chrisvoncsefalvay/vaers-outcomes huggingface dataset:
permanent neuropathy on the left side of her face; blurry vision; Zoster/ shingles; Zoster Conjunctivitis; ear infection; vertigo; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. No information regarding the pt's concurrent conditions, medical history, drug reactions or allergies, and concomitant medications was provided. In or around June 2016, the patient was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine adult health maintenance and for its intended purpose: the prevention of shingles. On 16-JUL-2018, the pt presented to a medical center with complaints of dizziness and pressure in her left ear, sinuses and left sided jaw pain. During this admission, the pt was diagnosed with vertigo and ear infection. On 19-JUL-2018, the pt returned to the medical center with complaints of left sided eye and facial pain with redness. During this admission, the pt was noted to have a rash on the left side of her nose and forehead along with clear drainage from her left eye. A doctor diagnosed the pt with zoster and zoster conjunctivitis. The pt's shingles outbreak lasted several weeks. The pt had permanent neuropathy on the left side of her face and she continued to have blurry vision in her left eye that required ongoing treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company wrongful conduct, the pt suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company conduct, the pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of zoster was recovered (exact date not provided). The outcomes of the other events were considered not recovered.  The established events were considered to be disabling. Upon internal review the events of zoster conjunctivitis and neuropathy were considered to be medically significant.
Patient indicated that he fainted/passed-out in front of the ice cream freezers. He bumped his head/face when he fell. he came to, and reported to the pharmacy. The nurse and TLC and the pharmacist sat him down, checked his pulse, blood pressure, O2 saturation, and got him a bottle of water. He was very pale, and his pulse was low.
This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of upper arm pain in a 57-year-old female subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced upper arm pain and pain in lower arm.  At the time of reporting the outcome of the events was unspecified.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Dose Number 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (Pfizer COVID 19), administered in arm left, administration date 05Oct2021 (Lot number: FF2590) at the age of 59 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: El3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021, outcome "unknown", described as "Dose Number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms". Symptoms included fever 102 F, sore throat,muscle pain, headache, loss of taste all on 19Nov2021, unknown treatment. The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) 102 Fahrenheit; sars-cov-2 test: (21Nov2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
pt recv vax 6AUG97 & 8AUG97 pt devel chickenpox w/greater than 1000 lesions & temp 102;
VARIVAX vaccine x 2. Exposed to aunt with shingles 1 month ago. Seen 4/2/12 - headache, fever all night, chills, sweats, on OMNICEF (3/28/12) for infected earlobes. Earlobes healed / viral illness - symptomatic Rx. Seen 4/3/12 - papular rash, (not pustulant or vesicular) getting new spots every few hours - consistent with mild chicken pox.
C/o tightness in chest & throat 20 mins after receiving vaccines and ERYTHROMYCIN. Has allergy to CECLOR, was given BENADRYL returned to division.
Nausea; cold; Chills; This is a spontaneous report from a contactable consumer (Patient) via a Program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) dose 2, via an unspecified route of administration on 10Mar2021 (age at vaccination: 71years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medications were not reported. Historical vaccine included dose 1 of bnt162b2 (Lot number was not reported) on 17Feb2021. She experienced nausea, colds, and chill a day after the 2nd dose that is on 11Mar2021, while her husband experienced the same symptoms 2 days after the 2nd dose. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
6 min post injection felt cold, lightheaded, HR increased to 155, and became flushed.
This spontaneous report received from a patient concerned a 65 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Previously patient could see better with his right eye. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 in total administered to left arm on 03-AUG-2021 for prophylactic vaccination. Age at time of vaccination 7 decade old. No concomitant medications were reported. On 05-AUG-2021, two days after the vaccination patient started complaining about a decline in vision with his right eye and since then his vision has not improved and he cannot able to read. His doctor told him that it could be a cataract, but the eye specialist said that his cataract was minor. Patient was upset on how his vision declined after the vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from minor cataract of right eye. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220414931- Covid-19 vaccine ad26.cov2.s - minor cataract of right eye. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Per patient- at 1200 about 45 minutes after receiving influenza vaccine she began to feel swelling in throat and face, palms became sweaty. She took oral BENADRYL and the symptoms went away about an hour later. That same day about 5-6pm she had another episode of the same symptoms and again took oral BENADRYL with relief of symptoms.
Patient seen on 12/3/09 by APRN for Well Visit, pt. was diagnosed with Otitis Media, prescribed Amoxicillin, MMR, Varicella, Hep A and PCV given. Patient developed a rash on 12/11/09, no fever.
