chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started feeling a bod after the 2nd dose; Bad pain on the right leg after the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bad pain on the right leg after the 2nd dose) and FEELING ABNORMAL (Started feeling a bod after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 29-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced PAIN IN EXTREMITY (Bad pain on the right leg after the 2nd dose). On 30-May-2021, the patient experienced FEELING ABNORMAL (Started feeling a bod after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) on 29-May-2021 at a dose of 650 mg. On 29-May-2021, PAIN IN EXTREMITY (Bad pain on the right leg after the 2nd dose) had resolved. At the time of the report, FEELING ABNORMAL (Started feeling a bod after the 2nd dose) outcome was unknown.            Concomitant drug was not reported.  It was reported that patient was feeling bad and needed help.
After receiving my vaccine on 09/30/2022 I noticed that there was a little flare up at the injection site.  On 10/12/2022 I started to feel very itchy on my neck and shoulders area as well as my scalp, I took a Zyrtec 10 mg and went to bed. 24 hours later I felt the itch come on again and I ignored it and by 10pm I seen the rash spread across my chest and back. I took Benadryl 10mg  and went to sleep. Later that night around 3 am I woke up and seen that I had hives all over my body. I reached out to the 24-hr. nurse hotline with the doctors office and they advised me to take Zyrtec until I can get an appointment and that still didn't help settle the irritation or hives. I booked an appointment for 9 am the following morning and they took pictures of the breakout, and they prescribed me prednisone 40 mg for 3 days and I still wasn't receiving relief after the prescription. I then reached out to retrieve a telehealth appointment, and they prescribed me 40 mg of prednisone over the course of another 3 days. That still was not helping, and I have not received any relief. I contacted them again and let them know I was still having flare ups and they just prolonged the duration of time and suggested 40 mg of prednisone for 5 days instead of 3, I also picked up some topical treatment from the pharmacy store which helped make me feel a little better, but it did not last long . I'm currently waiting for the dermatologist to contact me after they put in a referral for to see if there is something else that can be done.
Arm was sore after shot but it has lasted since the shot.  Arm hurts so much it is hard to drive, and lift, or even lift the arm.  The pain has awoken her from sleeping 12-01-2015.
Bruised above administration site remaining 5 days post administration, dark purple in color, 3-in width
pt recv vax & stomach upset then v;w/in 10min of leaving ofc, came back limp & pale;became non-responsive & w/in 5min exp anaphylactic rxn manifested by swelling, total pruritic body rash fine & red, somnolence, sz;hypotension,bronchospasm;
Had a terrible headache, the day after receiving the second vaccination, that required me to go to bed. I do have chronic migraines, but this headache occurred only two days after I had an actual migraine. Historically, it was much too soon for me to have another migraine. In my opinion, the headache may have been caused by the vaccination.
pt hospitalized after a fall; fx to left hip; surgically repaired; had a positive COVID test; dc'd to hospice; pt found deceased in the hospice facility
Slightly sore arm; Very slight queasy stomach; very slight stinging sensation in eye; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 10:45, the patient experienced slightly sore arm, very slight queasy stomach and very slight stinging sensation in eye. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse event. The clinical outcome of the events slightly sore arm, very slight queasy stomach and very slight stinging sensation in eye was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
6 days after vaccine, the arm (Left) in which the vaccine was administered became extremely sore.  On the 7th day, today, it is almost immovable.
Pt received 0.25ml of the Covid-19 Bivalent vaccine instead of 0.50 ml
developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.
Pt. has redness and swelling to injection site. Area is raised and warm to touch. Raised area measures 50 x 60 mm.
