chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure/still get mild cases; still get mild cases; very painful; nerve damage in both feet; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and nerve damage. On an unknown date, the outcome of the vaccination failure, pain and nerve damage were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shot and still get mild cases of shingles once in a while. The patient stated that shingles were very painful and had nerve damage in both feet.  The patient stated that had that for years but not cure. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and allergies were not reported. On unspecified dates since 14-DEC-2015, the unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX lot number L018002 with expiration date: 19-MAY-2017, lot number L025209 with expiration date: 07-JUL-2017, lot number L028277 with expiration date: 28-JUL-2017, lot number L023587 with expiration ate: 26-JUN-2017, and lot number L015048 with expiration date: 29-APR-2017, (strength, dose, frequency, route and anatomical location were not reported), which were exposed to temperatures outside the recommended range. Other suspect and concomitant therapies were not reported. Not adverse events were reported, and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Since the day after the last shot I have been extremely run down. I can?t make it through a full day without a nap and I can?t stay up late without struggling
Arm was hurting a little on day of injection two days later had to leave school early with nausea, headache, and developed a cough. Stayed in bed for 2 1/2 days. Now he is vomiting, coughing, and wheezing
CHANGE THE TEXTURE OF HIS SKIN; WARM TO THE TOUCH; ACHINESS; CHILLS; RASH; FEVER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hives, and concurrent conditions included: acid reflux, and amoxicillin allergy, and other pre-existing medical conditions included: The patient had no trouble with his breathing. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced change the texture of his skin. On 16-SEP-2021, the patient experienced warm to the touch. On 16-SEP-2021, the patient experienced achiness. On 16-SEP-2021, the patient experienced chills. On 16-SEP-2021, the patient experienced rash. On 16-SEP-2021, the patient experienced fever. Treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol.  The patient recovered from achiness, chills, and fever on 18-SEP-2021, had not recovered from rash, and the outcome of change the texture of his skin and warm to the touch was not reported. This report was non-serious.
(R) shoulder ? Varicella immunization site. Tx: ibuprofen/ warm compress.
ill; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.  A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after taking both doses of the Pfizer COVID 19 vaccine, patient became ill; went to the doctor and was in the hospital. Patient was seeking compensation. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JUN-2017, the patient was vaccinated with expired dose of M-M-R II lot # L023386, expiration date 25-JUN-2017 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot # L025374, expiration date 27-MAR-2018 (dose and route of administration were not reported). No adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with  ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2009, the patient was treated at a healthcare facility (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Didn't feel quite well, nor could I sleep.  Had put an ice pack on both arms and took Tylenol.  Upon waking up, noticed that my left arm (where I had received the pneumonia shot was given) had broken out in four different areas and was red and hot to touch). Three of the areas were large in size and the other was small in size.  Called the doctor's office, went in and saw the nursing assistant. It was determined that I had an allergic reaction to the injection and that my sites were hot to the touch.  An antibiotic was prescribed and I was told to continue with the ice pack, Tylenol and Benadryl if needed.  *On a separate note:  I was given a pneumonia shot in my left arm and a flu shot in my right arm*
Narrative: COVID infection following COVID vaccine series 03/19 COVID vaccine dose #1 04/13 COVID vaccine dose #2 12/14 pt presented to ED c/o scratchy throat x 1 day, chills last night head/nasal congestion, cough, dull headache; COVID positive; discharged from ED with rx for benzonatate: no further follow up noted
31JUL92 woke up w/hives which became increasingly worse during the day; BY 3AM 1AUG(2 hands, feet, lips were swollen; no breathing problems; some nausea; pt taken to hosp & given EPI & DPH;
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were repo Date of refrigeration include 07-May-2021.
She had several symptoms/ 2nd shot she had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had several symptoms/ 2nd shot she had side effects) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had several symptoms/ 2nd shot she had side effects). At the time of the report, VACCINATION COMPLICATION (She had several symptoms/ 2nd shot she had side effects) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.  It was reported that after second vaccination patient had side effects.
Headache, fever, body aches for over 60 hours. Loss of vision/blurriness beginning the day following the booster. In both eyes for a few days, still don't have regained vision in the right eye. Went to eye dr. and he is monitoring to see if vision improves over time.  I also had vision loss after my first dose of the vaccine on March 30,2021, but had regained that. Went to eye dr. the following day & was sent to the eye facility but they didn't see damage to the eye.
