has had rash, hives, intermittent and random throat swelling as well as numbness on left side of her body.   She has had left hand and foot swelling constantly since receiving vaccine.
Felt like a bad hangover that I couldn't get rid of. I had a 99 to 100 degree temperature. I had chills. I felt very very weak the whole day. I took the shot on Monday, felt horrible all of Tuesday, and on Wednesday I had a very slight headache, but felt much better than Tuesday. I drank a lot of water on Tuesday, but it seemed to help very little. A hot shower made me feel better on Wednesday night.
1st vaccine which eventually proved to be about 30 percent effective.; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient's friend. Age at vaccination was not reported. The 1st vaccine which eventually proved to be about 30 percent effective.  No contact details were available. For tolerance in 2nd dose refer case US2021AMR187069.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187069:same reporter