chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had moderna covid vaccines 1 Mar and 30 Mar 2021.  Noted epistaxis, headache, subconjunctival hemorrhages, headaches worsened.  Presented in 7/27/21 from PCP office with headache and was found to have bilateral SDH and platelets of 1k. He was treated with IVIG and steroids as well as 3 units of platelets. Platelets recovered to ~100k and patient underwent subdural evacuation with neurosurgery.  7/29/21: BMBx showed slightly hypercellular bone marrrow (50% cellularity) with slightly increased erythropoesis and granulopoesis and slightly decreased megakaryopoesis. No morphologic or immunophenotypic features of a myelodysplastic syndrome.  His platelet response was not sustained by the inital treatments with IVIG and steroids and he required intermittent platelet transfusions as an outpatient to try to keep platelets >50k as per neurosurgery. Spleen was normal size on exam and US.   Vitamin B12, folate, zinc and copper levels were WNL, HIV neg, ANA+, hepatitis a and C negative, hep B core IgM and surface antigen negative, hep B core antibody had been positive, DAT was negative on 21 September though it had been positive on 17 September 2021 for IgG, zinc had been low, creatinine normal, bilirubin 1.4, LDH 362, TSH suppressed at 0.055, 17 September 2021 haptoglobin was less than 8, 24 September 2021 white count 12.2, platelets 13, hemoglobin 9.7 with platelets of 13 and MCV of 107.  He was started on Eltrombopag 25 mg daily early Sep 2021 and was then increased to 50 mg daily, stopped after a couple wks due to lack of response. Reports of lack of response w/ romiplostim too in house. His platelet count decreased to 7k. Patient was admitted and received IVIG and solumedrol 60 mg q8hr IV as well as 8 units of platelets. Platelets only increased to 13k. Getting HLA matched plts.  He was then started on rituximab weekly x 4, completed 10/4/21. Most recent platelet count from 10/4/21 was 18k. He was also started on mycophenylate 500 mg BID in late September 2021 w/ prednisone 60 mg daily.  9/15/21: Repeat BMBx done due to low platelet counts and showed moderately hypercellular bone marrow with mild erythroid hyperplasia, megakaryocytic hypoplasia and minimal dyspoesis, negative for marrow infiltrative process  He denies use of heparin or quinine or significant antibiotics or Tylenol or NSAIDs or excess walnuts or medicinal teas or EBV or ulcers or malaria or other chronic infections or significant joint pains  CT head 27 July 2021 showed 2.1 cm right subdural hematoma CT chest 27 July 2021 with moderate peri and infrahilar bronchial thickening, suggestive of bronchitis Ultrasound of the spleen 28 July 2021 normal size spleen, liver 16 cm with hepatic steatosis 10 September 2021 CT head with significant decrease in right subdural hematoma 12 September 2021 CT abdomen pelvis spleen normal, mild bladder wall thickening, no lymphadenopathy
patient took 2nd pfizer booster 3/31. The next day 4/1 he was thrown into a-fib. He was advised to go to the hospital where he was then admitted. He is still in the hospital as of 4/3.
Patient received first dose of Pfizer Covid Vaccine on 04/01/21. Started feeling random episodes of dizziness on 04/04/21 and is still continuing.
This spontaneous report was received from a physician via a company representative, concerning a 22 year old female patient. Medical history and concurrent conditions were not reported. On 08-AUG-2014, the patient was vaccinated with the fourth dose of GARDASIL (dose, lot number and expiration date were not reported), intramuscularly. Concomitant therapies included hormonal contraceptives (unspecified). The physician reported that an anonymous patient received a fourth dose of GARDASIL, on 08-AUG-2014, after already completing the three dose series of injections. The patient, who had had already completed the three dose series from her primary care office; however, she explained to her Obgyn (name and demographics unspecified)) that she had only had two doses of GARDASIL and was then given a forth dose, in error. The patient did not experience any symptomatic adverse reactions. Patient did not seek medical attention or received treatment for the adverse event. Additional information has been requested.
Severe headache that generated nausea and vomiting. Injury at injection site consisting of swelling, redness, warmth and pain. Injection site reaction lasted until 1/4/2021.
My left arm at area of shot became rock hard and swollen also reddened. Today,  three days after shot, the redness has spread, it is still hard, swollen and itches a little.
Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side only including neck and torso left side only X 4 days .
JOINT PAIN; FEVER; This spontaneous report received from a patient via a company representative concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in excellent health. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced joint pain, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (units not given). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and joint pain was not reported. This report was non-serious.
Pain at injection site 2 hours after vaccination that lasted for 4 days & did not improve with otc pain relievers; approximately 18 hours after vaccine -extreme fatigue, chills, low grade fever, extreme body aches, severe headache, shooting pain down right arm, stiff neck, & muscle weakness, which increased in intensity over a 48hr period. Most symptoms subsided 4 days after onset (5 days after vaccine was received). Muscle weakness, and fatigue did not subside for 8 days after onset. Headaches have not subsided
Developed extreme chronic urticaria which lasted approximately one year. Intense hives and itching  would randomly occur all over the body at random spots and last for approximately 30 minutes to 2 hours in each spot. Urticaria would prevent sleep and normal daily functioning. Allergy medicines would temporarily alleviate symptoms and prevent urticaria but would require daily intake. Multiple steroid shots had little effect on alleviating urticaria symptoms.