Father brought pt to HD for IZ's stating 4-5 days, post vax, Comvax in right leg. Pt had 10cm size indurated area develop. Physician, surgeon and plastic surgeon, states cause was Comvax.
so sick; Initial information received on 11-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an Adult patient (unknown gender, age) who was so sick while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; route, strength, formulation: unknown) in unknown administration site as prophylactic vaccination (Flu vaccination).  On an unknown date the patient developed a non-serious event "so sick (illness)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Since this is a public post on the Sanofi flu shot, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I have had one flu shot it made me so sick I had to go get a shot to get over it never again that was in the early 90s. It is unknown if the patient experienced any additional symptoms/events".   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (so sick).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event so sick.
Low grade fever; Weight gain; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT INCREASED (Weight gain) and PYREXIA (Low grade fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    No Medical History information was reported.   In 2004, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 125 mcg (125 mcg,1 in 1 D). In 2005, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 112 mcg (112 mcg,1 in 1 D). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 88 mcg for three days and 100 mcg for four days (88 mcg,1 in 1 D). In January 2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 100 mcg (100 mcg,1 in 1 D). In February 2021, the patient experienced PYREXIA (Low grade fever). In 2021, the patient experienced WEIGHT INCREASED (Weight gain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In February 2021, PYREXIA (Low grade fever) had resolved. At the time of the report, WEIGHT INCREASED (Weight gain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The reporter's causality for the event of weight gain with Synthroid (levothyroxine) was a reasonable possibility. The reporter's causality for the event of low grade fever with Synthroid (levothyroxine) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-630557, MOD-2022-630556 (Patient Link).
Papules on hands (including palms and top of hand), in addition to papules on heels which started out approximately 3 mm and enlarged to 0.5 to 1 cm over a period of 5 days.  Denied any fever and no other accompanying symptoms.
Woke up with a very sore arm. Later that day the injection site started swelling, itching, burning and was hard to touch. The next day there were shingle blisters and the swelling covers most of my upper arm. Went to the doctors office on 06/10/15. I was diagnosed with shingles and an infection to the site. I am on Benadryl every 6 hours, Zyrtec twice a day, Keflex 500 Mg 2 caps 2 times a day for 10 days, Bactrim 800 mg 1 cap 2 times a day for 10 days, bactroban applied topically 3 times a day for 10 days, Valtrex 1 s tabs 2 times a day for 7 days. Gabapentin 300 MG 2 tabs 3 times a day. Also watching the swelling to make sure it stops and no red streaks. If the swelling gets worse or red streaks appear I need to go straight to the ER.
When I went for my routine colonoscopy, I was diagnosed with ulcerative colitis.  I have never had any prior colon issues, not do colon issues run in my family.   I believe something in the vaccine triggered my immune system to attack the colon.  With an autoimmune disorder, you have to be so careful.
Behavior changes started after receiving flu vaccine: aggressive, throwing things, running away very irritable, kicking, "fight or flight" appearance, harming self + others.
Pt states she had sharp pain immediately on administration.  She had pain radiating down right arm to her fingers and up the back of her neck and down into the axilla area.  She had difficulty sleeping due to the pain and discomfort and had a limited range of motion.  She spoke to the pharmacy manager approximately 2 weeks about the pharmacist who gave her the injection and was concerned the pharmacist "hit a nerve."  She was referred to her primary care provider for follow up.  She presented back to the pharmacy on 4/1/22 to speak with the pharmacy manager about her pain and limited range of motion.  She stated she talked to her doctor about the immunization, but did not specify what the doctor told her.  She said she still has soreness in her upper right arm and axilla area.
fever, swelling and rash at injection site, nausea, loss of appetite; tingling in fingers; hot and cold spells; tiredness
w/in 24hr of vax pt devel gen urticaria;pt was seen by MD & tx w/DPH;the hives recurred periodically over a day period;28OCT the hives had resolved;addtl info recv 1DEC98 indicated that pt remained recovered;
Six minutes after administration of the clients second dose of BioNTech Pfizer vaccine she began to have difficulty breathing and audible wheezing. She reported GI upset, headache, feeling dizzy, and impending doom.  She  self-administered puffs from her albuterol inhaler. Pulse ox remained above 97% , pulse 113, BP- 160/100.  EMS was activated. Epi 0.5mg administered into left deltoid at 12:25 pm.  Transferred client from chair to floor without difficulty. Continued to experience respiratory distress and became diaphoretic. Administered second dose epinephrine 0.5mg to left vastus lateralis at 12:30pm. Fire and Rescue arrived at 12:33pm. Transferred client to ED via ambulance.
