chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ROTATEQ given 12/17/07.  12/19/07 infant had blood flecks in stool on & off for 3 days, in about 1/2 of BM's.  He is breast fed and has about 19 stool 1 day.  Amount of flecks was "a few".  Was not seen by medical provider.  Mom did call & was referred to another CHN in this CHN absence.  Infant "miserable" for 1 wk temp 102 degrees, no V/D but stool dark green from normal yellow.  Stool with mucus.  No abdominal swelling.
blood transfusion; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TRANSFUSION (medically significant) with onset Sep2021, outcome "unknown", described as "blood transfusion". Clinical Course: The patient had a blood transfusion in Sep2021. The patient, has already had the 1st and 2nd doses of the COVID vaccine before he had the blood transfusion, he had this blood transfusion about 3 months ago, and now he wants to take this booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Redness in a ring around injection site, spreading outward. MD diagnosed as bacterial infection & treated with antibiotic.
Intense pain in the legs (was told to report this), similar to the flu. Similar, less intense lower back pain as well. Moderate headache which has lasted for multiple days so far. Initially had temperature swings (fever, then cold). Aceitometaphen was taken and wasn't effective. Ibuprofen was taken the following day to minimal effect as well.  After two days, the lower back pain, and headache still remain...
Delayed hypersensitivity reaction at site of injection, one week following injection. 5 x 6 cm raised red patch, slightly tender and indurated. Started with small erythematous macules, then coalesced. Reminiscent of a large + PPD reaction. No systemic symptoms. No prior history of documented COVID infection or exposure known.
I experienced staph infection at the injection site and my pain was tingly, very sore. I went to ER received antibiotics for 10 days.
Following vaccine administration, client developed a generalized, flat, red rash. No itching noticed. No other adverse signs or symptoms noted. No behavior changes noted. Client was taken by parent to his health care provider per recommendation. No treatment required. Contacted parent at home at 4:00 PM for follow-up. Parent reported child doing fine and that rash was fading and more localized to the areas where vaccines were administered.
Postural orthostatic tachycardia syndrome (POTS); Dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), and dizziness.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007498: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Vaccine administered ~16 hours after vial punctured from the evening prior, past the recommended 12 hour BUD time limit. No adverse effects noted.
4 days after administration of vaccine (left arm), patient developed moderate swelling and pain in his right and left axillary areas as well as behind both knees. He also felt feverish and overall achy and tired.
HYPOTENSION 11/1/2022,  11/4/2022,  11/18/2022,  11/20/2022,  1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805502 was crossed linked to original case 201804863 due to same reporter.
11/04/2021 The patient presents with weakness. Pt with hx dementia, lung and liver cancer, started her first round of chemotherapy on 10/20, supposed to receive it every 3 weeks. Pt's sister called 911 upon visiting pt at home while pt was doing her home physical therapy. Pt only c/o worsening weakness over the last week. Denies any abdominal pain or vomiting, reports she has had diarrhea "every day" after dx of DM, no new change per pt.  The onset was 1  weeks ago.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 12-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergic reaction to peanut butter, diabetes and peanut allergy. Concurrent vaccination included VARIVAX (Merck) given on 14 July 2011. Concurrent medications included HUMALOG and LANTUS. It was noted that the subject had a similar reaction to what was reported in this case to flu vaccine (manufactured by PNC) administered on 21 October 2010. On 14 July 2011 (around 08:30 or 09:00) the subject received 1st dose of BOOSTRIX at 0.5 ml in the left deltoid. At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site redness, hard lump (knot) at injection site and lump under arms (pea sized area in lymph node under arm). At the time of reporting the events were unresolved.
I missed my period since I had my vaccine.  I am not pregnant.  I have had it confirmed negative at my the hospital.
LOSS OF BALANCE, POSSIBLE VERTIGO; POSSIBLE PREMATURE VENTRICULAR CONTRACTIONS, FLUTTERING IN CHEST; This spontaneous report received from a consumer (company representative) concerned a 56 year old male. 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 was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced possible premature ventricular contractions, fluttering in chest. On MAR-2021, the subject experienced loss of balance, possible vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible premature ventricular contractions, fluttering in chest and loss of balance, possible vertigo was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Injection on Jan 22, no problems at first but 6 days later,  shivery on Jan 28,  then itchy rash on left arm near injection site noticed about 7p.m. on Jan 29 and spread a little more on Jan 30.  I feel a little shaky but may just be panicky.  No treatment thus far.
Baby given pediarix in right thigh at about 1130a 9/4/2008.  mom noted a knot in the skin 2 inches medial to the shot site.  the knot got bigger over the next couple hours and bruised looking.  parents brought the infant back on 9/5/2008, stating 'the nurse had stabbed the infant with the needle, it went though his leg.' Dr  looked at the leg and felt that the bruise/knot on the right top of thigh, 2 inches away was not related to the injection site on the lateral side of right leg
Chills after an 1 hour after vaccination. Red and swollen arm to elbows fever shortness of breath. Pt took BENADRYL.
