chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting  Oct 28, ten days after Moderna Bivalent booster (And 4 days after flu shot given by pharmacy, but we suspect cause was COVID19 booster), (I, the) pt noticed itchy erythema with raised wheals present on various spots around his body, notably around the underarms, the waistband, ankles, and hands. The itchiness, redness, and wheals grew on scratching.  Hands were especially itchy and occasionally slightly painful with a burning sensation (without noticeable swelling).  No fever, normal pulse and BP, respirations normal. No difficulty breathing, though pt experiences slight discomfort (maybe very tightening in the throat) Pt had not changed any detergent or bedding or had any notable changes in diet. No previous allergic-like reactions to vaccines.  Determined that itchy wheals would appear wherever a focused pressure was applied, with skin response and appearance of wheal within 1 minute, persisting for around an hour (longer, if the site was touched or scratched). Further experimentation showed that gentle lines made with fingernail or other thin object produced very defined wheals along path, consistent with Dermatographic Urticaria.    Pt treated with topical hydrocortisone cream (after 1 day) and 25mg diphenhydramine (after 4 days) taken every 4-5 hours as needed.   Condition was fairly pronounced with lots of itchy inflamed areas for the first 7 days, with a peak around day 5. Around day 8 it seemed less severe, with reduced itchiness globally and inflammation in the hands, and patient rarely needed the diphenhydramine or hyrdrocortisone, though the patient was also by then practicing not scratching (as much as possible) as that would quickly cause a 'chain reaction' of itchiness.   By day 10, the initial appearance of the wheal on drawing seemed noticeably slower and less itchy, though still appeared, albeit lower in pronounced height from the skin. Hands seemed less often irritated.   On day 11, pt finally went in to urgent care just to confirm diagnosis and get some treatment. Pt was confirmed with diagnosis of dermatographic urticaria and prescribed dexamethasone (12mg, with another 12mg in 3 days if still experiencing symptomatic urticaria) and fexofenadine.   Pt is writing this report on day 12 and is still symptomatic, albeit to a slightly more manageable degree. Pt has not yet picked up the newly prescribed medicines.
9/11/04 am awaken with whelps arms, back, shoulder, chest; itching, chest felt tight, sore throat, coughing. Temp 100.6-100.8. 9/14/04: complained of chest tightness, whelps were fading. No itching.
04/09/2022 I had a tickle in my throat, runny nose. Next morning coughing, sneezing-took an at home COVID-19 test it was positive. Felt tired, nausea, congested and would go from hot to cold then sweating. No medication was prescribed by my dr. Returned to work after 8 day sneezing, productive cough and no fever. One month after if I take a deep breath I will start coughing.
States that he started to feel "sick" that evening, continued to the following day, 2/3-unable to work. Lethargy, fatigue, diarrhea, body aches, headache. Arm soreness. 2/5/21 it was reported to me and pt states that he is feeling 75% better now.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The pharmacist reported regarding three patients who have received doses of PNEUMOVAX23 of lot number 0709AE, expiry date 04-JAN-2014, have experienced injection site reactions in the injection arm. On 30-OCT-2013 the patient was vaccinated with PNEUMOVAX23 lot # 0709AE, expiry date 04-JAN-2014, dose 0.5 ml, via intramuscular route in deltoid muscle of the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown) received in same administration session in the opposite arm. The same day she received the dose, the patient began to experience pain in her arm and difficulty moving her arm. The patient reports feeling eighty percent better on 03-NOV-2013 when the pharmacist followed up with her. The outcome of pain in her arm and difficulty moving her arm was reported as recovering/resolving. The pharmacist requested a lot check for 0709AE, expiry date 04-JAN-2014. This is 1 of 3 reports from same reporter. Additional information has been requested.
Vaccine given on 11-1-12. On 11-16-12 she stated the arm (right) hurts so badly it keeps her awake & she has to use her left hand (she is right handed). She said the shot was given on upper shoulder & that it bled a lot. She has some bruising. She stated she was allowing time for improvement but it only became worse. On 11-19-12 she went to her doctor. The doctor could see the injection site because of some yellowing around the site. Dr wasn't sure, but thought the joint may have been hit. Dr gave prescription for MOBIC & steroid injection to see if it helps.
1:10 PM Patient complained of dizziness and sweating and lower back pain. Immediately evaluated by onsite NP and EMS. Placed on monitor which showed Sinus Tachycardia and a rate of 125. Finger stick BS 81. Patient had minimal food intake prior to coming to clinic. Offered cereal bar and cool water. Tachycardia did not resolve. Patient pulse raised to 151. Patient remained pale. Placed in Trendelenburg. O2 4 liters non-rebreather added at 1:40 PM. Contacted fire department to transport patient to hospital.  1:15: PM A and O X 3.  Affect somewhat flat. BP 124/74 02: 99, Pulse 110  1:40 PM BP 130/80 P 125 02: 99. Continues to complain of lower back pain 3/10  1:50 PM: Fire department arrived to transport patient to hospital
Arm has been sore and in pain.  At approximately 1.30am (12 hours after receiving the booster shot) the patient went to the bathroom over night and lost consciousness.  He passed out for approximately 30-45 seconds.  He has no history of adverse reactions to vaccines or shots.
