chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myopericarditis following smallpox vaccination. Body aches began ~5/26, but were attributed to body armor - took 1000mg Tylenol evening of 5/27; woke up with CP on morning of 5/28. Pt presented at hospital with body aches and chest pain (sharp pain upon inspiration) on morning of 5/28.  Transferred morning of 5/28 by Rural/Metro Ambulance to another Hospital. Treated in route w/ IV, 324 mg baby aspirin and oxygen administered by nasal canula. Presented at hospital with angina.  Hospitalized 5/28-5/30.  06/04/2007 MR received for hospitalization 5/28-30/2007 for initial onset of body aches x 2 days preceding an episode of chest pain on 5/28/2007.  Chest pain was worst lying down and improved upon sitting or standing.  Initially seen at another facility where he was noted to have an ST elevation on EKG and elevated troponin.  Transfered to current facility for eval and tx. DX: Likely small-pox vaccination associated Myopericarditis. 08/03/2007 F/U records received from military.  DX: probable vaccinia related myopericarditis.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash progressed to hives), SENSITIVE SKIN (Skin sensitive after rash), RASH PRURITIC (Ithcing burning rash on arms,legs, stomach and back) and RASH (rash over legs, rash over abdomen, rash over arms) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 39k20A and 010u20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Allergy to animals (Allergic to cats). Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced URTICARIA (rash progressed to hives) and RASH (rash over legs, rash over abdomen, rash over arms). On an unknown date, the patient experienced SENSITIVE SKIN (Skin sensitive after rash) and RASH PRURITIC (Ithcing burning rash on arms,legs, stomach and back). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (rash progressed to hives), SENSITIVE SKIN (Skin sensitive after rash) and RASH PRURITIC (Ithcing burning rash on arms,legs, stomach and back) outcome was unknown and RASH (rash over legs, rash over abdomen, rash over arms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-075121 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient details updated, medical  history updated, event added, details of second vaccine  dose was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075121:first dose case
Skin Rash, Rash, Erythema Multiform & Urticaria Pruritus
Pt developed COVID-19 infection, symptoms starting 7 days after first dose was given.  Patient was admitted to hospital on 1/21 after falling (secondary to weakness) and striking head on toilet. Patient expired due to respiratory complications of COVID on 1/25.
11 hours post to injection, fever became elevated to 103°F, mentation became very confused, major aches through out body, elevated breathing and heart rate, some vision impairment
localized welling and redness reported on 7/12/2023, reports more redness and swelling yesterday. Denies any drainage, or bleeding. Denies any fever or any other symptoms. no shaking or chills, no vomiting or severe abdominal or flank pain. Patient has not problems with immune system or kidney failure. none other concerns reported, patient prescribed medication to treat localized area or swelling and redness. patients mother reports no change in playing/activity or eating.
NO adverse events or symptoms was seen after patient received her dosage, patient just got a full dose (0.5 ml) of moderna and this was her 4th dose, she had previously gotten a full dose (0.5ml) for her previous 3 doses since she is immunocompromised. I was unaware that the 4th dose, even though she is immunocompromised had to be 1/2 dose(0.25 ml) instead of 0.5 ml.
The evening (3/20/21)I received the vaccine I noticed fatigue, headache and chills. The next morning I developed shortness of breath. The day after that my left left began swelling for no reason, was slightly discolored and warm to the touch. As the week went on my shortness of breath became greater and my leg more swollen. On (3/26/21) I sent to the ER by my doctor. Had a ultra sound and discovered an extensive DVT in my left groin down to behind left knee. Had a CT and discovered blood clots in my lungs. I had never had any underlying health conditions or been on medications, don't smoke, no complaints prior. Was transported to hospital spent 2.5 days in ICU before being moved to a regular bed for a total of (4) days hospitalized. The doctor installed two sheaths on each side of groin, injected my lungs with medication to blast/dissolve the clots and installed a filter in the main artery to catch any clots that may break away from leg. I was also put on a Heparin drip while in ICU. The next day the doctor went and the procedure was a success dissolving the clots. He removed the sheaths. I went back to ICU. The next day (3/28/21) a second utlra sound was done to left leg and DVT is still in left leg. Have been described Eliquis blood thinner.
At approximately 3am (~13 hours post-injection) I experienced chills. I was asleep in bed and was awakened by my own shivering. My bedroom was its typical temperature, I had my usual bedding on the bed, and my wife (next to me) did not feel that the temperature was unusually low. I added additional blankets and suffered through these chills for approximately one hour until they passed.  At approximately 9am (~19 hours post-injection) I began to experience severe body aches and fatigue. I got up, had breakfast, and then slept approximately 3 more hours. I awoke for lunch, played with my children, and then fell asleep for approximately 2 more hours. Body aches continued through the day. Over-the-counter Tylenol was sufficient to ease the discomfort. I would describe the level of body ache as similar to having completed an extremely strenuous physical activity the previous day; the last time I can remember feeling this sore was following a multi-day 100-mile backpack trip at high elevation. At present (10pm, approximately 32 hours post-injection) the body aches are subsiding but still present. My fatigue is also subsiding.