Patient is c/o pain, numbness, heaviness and weakness in her right arm since receiving the Influenza vaccine. She reports being sent to physical therapy without improvement. At times she finds it almost impossible to even lift her right arm. She also reports similar symptoms from last year's Influenza vaccine which was given in her left arm but thought it was caused by the needle possibly "hitting a nerve" when it was injected. She received the FLUARIX QUADRIVALENT Influenza last year as well.
error diluting med with 0.8ml rather than 1.8ml reulting in a more concentrated form
After the vaccine my arm immediately swelled and stay swollen for a week. I developed a fever and body aches. After the swelling went down it became very itchy.
Pt. states that after receiving the 1st dose of Phizer 11/20/2021, started experiencing symptoms of 225 Pulse, disorientation, weakness, faint, and shortness of breath. No noted Primary visit/communications.
Patient was admitted to the hospital for pneumonia on 4/27/15 (vaccine administered 4/9/15) - unspecified organism.
Day 2 following the vaccine, patient began to experience flu-like symptoms (fatigue, head ache, body ache). Followed by a syncope episode, did not follow up with any emergency care. Did not contact primary care or go to the hospital, or take any medication to treat symptoms. Mentioned having eye soreness, eyes feeling fatigued which is not usual for the patient and coincide with timing of adverse effects.
Information has been received from a physician concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first, second, and third oral dose of Rotateq (Lot# "1116D," 656188/1238F, and 656194/0024U) on 17-JAN-2007, 02-MAR-2007, and 15-MAY-2007, respectively. There was no concomitant medication. On 26-APR-2007 the patient was treated at the emergency room for intussusception and then released. No other symptoms were noted. Subsequently, the patient recovered. No product quality complaint was involved. the patient's intussusception was considered to be an other important medical event by the reporter. A lot check has been requested. Additional ifnormation has been requested.  06/11/2007 MR received from CDC. Hospital record for ER admit on 4/25-27/2007 for c/o vomiting x6 which began the night prior. No stool noted that day.  Also c/o fussiness and  drinking less.  PE: revealed an alert but mildly fussy infant with sunken eyes and dry mucus membranes.  HR in the 140's.  Abdomen tender with guarding. pallor noted.  Ped. surgery note 4/27 reveals infant tolerating po, voiding well, no blood noted in stools, abdomen soft and round. D/C to home. DX:  Intussusception- Air enema reduced.
Rash and red, uticaria. Sulfamethoxazole/Trimethoprim 1 tab BID.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius)for 1392 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient became pale, heavily perspirating, and felt faint within about 5 minutes of shot.    Gave patient bottle of water, bottle of sunny d and cheese cracker to eat.  Within 5-10 minutes, he was feeling much better. Patient said he still felt "weird" as if he was "high" but his other symptoms had disappeared after 20 minutes. I told mom to call if she needed anything.
The participant had a wellness screening and a flu shot which involved a finger sick to check labs as well as the IM injection. Right after the flu injection the participate complained of feeling nauseated and light headed. The nurse had her to put her head down to her knees and another nurse placed an ice pack on her neck. After about 10 minutes the participant stated she was much better. She did not actually "pass out " or lose conscientiousness.
tonic-clonic sz began aobut 20 mins p/leaving office ( & about 30 mins p/vax given);
extremely itchy; whole body is covered with rash; slight fever; sore arm; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extremely itchy), PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache), RASH (whole body is covered with rash) and PYREXIA (slight fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache) and PYREXIA (slight fever). On 06-Mar-2021, the patient experienced PRURITUS (extremely itchy) and RASH (whole body is covered with rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (extremely itchy), PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache), RASH (whole body is covered with rash) and PYREXIA (slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f and 98.5 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient called this afternoon and stated that her arm where she was immunized yesterday was very sore, red, and swollen. And was hoping it would pass, however, this morning she noticed that it was even more swollen, red, and painful. Patient was advised talk to her provider and in the meantime could take ADVIL for the pain and inflammation as well as BENADRYL. Patient stated that she had ADVIL in her home but didn't have the BENADRYL. She did come into the pharmacy and her arm was looked at. Visibly red and swollen radiating down into the upper part of her forearm at that time she did state that the provider recommended that she go to urgent care because they had no available appointments today. Patient stated that she did not want to go to urgent care because it was too far away and expensive. While in the pharmacy she did purchase BENADRYL. She was also advised to call her doctors office in the morning and see if there were any cancellations to get seen. Also advised to seek emergent medical care if symptoms were to worsen. She stated she would be monitoring the site, and we at the pharmacy will be following up with the patient tomorrow.
