chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has a fever of 100.2F and loss of appetite/No appetite; She has a fever of 100.2F and loss of appetite.; Feeling unwell; Injection site pain; Tiredness; Headache; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 20Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband received the COVID vaccine yesterday early in the morning at a hospital. She was fine until the middle of the night and early this morning. On Jan2021, she had 6 of the 12 side effects, which she described as injection site pain, tiredness, headache, chills, feeling unwell and no appetite. She had a headache and felt her forehead and it felt warm, so she took her temperature and it was 100.2 degrees Fahrenheit. She has a fever of 100.2F. The patient underwent lab tests and procedures which included body temperature: 100.2 on Jan2021. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.
Administered Pentacel, Hep B, Hepatitis A, Prevnar 13, MMR, and VZV. At 10:45 AM red spots with slight bumps appeared on child's face. A few area appeared on child's trunk as well. Child did not have a pediatrician. Administered .5cc  of Oral Diphenhydramine 12.5mg/5ml.
the day of the vaccine I felt site swelling on injection site. A day after the vaccine I started to feel a headache and fatigued.  I also felt sore from the vaccine and had  what felt like  itchy throat
BACK ACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 19-MAY-2021, the subject experienced back ache. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, back ache, and chills. This report was non-serious.
I had the second dose on 3/25/2021. I started one new med on 04/27/2021 Toremifene 16 mg and after that the doctor increase my Crestor from 5 mg a day to 20 mg a day on 05/26/2021. Most of it was brain fog and lack of energy and some depression. Both medicines caused the side effects and the doctor said it was too much of the same thing. I also had a fall on the sidewalk on 06/09/2021, the doctor thought it was because I was dizzy. I tripped on the curve and fell face down my glasses made a little cut below my right eye. The bruise its still there. The next day I went to the eye doctor and they said there was no damage and no concussion. After that my primary doctor told me to go off Crestor for 2 weeks and let her know how I was doing, so I did that and I am doing much better. I have more energy. I still have some brain fog but I think the Toremifene is doing that. But every day I feel much better.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 26-AUG-2015, the patient was inadvertently vaccinated with an expired dose of MMR II lot # J010208, expiry date 26-AUG-2015. No adverse effects were reported. The outcome of the events were unknown. Additional information has been requested.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: Patient was scheduled to take her 2nd dose of the vaccine today but she was sick and had allergies. She was not sure if it was Covid that's why she wants to know if she can still take the 2nd dose today even if she was sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to an unknown number of patients. The patients' medical histories, past drug histories, and concomitant medications were unknown. The patients were vaccinated with PEDVAXHIB that had unsupported temperature excursions, (lot # K002935, expiration dates: 11-DEC-2016 and lot # K00331, expiration dates: 23-OCT-2016), 0.5 ml, unknown frequency, intramuscular between September 2014 and December 2014. The nurse believed that the vaccines were not really exposed to unsupported temperature excursions, but that the data was documented incorrectly. She believed that the medical assistant, who documented the vaccine temperatures between September 2014 and 23-DEC-2014, documented the set "high"and "low," which cause an alarm to sound. She should have recorded that "min" and "max." On 22-DEC-2014, an auditor visited the clinic and asked the nurse to check for stability data. It was unknown if there was any relevant laboratory data. As of 23-DEC-2014, it was unknown if the patients continue to take PEDVAXHIB or GARDASIL. Additional information has been requested.
stiff back; im a very anxious person; on my eye which is sore; itchy; headache; hives behind her ear, on her eye, and from her wrist to her elbow.; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.), MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore) and PRURITUS (itchy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pneumonia (The Patient had been hospitalized for 3 months prior to receiving the vaccine for pneumonia.).    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore), PRURITUS (itchy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Stiff back, at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) (topical) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.), MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore), PRURITUS (itchy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.   Reporter did not allow further contact
There is no adverse event known thus far.  Asked to enter as she verbalized she had the rabies vaccine (she is Animal Control) a week prior.
Slight dizziness; body ache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 66-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), intramuscularly on the left arm on 27Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes borderline. The patient has no allergies to medications, food, or other products. Concomitant medications included metformin (METFORMIN), and lorazepam (LORAZEPAM). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight dizziness, body ache and tiredness on 27Jan2021. No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the events. The events resolved on an unknown date.   Information on the lot/batch number has been requested.
