chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have a semi normal period but the next month it was delayed and extremely light; have a semi normal period but the next month it was delayed and extremely light; feel more bloated than normal; feel more bloated than normal; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Knwon allergy: Penicillin" (unspecified if ongoing); "bloated" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibp, reaction(s): "Allergy: IBP". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Have to find photo of card), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced card but it's in my home), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose"; MENSTRUATION DELAYED (non-serious), HYPOMENORRHOEA (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "have a semi normal period but the next month it was delayed and extremely light"; ABDOMINAL DISTENSION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "feel more bloated than normal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient took multiple pregnancy tests due to  delay.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Guest started hyperventilating after shot, complained of loss of motor function and felt the pain of being paralyzed. And also had hypoxia.
This spontaneous report was received from a back office lead and refers to a 52 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
1/2 hr p/vax felt hot, & palpitations-fainted in office; sequelas of nausea & stomach cramping;
It started with a sore throat, fatigue, deep dry cough, headache, low grade fever. I took an at home test and tested positive for COVID-19. The symptoms started to get worse. I went to the doctor and he prescribed me medicine for the cough. I still have a periodic cough.
given the ActHIB portion of the Pentacel, however sterile water was given instead of the provided diluent/No AE; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a four months old male patient who was vaccinated with a second dose of 0.5 mL of suspect vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5592A, expiry date: 15-nov-2019 via intramuscular route in unknown administration site on 28-May-2019, where only the ACTHIB part was administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included Rotavirus vaccine and Prevnar 13.  It was an actual medication error due to product preparation issue. It was reported that the patient was vaccinated with ActHIB portion of the Pentacel, where sterile water used instead of the provided diluent. The nurse did not give the DTAP or Ipol portion of the Pentacel injection.  It was reported that the patient had no adverse event.  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.  List of documents held by sender: none.
Information has been received from a healthcare worker concerning a 12 month old female patient who on 01-MAY-2009 was vaccinated with the first dose of VARIVAX (lot # 663819/0336Y). After vaccination on the same day the patient experienced injection site reaction with swelling and redness. The patient was diagnosed with "severe cellulitis and was treated". The patient had sought medical attention via office visit and recovered now. This is one of several reports received from the same source. Additional information has been requested.
Swelling, pain, redness at injection site. Chills, fever, pain, lethargy.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was (unlisted). Guardian,   consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is (unlisted) which made the vaccine a contraindication.  No known adverse reactions noted.
The first 5 mins felt dizzy like small fainting I started relaxed. I went home took shower I had a mild fever took Tylenol. The next day some headache and weakness. On day 2 mildness and weakness again. Then on day 3 fever and weakness was almost gone and headache is sill there.
After about 1 day she stated complaining of bad headaches (she has very rarely ever had a headache).  She continued to complain of terrible headaches for a few days, and then began having fevers and chills that got worse by the day.  One week later - by 11/11/2021 she was spiking fever up to 103 degrees.  On Saturday 11/13/2021 this happens again and on Sunday 11/14 we took her to Urgent Care. They had trouble reducing her fever and sent us to the ER where she was tested for everything (see below).
04/17/2022 I woke up and my fingers were numb and tingling. I noticed my toes were the same way, but not as bad as my fingers. I was also nauseated. I was very tired, lethargic and fatigued. I am still fatigued and  I am always tired.  My fingers and toes are still numb and tingling. I went to see Doctor and she took me off all my medications and did bloodwork.  She is still working with me.
This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history, drug reaction or allergies and concomitant medications were not reported. On unknown dates in June 2017, (reported as within last month), the patients were vaccinated with PNEUMOVAX23 (dosing details, route, lot/batch# were unknown) for prophylaxis.  On unknown dates in 2017, the patients experienced redness and soreness that extended beyond the injection site which lasted for a couple of days. The events had usually resolved after a couple of days (unknown date in 2017). Causality assessment was not provided by the reporter. No product quality complaint was involved. Follow up information was received from the pharmacist on 30-AUG-2017. This report refers to a female patient. The patient was vaccinated with PNEUMOVAX23 with lot# N003997. Other suspect therapies included PREVENAR 13 administered on an unknown date, prior to vaccination with PNEUMOVAX23. On an unknown date in approximately June 2017, the patient experienced severe injection site reaction within hours of receiving vaccination. The patient experienced redness and swelling which extended to elbow of involved arm. Complete recovery occurred within 48 hours. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA012158.
pt recv vax & w/in 1 wk-10 days pt exp onset of fever, rash & severe arthritis sx; pt was seen by MD & is still under care of arthritis sx;
Information has been received from a registered nurse concerning a 64 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experience redness, swelling and discomfort in arm that she received the immunization with pneumococcal 23v polysaccharide vaccine. The patient's status was not reported. There was no product quality complaint involved. No further information is available.
