chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I ended up having a Retinal tear and I had to get like an emergency procedure because of it; I got I have been given emergency eye surgery; Eye pain; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via intramuscular route in left arm in Apr2021 as dose 2, single for COVID-19 immunization in a pharmacy/drug store but not in a military facility. The patient's medical history was not reported. There were no concomitant medications/other products reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient didn't receive any other vaccines prior to COVID vaccine. The patient received the second dose of vaccination in early April around 08Apr2021. In the end of May, the patient started to have eye pain around 28May2021 and ended up having a retinal tear for which she got an emergency procedure/surgery in Jun2021. After that surgery, the patient didn't need anything but at the time of report, the patient started to hurt again and going to have a call with that doctor. It was reported as there was no investigation assessment. The patient was wondering if this could be a side effect from the vaccine since she was reading it on the website which showed there were some instances in the same way which resolved right away. The outcome of the events was recovered in 2021 but also reported as the events been persisting for about a week from the day of report.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events retinal tear and eye pain and the suspect drug BNT162B2 cannot be excluded.    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.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL (lot number not provided). The physician was visiting his dentist and was talking to the dental hygienist about GARDASIL. The dental hygienist said she had a friend whose daughter died after getting the second dose of GARDASIL. It was unknown if the patient sought medical attention. The reporter considered death to be disabling and life-threatening. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, hospital name (if applicable), and healthcare provider name and contact information. Additional information has been requested.
There were no averse events and no treatment required. Patient however was 11 at the time of the vaccine and was given a vaccine for 12 years and over. He returned to clinc for second dose and that is when it was realized that he had been given in error on 11/23/2021 the adolescent and adult dose for Pfizer vaccine. Second dose was not given when he returned.
Headache Pt experienced throbbing frontal headache 30 minutes after receiving 2nd dose of covid vaccine leading to ED visit. Given APAP and ibuprofen.
Covid arm, bump on arm, after first vaccine; Covid arm, rash on arm, after first vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced covid arm, bump on arm, after first vaccine, covid arm, rash on arm, after first vaccine. The outcome of the events limb discomfort, rash was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Information about lot/batch number [BNT162B2] cannot be obtained. No further information expected.
around 1 week before appt (4/16/21)  started noticing pain in underside of right arm,  gradually worsened and moved into axillae area and in to right chest wall.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 09-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Patient received second vaccine, Hepatitis A, in right arm. He was sitting in chair and had stated that he was "okay" after injection. When patient turned in chair to get up, he experienced syncope. Patient slowly leaned forward and bumped his head on the side of the bed. A nurse was able to assist patient to lean back on the chair. Parents declined cold compress for head. No injuries noted and patient stated that he was fine. Monitored patient for 30 minutes and obtained blood pressures with heart rates. Patient stayed in clinic for an hour overall while waiting for siblings to get vaccinations. Patient able to ambulate with a steady gait to car.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included (MERCK STERILE DILUENT lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 01-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1803USA003986: US-009507513-1803USA007255: US-009507513-1803USA007257: US-009507513-1803USA007258: US-009507513-1803USA007259.
Red, swollen, hot on left arm x 2 days. (-) lymphangitic, resolving, and fluctuance
Pain from vaccination site spread to under arm then got vertigo. Did not respond to a Medical location. Did not seem to be life threatening.
Had another event; Patches of red all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Patches of red all over her body) and VACCINATION COMPLICATION (Had another event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Patches of red all over her body). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had another event). At the time of the report, RASH ERYTHEMATOUS (Patches of red all over her body) and VACCINATION COMPLICATION (Had another event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided reporter. Treatment medications were not provided by reporter.   This case was linked to MOD-2021-236619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow-up information received on 04 Feb 2021. Added new adverse event vaccination adverse reaction. On 22-Apr-2021: Follow-up information received on 22 Apr 2021.Updated reporter's contact details. On 24-Jun-2021: Follow-up information received on 24 Jun 2021 included re-challenge details of the suspect vaccine.
On 4/20/21 visited a Clinic for stomach cramps, gastric issues, fullness and bloating with no cause.  Urine test was negative.  On 4/22/21 has abdominal ultrasound that was normal. On 4/23/21 went to PCP and did blood work but no dx.  Iron was low and platelets high.  On 4/27/21, went to see Gastro doctor and ct scan ordered and was normal.  On 5/14/21 went to hematologist.  On 5/22/21, dizziness and head spinning.  All vitals were fine but became nauseous and vomitted (same issue on 5/23).  On 6/2/21 had an iron infusion.  On 6/4/21, did well woman with OBGYN, normal. On 6/29/21; left shoulder pain for two weeks and went to PCP and inflammation.  Began therapy for shoulder. On 12/15/21, had booster and on 12/26/21 dizziness occurred.  01/10/22 went to ENT doctor and no vertigo.  unable to detect cause of dizziness.
