chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 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's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (17Jan2023) Negative, notes: 2 days after negative test; (19Jan2023) positive, notes: Test strongly positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 10Jan2023 to 15Jan2023.   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: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Sore arm at first with swelling and pain.  Later, fatigue. That night, freezing and chills, then sweating.  The next day, sore glands in the throat when swallowing food with/fatigue.  The next day, sore glands in throat when swallowing food and liquids and blowing nose/fatigue.
This spontaneous report as received from a licensed practical nurse refers to a 17 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-MAY-2016, the patient was vaccinated with the first dose of ROTATEQ orally (lot # and expiry date were not reported). No adverse symptoms were reported. Additional information has been requested.
chills; congestion; tiredness; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Medical history included diabetes, sleep apnea, post-traumatic stress disorder (PTSD), anxiety, herpes, vitamin d deficiency, environmental allergies, asthma, allergies to possible latex. Concomitant medications included unspecified medications in two weeks. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 on 16Jan2021 08:00 in left arm for COVID-19 immunization and experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. The patient experienced chills, congestion, tiredness, all on 06Feb2021. So far not near as bad as 1st time, but took 25mg benadryl and 1000mg of Tylenol, and a dose of pepcid just before she got the shot under advise of physician and nurse practitioner due to previous side effects. No Covid test post vaccination. The outcome of the events was recovered in Feb2021.   Information on the lot/batch number has been requested.
Fatigue, weakness, sleep disturbances, persistent headaches, skin rashes, respiratory issues.
skin rashes similar to purpuric skin rash in the palm, in the hands, parts of stomach, thigh and in the legs; skin rash in the palm, in the hands; skin rashes...parts of stomach; skin rashes...thigh and in the legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 18:45 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN B12 [CYANOCOBALAMIN]; COD LIVER OIL [COD-LIVER OIL]; VITAMIN K2 MK7. Vaccination history included: BNT162b2 (DOSE 3, SINGLE; Lot No: FD0810; Injection site: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: 22Oct2021, when the patient was 58-year-old, for COVID-19 immunisation; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rash in the palm, in the hands"; PURPURA (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rashes similar to purpuric skin rash in the palm, in the hands, parts of stomach, thigh and in the legs"; RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rashes...parts of stomach"; RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rashes...thigh and in the legs". Therapeutic measures were taken as a result of purpura, rash, rash, rash.  Additional information: The patient did not receive any other vaccines within 4 weeks. No covid prior vaccination and no covid tested post vaccination.
Low Grade fever  muscular pain  fatigue  tiredness malaise  joint pain  Chills  throat pain  pain in the left arm  swelling of the injection site redness and warm to touch
Patient was nervous before getting the vaccine and got the vaccine and was sitting in the waiting area. She then got up to go to the bathroom and her dad came to the counter stating she had fainted and fell in the bathroom. It looked like she had injured her leg so we called for the paramedics to make sure it was not broken since we did not want her to cause anymore damage to the leg.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, first dose of vaccine was administered after 3 days from first  puncture.  No Concomitant medication was reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information received contains No significant information.
Developed mile flu like symptoms on Sunday night at 9:30 - chills, muscle aches, fatigue.   Spent Monday in med.  Feeling normal, if a little weak, on Tuesday morning. (Today.)
At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate headache, weakness, sweats
strong nausea Headache Pain in the arm Fever Muscle pain Loss of appetite Cough Lack of air
Morning of 1/22/2021 upon awakening Bilateral swelling of lower arms and hands. Severe muscle joint pain in hands and loss of strength and mobility. At 0730 was given 15mg iv toradol and IM decadron 12mg along with 10 mg oral zyrtec. Swelling reduced minimally with this treatment. At 1730 was given 40 mg of depo medrol  continued on oral benadryl and ibu at home and next day. 0123/2021 Swelling in hands reduced some but still uncomfortable with lethargy and overall muscle weakness on daily activities. Continuing on ibu tylenol and benadryl.