I had moderate flu like symptoms the day after receiving the second dose of the Moderna Vaccine. Two days later, I developed a painful rash on my torso (under my breast on the right hand side). On  3/5 the rash spread to my back (if you drew a line from the rash on my torso to the rash on my back they would be in around the same spot on the right hand side).  The pain and itching intensified. I was able to get a Teladoc appointment. I participated in a video  appointment and had to send pictures of my rash. I was diagnosed with Shingles. I have never had Shingles prior to this. I?m only 38 years old.  The symptoms are still present with the same intensity and I am not able to work.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 16-NOV-2016, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster-related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provided for shingles. As a direct and proximate result of plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine. The patient had and will continue suffering ongoing injuries, including but not limited to: mental and physical pain an suffering; medical care and treatment or these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages, and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was unknown.
Patinet received the vaccine which was delay in shipment with no AE; Patinet received the vaccine which was delay in shipment with no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer or non-health professional  This case is linked to cases 2019SA295207, 2019SA295208, 2019SA295209 and 2019SA290919 (same reporter).  This case involves a 8 months old male patient who received 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686LA, expiry date: 30-Jun-2020), via intramuscular route in the right thigh on 17-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to the incorrect product storage and product shipment delay.   It was reported that the shipment of Fluzone QID was received late. On Thursday morning, the office had already given 5 children vaccines from this shipment before they realized that the vaccines were not viable.  At the time of reporting, 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.
Scratchy throat dry cough, itchy, red eyes about 3 hrs after receiving Influenza vaccine. Symptoms present for about 30 mins prior to seeking treatment. Conjunctiva infected. Increased pulse rate. Otherwise negative exam findings. BENADRYL 100mg no improvement. Sent to local ER for further evaluation.
48 year old patient reported receipt of routine typhoid Vi (#5 and lot # not documented) on 2/11/2011 to left arm. He remembers having a frontal 3/10 dull headache <24 hours later that progress to 6/10 headache within 72 hours that encircled his head and "flu like symptoms" -malaise and increaing fatigue. On 2/14/2011 he reported to medical complaining of generalized malaise and body aches (neck, back) x 3 days. He advise medical he felt "run down 7 days ago, recovered 5 days ago, then worse after typhoid shot". He denied any fever, sweats, chills, photo/phonophobia, neck rigidity, gait imbalance, rash, breathing difficulty or any other systemic complaints. The  provider documented he looked uncomfortable, pale and tired, temp 97.2F, normal vitals and exam (including neuro). He was diagnosed with generalized malaise of viral etiology (mono, viral syndrome, dehydration) and adverse reaction to typhoid immunization. Labs for TSH, CBC, mon, UA, BMP were all normal and he was rehydrated with 1000 mL normal saline, given 30 mg TORADOL IM, and prescription for Naproxyn 500 mg twice a day and oral TORADOL. A VAERS was filed by this provider (2/14/2011). On 2/15/2011 he advised his headache worsened (6/10) and he began to experience chills and a stiff neck. His wife transported him to emergency department where he advised his initial headache began 6 days ago (2/9/2013) and resolved 2/13/2013 only to return on 2/14/2013 after receipt of typhoid vaccine as a generalized headache with back pain, neck stiffness and nausea. Repeat labs 2/15/2013 showed normal CBC, BMP, Calciusm, and CT head w/o contrast. His physical exam was normal (including neuro). He was diagnosed with a headache secondary to typhoid vaccination and treated with IV DILAUDID, PHENERGAN and TORADOL with easing of headache (4/10). He was discharged with prescriptions for VICODIN, and PHENERGAN. Providers advised patient to return for spinal tap if headache did not improve or symptoms worsened. He followed up with ships medical on 2/16/2012 advising symptoms were improving. He advised his headaches completely resolved about one week later without reoccurrence as of 2013. Patient reported no adverse reactions following 2011 and 2012 flu vaccines. On 7/10/2013, patient was sent to clinic for clearance on headache after receipt of 2011 typhoid vaccine.
Spoke with mom on 3/8/21, states left arm was noted to be swollen and hot on 3/6/21, took child to PCP 3/8/21, PCP told her the swelling was a reaction to the tetanus vaccine and instructed to take ibuprofen as needed.
Received vaccine on 8/1/00. On 8/5/00, the pt experienced swelling from mid arm to shoulder, with dark bruising and pain. The pt also complained of itching from elbow to neck.
Information has been received form a licensed visiting nurse concerning a 10 year old male with von  Willbrand's disease and a history of shingles (August 2002) who was vaccinated with a dose of varicella virus vaccine live. The LVN reported that in 2003 the patient developed chickenpox. It was unknown if medical attention was sought.  It was also reported that the patient's sister (WAES 0303USA01321) and three other children (WAES 0304USA01539, 0303USA01670 AND 0304USA01540) also developed chickenpox after being vaccinated with varicella virus vaccine live. Additional information has been requested.
administered an expired dose of Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that the patient received an expired dose of Twinrix, which led to expired vaccine used. No further information reported. The reporter did not consent to follow-up.