SM received AVA #3 on 3/22/10 and found she was pregnant on 4/4/10.
will not be completing the Gardasil 9 series; henoch-schonlein purpura (HSP) rash in both of her lower legs, including blisters behind her knees; joint pain; This spontaneous report was received from a physician via a company representative referring to a 21 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The patient also completed 3 doses of the COVID vaccine prior to receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  On 08-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U006800, expiry date: 28-APR-2023, for prophylaxis (dose and route were not reported). This was the patient's first dose in the series and it was reported that she will not be completing the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series.  On 09-NOV-2021, the patient developed a henoch-schonlein purpura (HSP) rash and has some joint pain. The physician reported there was no renal involvement. The rash was on both of her lower legs, including blisters behind her knees. The patient had been seeing a rheumatologist for a couple of months for unspecified reasons. The physician reported to the employee that the patient had taking 2 unspecified medications from the Rheumatologist, however she was off of them prior to taking hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient had been to the emergency room twice and had seen a dermatologist. She was given steroids for the rash. The patient was not back at work yet. No additional information was reported. No additional adverse events presented and no product quality complaint present. The outcome of henoch-schonlein purpura and arthralgia was reported as not recovered. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.    The causal assessment between the events and the suspect therapies were not reported.
Firm swelling of skin and subcutis about 5-6 cm diameter, slighted raised. Swelling was red and itchy. Lasted 4 days. No treatment needed.
I start with cough and temperature then all the symptoms of the COVID-19 for 3 days then i make appointment to test
This spontaneous report as received from a register nurse via Company Representative concerning a 14 year old patient of unknown gender with diabetes. Medical history was not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, strength, route and lot number were not provided). Secondary and concomitant therapies were not reported. On an unknown date, the patient felt nauseous and may have suffered a diabetic shock after the first dose of GARDASIL was administered. The outcome of the events was not reported. Upon internal review diabetic shock was considered as an other important medical event. Additional information has been requested.
Raise surface, redness, warm, hard around the injection site otherwise tender, approx size of 40mm*60mm.
fever 102, breathing problems, crying episode lasting several hrs; fussy & irritable lasting 2 days; mom stated APAP was given;
Information has been received from a health professional concerning a female patient (age unknown) who on 15-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651406/0620F), intramuscularly.  On 09-NOV-2006 between 14:30 and 15:30 the patient was vaccinated in the other upper arm with a dose of FLUVIRIN (Lot # 7200).  Subsequently, "one hour after vaccination", the patient developed pain, swelling, redness at the site and splotchiness in the arm in which she was vaccinated.  The symptoms increased over the next few days.  The swelling continued and the patient complained of general malaise.  The patient alternated ibuprofen and aspirin and applied heat with some relief.  The patient did not go to the doctor.  The swelling subsided after three days.  The symptoms went away after 5 days.  On approximately 20-NOV-2006, the patient recovered.  Additional information is not expected.
Patient was under-dosed and given 0.25 ml rather than 0.5 ml
She got her vaccines, she had diarrhea and general weakness.  She has not taken anything for her symptoms.  She is hoping that they will stop shortly.
Extreme fatigue; Extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 13:15 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE QUADRIVALENT, administration date 23Sep2021; LOSARTAN; ATORVASTATIN; AMLODIPINE; METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 12Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), ARTHRALGIA (non-serious) all with onset 25Oct2021 13:30, outcome "recovering" and all described as "Extreme fatigue". Therapeutic measures were not taken as a result of fatigue, arthralgia.  Additional information included: Patient received Fluzone 65+ HD Pf 2021-22 -Left arm, within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Events did not result in prolongation of hospitalization. Device Date: 26Oct2021.    No follow-up attempts are possible. No further information is expected.
First vaccine very sore arm and fatigue. Second on Congestion, Runny nose feels like he is going to get a sore throat.
This spontaneous case reported by a consumer, describes the occurrence of nausea, fatigue (fatigue/tiredness) and pyrexia (low-grade fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. No reported medical history. On Jan 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 3, 2021, patient experienced nausea and fatigue (fatigue/tiredness). On Jan 7, 2021, patient experienced pyrexia (low-grade fever). At the time of the report, nausea, fatigue (fatigue/tiredness) and pyrexia (low-grade fever): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The concomitant medications reported included blood thinner and other unspecified medications. The treatment information not provided. Reporter's comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Patient requested alternative injection site due to bilateral rotator cuff injuries/tears. On site med consult, received verbal consent to administrate in the thigh via phone at 2pm.
Nothing serious but wanted to report since SHINGRIX is fairly new. My arm is very sore - more so than with the flu shot. Woke me up a few times last night. I have been taking OTC Ibuprofen (400 mg) which helps a little, but this is intense. I'm feeling unusually tired, especially after walking the dog this afternoon.
