chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 02:00 for prophylactic vaccination. Concomitant medications included ibrutinib for cancer.  On 09-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Patient had Johnson & Johnson vaccine approximately on April 7.  She did not report any symptoms until after the vaccine was pulled on Saturday the 10th.  On April 14 she called the clinic saying that he been having frequent headaches since learning the vaccine has been pulled.  No shortness of breath, no rash, no fever. She had been treating her headaches with over-the-counter meds and the headaches would resolve though would return.  She says she has been worrying about having been vaccinated and it is preying on her mind  Patient smokes
got Covid and had been very symptomatic; got Covid and had been very symptomatic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: MMR vaccine (non responder to the MMR vaccine and Hep B vaccine series, mostly meaning immune for a short time), reaction(s): "non responder"; Hep B vaccine (non responder to the MMR vaccine and Hep B vaccine series, mostly meaning immune for a short time), reaction(s): "non responder". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid and had been very symptomatic". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 24 hours of shot, shot site had a red bump. Redness spread within 48 hours. The red area was hard and warm to the touch. Redness was about 2 inches in radius going down from the shot site. Redness started to fade and is continuing to fade around 72 hour mark. Swelling/hardness is also decreasing.
Feeling of stuffiness in left frontal lobe of brain.  Dull ache no headache.
Today, 06/30/2022 at approximately 10:30 AM, the patient was administered 0.3 mL of the Janssen vaccine. The patient should have received 0.3 mL of the Pfizer vaccine. The doctor called the patient personally to inform her of the mistake that was made by the medical assistant who administered the vaccine. The patient was informed that she received the Janssen vaccination rather than the Pfizer vaccine and she indicated understanding. She did not have any adverse side effects to the vaccination and she is feeling well.
3rd dose: Swollen underarm started about 24 hours after vaccine given, worsened at 48 hours,  and still lasting on 9/27 (likely swollen lympth nodes; Ibuprofen does help the pain)--Unsure how long this will last. Noticed fever at about 24 hours after vaccine given and lasted <24 hours after 3rd shot (booster given ~7 months after 2nd dose). No Nausea.
fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL at a dose of 1 dosage form. On 19-Apr-2021, PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL at a dose of 1 dosage form. On 19-Apr-2021, PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided.
Patient began to experience minor pain in upper left leg in mid-April; patient noticed extreme swelling and discoloration in left leg evening of 05/01/2021; Admitted to ER morning of 05/02/2021. Diagnosis: Acute deep vein thrombosis (DVT) of left lower extremity; no family history of blood clots and no falls reported by patient.  DVT resolved after 24 hours of catheter directed thrombolysis. Residual nonflow limiting disease still present in the below-knee deep veins and popliteal vein with good collateralization of the deep venous system. Minimal residual disease still present in the femoral vein without flow limitation.
Child seen by PNP for 4 year old well visit and given DTaP in left arm. Parent returned to office about 10 minutes after shot given crying due to pain at site. Hives, erythema in 3" diameter circle surrounding injection site. Site tender, no swelling and slight erythema about 1/2" at IPV site. Benign flu site. Ice applied. Advil given. Parent informed to give Benadryl if erythema increased.
Pt developed a hard knot at injection site that was warm to the touch. It was slightly red.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT OF LEFT FEMORAL VEIN ACUTE DVT OF LEFT POPLITEAL VEIN
Patient had a rash approximately the size of 1/2 dollar that was red and warm to the touch on Friday after vaccine given on Tuesday. Patient had taken Aleve previous day. I called Dr. and they suggested she come by and they would check it out.
Information has been received concerning a pt who on 04/11/00 was vaccinated with varicella vaccine. On 07/13/00, the pt experienced over 100 lesions, mostly on his trunk, a few on scalp, face and neck and a fever of 103 F. The pt was taken to the ER. It was noted that all but a single lesion are scabbed over. One lesion on a toe was vesicular, but appeared not clear but more pustular. There was nothing associated with the lesions. A sample was taken and it was positive for wild type varicella zoster virus. Follow up information from a NP indicated that the pt was fully recovered and was fine 3 weeks after breakthrough varicella.
Sharp, shooting pain down front of right shoulder. Arm movement very limited. OTC pain meds & heating pad.
LUPUS; This spontaneous report received from a patient concerned a 69 year old white of unspecified sex and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient never had arthritis or lupus. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had increased joint pain which got severe. They sent patient to neurologist and did Laboratory test MRI brain (NR: not provided) unknown and MRI (NR: not provided) diagnosed with lupus. When patient asked them could it be from vaccine. They said that they couldn't rule it out or say for sure. Patient was walking with a cane now. Patient used to run. Patient's ANA (Antinuclear antibody test) Laboratory test (NR: not provided) high (5120). Since APR-2021, the patient had increased difficulty to move joints and difficulty balancing. Patient had multiple evaluations from primary physician, cardiologist who ruled out heart and neurologist. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, Electromyography (EMG) (NR: not provided) abnormal (EMG with neuropathy that looked like autoimmune). On 18-OCT-2021, Laboratory data included: EMG (NR: not provided) unknown. The patient visited to physician office. The action taken with covid-19 vaccine was not applicable. The outcome of lupus was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211036658--COVID-19 VACCINE - lupus. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Has been itching like crazy/rash/ super itchy at night; This contactable physician reported similar events for two patients. This is the 2nd of two reports (guy he works with).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), via an unspecified route of administration and date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The physician also stated that the patient which the reporter worked with had something similar event experienced (AER 2021008113). It was elaborated that the patient had rash and it was super itchy at night noted on an unknown date.  The patient received the same lot number and has been itching like crazy. They have both been trying to figure out what to do. It was clear as mud. Then, last week (Jan2021) they saw each other, and they were both having the same issue and suffering separately. They had no exposure to anything similar besides the vaccine. The patient did a steroid pack, which his itchiness went away and got better while he was on it. When he stopped it, the itchiness came back. It reminds him when he got poison ivy in medical school. It was the same scenario. It holds off on steroids, then comes back after you are no longer taking them. He said that the antihistamine he took, and the steroid cream did not help. He took brand new loratadine (CLARITIN) which was same for the cream. He used multiple tubes of cream and applied it twice a day. It says you could use it up to 6 times a day, which he was working so would use twice a day. If he was not working, he would apply it more. The outcome the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021008113 same reporter/drug, similar events, different patient
Day after 3rd booster Started to hear ringing in my right year that continue to progressively get louder and louder to the point where I couldn?t hear. It?s slowly started to lessen but never went away fully.  Became worse with Covid infection on 2/17/22.  Treatment to see primary care to before no wax build up or inflammation.  Referral to audiology, who referred me to ENT specialist and for MRI.