Dizzy, Blurry vision.  Administered ammonia inhalant.  Person recovered.
Myalgia INJECTION SITE PAIN, FATIGUE, NO APPETITE, MUSCLE ACHES Narrative:
Positive COVID-19 test; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive COVID-19 test) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive COVID-19 test). At the time of the report, COVID-19 (Positive COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, SARS-CoV-2 test positive: positive (Positive) Patient received moderna first dose after two days , tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.
Injection site redness, hardening, and itching 12 days post 1st COVID vaccine
2nd COVID vaccine 2/6/21 @10:02am. Episode of vasovagal syncope 2/7/21 @5:00a.  Also side effects of fever, N/V, diarrhea and weakness of approx. 1 hour.  Unable to eat/drink. Presented to the ED 2/8/21 @1:30p. Rec 1L LR, Tylenol, benadryl and compazine @5:25p.  CT head @6:00p. I was d/c from the ED 2/8/2021 @7:47p.  Severe vertigo 2/7 @5:00a-2/9 @4:00p.  Profound hearing loss noted @11:30a 2/10/21.  Appt with audiologist 2/12/2021 @8:00a, ENT 2/12/2021 @1:50p.  Hearing test X2 shows near 100% hearing loss in R ear.  Rec steroid injection behind R eardrum 2/12/21 @2:30p.  PO steroid taper 2/12/21 @5:30p.
localized reaction to vaxneuvance of redness, itchiness, and warmth of injection site of right arm. Pt aware can be a localized reaction from vaccine injections. She does take Allegra daily for allergies, advised can try topical hydrocortisone cream and apply ice to the area. Denied any other signs or symptoms, no chest pain, sob, or itchiness of throat. Pt otherwise ok. She will monitor if no improvement. No call back from patient noted.
Approximately a week after receiving my first dose of the Pfizer vaccine, I developed shingles. I had never had shingles before.
Pain and redness near injection site and Pain and swelling in left armpit. Overall fatigue and body aches.
Vomiting & diarrhea x3 the day after receiving VARIVAX # 2. Mom states "I know my daughter's chemistry & this is not a typical reaction to a vaccine". "I don't think this is a virus". Mom requested that a VAERS form be filed.
lip swelling; rapid heart rate; Sensitivity of lips; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration in the right arm on 10Apr2021 at 09:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medications in two weeks of vaccine. The patient previously took nonsteroidal anti-inflammatory drugs (NSAIDs) (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced allergic reactions to analgesics. The patient previously took oral steroids (MANUFACTURER UNKNOWN) used for prior allergic events and was avoiding so that it will not impact on her immunity. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the right arm on 17Mar2021 at 16:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. 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. On 11Apr2021 at 18:00, 36 hours post vaccination, the patient experienced sensitivity of lips. On 13Apr2021, 3-1/2 days post vaccination, the patient experienced rapid heart rate. On 15Apr2021, 5 days post vaccination, the patient experienced lip swelling. Therapeutic measures were taken as a result of adverse events which included treatment with antihistamines. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sensitivity of lips, rapid heart rate and lip swelling was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/21/2023 BPH W LOWER URINARY TRACT SYMPTOMS HYPOXEMIA 4/25/2023 BPH W LOWER URINARY TRACT SYMPTOMS
Patient presented with Herpes zoster (R) trunk. Symptoms resolved with only symptomatic treatment. No complications. His father later presented with a very mild case of chicken pox. He also recovered. No complications.
mini stroke; This case was reported by a consumer via interactive digital media and described the occurrence of ministroke in a male 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 ministroke (serious criteria GSK medically significant). On an unknown date, the outcome of the ministroke was unknown.   The reporter considered the ministroke to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's spouse. The age at vaccination was not reported. The reporter stated his/her husband had a mini stroke from the vaccine. The follow-up would not be possible as no contact details were available.
