chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vasculitis in fingers and toes; fleshy part of fingertips got red/purple,seemed almost like a burn.  As well as his big toes.; This is a spontaneous report from a non-contactable consumer (Patient). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 05Aug2021 (age at vaccination 12 years) as dose 1, single for covid-19 immunisation. The patient medical history was none. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Aug2021 the patient experienced vasculitis in fingers and toes, fleshy part of fingertips got red/purple, seemed almost like a burn. as well as his big toes. Patient visited healthcare professional office/clinic visit. The patient received aspirin for treatment. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Completed series, got shingles/Suspected vaccination failure; About one week ago patient got shingles. Across t12 Dermatone -right side.; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In January 2023, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The patient received Shingrix complete series approximately in 2022 and about one week ago the patient got shingles, across t12 dermatone in right side. The reporter consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
headache; feeling tired; feeling weak; having breathing problems/couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: 813249 (reported as "Pfizer 813249")), via an unspecified route of administration on 28Jan2021 08:30 at a single dose for covid-19 immunization at a hospital. The patient's medical history was not reported. The patient has no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received other medications within 2 weeks of vaccination (unspecified). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: ek9231), in the right upper arm on 07Jan2021 for COVID-19 immunization. The following day2 (2021), the patient experienced headache and feeling tired. The 3rd day after, patient was more tired and feeling weak and began having breathing problems. Day 4, more severe breathing problems noted. Day 5, the patient woke up and couldn't catch his breath. The patient went to the ER. The patient had numerous tests and was given breathing treatments, O2, and "Anit bo". The patient was tested for covid post vaccination via nasal swab which was negative. The outcome if the events was recovering.
On 02-27-2021, I felt very tired and my right arm pit started to bother me. Five days after my second vaccine, my lymph nodes got enlarged. I had 2 sonograms on lymph nodes. I just recently had a follow up my lymph nodes on my neck are still enlarged, 3 on my left side and 2 on ty right side. I also did a sonogram and it shows that my thyroid is slightly enlarged, a lot of blood work also done. My  blood work results are normal. I thought I had cancer and to this day I still do not feel 100%. My right armpit feels a bit better and I am actually going to see a gastroenterologist on 08-23-2021 just to check that everything there is fine. I was completely fine before receiving the Pfizer vaccine. My sonograms reports say that my lymph nodes are benign appearing non pathological. Prior to receiving the second dose vaccine, my thyroid was checked by Dr. and it was fine. I am also following up with another dr. for my lymph nodes on my neck.
Immediately following venipuncture pt said it hurt. Pt supported and encouraged to provide post-injection pain relief methods. She said it still hurt when leaving office and pt told to call if symptoms did not subside. Three weeks post-injection (1/21/09 pt. called to obtain advice as she felt her pain had not subsided since her Hepatitis A vaccination. She says the pain had gotten worse, although she described the shooting pain she initially experienced went away after the first 1-2 days. She describes her current pain as an ache at 3-4/10 on the pain scale. She says that the pain encompasses her shoulder/upper arm area and the pain feels muscular in nature. She says the pain has awakened her during the night. Pt says she did not take any tylenol/pain reliever and limited movement after injection due to pain. Pt encouraged to try a pain reliever and hot pack as well as exercising the arm. Pt receptive to  this information. She then recalled that 2-3 years ago she contracted a virus which has chronically weakened her immune system. Pt plans to contact her rhuematologist about this. Pt was called 2 days after original complaint (as agreed upon) to re-check symptoms. She said she had not taken the tylenol as the pain was, "not that bad." She said she has not had a chance to talk with her rhuematologist. The nurse and pt have agreed to check in again next week.
Patient started shaking uncontrollably, became very hot and had explosive diarrhea. Symptoms lasted approximately 3 hours.
Patient called the afternoon of 6-16-21, to report almost immediate reaction of irregular blood sugar levels ranging from 30 to 325. Patient reports extreme fatigue to where she could not keep her eyes open.
Noticed swelling (the size of a baseball) at the site of vaccination, 2 hrs after administration. Took ADVIL to relieve the pain. Developed hives 12 hrs after vaccination. BENADRYL provided no relief. Went to Dr's office on 9/15/14 after hives spread all over body. Was started on a 9 day course of prednisone.
Lightheaded within 10 mins, nauseous by 7:00PM...lightheaded everyday since...checked by my doctor going for further test.
numbness of her tongue and lips; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA ORAL (numbness of her tongue and lips) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (numbness of her tongue and lips). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (oral) for Adverse event, at a dose of 25 milligram. At the time of the report, HYPOAESTHESIA ORAL (numbness of her tongue and lips) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI On 04-May-2021: Additional information received
1:31 pm--received vaccine Im  1:50 pm--reported  nausea and dizziness.   1:58 pm  Bp 125/80, P84, R16, o2sat 98% R16.  1:59  pm --Zofran 4mg po x1 given  2:01 pm---pt wants to be discharged.  nausea and dizziness resolving.  pt discharged.  ambulated  with no asst.   2:59 pm ---called and spoke to pt and he is doing fine.  he was the one driving.
