chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX by a physician to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2009, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Patient received a dose of J&J vaccine and came in to get the Moderna booster.  Communication we received looked like those who got the J&J vaccine would receive the full 0.5ml dose of the Moderna booster so that is what this patient got.  We learned later that night that everyone who gets a Moderna booster should receive a 0.25ml dose with the exception of the immunocompromised.  Spoke to this patient to inform him that he got the full 0.5ml dose and he was feeling fine, just had a sore arm.
Upper lip swelling; Upper lip swelling and numbness; This is a spontaneous case received from a contactable other healthcare professional. A 44-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 21May2021 (age at vaccination 44-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included hypertension and supraventricular tachycardia. The patient was allergic to penicillin and sulfa drugs and the patient previously took amoxicillin and experienced allergy. Concomitant medications include CARVEDILOL, LISINOPRIL and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021, the patient experienced upper lip swelling and numbness. These events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of these events. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information was expected.
Hives, dizziness, abd pain/vomiting. - BENADRYL.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form at an unspecified frequency. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-Apr-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            Causality for event Vaccine exposure during pregnancy is not applicable. It was reported the she was am 23 weeks pregnant. As of 30 Dec 2020, she was 24 weeks pregnant.; Sender's Comments: Causality for event Vaccine exposure during pregnancy is not applicable.
Caller was Healthcare Business Professional. Caller reported AE for Patient.  Patient was administered improperly stored GARDASIL 9 on unknown, previous date: Improperly Stored / Administered Detail Summary is located within following space.  Caller; No additional AE reported; This spontaneous report has been received from other regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number 1780876 with expiration date in 11-SEP-2023 (formulation, strength, dose and route of administration were not reported).  The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was stored at a temperature of 35.0 Fahrenheit (°F) for the time frame of 18 minutes. No additional adverse events were reported.
started feeling soreness on his right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (started feeling soreness on his right arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INJECTION SITE PAIN (started feeling soreness on his right arm). At the time of the report, INJECTION SITE PAIN (started feeling soreness on his right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.
The patient came in today for a flu shot. The patient informed us that after he received the PNEUMOVAX vaccination in April, 2017 his left arm swelled up. He said it was warm and swollen for about a week and then improved. He shared no residual issues from the vaccination since it improved..
pt recv vax; fever x 3 days; inability to sleep; difficulty breathing; tx w/ Zithromax;
I had hives, rash and swelling on my finger, toes, eyelid, and ankle. It was all over. I had hair lost. I had asthma and wheezing. I had Joint pain and tightening pain in my sternum. I had swollen lymph nodes. I went to urgent care first. I was on vacation when we went to urgent care. When we went back home and I saw my PCP. She recommend allergist then saw a rheumatologist. I saw two endocrinologist and saw and ENT. They don't know what to do with me. They just prescribed Benadryl and prednisone. I am still experiencing the reaction.
Seizure 15-20 seconds of immunization administration, Pt confused, became oriented within 30 sec. 2nd seizure started 2 min after the first, lasting approx 30 sec.  Pt had decreased pulse, and b/p, skin color pale, pt expressed anxiety.  Ambulance called, vitals stable 20 min after 1st seizure. Pt calm and stable at time of transfer to ER at 3:35 pm. Ambulance arrived 1 hr after calling due to poor road conditions.  ER provider diagnosis was syncope.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out about 3 minutes after being given the shot. He was stiff at first but upon putting him on the floor  he relaxed and opened his eyes. 911 was called, patient refused treatment.
This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Allergies: Dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction: "Allergies: Benadryl allergy". The following information was reported: HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "recovering", described as "numbness in the legs"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovering", described as "numbness in the legs where they hurt"; PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "recovering", described as "started swelling". Additional information: After the first dose, the patient had numbness in the legs where they hurt and started swelling and patient had to keep moving throughout the day for several days to keep the circulation up. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101383394 same reporter, patient, suspect product, different event, and dose.