This infant's right thigh, the area where vaccines were given swelled 2 - 3" (per mom). It was red, and warm to touch. The mother called after hours service to report. She called the next day at the office to report, the swelling had decreased and the patient was doing fine.
mild pain; This is a spontaneous report received from a contactable consumer (patient's sister). A 52-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 08Jan2021 13:15, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild pain on 08Jan2021 in the evening. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
In February had shortness of breath while walking upstairs and low hgb; workup showed appendix cancer needing major surgery
Small red irritation starting about 3 hours after injection. Increasing in size to 4 inches in diameter 48 hours post injection and is ongoing. Itchy, swollen, hard to the touch, and very painful.
Patient developed maculopapular rash 8 days after 2nd Moderna COVID-19 vaccine on 1/23/21.  Pt reports waking up on 1/31/21 with an itchy macular, papular rash on trunk, back, face, scalp, arms, hands and feet.  She took Benadryl and Zyrtec later which helped.  Rash is mostly resolved on 2/1 and now very faint.
At 8:40 PM, about 40 hours after vaccination, started to feel itchiness in mouth and throat with coughing and swelling of lips. Throughout the night had chills, nausea, and headache. Symptoms mostly cleared up by 8AM the next morning.
herpes zoster oticus/Ramsey Hunt syndrome/vesicles in right ear/vertigo/problems with balance/ear pain; vomiting; Hearing loss; Shingles; Bell's Palsy/right sided facial weakness, tingling and numbness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 24-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered vesicles in right ear, vomiting, vertigo, problems with balance, hearing loss, ear pain, right sided facia weakness, tingling and numbness and was diagnosed with shingles (herpes zoster), Bell's Palsy (facial paralysis), Ramsey Hunt syndrome and herpes zoster oticus (herpes zoster oticus). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had 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. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis was not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster oticus, herpes zoster, vomiting, deafness and facial paralysis were considered disabling event by the reporter.  Upon internal review, herpes zoster oticus, deafness and facial paralysis were considered medically significant events.
From 6pm-5am I experienced a terrible migraine,  horrible body aches (every joint and muscle was throbbing), upset stomach, uncontrollable shaking/chills, and light headedness. Could only sleep short spurts after taking 400 mg of Ibuprofen. 24 hours after the vaccination, my body is still achey, sore at injection site, and uneasy stomach.
Two days after receiving the vaccine I woke up and my right eye was almost swollen shut, and my eyelid was very red.  Eczema rashes in various spots on my face began appearing on my face for the next two weeks; temples, chin, forehead, cheeks.    I made an appointment with the dermatologist and was prescribed a steroid gel to apply, and had to discontinue after 30 days, as per dermatologist suggestion.  The eczema faded and calmed down a bit in some areas, but then came back with a vengeance on 12/26/21.  I woke up and my left eye was almost swollen shut, eye ball was very bloodshot, eye lid bright red, and another spot on my chin and forehead.  My face continued to get red, itchy and flaky in almost every area of my face.  I am still experiencing redness and flaky patches, with bumps and oozing.
20 minutes after injection, my throat began to itch. I had to "clear" it by coughing. Shortly after, my whole body became itchy - including my face and neck. I did not notice any hives. Symptoms subsided after I took Benadryl and there were no similar symptoms once the Benadryl wore off.
"Moderna Arm" swelling, redness, and pain around injection site. Redness and swelling formed about a 3inch diameter circle around the injection site.
The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up  information on 10Feb2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer Sponsored Program.  A contactable physician, a contactable consumer reporting for herself and a contactable nurse reported that this 72-year-old female received PREVNAR 13 on an unspecified date, at single dose, for immunisation and REVATIO; (Film-coated tablet) oral from 2010 and ongoing at 20 mg, 3x/day, for pulmonary hypertension. Medical history included ongoing hypertension, ongoing atrial fibrillation and ongoing depression. Concomitant medication included CELEXA ongoing, once daily, for depression. The patient experienced pneumonia on an unspecified date in Dec2016 after receiving pneumococcal 13-val conj vac (dipht crm197 protein) and sildenafil citrate. The patient was hospitalized for pneumonia from an unspecified date in Dec2016 to an unspecified date in Jan2017. The patient underwent blood test on an unknown date when she was in the hospital. The action taken in response to pneumonia for sildenafil citrate was unknown. The patient completely recovered on an unspecified date in Jan2017. The patient did not provide any information to the reporting nurse regarding pneumonia with the use of the suspect products. Follow-up (27Feb2017): New information from a contactable nurse includes: confirmation that the patient did not provide any information to the reporting nurse regarding pneumonia with the use of the suspect products. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment. Based on the information currently available, the company does not attribute the event pneumonia to sildenafil citrate. 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.
