chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine was given; This is a spontaneous report from a contactable Nurse (reporting for herself).  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, bacth/lot no: EK9231 while expiry date was unknown), intramuscular on left deltoid on 07Jan2021 16:45 at a single dose for covid-19 immunization.  There were no medical history and concomitant medications reported. Patient has no prior vaccination within 4 weeks.The patient got her first dose of the  COVID 19 vaccine yesterday (07Jan2021) from her employer.  She started "feeling yucky" today (08Jan2021) around noon with a low grade fever,and developed a cough that was not persistent. Patient has soreness in the arm where vaccine was given. She was asking what should she do about it? Outcome of the events low grade fever, cough, feeling unwell, feeling abnormal were not recovered while vaccination site pain was unknown. The events low grade fever, cough, feeling unwell were considered serious medically significant and related to vaccine.; Sender's Comments: Based on the time association, the events fever, cough and malaise are possibly related to suspect BNT162B2 administration. 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.
This case was reported by a physician and described the occurrence of acute hepatitis B infection in a 46 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis.  The patient's medical history and concurrent conditions were not reported.  Concurrent medications included sustained-release bupropion (Wellbutrin SR).  The patient received injections of Twinrix (Lot # HAB299A4) on 05/08/2003 and 06/03/2003.  On 07/03/2003, two months post-immunization, the patient presented to the physician with complaints of malaise, dark urine, diarrhea, and fatigue. The physician noted that the patient was jaundiced and had lost weight.  Laboratory analyses revealed increased concentrations of total bilirubin, lactic dehydrogenase, alkaline phosphatase, aspartate aminotransferease, alanine aminotransferase, and gamma-glutamyl transferase.  Serologies for hepatitis A IgM, hepatitis A total antibodies, hepatitis B surface antibody, hepatitis B core IgM, and hepatitis B core total antibodies were negative.  Hepatitis B surface antigen was positive.  The physician made a diagnosis of acute hepatitis B infection and prescribed unspecified symptomatic therapy.  The physician stated that he had expected hte patient to be have protective antibody titers after two injections of Twinrix.  Additional information was received from the physician on 08/05/2003.  He reported that the acute hepatitis B infection had improved by 07/28/2003.  He stated that he "will repeat series with different brand".  He considered the events to be possibly related to Twinrix, and to be serious because they jeopardized the patient or required intervention.
Diagnosed with scoliosis and  this year 2021 due to back pain and lower lumbar nerve damage from previous knee surgeries on both knees in past years. Got my first dose of Pfizer and felt okay throughout the day until bedtime and woke up the next day in pain.Could NOT feel my back or left arm. It was Stiff, tiggling and  Hot/burning feeling all on my upper left side of my body. Felt half dead.   No OTC medicine fixed this. I suffered for days.  I am due for my next dose to keep my job, BUT i will NOT put myself through this again. I request exemption due to this and WILL NOT harm my body while still under-going my scoliosis process.
24 hours after administration, fever, chills, left arm swollen, bilateral palmar erythema and swelling of bilateral upper extremities (L>R, possible hives at onset of symptoms.  #21 father severly allegric to PCN/Sulfa with Repp swelling - none to vaccine.
Pt recvd 1 dose of Engerix-B & 60 hrs later had sixth nerve palsy resulting in double vision; was not treated; had partial improvement;
Pt vaccinated with Recombivax HB developed eye pain, photophobia & loss of vision.
pt recv vax 8NOV90 during pregnancy;LMP 8OCT90;pt delivered infant w/multiple malformations including mental retardation, speech, auditory & visual disturbances, tonic/clonic sz, growth retardation, abn EEG-mom felt child deformity r/t vax;
10/7/21 Booster given and another booster was given on 10/19/21
I woke up very achy had a very high fever and spasms in my hand and foot.  It then  went to my back and it lasted about two weeks, I did a telehealth visit and was tested for COVID which was positive.
just a little sore at the injection site; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he got the first round of the COVID vaccine and stated that everything was okay; he was just a little sore at the injection site on an unspecified date. The patient was just wondering if he was to be exposed to COVID prior to getting his next dose in three weeks; he was wondering what the recommendations would be regarding the second dosage. He was just wondering, because he had been pretty isolated as he lives out in the woods and he had been following protocols about wearing the mask and using hand sanitizer and such, but he was just wondering if something did happen and he got exposed, what would be the recommendations for the second dose. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Red flat rash noted as last of 4 immunization administered (prevnar). Latex free gloves, and bandaids used as parent reported that she was allergic to latex. Rash noted immediatedly at bandaid sites and on legs, face, L arm and abdomen. Lungs clear bilaterally.  Child alert waving, cooing and making eye contact with staff.  0.05ml Epinephrine given IM in Rt. Vast. Lat. per standing order.  911 called. Child's primary physician called.  Patient & mom tranported to ER.  Mom reports that child vomited in ER, screamed and had a fever of 100.5.  Child had an appointment at primary's office on 7-2-08.  At this time primary physician is awaiting ER report.  As of 7-2 rash had faded almost completely.  Mom reports a little blotchy rash on back remains.