Case completed primary Covid vaccine in February 2021, then was hospitalized for Covid in October 2021. Pneumonia due to COVID-19 virus Assessment & Plan Noted on CT scan, but no further symptoms at home on admission. Tested positive on 10/1 and finished treatment. On room air and off isolation on 10/12.
headache after first booster dose that resolved in a day; fever after first booster dose that resolved in a day; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after first booster dose that resolved in a day) and PYREXIA (fever after first booster dose that resolved in a day) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had a positive SARS-CoV 2 antibody test after his second dose in the primary series of the Moderna Covid-19 vaccine.).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced HEADACHE (headache after first booster dose that resolved in a day) and PYREXIA (fever after first booster dose that resolved in a day). At the time of the report, HEADACHE (headache after first booster dose that resolved in a day) and PYREXIA (fever after first booster dose that resolved in a day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative.         No concomitant medications were reported. Patient had a headache and a fever that resolved in a day. No treatment medications were reported.   This case was linked to MOD-2021-040897, MOD-2022-563509 (Patient Link).
Patient states initially the left deltoid was only tender following administration on Tuesday 4/12/22. Starting overnight on Sunday 4/17/22, patient was awoken out of her sleep with severe pain under her left armpit, radiating over her left breast. She notified her physician, who asked her to schedule an appointment for a Sonogram with Imaging on Wednesday 4/20/22.
pt recvd vax;on 2oct94 adm to hosp w/ a spinal epidural hematoma;pt recovered w/out residua;neurosurgeon states the cause of hematoma is unk;however,does not feel it is related to flu vax;pt will be followed w/ MRI exams;
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses (Oka-Merck) PROQUAD (lot#K003817 expiration date: 14-SEP-2015) (dose not reported) that were exposed to temperatures outside of ranges on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Received TC from patient's grandmother today. She stated that about 6 weeks after pt received her J&J shot she started having trouble hearing out of her left ear. On memorial day her grandmother took her to a walk in clinic and they "washed" her ear out and retrieved a small amount of ear wax. She continued to have trouble and her hearing continued to deteriorate. She was then Taken to center where they did a hearing test per grandmother report and were able to determine that pt had a "dead left ear". She also underwent an MRI and a brain scan to rule out a brain tumor. Pt's grandmother was prompted by Medicaid to call to report that she had been given vaccine and then had this reaction.
This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 41-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in left arm on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot: ER8727)via an unspecified route of administration on 18Mar2021 at 12:00 PM in left arm for COVID-19 Immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient was not covid tested post vaccination. Patient received vaccine facility in Public Health Clinic/Veterans Administration facility. The patient reported that she had heart pain daily, felt like I have heart attacks, I have shortness of breath, my chest feels tight, get paralyzed in the moment and it's hard to breath, I have a hard time moving my left arm to my right side. The events Heart pain daily, myocardial reinfarction, paralyzed assessed as serious (Medically Significant) and while other event was non-serious. Patient had no insurance. Patient has not visited the doctor. No treatment was received for the events. The outcome of the events was reported as not recovered.
2 hours after receiving vaccine she became very cold, shakiness, tired, chills, tingling, extremely thirsty, also felt like her tongue swelled up. Went to emergency. Everything was ok.
A report was received from a health care professional on 12/12/03 concerning a 52 year old female vaccinee who inadvertently received 1ml of Fluvirin on the same day. On 12/12/03, a vaccinee inadvertently received 1ml of Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
PATIENT STATES SHE HAS A SORE SHOULDER AND IS WORRIED THE VACCINE WAS NOT ADMINISTERED CORRECTLY. PER DISCUSSION WITH PATIENT ADMINISTRATION SEEMS LIKE CORRECT LOCATION (3-4 INCHES DOWN FROM SHOULDER, MIDDLE OF THE ARM) HOWEVER SHE STATES SHE HAD POLIO MANY YEARS AGO AND HAS LESS MUSCLE MASS IN HER LEFT ARM. SHE BELIEVES THE VACCINE MISSED GOING INTO THE MUSCLE. SHE WILL USE THE RIGHT ARM AT THE NEXT CLINIC. TOLD PATIENT I WOULD DOCUMENT ADR.
a lot of chills; fever; she "doesn't feel good" / ended the call saying she was going to go lay down; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and feeling unwell. On an unknown date, the outcome of the chills, fever and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follow: This case was reported by the patient for herself. The age at the vaccination was not reported. The reporter was experiencing a lot of chills and fever after receiving the Shingrix dose.  The patient also reported that she does not feel good. The patient then chose to end the call and stated that she was going to go lay down. The patient declined to provide her complete address, phone number, or email address. No further information was provided.