ITCHY SKIN OVER ENTIRE BODY. NO HIVES. NO RASH. NO THROAT SWELLING.
Short of breath, chest pain, pain down left arm, neck pain.   -Continued chest pain & heart arrythmias -Dizziness -Extreme Fatigue/ unable to stand -Heachache -Loss of cognative abilities - episodes of loss of speach and mobility
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the vaccine was stored in in freezer, and they take out one to two vials and place in fridge each day as needed.  No concomitant medications were reported. No treatment medications were reported.
Large welt (larger than 2 quarters side-to-side), knot under site, redness, heat, pain, severe itching.
61 yo female s/p Pfizer COVID vaccination: dose 1 on 3/27/2021 and dose 2 on 4/17/2021. PMH significant for T2DM, HTN, HLD, GERD, asthma, tobacco use, osteoporosis, obesity, depression. Presented to this institution on 8/20/2021 with COVID-19 pneumonia (symptoms of fatigue, myalgias, insomnia, nasal congestion, loss of taste/smell, loss of appetite, pounding headache, diarrhea. Increasing oxygen requirement during admission to 3L; CXR 8/25 demonstrates increasing bibasilar consolidative airspace opacities greater on L; MRSA/MSSA swab negative. She received 3 doses of remdesivir which was discontinued due to bradycardia. (cont.)
This case was reported by a healthcare professional via a sales representative and described the occurrence of Hepatitis B antibody negative in a 6-7 year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates, the subject received full schedule of PEDIARIX (unknown routes and injection sites, batch numbers not provided). On 23 April 2014, at an unspecified time after vaccinations with PEDIARIX, the subject had a needle stick injury. They had Hepatitis B titers drawn and they were either low or non-existent. No adverse events were reported.
Patient c/o nausea, light headed and dizzy, chest tightness, pain and pressure about 20 min following injection. No  rash or shorness of breath. NO swelling or redness to injection site. Transported patient to hospital in wheelchair for evaluation.
Immunizations given on 9/10/02. Client returned to clinic on 9/11/02 with c/o red, swollen arm, warm to touch and slightly painful. Client's grandmother present with client, states that she first noticed that pt's arm was swollen, red and warm in the arm of 9/11/02. L arm red, warm to touch with swelling one inch. Client examined by MD given prescription for Amoxicillin.
Abnormal movements, soreness and muscle ache.   Fever and movements improving with time.
I had a blister inside my mouth.  It dissolved by itself after about 2 days.  I also almost fainted after the vaccine which was the following morning after the vaccine after my routine run.  I also had a cyst on top of my foot which impacted my ability to walk for about 2 weeks.
outbreaks/psoriasis patient experiencing bad breakthrough/broke out; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (outbreaks/psoriasis patient experiencing bad breakthrough/broke out) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced PSORIASIS (outbreaks/psoriasis patient experiencing bad breakthrough/broke out). At the time of the report, PSORIASIS (outbreaks/psoriasis patient experiencing bad breakthrough/broke out) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter.  The reporter's causality for the event(s) of outbreaks/psoriasis patient experiencing bad breakthrough/broke out with humira 40mg/0.4ml(adalimumab) was a reasonable possibility.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Significant live follow-up information included updated event information.
t102, lethargic, vomited x1, gastroenteritis, loose stools;
ACUTE PULMONARY EMBOLISM 4/3/2023 SADDLE PULMONARY EMBOLISM W ACUTE COR PULMONALE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/2/2023 SADDLE PULMONARY EMBOLISM W ACUTE COR PULMONALE ACUTE DVT OF LEFT FEMORAL VEIN 4/2/2023 SADDLE PULMONARY EMBOLISM W ACUTE COR PULMONALE
The evening she received the vaccine, the pt developed body aches, malaise and low-grade temperature and headaches. Symptoms were significant enough that she missed school.
Urticaria and pre orbital rash 4' post MMR vaccine. Per pt's mother pt's Sx completely subsided on 09/29/09.
Developed a 10 cm ring of pink skin on the upper left arm centered at vaccine site, slightly tender and warm, was still present at office visit 11/25/2015.
pt recvd 2 doses of Hep B on 5AUG91 & 5SEP91 & approx 12SEP92 pt exp paresthesia throughout entire body; exp dizziness, muscle aches, arthritis involving knees & lt shoulder, muscle weakness, flushing, pruritic rash on rt forearm; ear clog