chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a lawyer and described the occurrence of autism in a 30 month old male pt who had discontinued DTP/DTaP vaccine and hep B vaccine. The case was received as a result of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received DTP/DTaP immunizations on 12/6/95, 2/16/95, 5/1/96 and 2/25/97. The pt received hep B immunizations on 10/6/95, 12/6/95, and 5/1/96. The pt received HIB immunizations on 12/6/95, 2/16/95, 5/1/96 and 2/25/97. According to the legal complaint, approximately 23 months after receiving the most recent hep b vaccination, and approximately 14 months after receiving the most recent DTP/DTaP and HIB vaccinations, the pt experienced "severe neurodevelopmental injuries" characterized as "autism injury," the multiple symptoms of which "were first manifest by approximately April 1998." The attorney alleged that the neurodevelopmental injuries were caused by his "exposure to excessive doses of ethyl mercury" that was an ingredient of the thimerisol component of the suspect vaccines. The attorney alleged that as a result of his injuries, the pt had incurred and will continue to incur medical expenses, had suffered "significant impairment in his ability to enjoy live," faced "significant obstacles to performing the tasks and activities of everyday living," and suffered "ongoing physical and mental distress." The events were unresolved at the time of reporting.
pt denied any allergies to chicken, eggs, feather, noemycin or mercury; denied any prev reac to flu vax; denied any recent illness; Fluvirin givne & pt had immed local react-swelling @ inject site-no other complaint;
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with RECOMBIVAX HB (route, dose, Lot# and expiration date not reported), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt showed up to ER 2/27/09 after receiving shot at Hospital with fever 39 + C + Febrile seizure.  HIB in FB #3 & PCV#3.
I had discomfort in my abdominal area, I noted it to my gynecologist. He ordered an ultrasound and discovered a mass and referred me to an oncologist. My appointment with the oncologist lead to an MRI in February to confirm the mass in my abdominal area. I have a follow up visit on April 25, 2023, for the oncologist to evaluate if the mass has grown. The doctors are trying to determine if the mass is just fibroid tumor that may have stopped growing in size since they have had me stopped using the Estradiol patch.
December 1, 2021 Vaccine vile moved from Freezer to Fridge. January 6, 2022 Vaccine administered.
At 11:55am pt reported left arm swelling and 25mg of oral diphenhydramine was given to patient (30 minutes after injection). Patient was monitored by staff from thereafter.  At 11:52am a second dose of 25mg diphenhydramine was given to patient due to possibly lip swelling reported by nurse. Patient denied shortness of breath or chest pain.  By 12:12pm marked lip and face swelling reported by nurse monitoring patient. Again patient denied shortness of breath/wheeze/chest pain. However, we advised patient that lip/face swelling is considered anaphylaxis and because symptoms were  progressing and not mitigated by diphenhydramine epinephrine would be advised. Epinephrine 0.3mg via auto injector pen was administered to patient on left outer thigh and 911 was called.  EMS arrived at 12:22pm and took patient to  local emergency department.
Dermography, shortness of breath, itching, continuous cough, herpetic lesions in the sacral area of back.  These increased and progressed over a 12 month period.  Treated with Advair, Accolate, loratadine, albuterol, Pepcid.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event.  No treatment medications were provided.
Patient called the pharmacy on 4/14/2021 to report a throbbing in her left shoulder which radiates down to her elbow. This is the arm she received the vaccine in. The throbbing began on 4/9/2021 after receiving the vaccine on 4/7/2021. The pain has not resolved as of 4/14/2021. We advised her to consult her primary care physician.
the child was given FluLaval and not Fluzone Quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered with vaccine INFLUENZA VACCINE INACT SPLIT VIRION 3V [FLULAVAL] instead of QUADRIVALENT INFLUENZA VACCINE[FLUZONE QUADRIVALENT]   On an unknown date, the patient received a 0.5 ml dose of suspect VACCINE INACT SPLIT VIRION 3V [FLULAVAL] lot unknown, expiration date: unknown, via unknown route of administration.  It was a case of actual medication error due to Wrong vaccine administered.  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.  Information on the batch number was requested.
