chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was 28 weeks pregnant and was known to be GBS positive with no other relevant medical history. EDD 07/01/2019. Pt was given a possible ineffective vaccine due to a temperature excursion of -0.2 degrees Celsius for estimated less than a minute, but was under the recommended 2 degrees Celsius for an estimated 12 minutes. The excursion was noted on 04/09/2019 et per manufacturers review was notified ok to use vaccine, later identified per email from manufacturer a miscommunication may have been noted. Manufacturer recontacted and was noted to have been a miscommunication as interpreted as 0.2 degrees Celsius vs actual -0.2 degrees Celsius and was then noted to not give and discard any/all of the in stock lot number 97NL3, which had then been notified patient already received vaccine. No adverse outcome noted at this time, patient was notified and offered revaccination due to possibly receiving ineffective vaccine and patient declined at 04/24/2019 visit.
11/17/21 presents to ED for "SOB" "productive cough". PMHx of "alcoholic cirrhosis currently undergoing evaluation for liver transplant, HTN, obesity"
Patient's upper right thigh, where the vaccines were administered, was damaged immediately. The indent has since "grown" to become deeper and has turned a deep blue in her leg. This is because the fatty tissue was damaged and dissolved at time of vaccination. She has not been able to build any muscle in this limb, due to the pain and discomfort of the injury. This has affected her mobile development. After the vaccination, patient developed a severe aversion to eating in all forms (breastfeeding, would refuse all bottles and supplementation and supplementation efforts, including pumped breast milk and several formulas, and later would refuse all solid food until about 9 months of age). She would eat just barely enough to survive, hence, she fell off the growth chart and stopped gaining weight for several months. She developed severe gastrointestinal issues, including reflux, slow stomach, etc. She stopped having bowel movements and has had adverse reactions to 4 common allergens.
Limping a bit today only going up the stairs; Trouble going up the stairs with joint pain in her right hip; Pain and soreness in her hip; A spontaneous report was received from a pharmacist, who was a  51 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced trouble going up the stairs with joint pain in her right hip, limping a bit today only going up the stairs, and pain and soreness in her hip.   The patient's medical history included exercising. No relevant concomitant medications were reported.   On 24 Dec 2020 at 11:30 or 12:00, about three hours prior to the events, the patient received her first of two planned doses of mRNA-1273 (batch 039k20a) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, around 15:00, the patient noticed she had trouble going up the stairs with joint pain and soreness in her right hip. She did not have any pain or soreness at the injection site, only in her hip. She was limping a bit today only going up the stairs. She had not treated the pain.    Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the evets trouble going up the stairs with joint pain in her right hip, limping a bit today only going up the stairs, and pain and soreness in her hip were unknown.; Reporter's Comments: This case concerns a 51 year old, female patient. The patient's medical history is not provided. The patient experienced trouble going up the stairs with joint pain in her right hip, limping a bit only going up the stairs, and pain and soreness in her hip. The event occurred on 24 Dec 2020, about 3 hours after the administration of the first dose mRNA-1273. The reporter causality assessment for the event was not provided. The sponsor assessed the event as possibly related to the mRNA-1273 vaccine. Pain of the joint is listed on the company's fact sheet for the healthcare providers. Additional information regarding the patient's medical history and concomitant medications will help to further assess the event of limping.
On 4/24/2021, noticed the tingling and itching sensation on my top lip that happens whenever a cold sore is about to present.  Took my prescribed Valtrex and it resolved in about 48 hours.
Beginning July 1999, symptoms mimicking rheumatoid arthritis in some ways have been persistently present. Debilitating pain and inflammation in knees is primary symptom, but there has also been chronic fatigue, and other arthralgia. This is not RA, and Sjogren's has also been ruled out. Follow-up information per pt, "Ongoing auto-immune arthritis symptoms. Still unresolved diagnosis or treatement plan as of 7/01/01.
This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report is in regards to an event reported in the patient's past medical history. A currently 66-year-old female patient of an unspecified ethnicity started to receive codeine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), PREVNAR (Lot number unknown), formaldehyde solution, lanolin, PLAQUENIL, via an unspecified route of administration from an unspecified date at an unspecified dose for unspecified indication. Medical history included latex allergy, shellfish allergy and nickel sutures allergy from unknown dates. The patient's concomitant medications were not reported. The patient experienced allergies to codeine, formaldehyde, ibuprofen, iodine, lanolin, PREVNAR, PLAQUENIL on an unspecified date. The action taken in response to the event for all the drugs were unknown. The outcome of allergies to codeine, formaldehyde, ibuprofen, iodine, lanolin, PREVNAR, PLAQUENIL was unknown. Pfizer is Marketing Authorization Holder of codeine and ibuprofen in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of codeine and ibuprofen has submitted the same report to the regulatory authority. The batch/lot number for pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up.