My arm started getting soar that nigh and persisted the next day followed by two days after that (headache, fatigue, fever). It gradually decreased in pain and on Wednesday it was gone (felt as though I had a rigorous workout). I slept all day Sunday after taking the shot on Saturday! The tele-doctor asked what were my symptoms (allergies and sinus trouble with a cough all the time). He had me to switch allergy medications and my eyes were no longer watering (switched from Zyrtec to Claritin. My eyes were watering so much until I could barely do anything.
Delayed reaction 10 days later; Delayed reaction 10 days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction 10 days later) and THERAPEUTIC PRODUCT EFFECT DELAYED (Delayed reaction 10 days later) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (Delayed reaction 10 days later). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DELAYED (Delayed reaction 10 days later). At the time of the report, VACCINATION COMPLICATION (Delayed reaction 10 days later) and THERAPEUTIC PRODUCT EFFECT DELAYED (Delayed reaction 10 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No corrective treatment was reported. The patient was misdiagnosed with bacterial infection and placed on antibiotics and was suggested not to continue with second moderna shot. The patient received Ist Pfizer shot on 15-Mar-2021. Patient was curious if its fine to continue with second shot of Pfizer.  Causality for Drug effect delayed event is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination complication, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Causality for Drug effect delayed event is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination complication, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. The patient's medical history was not reported. On 04-DEC-2013, reported as about a week ago, the patient was vaccinated with ZOSTAVAX (dose, lot number, expiration date were not reported). Concomitant medications were not reported. On an unknown date in December 2013 the patient experienced swelling at injection site.The outcome of swelling at injection site and relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Swollen lymph nodes (left and right underarms and sides of breast area, throat). Started on 3rd day following vaccine & lasted  approx 5 days.  Sore throat, heavy nasal congestion, laryngitis started approx 9 days after vaccine . Nasal congestion and laryngitis lasted approx 6 days. Sore throat has lessened but not resolved completely.  Have developed slight cough and general fatigue.  Most concerned about a vesicular rash on lower legs, ankles, abdomen, lower back, forearms, face, neck, and shoulders.  When blisters form, they Itch, scab over with hollow center. If scab is removed, itching continues. The rash started on my arms and slowly spread throughout body. It began about 6 days after vaccine and continues today.
Patient received vaccine advertently  after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity necessary to protect against  covid 19 on date vaccine was administered. Also patient did not call in to report adverse event.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient in her fifties. The patient's medical history included herpes zoster (two outbreaks). On an unknown date in 2010 (reported as "about 6 or 7 years ago"), the patient was vaccinated with ZOSTAVAX reconstituted with sterile diluent (MRK) for prophylaxis. On 07-AUG-2017, the patient experienced herpes zoster. The outcome of herpes zoster was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
An Anonymised Single Patient Print was received from the MCA on 26 November 2001 regarding a 71 year old female patient who experienced amnesia and blurred vision on 10 October 2001 after receiving fluvirin vaccine on the same day.  On 10 October 2001, the patient had blurred vision and temporary amnesia lasting approximately 2 hours.  The patient recovered and the reported did not consider the events to be serious.  There was insufficient information to determine the reporter's causality assessment.
Patient stated that the day following administration (5/13/21) she got a rash and today (5/14/21) her lip was swollen
Anthrax vax given in left arm.  Approx 3 days later, experienced itching and swelling in left arm.  Seen 5 days after vaccination in Internal Medicine Clinic -- edema in left arm extending below left elbow, no other lesions, erythema noted. No systemic symptoms.  Treated symptomatically -- benadryl for itching, limited activity in arm, ice as needed.
Area around injection site began to itch 1 week after injection and became red, rash appeared and became warm to the touch.  Over the next 24 hours it increased in size to about 5 inches by 3 inches.  Rash reduced but the area became tender and remained so for 2 days. The area has remained red and itchy through today 1/18/2021
Six hours after injection, extreme chills began with fever of 101.6. Temperature was monitored every 30 minutes.  It continued to increase.  Ibuprofen and Tylenol were given every 2 hours, alternating.  Fever reached 104.3 within 4 hours of beginning.  Fever returned to normal after 9 hours.  Next day, very tired and fatigued.
Arm and shoulder pain and tenderness lasting several months; pain and some loss of mobility remain 8 months later.