This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored RECOMBIVAX HB 5mg/0.5ml (lot#, expiration date, route, dose not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
COVID vaccine Chills & difficulty getting out of the bed " I cant get out of bed; COVID vaccine Chills & difficulty getting out of the bed " I cant get out of bed; elevated blood pressure; feels being tired lately; This is a spontaneous report received from a contactable consumer, A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration, on 17Mar2021, as single dose for covid-19 immunization. The patient's cosuspect medication included LENVIMA 20 mg, orally for Endometrial Cancer on 13Mar2021. Patient medical history included hypertension and receiving treatment which inluced diltiazem /triamterene/Olmesartan for pre-existing hypertension, MD is unaware. MD follow-up on 29Mar2021. The next COVID vaccine is on 17Apr2021. On 17Mar2021 patient had chills and difficulty getting out in the bed (she cannot get out of bed) symptoms of the COVID 19 lasted for two days (resolved) and increased the blood pressure 143/101 (elevated), when the day she had the vaccine. No missed doses and no hospitalization noted. She feels being tired lately, started after taking the therapy on Mar2021. The patient underwent lab test and procedures which included blood pressure (143/101) on 17Mar2021. Outcome of the events chills and difficulty getting out in the bed resolved on 20Mar2021 and outcome of the events feels being tired lately and elevated blood pressure was unknown.
Moderna COVID-19 Vaccine EUA  Fever spiking to 104.2 at 24 hours after injection. That is WAY TOO HIGH for a man of 66 years of age. Tylenol took it down to 101,5  after a couple of hours. Additional Tylenol in the evening brought it down to 99.5.
Several days post vax, the pt developed a varicella like rash around the injection site. The pt sought unspecified medical attention. The pt did not report any further side effects and at an unspecified date recovered. No further information is expected.
HYPERACUSIS; DIZZINESS; SORENESS IN ARM; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hypothyroidism, tinnitus, nonsmoker, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced hyperacusis. On 07-MAR-2021, the subject experienced dizziness. On 07-MAR-2021, the subject experienced soreness in arm. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hyperacusis, and dizziness on 07-MAR-2021, soreness in arm on 08-MAR-2021 17:00, and tiredness on 08-MAR-2021. This report was non-serious.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 57 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received te4mperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Extreme tremors, lower legs became heavy, neuropathy, neurological disorders, vomiting for 4 day.  Still extremely nauseated effecting digestive tract.  Severe diet disorder.
SWELLING OF INJECTION SITE, FOLLOWED BY ARM, FOLLOWED BY FACE/NECK
Pfizer vial diluted with 1.6mL instead of 1.8mL diluent. Patient received higher dose than required.
This spontaneous report as received from a physician via a company representative refers to a 66 year old female patient. On 05-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030849, expiration date 09-JUN-2019 in the left arm for prophylaxis. In approximately 2018, the patient experienced enormous pain, warmth, redness, and swelling of the left arm. The patient was unable to move her left arm and felt like she was going to pass out when she stood up. The patient was treated with unspecified antibiotic medication and fully recovered (in approximately 2018). Causality assessment was not provided.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036177, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
pt brought to ED via EMS with c/o O2 sats at home in the 60s; positive for COVID; EMS placed pt on O2 via NC and 100% NRB mask; O2 sats 80%; respiratory distress and kidney failure; intubated and admitted to hosp; too unstable for dialysis; O2 in 70s% on high PEEP and 100% FIO2; condition drastically worsened; pt passed away before family made it to the hospital
pt recvd vax & on 7DEC92 pt devel diffuse arthralgia involving the lt knee, wrist, & the fingers & toes of both hands & feet; pt was seen by MD 15DEC92 & the arthralgia in the small joints of hand, feet, lt wrist persisted;
Outstretching of arms & legs for a few seconds at a time repeatedly through evening. Seen by RN in ED - concern for infantile spasms. Admitted overnight - resolved.   8/21/09 Hospital records received DOS 6/5/09 to 6/6/09. Assessment: Spells. Parents report that arms and legs stiffened and eyes twitched 8 times. Fever. Odd expressions.   ICD-9 Codes 780.39 Spells.