Patient was admitted to the hospital with COVID symptoms and was treated with typical COVID medications. Patient expired while in the hospital.
PATIENT TESTED + FOR COVID 2/2022 AND PASSED 2-24-22. I HAVE NO OTHER INFORMATION OTHER THAN SHE WAS RESIDENT OF LOCAL HEALTH AND REHAB AND HAD A LAB + FOR COVID 2-19-22.
February 13, 2021, 10 days after receiving dose one of the Moderna vaccine I began breaking out in hives. I contacted my primary care provider and she suggested Benadryl and Aveeno Oatmeal bath. On February 17, 2021 the hives are still breaking out. I visited my PCP and she increased my dose of Protonix and added Adderax for treatment
pt exp temp 102,  severe vomiting, diarrhea, lack of energy, nausea, severe stomach upset
Pt arrived with shortness of breath. Pt has a PMH of complete heart block with pacemaker placement and bladder cancer status post resection and neobladder. Pt is COVID positive with acute respiratory failure.
Pt recvd MMR vax in 1976, was re-vaxed on 28NOV89; On 23JUL90, pt was inadvertently given MMR vax; As of 08AUG90, no adverse effects had been repored; No further details were provided;
The baby cried and cried unusually with tremendous pain for about 4 hours. The baby's thigh area around the place, where vaccine was given, became reddish in color and became stiff (area about 5 cm in diameter).
Felt fatigued; Aches; This is a spontaneous report from a contactable other health care professional (patient). This report was received via a sales representative. A 5-decade-old (age: mid-40s, unit: unknown) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for COVID-19 immunization. The patient reported having a rough time after his second vaccination which was received on a Wednesday. He left work early Thursday. The patient experienced felt fatigued and aches. Therapeutic measures were taken as a result of the events which included Tylenol. The outcome of the events was unknown.
Pulsatile Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 18Feb2021 (at the age of 48-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Known allergies was reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included asthma medication (unspecified) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On an unknown date in 2021, the patient experienced pulsatile tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pulsatile tinnitus was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
CHIEF COMPLAINT:   Symtpoms last wednesday, at home test Friday. (+) covid. inc sob/weakness. normally on 3lmp NC with spo2 at home 90-92%. Hx copd. 4lpm spo2 96%. Ruptured polyp on bottom that is bleeding with clots. LLQ abd pain   HISTORY OF PRESENT ILLNESS:     pt with 6 days of covid sx. + test 4 days ago. Movement makes worse, rest improves. Course variable. increased O2 from her baseilne.  Reports vaginal bleeding thinks that she has been coughing too hard and may have strained and ruptured a uterine fibroid.  Should bleeding through about 1 pad per day. + fever and chills. no uti sx. No radiation of pain.  Denies nausea, vomiting, diarrhea, or abdominal pain.
pt recv vax 26SEP97 & 29SEP97 reported onset of episode stomach cramping 27SEP97 AM w/1 episode of vomiting;denied diarrhea, fever, chills, states cramp sensation is now subsiding;
SHINGRIX administered 11/8/18. Woke up early 11/9/18 with back pain, fever, chills and generalized weakness and achiness. Arm was a little sore.
Pt states on the evening recvd vax devel a severe h/a, inc temp & nausea which lasted that entire evening;
Woke up at two o'clock to find pt with a fever and pulsating soft spot. He was still sleeping. Cooled his body with wet rags and fever diminished. Later that morning I noticed him very fussy and would not roll over or babble like he had been. His voice also changed to a high pitch cry instead of his normal one.
Information has been received from a physician assistant concerning a 44 year old male who in approximately 1999 was vaccinated with a 2 dose series of varicella virus vaccine live (Oka/Merck) at another location. There was no concomitant medication. A recent titer was negative. No additional information at the time. Unspecified medical attention was sought in the office. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
No additional adverse events; 14 old month patient was inadvertently administered PROQUAD and VARIVAX; This spontaneous report was received from a Registered Nurse referring to a 14 month old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not provided.     On 18-MAY-2020, the patient was inadvertently vaccinated with varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003176, expiration date:30-JUL-2020) (strength, dose number, dose, frequency, route or location were not provided) and with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S002874, expiration date:29-JAN-2021) (strength, dose number, dose, frequency, route or location were not provided) for prophylaxis. No additional adverse events and no additional information were reported.