At around 40 hours post vaccination, developed severe abdominal pain and went to an emergency room for evaluation on 1/1/21.  Abdominal pain was eventually diagnosed as appendicitis requiring appendectomy on 1/2/21.   Emergency room visit and hospital discharged patient early on 1/2/21.  It was then determined that the on-call team covering mis-read the CT scan and acute appendicitis was found.  Patient then went to Medical Center on 1/2/21 for appendectomy and was discharged later that night following operation.
CHILLS; SEVERE HEADACHE; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 26-MAY-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced low grade fever. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99 F. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, low grade fever, severe headache and fatigue was not reported. This report was non-serious.
Moderna administered on day 21; correct interval allowed is day 28 with a 4 day grace period (day 24)  First dose was 6/9/2021, Second dose received on 6/30/2021
Initial report was received on 30 September 2013 from another manufacturer who received the report from a consumer. An unidentified male patient with no reported past medical history had received tetanus adsorbed toxoid (manufacturer, lot number, route, site and date of administration not reported and an unspecified amount of time later died. According to the report, the patient's sister reported that patient died after "12 doses of tetanus vaccine". No further information was available at the time of the report. The patient's outcome was fatal. Addendum 09 October 2013: Upon internal review of this case, the vaccine was amended from tetanus adsorbed toxoid to tetanus toxoid. Documents held by sender: none.
Patient was give Flublok vaccine (for 18 yrs and older).  He is 7 years old.
received the first dose of the Pfizer COVID vaccine on 28Dec2020 and tested positive for COVID 03Jan2021 (nasal swab) & symptomatic; received the first dose of the Pfizer COVID vaccine on 28Dec2020 and tested positive for COVID 03Jan2021 (nasal swab) & symptomatic; This is a spontaneous report from a contactable Nurse (patient). A female patient of unspecified age received BNT162B2 (Pfizer, lot number: EL0140) first dose on 28Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive for COVID 03Jan2021 (nasal swab) & symptomatic, her second dose of the vaccine is scheduled 18Jan2021. She was wondering if she still get the second dose. The outcome of the events was unknown.; Sender's Comments: The reported tested positive for COVID  (nasal swab) & symptomatic after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
adult received pediatric dose; adult received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 49-year-old female patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th July 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 5th July 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: A nurse reported that an adult patient received a pediatric dose of Engerix B. The reporter consented to follow up. Additional Supportive Information:  An adult patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
On 14-OCT-2016, the patient received M-M-RVAXPRO (rHA (recombinant human albumin)) (lot# reported as A69FE139A)). Reaction started 10 days after receiving vaccination (on 24-OCT-2016), the patient developed swollen wrists, ankles, knees and nerve pain down right arm (site of vaccination into right arm). General practitioner, who saw her prescribed naproxen and amitriptyline.  The symptoms subsided after one month. Stated was not taking any other medication at time of vaccination. As a result of reaction, second measles mumps and rubella vaccine not given.
Pt received DTaP 5/28/04 right thigh. 7/30/04: pt has red, swollen area around injection site and tender. Placed on Keflex 250 mg 1/2 tsp TID x 10 days. Cool compress to site.
A report was received from a health care professional on 05Jan03, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 02Jan04. On 02Jan04 the vaccinee, who was less than 4 years of age, inadvertently received Fluvirin. The vaccinee had not experienced any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP200400003.
No adverse effects reported; patient inadvertently received an expired dose of PROQUAD; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent.  On 19-JUL-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R001540 (verified to be a valid lot number), expiration date reported and established as 15-JUL-2019, for prophylaxis. No adverse effects were reported.
p/vax pt exp redness; swelling; and soreness at inj site; addl pt had a rash all over chest; no tx given; lymerix discontinued;
Extreme vertigo woke up in the middle of night dizzy and teeth chattering. No fever.
bone pain; feels dizzy; fever of 102; chills; A spontaneous report was received from a healthcare professional concerning a 40 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed feeling dizzy, fever of 102, chills and bone pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # 025J20-2A) on 30 Dec 2020 in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   Nurse called to report she had received the COVID-19 vaccine on 30 Dec 2020 in her left deltoid. She reported feeling dizzy, fever of 102, chills and bone pain 12 hours after receiving the vaccine. She reported taking ibuprofen and had no symptoms the next morning.   Treatment for the event included ibuprofen.   Action taken with mRNA-1273 in response to the events was not provided.   The event, feeling dizzy, fever of 102, chills and bone pain, was considered resolved on 31 Dec 2020.   The reporter did not provide an assessment of the event, feeling dizzy, fever of 102, chills and bone pain.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded. Fever and chills are consistent with the known safety profile of mRNA-1273.