PT W/ EMESIS, ERYTHEMATOUS FACE + LETHARGY AFTER 4 Y/O VACCINATION. EPIPEN JR GIVEN @ 1000, BENADRYL + PREDNISONE ALSO GIVEN. WITHIN 15MIN LETHARGY WAS IMPROVING. PT WAS MONITORED WITH PULSE OX + VITALS FOR 3 HOURS. DISCHARGED HOME WITH EPIPEN STEROIDS, + ANTIHISTAMINES. STABLE OF BASELINE AT DISCHARGE.
MUSCLE TWITCHING ON THE RIGHT LEG; TWITCHING IN THE BRAIN; CHILLS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, high cholesterol, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced muscle twitching on the right leg. On 02-MAY-2021, the subject experienced twitching in the brain. On 02-MAY-2021, the subject experienced chills. On 02-MAY-2021, the subject experienced muscle aches. On 02-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from twitching in the brain, and fever on MAY-2021, was recovering from muscle twitching on the right leg, and the outcome of muscle aches and chills was not reported. This report was non-serious.
My autoimmune disorder went into overdrive and stayed there. I had joint pain and swelling, severe neuropathy, muscle pain, extreme fatigue and nausea that seems to never end. I still feel nauseated three hours after eating.
patient was administered the product IPOL but the patient was suppose to get 10units of insulin with no reported adverse event; Initial information received on 28-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 57-year-old male patient who experienced patient was administered the product IPV (VERO) [IMOVAX POLIO] but the patient was suppose to get 10units of INSULIN ASPART (Novolog) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 28-Feb-2023, the patient received suspect IPV (VERO) suspension for injection at a dose of 10 U (lot V1A022M, expiry date: 17-Feb-2024 via subcutaneous route in the right arm for immunisation.  On 28-Feb-2023 the patient was administered the product IPOL but the patient was suppose to get 10units of insulin with no reported adverse event (wrong product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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 the guidelines. 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.
Hospitalization: 9/26/2022 - 10/1/2022 Presentation to the ED: Weakness and lethargy.  COVID-19 + date: 9/26/22. Treatment: VANCOMYCIN. Discharge to: SNF.
Within 2 hours after injection, large blood vessel in eye broke.  Lasted about 4 days.  Never had this happen before.
Pt vaccinated with DTP/OPV & experienced allergic event described as becoming somewhat floppy, responded to stimuli, hands & feet became extremely erythematous, face turned pale & crying.
Patient received covid19 vaccination. Prior history of vasovagal when patient received Covid vaccine. After vaccine was successfully administered, patient had complaints of seeing spots, decreased hearing and stated "queasy". EMS responded to evaluate patient. Patient condition improved post 30 min in observation. Patient declined transport.  Patient left without incident. Patient had ride from mother from site.
Fever of 103.6, rigors, chills, vomiting, sever headache, bodyaches
expired dose of Fluzone Quadrivalent administered; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 months old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that expired dose of Fluzone Quadrivalent administered (expired vaccine administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 11-Nov-2019, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On 16-Dec-2019 she also received a second dose (0.25 ml) of the same vaccine lot UP6259LA and expiry date: 30-Jun-2019 via intramuscular route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  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.
Accelerated heart rate; high blood pressure 136/83; Headache; felt a weird sensation in my brain; Chills; night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEXAPRO. Past drug history included: Diflucan, reaction(s): "allergies"; Bactrim, reaction(s): "allergies".  The following information was reported: HEART RATE INCREASED (non-serious) with onset 04Mar2021, outcome "recovered" (07Mar2021), described as "Accelerated heart rate"; HYPERTENSION (non-serious) with onset 04Mar2021, outcome "recovered" (07Mar2021), described as "high blood pressure 136/83"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "Headache"; FEELING ABNORMAL (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "felt a weird sensation in my brain"; CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "Chills"; NIGHT SWEATS (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "night sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypertension, headache, feeling abnormal, chills, night sweats.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.