found myself having difficulty in remembering anything; having difficulty with breathing/difficulty with my entire respiratory system; don't have strength to lift anything; stomach is involved in the way that it is not getting enough oxygen supply; can't even do breathing exercises to bring my breath back; mouth is full of bumps; have a sore tongue; lowblood pressure; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), DYSPNOEA (having difficulty with breathing/difficulty with my entire respiratory system), ASTHENIA (don't have strength to lift anything), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply) and DYSPNOEA (can't even do breathing exercises to bring my breath back) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Caffeine allergy (migraine triggers), Alcohol allergy (migraine triggers), Allergy (Tobacco-migraine triggers) and Migraine (right ear - Meneriers) since 28-Jan-1943. Concomitant products included ALPRAZOLAM from 05-Jun-1993 to an unknown date for Migraine, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Mar-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021 at 3:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), DYSPNOEA (having difficulty with breathing/difficulty with my entire respiratory system), ASTHENIA (don't have strength to lift anything), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), DYSPNOEA (can't even do breathing exercises to bring my breath back), ORAL DISORDER (mouth is full of bumps), GLOSSODYNIA (have a sore tongue), HYPOTENSION (lowblood pressure) and FATIGUE (fatigue). At the time of the report, MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), DYSPNOEA (having difficulty with breathing/difficulty with my entire respiratory system), ASTHENIA (don't have strength to lift anything), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), DYSPNOEA (can't even do breathing exercises to bring my breath back), ORAL DISORDER (mouth is full of bumps), GLOSSODYNIA (have a sore tongue), HYPOTENSION (lowblood pressure) and FATIGUE (fatigue) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Updated:Patient tab: Height, added complete Other relevant history, checked on concomitant drugProduct tab: updated the time and dates of the drug doses, added concomitant drug information.Event tab: Updated the events.
Initial information received from a healthcare professional on 05 September 2012. A 87-year-old female patient whose medical history included Alzheimer's like symptoms and with no reported concomitant medications received an intramuscular dose of FLUZONE (Batch lot number UH721AB) on left deltoid on 05 September 2012. The reporter stated that the patient experienced headache, numbness of face, after receiving FLUZONE on 05 September 2012. The patient was observed in office for 20 mins and discharged without complaint on the same day i.e. 05 September 2012. Corrective treatment was not reported. The events were resolved on 05 September 2012. Documents held by sender: none.
Developed morbilliform rash, fever to 102, malaise, myalgias;
Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE, start date: 10Dec2007. Past drug history included: Sentra, reaction(s): "Known allergies: Sentra", notes: Known allergies: Sentra; Minocycline, reaction(s): "Known allergies: Minocycline", notes: Known allergies: Minocycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Covid 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: Rebound of Covid 19 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient received Paxlovid treatment on 21Dec2022 to 25Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  Drug ineffective and COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Patient spiked fever a few hours after receiving the 3rd dose, along with joint pain, body ache and fatigue. Symptoms were severe and she went to ER 2 days later and received IV fluids and pain medications. Fever lasted for 3 days. Her symptoms gradually resolved on day 4.
Patient returned to office with history of sore throat, fever (102), red cheeks, and fine macular rash all over body.
Claimant alleges she received the vaccine at the pharmacy and began feeling dizzy and fell to the ground while in the waiting area.
numbness at times; crampy toes; Couldnt sleep; abdominal pain; Pain on back; pain at both legs; pain at both arms; headache; very hot upper body; very cold feet; nauseated; shooting pain on legs; felt like excruciated pain on everybone especially night of vaccinatedday; very shaky feeling; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49 years) at 09:00 as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to vancomycin and celecoxib. Concomitant medications included, mesalazine (LIALDA), omeprazole (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), budesonide (UCERIS) (MANUFUCTURER UNKNOWN) for unknown indications. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19. since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced, pain on back (all along spine) through both legs and both arms along with very bad abdominal pain (as if it will burst anytime soon) pain on head (explosive feeling), very hot upper body and very cold feet and nauseated, shooting pain on side of both legs, it felt like excruciated pain on every bone especially night of vaccinated day, day after and the third day that was on 26Mar2021, the patient couldn't sleep or moved around and felt very shaky after the third day, still had bad back pain, pain on right leg and right arm (numbness at times), crampy toes can't sit as before the vaccination. The adverse event had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events back pain, leg and arm pain, abdominal pain, headache, hot feeling, sleep loss, cold feet, nausea, shooting pain on legs, bone pain, shaky feeling, numbness and crampy toes were not recovered.  No follow-up attempts are needed. No further information is expected.
Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA588A, expiry date 31st August 2022) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st September 2022, unknown after receiving Menveo, 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-Sept 2022 Reporter's comment: The medical assistant called to inquired that the patient should be revaccinated. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Menveo on the day of reporting, which led to expired vaccine used.
I was given the first dose of the moderna vaccine. 9 days later I have a large red/pink rash on the arm that the vaccine was injected in. I looked it up and it is called Covid arm.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked to cases 2018SA315702 and 2018SA315692. This case involves a 15 years old female patient and reported that a twin received a FLUBLOCK QUADRIVALENT that day in her right deltoid, IM, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QSAA1804 and expiry date: 01-Jun-2019) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any 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.
Pain, redness, swelling, itching for about an 1 1/2 around injection site. This was from the seasonal flu shot.
Disruption of menstrual cycle: cycle is usually regular, but started a week early (started the day after vaccine was administered)
Parents present to clinic with child on 5/8/17 around 1pm. Report child started to have high fever early last week and later a rash that started on Friday 5/5/17. Child no longer with fever today, rash still present. Parents wanted to ask if symptoms are related to vaccine from 4/17/17.
Back ache; Felt a whole pain; Fever; Headache is killing me; Arm was swollen a bit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen a bit), BACK PAIN (Back ache), PAIN (Felt a whole pain), PYREXIA (Fever) and HEADACHE (Headache is killing me) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C2119) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient mentioned that she had COVID back in January).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen a bit). On 23-Apr-2021, the patient experienced BACK PAIN (Back ache), PAIN (Felt a whole pain), PYREXIA (Fever) and HEADACHE (Headache is killing me). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 milligram every four hours. At the time of the report, PERIPHERAL SWELLING (Arm was swollen a bit), BACK PAIN (Back ache), PAIN (Felt a whole pain), PYREXIA (Fever) and HEADACHE (Headache is killing me) outcome was unknown.        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.   Treatment Patient drinks water to treat symptoms
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was reported. On 09-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929, expiration date: 27-MAY-2017 (dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Moderate pain in upper arm near injection site, preventing normal activities. Headache, lethargy, general malaise.
0840 Patient received vaccine.  No reported allergies to any medications or immunizations.  COVID19 pre-vaccination checklist completed.  Patient moved to observation.  0852 patient complained of tightness in throat and slight shortness of breath.  0853 RN took BP 180/100, R 18, P66.  Patient was sitting upright and took off jacket.  0858 Patient reports symptoms are the same.  BP 172/108. 0859 Patient reports difficulty breathing and continued tightness in throat.  RN administered 50mg IM Diphenhydramine.  0908 Patient reports that symptoms have started to improve.  Reports continued some tightness but no longer having difficulty breathing.  Patient reports that she is feeling some better.  Family arrives.  Patient explains that she has had the need for Benadryl with insect stings and had extreme reactions to some other items that were not previously reported to RN.  Patient was observed  and was feeling better.  Instructed patient to contact PCP to report reaction and follow-up with PCP.  Instructed patient to call 911 immediately with any further adverse reactions after returning home.  Family to drive patient home and continue to monitor patient.  1500 patient called back to explain that she was feeling better.  Some swelling in tongue.  Patient follow-up with PCP today.  PCP to continue to follow.  No further medication needed at this time.
patient was administered dose.  he was still sitting and he informed his wife and immunization tech  that he was feeling lightheaded.  patient started sweating at which time pharmacist was informed.  Patient could not stand up and 911 was called. patient was checked by emt and released.
I felt tired that night. Right arm at injection site was red, swollen, hot. It stayed that way for 2 weeks, though the swelling went down day by day. Then on 3/20/21 I noticed a red ring and a bigger area of redness than had been before. It looks like the typical "covid arm" pictures online from the Moderna vaccine. It does not hurt. It itches slightly and has not changed in redness since I noticed it.