4 brief (< 30 sec) episodes of shaking & breathing assoc /w low fever (< T 101) ? of seizure activity
Lupus got worse; Lot of bleeding from her womb and rectum; Lot of bleeding from her womb and rectum; COVID positive; Dizzy; Strong reaction; Can't get out of bed; A spontaneous report was received from a consumer who was also a 63-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Lupus got worse, lot of bleeding from her womb and rectum,COVID positive, dizzy, strong reaction and can't get out of bed.  The patient's medical history included lupus. Concomitant medications included prednisone, enoxaparin, folic acid and pain killers.  On 12 Jan 2021, approximately fifteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Jan 2021, 15 days later, patient had a "strong reaction" and went to the hospital where patient got diagnosed with COVID. Patient says patient cannot even stand, felt dizzy and had to lay in bed all day. The patient had lupus, which worsened after vaccination. She had a lot of bleeding from womb and rectum.  Patient said she won't get the second dose because it will kill patient. Treatment for the event included tylenol but symptoms did not get better.  The mRNA-1273 was withdrawn in response to the events  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the event -tested positive has been provided at this time.  Further information has been requested. However, based on the mechanism of action of mRNA-1273, the event- COVID-19 is assessed as unlikely related to mRNA-1273.
Oval shaped red rash on injection arm that starts below the injection site. The size of the oval is 2.25 inch tall, 1.5 inch wide. Appeared about 1.5 days after injection
My babies face and neck developed hives and swelling. He was coughing and his eyes swelled up along with other parts of his face
On 8/12 patient developed nose bleed and was admitted to hospital  Bone marrow bx showed acute myeloid leukemia.  Chemo therapy started.  Patient became septic on 10/9 with hypotension and was intubated.  She coded on 10/10 and expired.
1 of 3 pts vaxed from the same lot# exp a react; pt had local react the size of a half dollar; No systemic react reported;
5 inch swelling area around site. 101 temp, difficulty breathing, flu like symptoms.
I received notification of the evening of 4/2/2023, it said that my phone said I was in close contact with someone who later reported they were positive for COVID-19 on 03/29/2023.  On 04/04/23 I started not feeling well. I tested negative. 04/05/2023 I tested positive with a COVID-19 home test. I was feeling worse, my fever never went over 99.7. My normal range is 97 degrees. I did have a bit of a temperature. On Wednesday 04/05/2023 I had a telehealth with the Urgent Care. Based on my age and Crohn's Disease, the doctor prescribed Paxlovid.  On Wednesday I started using Nyquil to control my fever and body aches. On Wednesday and Thursday, I took only 1 capsule of Nyquil every 4 to 6 hours. I never exceeded what is more than 4.5 doses of the Nyquil in a day.  I took the Paxlovid for 5 days. By Friday I started to feel better. By Friday evening my temperature went down, and I did not have a fever. Other than the first night. I never really coughed that much. On 4/12/2023 I started testing negative.
Patient states she is having a shooting pain up her arm into her collar bone. He arm hurts when she tries to move it.
Arm soreness; Arm redness; Headaches; Hives cover her entire body; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th October 2020, 4 days after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced pain in arm, erythema of extremities and headache. The patient was treated with prednisone. On an unknown date, the outcome of the pain in arm, erythema of extremities and headache were unknown and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, headache and hives to be related to Shingrix.  Additional details were provided as follows: Less than 2 months after vaccination, the patient experienced arm Soreness and redness and headaches.  Hives covered her entire body and were stil present at the time of reporting. The patient had been to the emergency room, and had been treated with Prednisone twice. She was waiting for a call back from her dermatologist.  The reporter consented to follow up.
Swelling and redness right shoulder for 1 1/2 day. Had vaccines 3/12/07.
Pt started to comaplin of his throat was feeling "itchy", PO bandryl was given and was obsserved and assessed by nurses and paramedics.  he stated to feel better, declined to be taken to the ER
(L) arm redness, swelling, mildly tender at vaccine administration site, began evening of 8/19, continued through 8/22/11 - presented to pediatricians office 8/22/11.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Got a cold overnight/her cold was a runny nose and sneezing; This is a spontaneous report from a contactable consumer (patient). A 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in her left upper arm on 24Jan2021 15:30 at 0.3 mL, single for COVID-19 prophylaxis. Medical history was reported as none. There were no concomitant medications. The patient said that she got the vaccine at 15:30 yesterday on 24Jan2021. She was told not to take Tylenol. She said that she got a cold overnight on 24Jan2021 and her friend told her to take Tylenol and she did and she wanted to know if she was going to die. The patient clarified that her cold was a runny nose and sneezing. She stated that the cold pill helped. The patient said that the Tylenol helped her cold symptoms and it is not as bad as it was, it was over the counter Tylenol Cold Medication. The outcome of the events was recovering. Information on the lot/batch number has been requested.
a few days after his congestive heart failure got worse and continued on a down ward spiral. He refused to go to hospital and last few days hospice was brought in. He died not being able to breath. Autopsy was not done.
Induration and erythematous rash proximate to vaccine administration site. Treated for cellulitis.
Pt came in 8/17/07 with swollen left leg. No fever, mild tenderness at site. hx of previous culture +. MRSA wound. Presumed MRSA cellulitis at site of IPV injection.