blister has come up on her lower hip; ITCHINESS ON SCALP; ITCHINESS AROUND MOUTH; Upset stomach; FEELING LIKE CANNOT CATCH HER BREATH; Diarrhoea; WOOZINESS/DIZZINESS; ALLERGIES WORSENED; FEVER; This spontaneous case was reported by a health care professional and describes the occurrence of BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach) and DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included AMBRISENTAN, DILTIAZEM and SILDENAFIL CITRATE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and SELEXIPAG (Oral) 200 microgram twice a day. On an unknown date, the patient experienced BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH), DIARRHOEA (Diarrhoea), DIZZINESS (WOOZINESS/DIZZINESS), HYPERSENSITIVITY (ALLERGIES WORSENED) and PYREXIA (FEVER). At the time of the report, BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH), DIARRHOEA (Diarrhoea), DIZZINESS (WOOZINESS/DIZZINESS), HYPERSENSITIVITY (ALLERGIES WORSENED) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I was having a lot of pain - mainly around my back and side; also when I was urinating. My legs were feeling weak. I thought it was a UTI. Doctor said I should come in - for an e-visit and call the nurse. They told me come to ER or Urgent Care. They told me - after testing - that it was not a UTI. The test results said there were multiple organisms present in sample - it wasn't a UTI but they couldn't figure out what it is. They gave me Antibiotics - less then a one week course- I started on Thursday and I'm still on them; but pain has migrated under the rib area. Severe pain that prevents me from sitting or standing for a long time in any position; a lot of pain. I was in the hospital for about a day on Thursday - I went to ER and they admitted me to the hospital. They gave me the medication and sent me home with it. Had a follow up with doctor - phone visit - they prescribed more pain killers.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 01-FEB-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion below 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49. 1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335: US-009507513-2203USA003320: US-009507513-2202USA003592:
Redness, tenderness, induration of right left hours after receiving Prevnar in that leg.
It started with a sore throat. I am prone to strep but when I tested it was negative. I went to urgent care  on 03/29 and 03/31 and they said I had an ear infection and fever (101.5) and so I did medication for 2 days with no improvement. I went back and got a steroid. I was better after a week. I did have a headache at the beginning after I received my vaccine on 01/19/2021.
Stomach Issues; Runny Nose; Aches; Muscle pain; Feeling tired; Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On 9th August 2019, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms, pain, muscle pain and tiredness. On an unknown date, the patient experienced stomach discomfort and runny nose. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the stomach discomfort and runny nose were not recovered/not resolved and the outcome of the pain, muscle pain and tiredness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, stomach discomfort, runny nose, pain, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller reported Shingrix received and on the 2nd day, the caller had flu like symptoms from the neck down including aches, muscle pain, and feeling tired. The caller reported flu like symptoms passed in less than 24 hours. One week later after vaccination caller reported having stomach issues and a runny nose that has not resolved. The reporter did not give consent to follow up. The caller declined to provide address and only wanted to provide limited information. The caller did not want to receive mail for follow up and did not consent for medicine doctor follow up.
p/pt recv vax 5/21/99 had react, swelling, hot to touch & baby was crying a lot.
I initially had a severe leg cramp and muscle cramping; I have pins and needle in my feet, and they are numb; I have pins and needle in my feet, and they are numb; Swollen lymph nodes; It's nerving a little bit; This is a spontaneous report received from a contactable Consumer from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Both my feet have been ice cold before and after receiving the vaccine." (ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "I initially had a severe leg cramp and muscle cramping"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "I have pins and needle in my feet, and they are numb"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; NERVOUSNESS (non-serious), outcome "unknown", described as "It's nerving a little bit". Additional information: patient has been experiencing some side effects, initially had a severe leg cramp and muscle cramping, she had pins and needle in my feet, and they are numb. These symptoms come and goes. The patient generally doesn't get flu shots or anything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hot flashes; Chills; Body aches; Migraine; Neck pain; Fatigue; This is a spontaneous report from a non-contactable Nurse.  A non-pregnant 22-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), intramuscular in the right arm on 11Jan2021 at 11:30 AM (at the age of 22-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported.  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular, right arm  on 21Dec2020 for COVID-19 immunization. On 11Jan2021 at 23:30 PM, the patient experienced hot flashes, chills, body aches, migraine, neck pain, and fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events hot flashes, chills, body aches, migraine, neck pain, and fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Irritability, dizziness and unexplained vomiting episodes presenting at around 13-14 months followed by rapid neurologic decline including severe hyper and hypotonia. Resulted in loss of walking ability, speech, etc.  Diagnosed with rapidly progressive, fatal neurologic disease.  Has since regained most function and appears to have CP most likely attributed to viral illness of unknown origin. (ADEM+ Accute diseminated encephalitis)  Does not appear to have chronic neurolic disease as first diagnosed. MRI has dramatically improved over last 6 years.  Outcome = Cerebal Palsy. 01/16/07-records received and reviewed form MD DX: degenerative encephalopathy possibly due to a mitochondrial disorder. Leukodystrophy, unclear cause. Developmental regression followed by plateau and associated leukodystrophy. Which makes us think that it is a mitochondrial disorder whereas the spectroscopy shows some evidence against that. Per 60 day follow up report: Spastic CP as result of ADEM. Non-ambulatroy, WC user. Complete onset at 14 mos. Records show encephalopathy. Initial diagnosis: Fatal (though * Neurologic disease) Presented as leukodystropy, second dx was mitochondrial disease, dx still unknown. Thanks for your consideration. Please contact if add'l info is needed.
onset hives 14 hours after vaccine.  72 hours later she is covered head to toe in hives. every inch of her body.  severe itching.