Minor surgery on foot that caused blood clot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of POSTOPERATIVE THROMBOSIS (Minor surgery on foot that caused blood clot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 18-Mar-2021, the patient experienced POSTOPERATIVE THROMBOSIS (Minor surgery on foot that caused blood clot) (seriousness criterion medically significant). At the time of the report, POSTOPERATIVE THROMBOSIS (Minor surgery on foot that caused blood clot) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication  were not provided. Treatment medications included blood thinner, rivaroxaban for blood clot.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt called EMS for "impending doom" on 7/5/2021. Upon arrival EMS found oxygen saturations 80%, patient just states he feels like he is dying.  Seen in ED and admitted for pneumonia due to COVID-19. Previously tested (+) for COVID-19 on 12/22/2020 prior to hospital admission for SI, with left proximal humeral fracture complicated by H. pylori PUD. Tested (-) on 12/7/2020 in ED when evaluated initially for pain due to humeral fracture from fall on 12/3/2020. Tested (-) for COVID on 12/12/2020 prior to EGD.
Hot flashes and fevers alternating with cold and shivers and low temperatures.  Progressed on 9/20/12 to sore throat, fatigue, muscle aches.  Progresed on 9/21/12 to head and chest congestion, severe cough, rattling in chest. 9/26/12 Continued symptoms with worsening breathing issues, chest rattle, cough, fluctuating temperatures, etc.  Progressed to low oxygen sats (92%) severe bronchitis, etc. on 9/29/12.
Patient still have trouble moving her arm and she still have pain after 3 weeks after the injection.
Subject BIT010006, a 19 year old male with no known previous medical conditions, received the 2nd dose of Anthrax vaccine (Lot FAV044) on 01/11/2000. Other vaccines given on this date included, yellow fever, typhoid, influenza, and hep A. The pt was taking no concomitant medications at the time of the event. No previous reactions to the Anthrax vaccine are known. In March 2000, the pt experienced the first of seven episodes which lasted less than one minute and occurred over an eleven month period. The first episode began with heat exhaustion during a road march in late February or early March 2000. The second episode occurred in April 2000 during a 12-mile road march. The last syncopal episode occurred in June 2001. The pt had evaluations by cardiology, pulmonary, endocrine, and psychology specialists and no etiology has been identified. Treatment for this event and the outcome are unknown at this time.
Redness; Itchiness on arm; body aches; Headache; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events body aches, redness, itchiness on arm, headache.  The patient's medical history was not provided. Concomitant medications reported were Aleve, Aspirin for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) body aches, redness, itchiness on arm, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), body aches, redness, itchiness on arm, headache was unknown.
Information has been received from a physician concerning an 86 year old white female with hypertension, anxiety, on anticoagulant therapy, on diuretic, and on potassium supplement who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 654977/0888F) IM. Concomitant therapy included lisinopril (MSD), LASIX, K-DUR, warfarin, AMIODARONA, ATIVAN and therapy unspecified for hypertension. On 01-NOV-2007, the patient experienced pain, redness, and swelling at the injection site and returned to the physician. On an unspecified date, the patient recovered. No further information is available.
long haul covid for 2 years; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (long haul covid for 2 years) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (long haul covid for 2 years). At the time of the report, COVID-19 (long haul covid for 2 years) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Reporter stated that one lady got covid after vaccine and had long haul COVID for 2 years. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Redness and swelling just above injection sight on L arm.  Instructed patient to take Benadryl and ice sight.
Diarrhea, bloating, fever, chills, muscle aches, head-ache, fatigue.  48 hours total: Felt ill first 24 hour and felt really bad the last 24 hours.  Took Advil and Immodium then slept for 15 hours.
Dose administered after 30-day Use By Date; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was initially stored in the refrigerator on 31-May-2023.  Vial was individual vial with multi dose 0.5 ML.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 9th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master Case
no adverse event. Patient is under the age that is approved for the vaccine. He is 15.