Pinched nerve developed on the left side of my neck shortly after obtaining a dose of the vaccine.
Warm to the touch; Slightly swollen; It is red/pink; Tenderness at the injection site; Soreness on the left arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness on the left arm), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Slightly swollen), VACCINATION SITE ERYTHEMA (It is red/pink) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness on the left arm). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Slightly swollen), VACCINATION SITE ERYTHEMA (It is red/pink) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, PAIN IN EXTREMITY (Soreness on the left arm), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Slightly swollen), VACCINATION SITE ERYTHEMA (It is red/pink) and VACCINATION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product include lood pressure medication.  Treatment for the event included none.; 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.
Patient received J&J vaccine on 4/2021, Moderna COVID vaccine on 5/12/2022, and Pfizer COVID vaccine on 5/25/22. No adverse effects noted.
redness, soreness @ site of inj (?rash), itching;no fever;hot to touch
Clonic posturing, tardive dyskenesia, "frozen tongue" hyperventilations SOB. Treatment = Epinephrine, IV, observation in emergency room
left upper arm hard swollen knot with bruising hot to the touch very painful. Left knuckle area swollen bruising very painful.
Chills, uncontrolled shivering 12 hours after vaccination; muscle aches, fever (up to 100.5 F) for ~30 hours. Tylenol dampened fever. All symptoms resolved within 36 hours.
10:45 am 3/11/2021 brain fog or loss of thought process about 3 minutes after shot, heart palpitations, shortness of breath 5:00 pm 3/11/2021 begin running fever, tired, slight body aches 6:00 am 3/12/2021 fever of 100.3, tiredness, body aches, chills, headache, forgetfulness, these continued for approx 24 hours; fever broke 3/13/2021 about 11:00 pm. Continued body aches, head aches, severe dizziness, forgetfulness through 3/17/2021 3/16/2021 went to walk-in clinic due to symptoms; treated for possible ear/ sinus infection and given antibiotic; no real diagnosis for symptoms 3/17/2021- 3/272021 took antibiotics from doctor. Fever went away, dizziness slowly improves 4/10/2021 - continued dizziness, headaches and brain fog, forgetfulness. It is a struggle to pay attention.
fever, dehydration, tiredness, hot spot at injection point, swelling of right arm and shoulder, inflammation in the neck
PARTIAL FACE /HEAD PARALYSIS; NUMBNESS; TINGLING; ALLERGIC REACTION TO VACCINE; 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, 5 days after vaccination, the patient had to go to the hospital because of numbness and tingling and partial face and head paralysis and they said it was an allergic reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness, tingling, partial face /head paralysis and allergic reaction to vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  20210439359-covid-19 vaccine ad26.cov2.s-partial face /head paralysis, numbness, tingling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
patient was given a Moderna vaccine booster injection of 0.25 mL from a vial that expired on 11/06/2021
My daughter broke out in hives about 5 hours after receiving her vaccinations.  She received DTaP, Polio, Chicken Pox and MMR.  She had two shots in each leg.  This completes her immunizations, and she never reacted before.  She ended up getting a prescription for Prednisone from a clinic the next evening.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. IT was reported that on unknown date in 2013 (also reported as from 19-JUL-2013 until 17-OCT-2013), the patients were vaccinated with improperly stored doses of liquid PEDVAXHIB (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
rash; nausea; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced generalized rash, nausea and papular rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved and the outcome of the nausea was recovered/resolved and the outcome of the papular rash was unknown.   The reporter considered the generalized rash, nausea and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine few days later and she felt a bit nauseated but that resolved after several days.  A couple of weeks later, she started breaking out on her forearms. It then spread to her legs then to the trunk of her body.   The patient described it as little dots and this dots have gone down a bit on her arms but the dots on her legs and trunk remain raised. The reporter consented to follow up. The patient  agreed to having the letter from Safety sent to her as she hasn't spoken to her physician yet so she wanted to do that before the physician received anything from Safety.
This spontaneous report received from a healthcare professional, concerns a 71-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced adverse events: really bad gastrointestinal symptoms, diarrhea and bad flu. The patient's medical history reported as had flu shot last year. No concomitant medications reported. On Jan 5, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (batch/lot# 011J20A), intramuscularly, for prophylaxis of COVID-19 infection. On Jan 26, 2021, patient experienced really bad gastrointestinal symptoms (abdominal discomfort), diarrhea and really bad flu (influenza). On an unknown date the outcome of events: really bad gastrointestinal symptoms, diarrhea and really bad flu: not reported. No treatment information provided. Action taken with mRNA-1273 in response to the events: not reported. Sender's comments: Very limited information regarding this events has been provided at this time. Further information requested. Events assessed to be unlikely related to the product.
nausea, vomiting, diarrhea, chest pain and tightness, lethargy, chills
Patient received their Covid booster shot outside of (Privacy) on Thursday. Friday evening developed tightness and burning in throat and chest, fever and lightheadedness. Symptoms have worsened today. Lot # provided. Was at  a pop up clinic.