Patient received 2nd dose of HPV (left arm) and Seasonal Influenza (right arm) at PE on 1/29/2020. On 1/31/2020, Mom and patient reported at the site of the flu vaccine patient had redness and swelling and itchy. Patient took a picture of her R arm at the site and had hives. Mom called our office on 02/04/2020, advised to gave Benadryl which she did and hives resolved.  Patient seen on 02/05/2020 in follow up due to headaches, nausea, itchiness and dizziness. At that visit, patient was still very itchy (whole body) but no more rash/hives.
a large pink reddish rash(ring rash thing)around the injection site; tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a large pink reddish rash(ring rash thing)around the injection site) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported.). Concomitant products included MELOXICAM, COLECALCIFEROL (VITAMIN D3) and PARACETAMOL (TYLENOL) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced FATIGUE (tired). On 07-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (a large pink reddish rash(ring rash thing)around the injection site). On 30-Apr-2021, FATIGUE (tired) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (a large pink reddish rash(ring rash thing)around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       A Patient calling to report that she took the 1st dose of Moderna COVID-19 vaccine on 28Apr2021( Lot number: 009C21A Expiration Date: 15Oct2021) in her left upper arm muscle. She mentioned that first two days after the shot she was tired which was normal to her.  But on 07May2021 she started getting large pink reddish rash( like a ring rash thing) around the injection site. She wants to know if this is normal and if it is going to effect her 2nd dose that she is scheduled on 26May2021 and mentioned the rash has started to fade away.
Severe itching and hives started 5 hours after vaccine, subsided in 2 hours, then restarted after 17 hours of vaccination with more severe itch and whole body rash, making it necessary to take antihistaminics
Patient received the vaccination on monday and on saturday patient started experiencing a sensitive bump on the back of the head the bump is the size of tip of her thumb.  Patients states cannot tell if discolored or not.  I stated I though it was unrelated to the vaccine but monitor the lump and if it increased got worse or didn't go away to follow up with her PCP.
p/vax day 1-severe pain w/movement around site of inj; discoloration to red/purple; grogginess lasting 12-18 hours;
A patient received a Shingrix vaccination on Saturday. He experienced an injection site reaction that started Sunday afternoon and consisted of a raised, red, feverish area that streaked around to the back of his arm where the vaccine was given. He went to the ER because he was experiencing chest pain and was worried that he might be having a heart attack, and the ER doctor told the patient his radiating pain was likely inflammation from the vaccination.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 14-AUG-2014, the patient was vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Patient states that two to three weeks after her second dose of the COVID-19 Pfizer series she has had daily bouts of vertigo.
COVID 19 Treatment.; COVID 19 Treatment.; Dose 5: Moderna; Dose 4: Pfizer/Biontech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 04Apr2021 as dose 2, single (Lot number: EW0151), in right arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 25May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Sep2022 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient had no relevant medical history. No allergy. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Dose 5: Moderna; Dose 4: Pfizer/Biontech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment.". The patient was tested negative at home after Paxlovid, but hoarseness and runny nose resumed, and tested positive at home five days later, 29Mar2020
My nose keeps running; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for herself that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation, tofacitinib citrate (XELJANZ XR 11mg) , via an unspecified route of administration from an unspecified date at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. During an inbound call with the patient, the patient stated that she had the covid shot and she was watching herself while taking her tofacitinib citrate. Her nose kept running. The action taken in response to the event for tofacitinib citrate was unknown. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
At approximately 8 pm pt. sucked in a deep breath, head began to roll and he began twitching on the right side of his body. Pt. only has muscle function in the right side of his body due to his stroke damage. His wife immediately approached him in his chair and asked him what was wrong and all he was able to state was "I don't know" before loosing consciousness and stopping breathing. 911 was immediately called and due to his wife being frail herself she was not able to remove him from his wheelchair to perform any CPR. EMS arrived and begin performing CPR until the DNR papers for pt. were located. Medical examiner came to the home and stated she did not feel that an autopsy was needed even though family had told her NUMEROUS times that pt. had received his second Covid vaccine the day prior. He was pronounced dead by the medical examiner and taken directly to the funeral home due to the DNR papers being present.
Hep A vaccine in the afternoon Day 0.  That evening head ache and photophobia.  Day 1 general myalgias and parathesias. Day 2 vomiting and worsening HA. Day 3 HA improving but left leg pain.  Day 5 bilateral leg pain, toe walking, difficulty walking, rash.  No fevers throughout.
Big red spot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red spot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced ERYTHEMA (Big red spot). At the time of the report, ERYTHEMA (Big red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.
Private vaccine lot number expired on 3/5/2023 and was administered to patient on 3/7/2023. Nurse did not pay attention to lot numbers when selecting. In the process of trying to reach mother to have her scheduled for repeat Pediarix dosage. Incident form has been completed with practice.
1;25 pm left deltoid small amount of swelling noted hardened area around swelling. Bruise noted 3:45 pm, swelling reduced area not as hardened.
Post vax, the pt developed right leg swelling and redness for 2 days, warm to touch. Treated with Motrin, and ice/warm compresses.