chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Detached retina; This serious case was reported by a consumer via interactive digital media and described the occurrence of retinal detachment in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced retinal detachment (Verbatim: Detached retina) (serious criteria GSK medically significant). The outcome of the retinal detachment was not reported.   It was unknown if the reporter considered the retinal detachment to be related to Shingles vaccine.     It was unknown if the company considered the retinal detachment to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-Mar-2023 The reporter's friend got a detached retina as a result of the shot. It did not happen often but was listed in the contraindications. The reporter had the single shot years ago and she had kind of skittish about the two-step new one.
Pt with severe body aches, sudden onset. Sx lasted through the night.  Pt took 800mg of Ibuprofen at 8:00AM on 11/17/2009 and sx were better.  Completely resolved by the afternoon of 11/17/09.
What I had was a positive Covid-19 test result months after my booster shot was taken. My symptoms were headache,fever,body aches,cough,runny nose and chest pain.  I don't know if this will be classified as adverse event or not
Patient stated that the whole right side of her body is hurting.  The patient right shoulder blade is swollen and very irrated.
temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported.   Since 25-JUL-2021, there was temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), which was stored from 6 F to 14 F (7.3 F) for 37 minutes. On 11-SEP-2021, the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (at the dose of 0.5 ml, subcutaneous; lot # T016990, expiration date 11-NOV-2021) was administered to the patient as prophylaxis (product storage error).
This spontaneous report was received from a medical assistant and refers to a 13 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. On unspecified dates the patient was vaccinated with the first and second doses of GARDASIL (dose, route, frequency, lot number and expiration date were not reported). On 18-AUG-2016 the patient was vaccinated with a dose of GARDASIL 9 (lot number M018810, expiration date 28-MAY-2016), intramuscular in the right arm (dose not reported) as the third dose administration in the series of three. On 18-AUG-2016, within one hour of the administration of GARDASIL 9, the patient experienced left arm pain that shot around to her back, around to her collar bone and down her left arm, that was a "five" out of "ten" on the pain scale. The reporter indicated that the pain was in the left arm, the opposite arm that the GARDASIL 9 injection was given in. The patient called to the pediatric office on 22-AUG-2016 to report the arm pain that developed on 18-AUG-2016 and a nurse practitioner advised her to take an unspecified dose of ibuprofen for the pain. The outcome of the above mentioned events was unknown at the time of the report. There was no product quality complaint. Additionally the reporter did not assess the causality between GARDASIL 9, GARDASIL and the above mentioned events. Additional information has been requested.
Temperature; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th June 2020, 8 hrs after receiving Shingrix, the patient experienced headache. On 1st July 2020, the patient experienced fever. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were reported as follows The patient  received Shingrix in the morning at her primary care physician's office and in the evening approximately 8 to 9 hours later had a headache. Next morning she had a temperature of 101 Fahrenheit. Headache and temperature were unresolved. The reporter did not consent to follow up.
Information has been received from a medical assistant concerning a patient who was vaccinated with WISTAR RA 27/3 or JERYL LYNN. Concomitant therapy included "Flu-shot and possibly other vaccines were given." On "07-NOV-2008" the physician sent the patient to the Emergency Room after receiving either WISTAR RA 27/3 or JERYL LYNN vaccines. The patient had sought medical attention. Additional information has been requested.
2 DAYS AFTER INJECTION, SHE DEVELOPED PAIN, REDNESS AND SWELLING AT INJECTION SITE.  ALSO FEVER AND GENERALIZED RED RASH ALL OVER HER BODY.
rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid again.  Clinical course: Case Category: Product Specific Inquiry, Case Subcategory: Adverse Event/Product Complaint, Description of Event Outcome, Forwarded as an Adverse Event by the medical team on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 You need to update your records on rebound Covid after taking your antiviral medication. In patient small circle patient know 7 people that have gotten covid again. Patient was wait too see if patient do my husband has it again and patient was still testing positive. Patient never would have taken it if patient knew that percentage of peoples that get it again . It should only be given to very high risk people. Event Awareness Date:14Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.;
Nausea, vomiting, migraine, muscle fatigue, muscle pain, joint pain, chills, sweating
9FEB96 pt recvd vax w/o incident by nurse;13FEB96 mom noted black/blue quarter size lump @ inj site & called to say nothing unusual until now;mom put alcohol on area & applied warm compresses w/o relief;pt reluctant to stand-fretful
Patient was administered Moderna Vaccine that was not thawed per company protocols. Vaccine was removed directly from freezer and  thawed in hand for 15 minutes. Vaccine was then drawn up and administered to patient
gave a patient expired IMOVAX with no adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who was given expired imovax with no adverse event ,while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2022, the patient received a dose number 1 of suspect RABIES (HDC) VACCINE( lot 76894 and expiration date:17-Jun-2022) at a dose of 1 ml once via intramuscular route in unknown administration site as post exposure Immunization.  On 07-Jul-2022(latency: same day) , it was reported that the patient given a expired imovax with no adverse event (expired product administered) and asked what they should do, should they re-do the vaccination.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (gave a patient expired IMOVAX with no adverse event).  At time of reporting, the outcome was Unknown for the event gave a patient expired imovax with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
lost control of my arms and legs; lost control of arms and legs/could not stop my movements; very scary; This case was reported by a consumer via interactive digital media and described the occurrence of ataxia 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 ataxia, movements involuntary and fear. On an unknown date, the outcome of the ataxia, movements involuntary and fear were unknown.   It was unknown if the reporter considered the ataxia, movements involuntary and fear to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient reported that he/she received dose of Shingles vaccine and experienced lost control of arms and legs, could not stop movements after the shot, which was very scary. Additional Supportive Information: The follow-up would not possible as no contact details were available.
sore at injection site; left arm warm to touch; burning sensation left arm; redness left arm; fever; nausea; headache; swelling on her left arm from the shoulder to the elbow/ swelling left arm; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   On 4th April 2019, the patient received the 1st dose of Shingrix. On 5th April 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, injection site erythema, fever, nausea and headache. The patient was treated with dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, fever, nausea and headache were recovered/resolved and the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, injection site erythema, fever, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The next day after vaccination, the patient experienced a fever of 101 degree Fahrenheit.  The patient experienced redness and swelling on her left arm from the shoulder to the elbow after receiving the vaccine. The swelling lasted 2 weeks and the redness had decreased, however there was a little redness still there. Patient also experienced a burning sensation on her left arm. The patient put a cool wet rag on her arm but that did not help with the burning sensation. Patient used cream on her arm to relieve the burning. The burning sensation felt the same as when the patient has had shingles in the past. Patient did not plan to get the 2nd dose of Shingrix. The reporter consented to follow up.
patient felt dizzy and lightheaded after the vaccine, she was coming in and out of lucidness. 911 was called and EMTs took her to the hospital
A week after receiving the vaccine, I have developed a red, raised rash that is a little warm and itches.
pt. noticed are was bruised, tender to touch, it was reddish in color and swollen, warm to touch. Area was very painful.
Patient presented to mass vaccine event using Moderna and indicated that this was his first dose and that he had not received prior dose of Moderna, Pfizer, or J&J. He answered  two screening questionnaires indicating he had not been vaccinated previously, and confirmed at the time of vaccination that he had not been vaccinated previously.  He was administered Moderna today as a first dose.  Then, when his info was being entered into the Database, it was noted that in his account he had a dose of Pfizer COVID-19 vaccine administered on 2/5/21 by another organization at another site.  He was contacted and admitted that he had received Pfizer on 2/5/21 but he missed his second dose 21 days later so decided "to just start over with Moderna today."  He was instructed that per CDC guidance, this Moderna dose will be considered his second dose of the series, and he is now considered fully vaccinated and does not need another Moderna dose 28 days after today.  He expressed understanding and agreement with this plan.