Running nose; Sneeze a lot; Throat itch occasionally; Itchy nose; Light headed; Allergy symptom; Sore arm muscle on left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose) and DIZZINESS (Light headed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus pain.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose), DIZZINESS (Light headed), HYPERSENSITIVITY (Allergy symptom), MYALGIA (Sore arm muscle on left arm) and FATIGUE (Fatigue). At the time of the report, RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose), DIZZINESS (Light headed), HYPERSENSITIVITY (Allergy symptom), MYALGIA (Sore arm muscle on left arm) and FATIGUE (Fatigue) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-060551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographic details updated. Relevant history added.
Pt. felt flushing right away with vaccination then quickly after noted tightening of her throat. She had never experienced that sensation before, she took two doses of Albuterol while under observation with slight improvement but the feeling persisted.  It did not worsen either, she had no difficulty breathing, no change in her voice.
This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Side effects to the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Side effects to the injection site). At the time of the report, VACCINATION SITE REACTION (Side effects to the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 65-year-old female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pounding in head. On an unknown date, the outcome of the pounding in head was recovered/resolved. It was unknown if the reporter considered the pounding in head to be related to SHINGRIX. Additional details were provided as follows: In January 2019, the patient received 1st dose of SHINGRIX, and only had a pounding headache. The pounding headache resolved on an unknown date. For tolerance of 2nd dose, refer case number US2019060805.
I have had altered  taste and smell since having the second Pfizer coronavirus vaccine.  My toothpaste, soap and shampoo smell like sewage.  Many foods taste like chemicals.
Diagnosed with Covid in early November 2020, diagnosed with Guillian Barre Syndrome early December 2020.
severe headache ,back and  neck pain ,body aches ,fever 102.7 . had reaction after first vaccine with chest pain and shortness of breath and decreased oxygen saturation that she didn't have  this time.  1/27/21 symptoms  less with fatigue and mild baby aches continued
1/2 hour after receiving H1N1 vaccine patient developed swelling on both sides on the cheek near the eye with itching - got worse this morning and was getting better when he saw me.
Awoke from sleep with need to vomit. Vomited on three occasions that night and once again the following afternoon.
Seen on 4/7/21; diagnosed with periorbital cellulitis and bacterial conjunctivitis - resolved. Seen on 4/27/21; diagnosed with bacterial conjunctivitis. Treatment is pending.
This spontaneous report was received from a registered nurse refers to at least 5 patients of unknown demographics. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L016428, expiry date: 30-JUL-2017) (confirmed that it was not GARDASIL). No adverse symptoms were reported. Additional information has been requested.
Headache, Arthralgia, After both doses - HA and site pain. Worse on 2nd dose with added muscle aches. Narrative:
a staff member gave a 6 month old Adacel instead of Pentacel; a staff member gave a 6 month old Adacel instead of Pentacel; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 6 months old patient (gender not reported) who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.   Documents held by the sender: none.
69my/o M PMH of DM, HTN, dyslipidemia, COPD, GERD, seasonal allergies, prostate CA s/p prostectomy. Pt presented to hospital on 1/10/10 c/o ataxia, imbalance, incoordination of the R side, and bilateral leg weakness. Symptoms began on 1/9/10. Pt received seasonal flu vaccine and H1N1 vaccine on approx 1/6/10 before admission to hospital. Pt was admitted to neuro ICU on 1/12/10 w/quadriparesis. Suspected Guillain-Barre Syndrome. Pt s/p plasmapheresis on 1/12, continue every other day for 5-7 exchanges. Continue to monitor patient.