Soreness and tightness day 1. Pain on day 3-4. Been on steroid for 4 days, will continue for 3 more days and then reevaluated.
Arm soreness, fatigue, severe burning sore throat, persistant hard cough, loss of voice, severe congestion of sinus, ears, eyes and lungs, low-grade fever, headache, nausea, diarrhea, loss of appetite,  moderate muscle aches, severe shortness if breath, wheezing, dizziness. Primary Dr notified after 1st dose symptoms began and COVID PCR test ordered on 04/17/2021. Results were Negative on 04/18/2021. Symptoms persisted for 3 weeks worsening until 2nd dose was taken.  Symptoms multiplied within 24 of 2nd dose. Primary dr notified 48 hrs later and ordered chest xray for possible pneumonia. Results came back verbally per admin asst negative for pneumonia but no official results  received yet. Based on symptoms, chest xray and vaccine taken my primary ordered Medrol dosepak, zpack and albuterol was taken due to past history of pneumonia last year. Symptoms abated almost completely on 3rd day but then returned worsening since. Still sick now.
Injection site hard; Rash around the injection site; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (Crab allergy) and Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include blood pressure pills. Treatment information was not provided.
pt recv vax & devel an inj site rxn;pt was dx as having cellulitis;use of ATB for tx of the rxn has not been confirmed;this is one of three patients from this site who recv same lot# & exp the above rxn;
2 days after the 1st COVID-19 dose my right foot and leg started to tingle and feel slightly numb in the early afternoon.  About 10 minutes later I had a intense stabbing pain in the lower spine with uncontrollable spasms.  It felt as though needles were being injected into my spine repeatedly causing intense spasms.  I went to Urgent Care that evening due to it not getting any better.  An x-ray was done of my lower spine and it did not show any issues.  The doctor advised me to take a muscle relaxer and Ibuprofen.  As of today I still have some spasms and spinal pain.  It is not as intense, but it's still very much there.
Nasal congestion, dry throat, malaise, fever for three night, extreme tiredness, intermittent nausea, occassional diarrhea, runny nose, moist cough.
Day after injection:fatigue, chills, headache, loss of appetite. Injection site had 3x3 inch, warm, red and painful welt.
This vaccine was stored at room temperature outside of 2 hours.  The vial was opened around 11AM and the vaccine was administered around 246PM.  I did not realize this was incorrect until 11/5/21.  I have contacted my managers and the manufacturer who did not have stability data past 2 hours and advised to use clinical judgement.
generalized Malaise/significant pain in arms; significant leg pain; Unable to walk; Unable to lift; Weakness; This case was reported by a physician via call center representative and described the occurrence of general malaise in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced general malaise, leg pain, unable to walk, mobility decreased and weakness of arms. On an unknown date, the outcome of the general malaise, leg pain, unable to walk, mobility decreased and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the general malaise, leg pain, unable to walk, mobility decreased and weakness of arms to be related to Shingrix.  Additional details were received as follows: It was reported that, few days after receiving Shingrix, the patient experienced generlaized malaise, significant leg pain to the point that she was unable to walk and significant pain or weakness of her arms that she was unable to do lifting. The reporter consented to follow up. The outcome reported for all AES in the structured field of XML is "recovering" instead of "not resolved" (outcome uploaded)
"worsening of fever blisters on mouth"; condition aggravated; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number Y5J27, expiry date 8th November 2021) for prophylaxis.   Concurrent medical conditions included fever blister.   On 8th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced fever blister and condition aggravated. On an unknown date, the outcome of the fever blister was recovering/resolving and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the fever blister and condition aggravated to be related to Shingrix.  Additional details were reported as follows: The patient had a history of oral fever blisters previously, and these blisters was worse in the last month since receiving the vaccine. Reporter consent to follow-up.
Stevens Johnson Syndrome; This serious case was reported by a pharmacist via call center representative and described the occurrence of stevens johnson syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stevens johnson syndrome (Verbatim: Stevens Johnson Syndrome) (serious criteria GSK medically significant). The outcome of the stevens johnson syndrome was unknown.   It was unknown if the reporter considered the stevens johnson syndrome to be related to Shingrix.     It was unknown if the company considered the stevens johnson syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date- 01-NOV-2023 The pharmacist inquiring about use of Shingrix following Stevens Johnson Syndrome. The patient had Shingrix vaccine about 6 months ago and developed Stevens Johnson Syndrome.  The reporter consented to follow up.