Pt. presents to clinic on 11/13/2023 with c/o left arm being sore. She reports having both COVID and influenza vaccines administered on 10/22/2023. She states the pain in her left arm started at that time and did not go away. She reports some redness and warm to touch at the time of injection, but it did not persist.  Soreness has gotten persistently worse and she now needs assistance getting dressed. She was prescribed warm compresses, acetaminophen and ibuprofen PRN, Prednisone 20 mg , 2 per day x 5 days. Physical therapy was also prescribed at this time.
Could have received only the adjuvant portion; Could have received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: Healthcare professional reports that the clinic was currently investigating whether or not patients could have received only the adjuvant portion of Shingrix. It was currently unknown whether one or more patients received adjuvant-only.  No further details were available at time of call. The reporter consented to follow up from safety. Additional Supportive Information: The reporter reported that the clinic was currently investigating whether or not patients could have received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Pruritus, internal tremors, began 2 hours after injection - BENADRYL 12.5mg IM, DECADRON IM - then c/o chest discomfort. EKG done.
Numbness, pain in elbow, wrist and hand joints,  severe shaking in arm of injection 15 minutes after injection, large, tender and itchy swollen mass on upper arm approximately one inch from injection site. Itchiness and pain started roughly an hour after injection, red bump about an inch and a half in diameter appeared 6 and a half hours after injection.
Lost consciousness in a footrace while walking, no memory of a fall, required assistance to get to finish line
extensive  hives and redness on L leg and arms, extensive soreness of whole rt shoulder lasting 5+days
Swollen ankle after Moderna Covid 19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a respiratory therapist and describes the occurrence of JOINT SWELLING (Swollen ankle after Moderna Covid 19 vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swollen ankle after Moderna Covid 19 vaccine). At the time of the report, JOINT SWELLING (Swollen ankle after Moderna Covid 19 vaccine) 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.; Sender's Comments:  :MOD21-099943
-slight lightheaded feeling after vaccination-pt. indicated that it was very slight, brief had subsided -reported next day redness and irritation at injection site with slight fever (99 deg) and swelling -MD said to take Benadryl on 6/28 and did not require office visit
Tired/fatigue; Headachy; a puffy corner on the side of her eye; toothache; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 21May2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported she received the second dose of BNT162B2 on 21May2021 and she was still feeling tired and "headachy." She also had a puffy corner on the side of her eye and a toothache that developed right after the vaccine. The patient had a video appointment with her doctor, and they were unable to see the puffiness but gave the patient a referral. The patient reported she was now (as of 25May2021) experiencing headache and fatigue even a few days after the vaccine. She inquired if it was common to last this long, if she could call out of work, and if tooth pain was a reported side effect. The clinical outcomes of tired/fatigue, "headachy," puffy corner on the side of her eye, and toothache were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient received dose 1 of pfizer vaccine on 8/14 after previously vaccinated with Janssen vaccine on 4/1
PT RECEIVED MONOVALENT PFIZER INJECTION (EVEN THOUGH PT WANTED BIVALENT PFIZER). THIS WAS DOSE  #4. PT MADE AWARE OF INCIDENT AND TO COME BACK IN 2 MONTHS TO GET THE OMNICRON BIVALENT ONE. TOLD PT TO UPDATE THEIR COVID CARD TO CORRECT LOT NUMBER.
Red, itchy rashes resembling "goose bumps" or poison ivy  on both arms including both shoulders, both upper arms, both forearms, both wrists. The left and right arms have almost identical patterns. It is not only in the arm that got the injection. Rashes are also on both legs and shins. The rashes appeared approximately 5-6 days after the first dose on Jan. 18 and continue to spread .
Within 5 hours of receiving the vaccine, pt. began complaining of nausea and stomach cramping.  He pointed to his upper abdominal as well as his lower abdominal area as sources of sharp pain and discomfort.  Each day following his symptoms compounded including diarrhea and vomiting regularly through out the day.  Within 1 week, he had lost 8 lbs and was unable to eat most days.  We have had to incorporate high protein Boost/Ensure drinks to attempt to get Calories into him, but he can only consume a few ounces at a time before becoming nauseous.  He cannot eat more than a few bites or a few ounces of fluid at a time and we attempt to feed him 8-10 times a day now just to get Calories in.  He has a scheduled appointment with his doctor next week (earliest available appointment).
