chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date of Admission:  3/8/2022   Chief Complaint:  R hand pain   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 57y.o. male the past medical history of gout, hypertension who presents to ED endorsing right hand pain.  Patient was recently admitted for perforated diverticulitis s/p sigmoidectomy with ileostomy.  He states that towards the end of his previous admission he started to experience right hand pain but attributed to his long history of gout and thought not much of it.  After discharge his pain continued and he started develop blue discoloration of his right hand fourth and fifth digits prompting him to present to the ED.  He denies any fevers, chills, chest pain, shortness of breath, abdominal pain.   In the ED: BP 113/85, HR 109, RR 18, SPO2 100% on room air, T 96.6F.  Labs remarkable for sodium 128, potassium 5.5, magnesium 1.3, chloride 95, bicarbonate 19, WBC 10.8, Hgb 12.4, platelets 570.  Chest x-ray shows NAP.  Nasal swab positive for COVID.  ECG shows sinus tachycardia with HR 107; no acute ischemic changes.  X-ray right hand shows no radiographic evidence of acute process; chronic appearing erosions along the ulnar aspect of the carpal head.  Patient is admitted to internal medicine with consult to vascular surgery.
Adverse symptoms after 2nd dose: Muscular aches/pains, chills, slight nausea, fatigue, slight pain-injection site.
1/5/2022  pt arrives for covid testing.  She is vaccinated.  No known exposure.  Reports noticing a tickling sensation in her throat last yesterday.  Today, had a runny nose and post nasal drip.  Reports a dry cough.  No chest pain, soa or fever. Physical Exam Constitutional:      Appearance: Normal appearance.  HENT: Nose: Congestion present.     Mouth/Throat:     Pharynx: Oropharynx is clear.  Cardiovascular:  Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary: Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Neurological:  Mental Status: She is alert.
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: patient passed out. did not know were she was. went to her car. came back and was crying, she did not remember getting the shot.
Pt devel fever to 103.4, febrile seizure lasted 2 1/2 min, sl loose BM's x 3 days; Dx febrile seizure-?viral synd, enterovirus;
It was reported in a published article, title as stated above, that a 16 month old female who was vaccinated with a first dose of MMR II. Ten days following the receipt of her first dose of MMR II she developed an episode of thrombocytopenic purpura with generalized purpura and petechiae without a major bleeding event. Her platelet count was documented below 20,000/cu mm. She was treated with immune globulin with subsequent normalization of her platelet count. At ten years old the patient presented for immunization recommendations due to loss of immune protection to rubella and rubeola but not mumps. The patient's family was presented with four options and the associated benefit and risk each. Options included no intervention, immune globulin prophylaxis every six to twelve months, administered MMR II and follow platelet counts or administer on the necessary vaccines one at a time with more than month between dosing. The patient received the standard of care doses of rubella virus vaccine live (manufacturer unknown) followed by measles virus vaccine live (manufacturer unknown) with monitoring of platelet counts before and after each immunization. Both vaccines were tolerated with no laboratory or clinical evidence of platelet count reduction. Upon internal review, the patient's thrombocytopenic purpura was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Initial report received from a health care professional via an Institute (PEI2010002278) and forwarded by license partner. This patient was a pregnant. She received GRIPPE-IMPFSTOFF N HEXAL for immunization (batch no 096201B) on 09 Nov 2009. She had vaginal bleeding at 27 week and 2 days of pregnancy and was hospitalized on 31 Dec 2009. On 31 Dec 2009, intra-uterine death of foetus was established. The serology test showed rhesus positive. She received CYTOTEC for induction of labour and had spontaneous delivery on 05 Jan 2010. Contraceptives and CABASERIL for ablactation were given. An autopsy of the foetus would be done. It was reported that a certain causal connection between the influenza vaccination and the intrauterine foetal death could not be established. Follow up received from quality assurance department on 09 Feb 2010: Batch review was requested for concerned GRIPPE-IMPFSTOFF N HEXAL batch and product technical complaint (FTC) reference number was provided as 56575.
My shoulder started having a light burn and after the next six days it got worse and worse - my left shoulder. I got x-rays and started doing physical therapy. I took Tylenol for pain. Started improving - I'm probably about 40% better. I received the second dose on January 20th -  just had a slightly sore arm.