Information has been received regarding a 21 year old female who received a booster dose of TD because of a scrape on her hand from a rusty fence. Three to four days, post vax, the pt began to experience loss of body weight and developed persistent nausea, early satiety, abdominal cramps and vomiting. She was hospitalized and treated with IV fluids. A dx of gastroparesis was made. She was initially treated with metoclopramide and erythromycin and later with cisapride. The pt experienced only mild improvement of her symptoms. Cisapride was replaced by domperidone. She has taken domperidone for 9 months of therapy and her symptoms have improved significantly and her body weight has stabilized.
We had a lady come get her second pneum. shot the 23 on Monday morning. She called Tuesday saying her arm swelled about 4 hours later and it was red and itched. When she called the swelling had stopped --These are all listed side effects of the vaccine I told to keep any eye on it and she can contact her provider--I followed up with her the next day Wednesday-she said the swelling had gone down and she was able to sleep on that side but it was not completely gone--she did attempt to call her doctor around 4 clock and not heard anything back. Today (Thursday) she was shopping and stopped by the pharmacy--her arm was still swollen and had red patches and she stated she had again reached out to the doctor and was waiting- I told her it may be allergic to vaccine and she have the doctor advise her what do next. Friday she came in again and talk to different pharmacist and stated arm was moving normally and red patches were not at site of injection. The pharmacist advise pt to take BENADRYL.
Strong PMS symptoms; Extremely heavy periods; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 08Mar2021 at 09:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression and rosemary allergy. The patient did not receive any medication within two weeks of vaccination. 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 an unknown date in Mar2021, the patient experienced strong Premenstrual  symptoms (PMS) for three for three days after each dose, and on top of regular PMS for the month and also, extremely heavy periods after each dose, had to change out pads every four hours instead of eight. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strong PMS symptoms was recovered on an unknown date in Mar2021. The clinical outcome of the event extremely heavy periods was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Beginning the month after the first injection, my menstrual cycle became extremely heavy, with a large volume of very big clots. I have never experienced this in 20 years of having a period. My cycle went from 4 days to 7, and I have to wear an adult diaper during these days now. I have had bloodwork and an ultrasound, which showed increased thickness in uterine lining. Now having to have a biopsy done. This has continued with every cycle following my first injection.
Severe swelling of left leg, where immunization was given. Painful, warm to the touch. Pt was hospitalized. Vaccine given 11/02, hospitalized 11/03.
Sharp/ stabbing chest pain after both doses. First time happened within 2 or 3 days after the first dose; symptom lasted (on and off) all day, and came back at reduced frequency the following days. Symptoms went away in around 10 days. Symptoms from the second dose was less frequent, but can still last for a few hours (on and off). Pain area could spread to the right side of chest and back.
high pitch scream & inconsolable crying for 3 1/2 hrs; t99.3; MD prescribed (Motrin);
This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of RECOMBIVAX HB injection, (lot # M033334; expiration date: 11-AUG-2018), (lot # reported as M034894; expiration date: 11-NOV-2018), (route of administration, strength and dose were not reported) for prophylaxis. The temperature excursion with RECOMBIVAX HB was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA010293: US-009507513-1612USA010294: US-009507513-1612USA010291: US-009507513-1612USA003446:
Within 3 hours of the shot, my son began having intermittent eye rolling which look like it was without control.  The eye rolling got worse over the next week.  We took him to a pediatric neurologist 10 days later who did an EEG.  At the time he had no sign of permanent damage, she suggested following up with a longer test if the symptoms continued.