VZV given on 1/8/01. Pt presents on 1/29/01 with a rash consistent with mild varicella. No fevers; blanching, erythema, circular lesions 2-7mm macular, some papular and a few with vesicles over trunk and extremities. Spares palms, soles and oral cavities.
Pt was given Kinrix which already has Ipol and a dose of IPol. Discovered when Inventory count was done. Provider Review, with no Adverse reactions callout to pt's mother, waiting call Back
Dry cough until December 15, then, cough with mucus.  To date am coughing up and wheezing.  Taking otc cold and cough syrup. I am on second bottle. At times I feel fine, then, relapse and cough and wheeze. The mucus is thick, it started out clear, then, yellow, now white and clear.
Headache, NauseaVomiting Sore throat w/ swelling, runny nose Narrative:
Patient was given double doses.  .25 mg x 2.  Fever 100, malaise, fatigue, chills.
Pt. called the day after receiving the vaccine, states it started in the morning with erythema on the site of injection, swelling and redness on her shoulder up the side of her neck, numbness of her cheek, and a change in her left eye. She also was dizzy.
11 days after vaccination, developed redness, itching, warm area 3 inches in diameter at vaccination site. Also experienced minimal soreness of vaccine site.
The patient called stating she had random hives and joint pains that began several hours after receiving both the Fluzone HD and the Pfiizer Covid vaccine. She was not having any swelling of the mouth or throat and no difficulty breathing. I advised her to contact her doctor but she does not have one currently. I then advised her to keep an eye on the reaction and go to the ER if she does experience difficulty breathing.
Two days, post vax, pt experienced an injection site rash that extended down the arm, spread to the hip, buttocks, then radiated to the left side. There were greater than 50 lesions. The pt also experienced itching. the lesions faded in 5 days and were no longer visible at the time of the report.
My left arm at the injection site is very hot and red. It also is itching. It is still very sore to lift my arm, even after 4 days
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 5 year old female patient (child). On 26-FEB-2014 at 09:05 am, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
The next morning after my vaccine I got my period which was very heavy for 5 days with very bad cramps for the entire 5 days. I had not gotten my period since 12/26/2020 and thought I was starting menopause.  The only treatment was taking three Advils  every four hours.
pt devel severe diarrhea & irritability;MD reported that pt has been exp persistent neutropenia for the past 3wk that is thought to be a viral suppression from vax;pt "looks great" however appetite is almost gone & is not eating; A physician reported that a 2 month old male received Rota Shield, Hib-Titer, Infanrix, Engerix-B, and IPV vaccines on 07/05/1999.  On 07/07/1999, the infant developed "severe" diarrhea and irritability.  The physician reported that infant has been experiencing persistant neutropenia for the past three weeks that is thought to be "a viral suppression from the vaccine".  On 07/28/1999, the physician saw the infant and reported that "he looks great"; however, appetite is "almost gone" and he is not eating.  Because of the lack of appetite, an upper gastrointestinal series was performed; it was negative.   White blood cell count as of 07/28/1999 was 7300/mL and ANC 511/mL.  This event is considered medically important.  Copies of this report have been forwarded to the manufacturers of concomitantly administered vaccines.
Pt experienced swelling immediately following injection. Pt was observed for 15 minutes following injection. After 15 minutes, pt left arm was red with a rash approximately 6 in in length. Site was warm to the touch. Pt denies pain or itching and denies any difficulty breathing.
Approximately 8-10 days post-vaccination, pt developed neck strain, neck stiffness, and lesions on her scalp. Later she found painful pustules on her scalp. On the first two visits to the doctor, 12/03/09 and 12/09/09, she was misdiagnosed and continued suffering. On 12/11/09 she made a third visit to the doctor and was diagnosed with shingles. She was then treated with anti-viral course and as of 01/05/2010 she has completed her anti-viral course and is recovered. The diagnosis of shingles was made clinically by the doctor (not based on lab test results). She had chicken pox previously. (about age 22).
Suddenly went limp, pulseless and cyanotic.  Needed CPR then came to and was breathing spontaneously, had a HR of 60 and then after a few min went blue again and pulseless. CPR started again. Transferred to ED via EMS and needed CPR for about 3 hrs, ended up on ECMO with severe cardiac arrest and V tach.