chills; headache; feverish; sore throat; tired filling; aching; nausea; trembling; jaw ache; teeh ache; rapid heart beat; dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 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, immediately after receiving Shingrix, the patient experienced chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness. On an unknown date, the outcome of the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness were recovered/resolved.   It was unknown if the reporter considered the chills, headache, fever, sore throat, tiredness, pain, nausea, tremor, jaw pain, toothache, heart rate increased and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced headache, feverish, sore throat, chills, tired feeling, aching, nausea, trembling, jaw ache, teeth ache, rapid heart beat, dizziness for 4 months since second dose. The reporter reported to son who was a doctor and friend and sister and pharmacy where he/she received shot. Consent to follow up was granted.      Lab Comments: On an unknown date, lab test was performed.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 11:30 as dose 1, single (Lot number: EP7534), in left arm, on 03Apr2021 at 11:00 as dose 2, single (Lot number: EW0151), in left arm, on 25Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 27Jul2022 at 11:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN (Brand: pharm), start date: 05Jul2010; GABAPENTIN (Brand: Aurobindo), start date: 01Apr2022, also reported as other medication in 2weeks. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin"; Dilaudid, reaction(s): "Known allergies: dilaudid". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Oct2022) Negative; (20Oct2022) Positive, notes: Tested positive for COVID-19 48 hours after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid, started on 10Oct2022 and stopped on 15Oct2022. Clinical course was reported as, Tested positive for COVID-19 on 20Oct2022 at 08:00, 48 hours after testing negative, 5 days after finishing full course of Paxlovid. Patient not received any treatment and was recovering.
Pt left arm, red, swollen, hot to touch. Started 2 hours after injection. 6 cm n diameter 2+ pulses (wrist).
At around 9 hours after receiving the MCV-4 (Meningococcal) vaccine patient began running a fever. His symptoms progressed through the night into fever, nausea, diarrhea, sensitivity to light, and numbness in feet. At around 24 hours after vaccine was administered, patient's mother contacted clinic in regards to his symptoms. Clinic recommended patient to report to Emergency Room for further treatment.
Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago.  Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do.  She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021  Information about batch/lot number has been requested.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil. On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot # unknown) injection. After receiving the second dose the patient developed a rash at the injection site. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. No further adverse event information was given. Additional information has been requested.
flushing on chest; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FLUSHING (flushing on chest) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced FLUSHING (flushing on chest). On 05-Jan-2021, FLUSHING (flushing on chest) had resolved.        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 information was not reported.   Reporter did not allow further contact
Erythema multiforme consider a poss reaction to vax? MMR? was seen by MD 18MAR92;
I noticed my body temperature becoming warm approximately 1 1/2 hours after receiving the vaccines. I then noticed at  2/12 hours, I had a red, blotchy rash on my chest, neck, back, arms and abdomen.  It was not itchy, I was warm and red. I did feel a slight fullness in my throat, but I was not short of breath.  For treatment, I was given 50 mg of oral benadryl immediately. I was admitted to the emergency department and given 10 mg of IV decadron and pepcid (I don't know the dose). The redness dissapated at 1 hour after the decadron. And I felt "normal" without any side effects approximately 3 hours after the decadron.
12/3/02am red rash at injection site-non-tender. Two weeks prior received varicella.
abscess in her mouth; sore arm at injection site; This is a spontaneous report from a Pfizer-sponsored program a Regulatory Authority .   A contactable female (Patient) of an unspecified age (Age: 66; Unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 24Feb2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not re-ported. On 24Feb2021, the patient experienced sore arm at injection site and on an unspecified date she experienced abscess in her mouth. Patient was prescribed with 500 mg Amoxicillin to take, while patient wanted to know would that affect efficacy of the vaccine. The outcome of the events was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Experienced hives/rash - treated with BENADRYL/history asthma inhaler.
Developed left leg pain and swelling, was diagnosed by ultrasound with a DVT in the left lower extremity  Narrative:  The employee reports developing acute leg pain and swelling during an evening martial arts class. He was diagnosed that night by ultrasound with a DVT of the left lower extremity. Denies any history of prior DVT.