The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023; No adverse event; Dose administered after 30-day Use By Date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2023 and was forwarded to Moderna on 24-Feb-2023.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE 13V on 16-Jan-2023, PEDIARIX on 16-Jan-2023, ROTAVIRUS VACCINE on 16-Jan-2023, INFLUENZA on 16-Jan-2023 and INFLUENZA (second dose) on 13-Feb-2023. Past adverse reactions to the above products included No adverse event with INFLUENZA, INFLUENZA, PEDIARIX, PNEUMOCOCCAL VACCINE 13V and ROTAVIRUS VACCINE.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Jan-2023 and was administered on 13-Feb-2023).    Concomitant drugs were not reported. The patient did not reported any reactions. It was reported that the monovalent vial of unknown size was first thawed on 05-Jan-2023 and was expired on 04-Feb-2023. It was also reported that the vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712529 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712529:same reporter
Received flu shot 3 weeks ago (10/19/2011) injection site still sore; discolored area (light) surrounded by reddened area still present.
Initial report received from a consumer on 17 SEPTEMBER 2012. A 70-year-old female patient received FLUZONE HD intramuscularly in the right arm (batch number: U4496AA) on 12 SEPTEMBER 2012. Medical history included environmental allergies, many antibiotics, Diabetic, Hx triple by pass 2007, Lt breast lumpectomy 2011, Staph infection for 11 months 2011. Concomitant medications not reported. On 12 SEPTEMBER 2011, within short time after vaccination the patient developed sore throat, sinus and ear pain. Later that night the patient had 102 degree Celsius fever and cough. Treatment included Tylenol and saline solution. Lab investigations were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
From the ribs to the hips if it iss inside your body it hurts; Found sits in my liver and kidney; Found sits in my liver and kidney; This spontaneous case was reported by a consumer and describes the occurrence of PAIN, LIVER DISORDER, and RENAL DISORDER in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN, LIVER DISORDER, and RENAL DISORDER. At the time of the report, PAIN, LIVER DISORDER, and RENAL DISORDER outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.  The patient said that has kind of internal problems, that started overlapping with the Moderna vaccine, started in December, January, and then in the middle of the summer got significantly worst after the second dose of the vaccine. From the ribs to the hips if it was inside your body, it hurts. Found sits in liver and kidney and they do not know if it was going to a mayor disease or cancer. Patient had trouble with steroids in the past. This case concerns a 74-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious events of pain, liver disorder, and renal disorder following administration of the second dose of the Moderna COVID-19 Vaccine on 05Mar2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Further information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 019B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concomitant products included LORAZEPAM for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On 20-MAR-2021, Patient stated that she had less fatigue and things were getting better at the time of the report. Treatment details were not reported by the reporter. This case was linked to MOD-2021-086827.
A report was received from a health care professional on 11/14/03 concerning a 74 year old male vaccinee who received expired Fluvirin SC on 11/11/03. On 11/11/03, the vaccine received expired Fluvirin SC. The vaccinee had not experienced any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Uncontrollable pain in previous surgical sites and other sites of arthritis; not controlled with NSAIDs; muscle spasms x 5-6 days
Engerix-B vax given 23JUN92, 20 mins later broke out in rash, noted redness @ site of inject; DPH given;
illegal drugs were entered on 3 separate occasions by false pretense of novocain - the vials were heated , there were three separate injecetions for one tooth a red yellow and other vial that produced antihypertensive or psychotropic side effects. the victim does not take pharmaceuticals, alcohol drugs or anything else the conduct is covert illegal and violates religous rights. office contracts with us government medicare
RED ITCHY RASH AT INJECTION SIGHT -2-3 DAY AFTER SHOT. DIDN'T THINK ANYUTHING WRONG-MAYBE AN ALLERGY REACTION TO BANDAGE UNTIL IT BEGAN ITCHING. AGAIN, NOT WORRIED. THEN READ ARTICLE YESTERDAY (3/7/21) THAT IT WAS A REACTION TO THE MEDERMA VACCINE (WHICH I DIDN'T GET) I THOUGHT CDC SHOULD KNOW IT'S POSSIBLE MAYBE WITH PFIZER.
first thought it was a rash, and after he went to the Dr., she confirmed that what he had was actually the shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL1283), via an unspecified route of administration on 15Jan2021 17:00 (at 72-year-old) at single dose (Left Arm) for COVID-19 immunization.  Medical history included type 2 diabetes (he uses insulin for this), bladder cancer (he was a former bladder cancer patient). Concomitant medication included insulin for Type 2 diabetes. Patient had the first dose of the Pfizer BioNTech COVID-19 vaccine. A week later, he had developed a rash and it turned into shingles. It is currently clearing up and he is taking medications for it. He is due for his second shot of the vaccine on 05Feb2021 and was wondering if there are any recommendations for him not to take it. It was clarified that on 22Jan2021 a rash developed on his face which was found to be shingles. He saw a personal doctor, the doctor even put him on medication. All has gone well, once he started taking the medication the shingles didn't progress and dried up and is now in the late stage of drying up. He asked if he should be reporting this, he also would like to know if he should get the second covid vaccine. The Rash started on 22Jan2021 and was on the face, hair scalp region. He specified further that the rash was located in the upper right quadrant on his face, also being on the eye lid and hairline. He added that he actually had a second doctor check this as well, because the rash was on the eyelid. His Primary Care doctor had him see a ophthalmologist. Patient clarified that he first thought it was a rash, and after he went to the Dr., she confirmed that what he had was actually the shingles. Outcome described as still with a little bit of redness, but it is healing and it is dried up. Dr prescribed him Valtrex for the shingles. The patient underwent lab tests and procedures which included that he has had no positive covid tests. In Dec2020, he had the regular covid test and that was negative. In early Jan2021, he had the regular covid test as well as a covid-19 antibody test, and both were negative. Patient mentioned serology test, he then confirmed that he used the word serology inadvertently, and meant antibody. He has had no issues with vaccines in the past. The outcome of the event was recovering.