Compromised breathing; Tight chest; Dry cough; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199), via unspecified route of administration in left arm on 01Mar2021 03:15 PM (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. Vaccination facility type was reported as hospital. The patient's medical history was not reported. No COVID prior vaccination was reported. No concomitant medications were taken by the patient within 2 weeks. No other vaccine was administered within 4 weeks. On 03Mar2021 08:00 AM the patient experienced tight chest, dry cough, and compromised breathing. No treatment was received due to the events. Patient was not tested for COVID post vaccination. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-AUG-2014, the patient was vaccinated with an unspecified improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 4200 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
On Wednesday April 7  started to feel like she was getting a cold. Because her husband tested positive for Covid  April 6 and her daughter's were showing symptoms, she and her daughters were tested. All of their tests were positive. So her first positive test was April  7th  which was a PCR but was taking long to come back so she got a rapid test on April 9th and that was positive as well. She had cold like symptoms, a low grade fever that never went above 100.0 and cough for about 5 days.  She felt tightness in her chest but no shortness of breath and her pulse ox was 98-99. She took Tylenol every 6 hours as needed.  The cough and fever resolved after about 4 days but the nasal congestion is severe and very uncomfortable.  She also has a burning sensation of nose and no taste or smell. She is also very fatigued but able to maintain ADL's and care for her family.
This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. Concurrent conditions and medical history were not reported. On 10-JUN-2015, the patients were vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016) (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax; 1 yr after the vax, lab evaluation was pos for hepatitis C;
ITP (PLATELET COUNT 8000 ON ADMISSION), MULTIPLE ORAL ULCERATIONS/BLEEDING, PUPURIC SPOTS ON ARMS AND LEGS, RECTAL BLEEDING. 7/26/07-records received.for DOS 03/24-04/04/07-DC DX: Idiopathic thrombocytopenia. Hemolytic anemia. Admitted with sore throat and bleeding for a day. Known to have extensive oropharyngeal petechiae and extensive bleeding in extremities.  Treated with IV gamma globulin and changed to steroids. Developed hemolytic anemia. Week prior to hospitalization, upper respiratory symptoms, self administered Levaquin. Noticed progressive hemorrhagic blisters throughout mouth. Ulcers started day she started taking Levaquin.
Broke out in painful itchy red hives all over body.  Lasted about 6 hours. First time ever experienced anything similar. No clear cause.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 23-OCT-2017 the patient was vaccinated with M-M-R II, therapy type: unknown, intramuscular injection, lot # N009775; expiry date: 20-SEP-2018 (dose, dose # and anatomical location unspecified) for prophylaxis. Concomitant therapies included sterile diluent. It was reported that the patient received a properly stored dose of M-M-R II, via intramuscular route instead of subcutaneously. No adverse reaction reported. No further information provided. Lot number lot # N009775; expiry date: 20-SEP-2018, is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
devel hives on 21OCT93 p/receiving vax on 19OCT93; used calamine lotion and baking soda bath x 2;
arm pain after injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain after injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CDC reports: 9 mo infant developed fever 104 & convulsion following immunization. Lumbar puncture normal.
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: Pt reports chest congestion, cough, bad sore throat, ear clogged, chills, no fever. started 3 days after and it has been 7 days and still ongoing.
post concussion syndrome; This spontaneous case was reported by a consumer and describes the occurrence of POST CONCUSSION SYNDROME (post concussion syndrome) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In June 2023, the patient experienced POST CONCUSSION SYNDROME (post concussion syndrome). At the time of the report, POST CONCUSSION SYNDROME (post concussion syndrome) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  The patient has received Moderna Covid-19 vaccines in the past before she suffered a concussion in June-2023 as the result of an accident with post-concussion syndrome that continues.  Treatment medication use information was not provided by reporter.