Bilateral lower extremity weakness/numbness/pain. Bladder dysfunction. Received IV SOLU MEDROL x 5 days.
Initial misuse report received from a healthcare professional on 23 October 2013. The cases were received on 21 March 2014. It was reported that patient had received FLUZONE vaccine instead of FLUZONE HD leading to wrong vaccine administration. No adverse event was reported. List of documents held by sender: none.
Patient became nauseous and dizzy 5 minutes post vaccine.  Then developed a severe headache and chills 10 minutes later.  Elevated legs, wrapped patient in fleece blanket.  Pulse was normal rate- slightly weak.  Patient had  downed a half bottle of water directly after the vaccine administration.  Sat with patient instructed on breathing and use of acupressure point for nausea.  BEtter after 15 minutes but stayed 45 until I felt comfortable to escort her out.
Vaccine Monday 1/11/2021 1530. Wednesday 1/13/2021 woke up with mild site pain, fatigue, arthralgia.  1/14/2021 Pain in shoulder blade area. 1/16/2021-1/17/2021 developed painful, unilateral truncal rash and tingling pain. Sought help with PCP; Dx. with SHINGLES; started on Valtrex, etc..  Positive COVID history 12/9/2021.  States when had her blood tested to donate in January the week before her vaccine she tested negative.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 20-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Soreness in my arm; Tired for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th September 2022, the patient received the 2nd dose of Shingles vaccine. On 30th September 2022, less than a day after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's Comments: This case was reported via interactive digital media. The patient got his/her second shingles shot.  He/she was very tired for 24 hours. A little soreness in my arm.  Additional supportive information: Follow up would not possible, as no contact details were available.
Ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew01658/21) via an unspecified route of administration in the left arm on 30Apr2021 at 18:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021, the patient experienced ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, 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 ringing in ears was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
On day 7 I developed itching and raised welts at the injection site. On day 8 and 9 the itching and raised welts were gone but left a red circle about 2 1/2"x2 1/2". Applied topical Benadryl for the itching. Personal doctor was not contacted.
Pt states area turned red right away, redness continue to get larger, now has hives on other side of arm as well as neck and face.
10/26/99-Pain lwr. rt. arm, soreness lwr. radial side. Could not turn door key & tie shoes. 10/28/99-discoloration, like a bruise. No problem in injection site at upper arm. 11/15/99 pt. much improved.
bruise at the injection site, like blue and different colors; hemorrhoids and tended to bleed; bled at the site of the injection; A spontaneous report was received from a healthcare professional concerning a 60-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bled at the site of the injection, bruise at the injection site, like blue and different colors and hemorrhoids.  The patient's medical history was not reported. Products known to have been use by patient, with in last two week  included vitamin C and vitamin D3.   On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 062G20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.    On 22-Jan- 2021, same day of receiving vaccine, the patient experienced bled at the site of the injection. On an unknown date, the patient experienced bruise at the injection site, like blue and different colors and had hemorrhoids. Treatment information was not provided.   Action taken with mrna-1273 in response to the events was not reported.   The outcome of events experienced bled at the site of the injection , bruise at the injection site, like blue and different colors and hemorrhoids were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.
Patient felt ok right after getting the shot, but due to her past history of fainting, she was asked to stay at the pharmacy afterward. After 5 minutes or so, pt passed out, loss of consciousness for 30 seconds or so
Generalized pruritis, no treatment necessary; pt recently had change in medicine diabinese d/c'ed; Micronase begun 2 weeks prior to vax;
2-10-11 diarrhea x 1 wk. 2-19-11 continue with bowel problems, weight loss, fussy since immunizations.
Fever severe rash that appeared like the measles and caused severe itching and discomfort. Doctor did not give any treatment.
Sore/tender right arm near injection site. Fatigue. Body aches at times.
No additional AE reported.; expired MMR II was administered to a patient.; This spontaneous report as received from a medical assistant refers to a 53 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 27-FEB-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneous Injection (therapy type: recombinant Human albumin (rHA) (0.5 milliliter, lot # U006489, expiration date 26-FEB-2023, route was not reported) for prophylaxis (expired product administered). No additional adverse event (AE) was reported.
Very sore red swollen right arm for 4 days, fever to 101 degrees for 2-3 days. achey all over, sick enough to stay in bed and cancel commitments for 3 days.
States arm she received flu shot in started aching yesterday called clinic and said arm now red, swollen and warm to touch (10-01-09) at 11:20 am.
fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
The patient is a 61-year-old female who came to the ED via EMS on 7/29/2022.  She was admitted to the hospital after testing positive to COVID-19.  Her symptoms when presenting at the ED were nonstop coughing and significant weakness.  The patient has risk factors of history of cerebral palsy and recurrent bronchitis.  Chest x-ray did not show a definitive infiltrate.  The patient was started on IV remdesivir due to risk factors.  Patient had borderline O2 sats on room air in the emergency room between 90% and 93%.  Likely the patient will be staying over an additional midnight stay.  Based on high risk for worsening condition and possibly requiring O2 supplementation, recommendation is to maintain current inpatient status.
Severe arm pain at injection site  Stomach pain  Nausea  Vomiting