Information has been received from a female consumer of unknown age referring to herself. Information about patient's concurrent conditions and medical history was not reported. "Recently", in 2015 the patient was vaccinated with a dose of M-M-R II subcutaneous injection (lot#/expiration date not reported, 1 shot). Concomitant medications were not provided. On an unknown date in 2015 a blood test was performed and the result showed somewhat low titers for the rubella. No treatment was given for the event. Outcome of the event was unknown. The causality was not provided. Additional information is not expected because there was no reporter's contact information.
Outbreak of shingles 10/8/12 left axilla, approximately cluster ten blisters, physician visit 10/9/12,, rx valcyclovir HCL 1 gram 1 tab BID x 5 days - still fading.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
expired Daptacel was administered to a patient; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age male patient who was vaccinated with expired vaccine 0.5ml dose of  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5190AA, expiry date: 24-Apr-2019) via intramuscular route in the left thigh, on 06-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MMR vaccine.   It was an actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 25U/0.5 ml injection (lot # K005323, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
PT GOT VACCINE AT AGE 16 WHEN APPROVED FOR 18 AND UP
Patient said her throat felt funny.  Long history of allergies.  Primary MD told her not to get the vaccine.  No stridor or wheezing noted.  No shortness of breath. Initial BP 176/81, HR 83, O2 sat 98%, resp 18.  Follow up vitals  7 min later - 143/89, HR 77, O2 sat 99%, resp 17.  Vitals 20 min later - 135/78, HR 69, resp 15, O2 sat 99%.  No difficulty with swallowing and no signs of respiratory distress.  Left at 1335.
I have a history of retinal detachment. I had one in each eye. I had surgery in August. I started having vision problems in left eye ad had partial loss of vision. I went back to see my surgeon. He diagnosed several holes in the retina. The holes let the fluid seep behind the retina and cause another detachment. It got progressively worse over the next few days. I had a follow-up appointment 10 days later. He determined I had to have another surgery to fix the problem. I had the surgery on November 30, 2022.
Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue, Chills Narrative:  Had symptoms for 2 days
A week after the 2nd dose I began to experience stomach aches & nausea after every time I eat food. I have also experienced general malaise.  It has been a little over a month & I am still getting intense stomach aches and nausea whenever I eat. About 2 weeks I ago I also developed hemorrhoids. I have never in my life had this before, & until I had this 2nd dose, I have almost never got sick. I can barely eat more than once a day and have lost weight.  I wish I knew if or when this would go away. My biggest regret is getting the 2nd shot. I wish I only got the first one or none of them. How long is this going to last?
6/3-6/4: Patient complained of sore legs and felt sick. 6/5-6/6: Patient legs felt better but new complaint of localized swelling, "hotness", and "redness" at site of injection (left deltoid) with itching and light pain. 6/7: Patient went to see MD and was prescribed levocetirizine and prednisone. When inquired, per husband, pt feels a little better. Pharmacist suggested could ice along with medications prescribed.
"Received COVID vaccination (#1) on 12/28/2020 at 1320 to L arm. Developed tenderness to injection site that day along with a headache which resolved with Ibuprofen. On 12/29/2020, I noticed increased discomfort to injection site and upon arriving home (approximately 1630) noted new erythema, warmth, swelling, and firmness to touch. Developed chills, body aches, and fatigue on 12/29/2020 in the evening which resolved by 12/30/2020. Erythema, warmth, tenderness, firmness, and swelling continue to present at injection site."
Pt reports fever of 101 the day after vaccination. Pt advised to Proceed to PCP for evaluation
Patient vaccinated with preservative free H1N1 formulation intended for ages 36 months and older.
began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week -  diagnosed with diabetes on March 1
Low grade fever (100), sore muscles, rash all over body. Flu like symptoms.
Heart palpitations, chest pain/pinching/burning. Insomnia, muscle flinching, high blood pressure/heart rate.
Had both shots in Oct/2022, still got shingles/Suspected vaccination failure; Got shingles after immune system tanked; Had both shots in Oct/2022; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included immune system disorder (immune system tanked). Concomitant products included rituximab (Rituxan Infusion).   In OCT-2022, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In OCT-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Had both shots in Oct/2022). On an unknown date, the patient experienced vaccination failure (Verbatim: Had both shots in Oct/2022, still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles after immune system tanked). The outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.    It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient took both Shingrix shots in October 2022.  The patient still got shingles after his/her immune system tanked due to Rituxan infusion.  The patient's PCP (primary care physician) said it would had been worse if he/she had not had the Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The follow up would not possible as no contact details were available.
Approximately 33 hours after the vaccines were administered he had an all over body rash, hives and swelling of the face and ears. Seen in the ER and given BENADRYL. Still having swelling of the ears. Advised to follow up today with Primary Care Provider.