chest pain, dizziness, lightheaded, flushing, sweating headache and tingling
SIGNIFICANT REACTIONS; This spontaneous report received from a physician concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced significant reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of significant reactions was not reported. This report was non-serious.
Abd pain, hospitalized for bowel obstruct. Symptoms included nausea, vomiting, diarrhea.
The patient received a Shingrix vaccination in the morning of 9/6/20. The reaction started the evening of 9/6/20. The patient had irritation and pain at the injection site.  The patient applied at warm compress to the area. The pain continued through the night and the patient woke up with blisters at the injection site and pain in his arm.  The patient went to an urgent care and received antibiotics just in case he developed an infection.
Pfizer-biontech covid-19 vaccine eua 15 minutes after receiving shot my head became itchy. that resolved within 15 minutes. around 1430 that day i developed nausea and diarrhea, which lasted until 12/25/20 at  2130.
Pt indirectly exposed to MMR when she was squirted in the eye. Later that day pt presented w/"throat burning, eye burning & h/a". Additional information has been requested.
type 2 diabetes mellitus; herpes pain has disappeared; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the first dose on 28Dec2020 (lot number: EJ1686, Expiry Date: Mar2021) at single dose in Left arm, via an unspecified route of administration at the second dose on  19Jan2021 (Lot Number: EL3249, Expiry Date: Mar2021) at single dose for prevent infection from Coronavirus. Medical history included ongoing essential hypertension and allergy, patient had genital herpes virus since age 26 and ongoing. Ongoing concomitant medications included chlortalidone from Oct2020 at 25mg daily for essential hypertension, montelukast sodium (SINGULAIR) from Oct2020 at 10mg at bedtime for Allergy and took vitamins, immunity booster and natural remedies. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient experienced herpes pain has disappeared in Jan2021 and was reported to serious due to Medically significant. The reporter considered the event herpes pain has disappeared was related to BNT162B2. Caller was reporting a positive effect with Covid-19 vaccine. She had had genital herpes virus since age 26. She had always had pain and flares. 4-5 days after receiving the first dose the pain has disappeared. She received the second dose on Tuesday 19Jan2021. She had no pain. She felt normal. She didn't get medical attention for this. She used an immunity booster and natural remedies. Caller was working at a clinic administering the vaccine to residents to a long term care facility. After the residents were vaccinated she was offered the vaccine since she is also a nurse. She went to a drive thru clinic for the second dose. The patient reported she had type 2 diabetes mellitus from 19Jan2021 (also reported it was medical history from 19Jan2021). The patient had no relevant tests. The outcome of the event herpes pain has disappeared was not recovered, the outcome of the type 2 diabetes mellitus was unknown.; Sender's Comments: The event type 2 diabetes mellitus was most likely an underlying condition and unrelated to suspect vaccine BNT162B2. 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.
patient received an expired dose (2022-July-4) of the Engerix-B vaccine on 2022-July-15) inadvertently; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HBV (Engerix B) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 15th July 2022, the patient received Engerix B. On 15th July 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-AUG-2022 Reporter's comment: The Healthcare Professional (HCP) reported that a patient had received an expired dose of 4th July 2022 of the Engerix-B vaccine on 15th July 2022 inadvertently. The reporter consented to follow-up.  Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used. The case was linked with case US2022AMR114215, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR114215:Same reporter
Patient said 5 days after the vaccine she started getting rash around the area where she had tinglings before the vaccine and it started spreading a bit to mid spine today.  She had to hard time to contact her primary and so reported to us.  She said she would find a way to get to urgent care or online md to get the rashes taken care of.
Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not had COVID-19 preceding month of vaccination. Patient had no known allergies of medicines and food.  Concurrent medical conditions included Hyperlipidemia. Concomitant products included ASA, VALACYCLOVIR [VALACICLOVIR] and ATORVASTATIN for an unknown indication.    On 06-Apr-2022 at 3:07 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions. No Treatment information was reported.