Rash to neck, chest, BL arms, BL thighs (5/15/19) Chills, headache, & body aches (5/13/19)
1/21/03 - PT received #6 Anthrax with 2.5 yr between dose 5 and 6. First 24 hrs had an ache, sting took Tylenol. 1/22 - increased aching site swelling began with increased left arm pain. Tx with naproxsy/Tylenol/ice. 1/23 - Woke with increased swelling redness, tried to get seen by sick call ?? Fill up report with T2, increased swelling down arm with joint pain, back pain. 1/24, Gone to vaccination clinic seen by an MD and sent to IL (?).
Doses Administered Past BUD; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses Administered Past BUD) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (Doses Administered Past BUD) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses Administered Past BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided. Date Shipped: 22 Feb 2021 Approx BUD: 26 Mar 2021
ACUTE PULMONARY EMBOLISM 10/28/2021 WEAKNESS OF BILAT LEGS ACUTE PULMONARY EMBOLISM 10/28/2021 DM 2 W HYPERLIPIDEMIA ACUTE PULMONARY EMBOLISM 10/28/2021 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 10/28/2021 ABDOMINAL PAIN
This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported for a 94-year-old female patient (reporter's mother) that she received PREVNAR 13 (Lot Number and Expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for pneumocal vaccine. The patient medical history and concomitant medications were not reported. The patient received the vaccine and had redness and mostly local reaction on an unspecified date. She did not know when this happened other than it was within the last 6 months. The outcome of the event was unknown. Follow up has been requested for lot/ batch number.
Patient admitted to LTACH with increasing oxygen requirements.  Tested positive for COVID.  Patient developed cardiopulmonary arrest. ROSC was unable to be obtained.  Patient CTB
the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-AUG-2020, the patient was vaccinated subcutaneously with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: rha, lot # T001187, expiration date: 11-JUL-2020 (dose was not reported) for prophylaxis (reported as "well check"). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 1 hour and 15 minutes in the temperature between -9 degrees Celsius (C) and 8 degrees Celsius (6.1C) and for an unknown time frame in the temperature from -9 degrees Celsius and 8 degrees Celsius (-6.1C) (multiple excursions). There was no previous temperature excursion. Digital Data Logger was involved.  The outcome of product storage error was unknown.
Patient developed itching at site of injection and had "lump in throat" on evening of injection--resolved with no treatment.  Developed severe upper arm pain during that night.  Now arm feels better but is still tender.  Today (9/25/06) upper arm feels warm to touch and has palpable lump above area of injection.  B/P 108/80, no lymphadenopathy.
Asthma; Ended up getting Covid-19; Ended up getting Covid-19; Sick; very weak; This is a spontaneous report from a contactable Nurse. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. It was reported that patient had been very careful even after being vaccinated. She had been mask-wearing even after second vaccine but on an unknown date in 2021, she was ended up getting Covid-19 and it's been a month and she was still sick. She was hospitalized because she has asthma, she was still very weak which was horrifying because she was an active woman. In 2021, the patient underwent COVID-19 test which resulted positive. Outcome of the events sick and very weak was not resolved and whereas other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: The possibility of COVID-19, Drug Ineffective, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out. As there is limited information in the case provided, the causal association between the event "asthma" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is 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.
Hospitalized with rapidly progressive transverse myelitis of thoracolumbar spine, onset of symptoms 9 days after second booster (fourth of series), currently paraplegic on high dose steroids.  Multiple CSF and serologic studies sent and pending
Severe lymphadenopathy (golf ball size near left clavicle); fatigue; muscle aches; This is a spontaneous report from a contactable consumer. A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN9581), dose 2 via an unspecified route of administration, administered in Arm Right on 10Feb2021 15:15 as DOSE 2, SINGLE, and bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 15:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism and food allergy (allergies Cantaloupe) from an unknown date. Patient previously took bnt162b2 for covid-19 immunisation. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication. The patient experienced severe lymphadenopathy (golf ball size near left clavicle), fatigue, muscle aches on 12Feb2021 06:00. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 16Feb2021. Outcome of the events was not recovered.  No follow-up attempts are needed; no further information expected.
Fever; Chills; Nausea; Loss of Appetite; Shoulder pain; sweating; This case was reported by a physician via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received the 2nd dose of Shingrix. On 24th May 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, nausea, appetite lost, shoulder pain and sweating. On 25th May 2019, the outcome of the shoulder pain was recovered/resolved. On 27th May 2019, the outcome of the fever, chills, nausea, appetite lost and sweating were recovered/resolved.   It was unknown if the reporter considered the fever, chills, nausea, appetite lost, shoulder pain and sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix on Friday afternoon and then experienced 3 days of sweats, fever, no appetite and nausea.   The patient stated it was the worse medical experience of their life. The reporter consented to follow-up. This case was linked to case US2019096176 through same reporter.