About 72 hours after vaccinations below had 2 short seizures (1 minute apart) with temperature: 106.2 pr.  Also took 1st dose of Mefloquine 1/4 tablet for Malaria prophylaxis.
was diagnosed with covid 19; was diagnosed with covid 19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCITRIOL; ALLOPURINOL; PREDNISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "was diagnosed with covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The patient stated that he was diagnosed with covid 19 and was positive for 3 weeks but is recovering now. It was not known that reporter consider event caused by suspect product or not with COVID 19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
onset of varicella rash 21 days after vax (>50 lesions)-no fever, no severe systemic rxn;group home resident isolated from other kids @ onset;
Jaw locked ~3 hours , severe throbbing headache <1 week,  pins and needles in hands and feet on and off for over a month, random loss of muscle control, falling, dropping things, memory lapse, headaches still occurring 3+ months, extreme fatigue lasting 3+months
Approx 5 hrs after vaccine, symptoms similar to panic attack for 5 mins, then fainted in gas station parking lot. Regained consciousness quickly. Then felt fine.
Chills; fever; body aches; This is a spontaneous report from a contactable 47-year-old female Nurse. A 47-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: En6201), via an intramuscular route in the right arm on 10Feb2021 at 15:45 (age at vaccination: 47-year-old), as a single dose for covid-19 immunization. Medical history included Dm1, htn and high lipids. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: El3248), via an intramuscular route in the right arm on 12Jan2021 at 15:00 (age at vaccination: 47-year-old) as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 11Feb2021 at 08:00, patient experienced chills, fever and body aches. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  Follow-up attempts completed. No further information expected.
Upper arm pain from elbow to shoulder  and throbbing.   Some swelling in lower arm near wrist.  Considering Urgent Care Visit
fever > 102 R starting 3-4 hrs p/vax & lasting > 48 hrs; APAP given q 4 hrs; persistent inconsolable crying starting 3-4 hrs p/shots administered & lasting >48 hrs;
a)  Expected left arm soreness, visable bruising, immediately following vaccination on day 1 b) Fever 101.2 body aches and severe headache, the following morning, day 2, nauseous and severe headache with episodes of regurgitation started afternoon of day two  c) Headache and abdominal pain persisted and escalated prompting 5 hr ER Visit, offered script for pain and nausea, CAT-scan performed, sent home on day 3.  d)  abdominal pain increased significantly prompting return to ER evening of day 3, ultrasound of gallbladder with negative results,  continued pain management with tordahl. Sent back home. e) abdominal pain, headaches and vomiting persisted for 3 days until it was unmanageable on day 7 prompting Additional information for Item 18:  e) continued - Return to the ER on Saturday early morning at which time inflamed colon was identified, provided oxi-pain management, antibiotics and sent me home. f)  On day 8 (Sunday),  abdominal pain and vomiting with dry heaves persisted, headache improving through Monday.  g) Tuesday, late evening called ambulance due to overall miserable suffering, they did not transport thinking I was still relatively stable and talked me out of going to ER.  h) Wednesday morning still sever abdominal pain and suffering went to ER where they administered pain medications and admitted me for ongoing pain management.  Beds were not available, spend the night and next day in the ER. i) Wednesday the 17th the Gerontologist visited me in hospital, performed endoscopy and revealed Hiayatal-hernia and inflammation, continued pain and nausea medication for four days until discharged on morning of 21.
not able to eat; Lethargic; nutrients not absorbing in body; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (not able to eat), LETHARGY (Lethargic), MALABSORPTION (nutrients not absorbing in body) and ABDOMINAL PAIN UPPER (Stomach pain) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 028A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Asthma chronic (almost died from), Non-smoker and Abstains from alcohol.   In December 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. In August 2021, the patient experienced FEEDING DISORDER (not able to eat), LETHARGY (Lethargic), MALABSORPTION (nutrients not absorbing in body) and ABDOMINAL PAIN UPPER (Stomach pain). In August 2021, FEEDING DISORDER (not able to eat), LETHARGY (Lethargic), MALABSORPTION (nutrients not absorbing in body) and ABDOMINAL PAIN UPPER (Stomach pain) had resolved.            Concomitant product use was not provided by the reporter.  Action taken of ADALIMUMAB (HUMIRA) was reported as unknown.  Treatment information was not provided.  The reporter's causality for the events of not feeling well, not able to eat, lethargic, nutrients not absorbing in body and stomach pain with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.  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.   This case was linked to MOD-2022-625949, MOD-2022-626091 (Patient Link).   Reporter did not allow further contact
61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills.  Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen.   Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin.   Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.