Flu-like symptoms began at 10 PM the same day as the vaccine. Symptoms started as chills, then moved into feverishness and headache, some body aches. Treatment was high doses of pain reliever. There was no nausea or digestive issue detected. 24 hours later all symptoms had subsided and I resumed a normal workday the Thursday after the Tuesday vaccination.
I have not seen the patient all info via phone. Patient described pain and swelling at injection site in Left Deltoid, stated that 1.5 days after injection a rash appeared a few inches below injection site. I tried to clarify if rash or redness, she was unsure. Stated that it is about 2 x3 inch area or rash/redness and warm to touch.  Now the swelling is gone but the redness/rash persists.  Patient weighs 140 lbs and a 25g 1 inch needle was used. Patient has call in to her MD.
Burning in arms; Constant pain in arms; Believes pain in neurological; Burning pain in legs; About 2 days after vaccine I experienced increasing pain in legs; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GR8737) via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus and anemia. The patient had no known allergies. Concomitant medications included insulin human, insulin human injection, isophane (NOVOLIN 70/30 INSULIN) from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, about 2 days after vaccine, the patient experienced increasing pain in legs. On 10Apr2021 had burning pain in legs and on 14Apr2021 has constant pain and burning in arms. The patient visited the doctor and doctor believed pain was neurological. The patient had type 1 diabetes and had never experienced any neuropathy pain before. Therapeutic measures were taken as a result of events and included treatment with TYLENOL. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events increasing pain in legs, burning pain in legs, constant pain burning in arms and pain was neurological was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
01/18/08 Received the Zoster vaccine. 01/24/08 Painful bump appeared on my left arm, felt light-headed, general malaise. 01/25/08 All muscles and joints sore (as if hit by a Mack truck), 100.6 F, slept all day, sweating a lot. 01/26/08 Still very sore, 100.6 F, slept all day, sweating a lot, took in 2 liters UN electrolyte solution, 5-6 mugs detox tea. 01/27/08 Hardly sore, 100.6 F, slept all day, less sweating. 01/28/08 Soreness gone, 97.6 F, felt quite weak and lightheaded. 01/29/08 Felt weak and lightheaded, showered under supervision, mostly still in bed, developed a cough, sputum clear. 02/11/08 Coughing continuing, sputum clear, intestinal cramping after lunch and evening meal, yellow "baby" stools. 02/14/08 Continued afternoon and evening cramping, bowels more normal, burning on urination with chills. 02/17/08 Burning, itching mini-blisters on L lateral malleolus, continued afternoon and evening cramping. 02/23/08 Noticed miniature scabs on lateral upper thighs, removal of scabs showed chicken pox-like "craters". 02/24/08 Still have low energy and occasional lightheadedness.
female patient received ADACEL instead of DAPTACEL/ NO AE; four year patient received ADACEL vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00459383).  This case involves a 4-years-old female patient who received 0.5 mL DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (frequency: once, batch number: C5609AA, expiry date: 04-Apr-2021 via an intramuscular route in right thigh) who was intended for scheduled fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong vaccine administered and product administered to patient of inappropriate age) on 03-Feb-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  No adverse effects reported.   Staff reports that physician requesting information who was at a different clinic on that and requested for contact. Discussed use in children less than 10 years-old.  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. 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.  There will be no information available on the DAPTACEL batch number for this case.
After first dose I started throwing up randomly and bad pain upper abdominal inflammation . I now have been told by a surgeon I need my gallbladder removed asap.
Forgot to reconstitute the vaccine; Administered just the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number P2275, expiry date 25th September 2021) for prophylaxis.   On 15th May 2020, the patient received Shingrix. On 15th May 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The Pharmacist reported that she accidentally administered just the adjuvant for Shingrix, forgot to reconstitute the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked with US2020083390, reported by same reporter.
After 15 minute wait period, left vaccination site. Reports felt "like I couldn't breathe and nauseated but I went home". Started feeling "burning on left side of head and neck".  He called the prescribing doctor and was referred to emergency room by prescribing doctor.