Fever of 101; terrible headache; muscle aches and more; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included idiopathic thrombocytopenic purpura.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, headache and muscle pain. Shingrix was discontinued. On an unknown date, the outcome of the fever, headache and muscle pain were unknown.   It was unknown if the reporter considered the fever, headache and muscle pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported.  The age group was captured as an adult as per vaccine indication. The patient had an Idiopathic thrombocytopenic purpura (ITP). The patient received Shingrix injection a week and a half before reporting, within 12 hours he/she began with fever of 101 degree F, terrible headache, muscle aches and more. The patient's primary said he/she should not take the second vaccine.
her arm was sore at the injection site; had body aches; have bouts of vomiting; began to have bouts of diarrhea; she is tired from having to get up during the night to handle these symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain, vomiting, diarrhea and tiredness. On 5th February 2020, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the injection site pain and diarrhea were not recovered/not resolved and the outcome of the general body pain and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, vomiting, diarrhea and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of the Shingrix Monday in the afternoon.   On 3rd February 2020, same evening her arm was sore at the injection site and she had body aches.  During the night she had bouts of vomiting and diarrhea. This had continued.   On 5th February 2020, she still had the diarrhea.   The patient was tired from having to get up during the night to handle these symptoms. The reporter consented to follow up.
3/25 Pt improved, pending discharge. Potential delay due to transport issues. Okay to transport by family if medical transport not available. Dc'd with steroid taper and 2 additional days of paxlovid to complete course.    Assessment and Plan Patient is a 87 y.o. male patient of, MD with history of BPH, hypertension, hyperlipidemia, osteoarthritis, obstructive sleep apnea presented with hypotension and COVID-19.   Generalized weakness Hypotension Likely secondary to COVID-19 infection and dehydration. No leukocytosis.  Dehydrated and hypotensive responded well to IVF Urine dipstick-unrevealing. No bacterial source of infection Blood culture sent from ED-no growth to date Consulted PT/OT -recommendation is SNF Resolving  Covid-19 Virus Infection Date of onset of symptoms: 3/19/2023 Symptoms present on admission: Generalized weakness, cough. Tmax 102.6 on 3/20/2023 and 101.2 on 3/21/2023. T max 101 on 3/22/2023 Date of covid positive test: 3/20/2023 Vaccination status: vaccinated Imaging: Chest x-ray nonacute CRP 55.3, LDH --208, ferritin 644 Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: Steroids and Paxlovid Consultants following: Infectious disease Anticipated special isolation end date: 3/27/2023   Continue Paxlovid, hold Sonata while completing course per ID 3 days of 5 completed in house, continue 2 additional days on DC Prednisone taper on discharge   Acute exacerbation of asthma Likely precipitated by COVID-19. Has wheezing on lung exam today with rhonchi PO steroids taper on DC Duonebs prn on DC then albuterol prn   NSVT 6 beats NSVT on 3/22/2023. Improved/did not recur with correction of electrolytes and treatment of covid Hypertension Home Rx: Toprol-XL 12.5 mg daily. Toprol-XL with holding parameters   Hyperlipidemia Resume statin   Elevated troponin Serial troponin 44> 40 No active chest pain.  Not consistent with ACS No further w/u needed at this time   Insomnia Sonata HELD with on Paxlovid  Obesity BMI 31.01   Dementia Reviewed OV notes from neurologist Dr. According to his notes, MRI consistent with a vascular parkinsonism and likely mild vascular dementia.  Did not respond to Sinemet Caregiver for wife who has severe vascular dementia who is verbally and physically violent. Continue Wellbutrin 300 mg daily
COVID; COVID; MODERNA COVID-19 VACCINE, on 06Dec2021 as dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP7534), in left arm and on 17Apr2021 as dose 2, single (Lot number: ER8729) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 as dose 3, (booster), single (Lot number: 06OH21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Past drug history included: Diflucan, reaction(s): "Drug Allergy"; Miconazole, reaction(s): "Drug Allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Jul2022, outcome "not recovered", described as "MODERNA COVID-19 VACCINE, on 06Dec2021 as dose 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Positive, notes: I took a test on 3Aug prior to symptoms returning and it was very faintly positive; (05Aug2022) Positive, notes: On 5Aug I felt sick again and took another test which was very bright and clearly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, interchange of vaccine products.  Clinical course: COVID rebound after finishing a course of paxlovid from 28Jul2022 to 01Aug2022 for the treatment of covid. She took a test on 03Aug prior to symptoms returning and it was very faintly positive. On 05Aug she felt sick again and took another test which was very bright and clearly positive. Symptoms aren't as severe as the first infection so far.
Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have patients describe migraines where noises make them feel dizzy, but I did not get a headache. Movements, lights and noises made the symptoms worsen. I was feeling better by the 21st and now symptoms have resolved.
Vaccine had been mixed with too small amount of diluent, suspect 0.8cc versus 1.9cc
Swelling 10 x 8cm (L) deltoid with erythema. (L) axillary node 3 x 5 cm.
Terrible rash all over her body; Eczema; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated she received the COVID vaccine on the 01Feb2021 and from 02Feb2021 she started experiencing terrible rash all over her body. She said she did not have difficulty in breathing. She saw her doctor and her doctor said it was eczema. She said she wanted to know if she could take the second dose of the vaccine. The outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.