High fever (102-104); Chills; Knee pain; Back pain; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).   A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on an unknown date as dose 3, single (Lot number: unknown) at the age of 43 years for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown), for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 25Apr2022, outcome "recovering", described as "High fever (102-104)"; CHILLS (non-serious) with onset 25Apr2022, outcome "recovering"; ARTHRALGIA (non-serious) with onset 25Apr2022, outcome "recovering", described as "Knee pain"; BACK PAIN (non-serious) with onset 25Apr2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, arthralgia and back pain.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment taken as a result of pyrexia, chills, arthralgia and back pain included TYLENOL. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Arm started getting very sore around where the shot was injected; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm started getting very sore around where the shot was injected), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 045B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE PAIN (Arm started getting very sore around where the shot was injected). 10-Dec-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 13-Dec-2021, VACCINATION SITE PAIN (Arm started getting very sore around where the shot was injected), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No concomitant medications were provided. No treatment medications were taken by the patient.  The patient's symptoms were 80% resolved within 2 days, and were completely resolved within 3.
Brief apparent grand mal seizure. CT negative. EEG: episodic. Glowing of background,rhythm. Episode in 1995: EEG then negative.
Concomitant administration of VARIVAX and PROQUAD to a one year old patient.; This spontaneous report was received from a medical assistant concerning a 1-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   On 13-MAY-2022, the patient was vaccinated concomitantly with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (ml), lot # U030162, expiration date 28-SEP-2023, and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml, lot # U0315694, expiration date 06-APR-2023, for prophylaxis (route of administration and anatomical location was not reported) (Overdose). No additional information was provided.   Lot number U0315694 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Lot number U0315694 does not match any Company product as confirmed by Lot Verification team.
This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 07-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
The patient began crying/coughing and red in the face while receiving the rotavirus drink. I sat the pt. up immediately - he continued coughing/crying. Mom picked him up - he became quiet, unresponsive, pale, listless w/in 5-10 seconds. The doctor was notified immediately and gave back blows. He cried w/in 10 seconds and remained stable.
The patient had no adverse event to receiving the vaccination.  Patient was 14 years of age at the time of the vaccination and received his vaccine prior to EUA approval for this age group.  Mother brought this child in under his 16 year old brother's name in order for him to receive the vaccine.
This case was reported by a nurse via call center representative and described the occurrence of taste metallic in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number 572KT, expiry date 26th May 2018. The patient's past medical history included convulsion disorder. Concomitant products included Spironolactone. On 23rd October 2017, the patient received FLUARIX QUADRIVALENT. On 23rd October 2017, 15 sec after receiving FLUARIX QUADRIVALENT, the patient experienced taste metallic, speech disorder, tremor and disease prodromal stage. On 23rd October 2017, the outcome of the taste metallic, speech disorder, tremor and disease prodromal stage were recovered/resolved. The reporter considered the taste metallic, speech disorder, tremor and disease prodromal stage to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter stated that, on 23rd October 2017 07:45, the patient had a metallic taste, prodromal symptoms, stated patient's speech was affected, and the patient had tremors in her right arm 15 seconds following a FLUARIX administration.
p/vax pt devel severe diarrhea requiring oral rehydration 2 to 3 days post immunization;
My blood pressure elevated to 220/ 120 two weeks after the vaccination. At the time I only experienced soreness and pain at the injection site. I later developed hypertension, tremors, rapid heart rate and I was not able to sleep at night. My primary care provider started me on new blood pressure medications, ordered ultrasound on abdomen and liver 10/14/2022 and I was out of work for two weeks so my doctor can monitor. I went back to work on the 17th and was experiencing high blood pressure and tremors and they called the ambulance, and I was admitted the same day. My hypertension specialist reviewed my test and has determined that it what I was experiencing was due to the vaccine, and she says she has seen this in multiple patients. She started me on a medication 10/18/2022 (amitriptyline) which helped with the trouble of sleeping. I am currently still hospitalized and awaiting to be released.
Ache joints, neck, hip, back, headache, sore redish eyes. brain fog, memory problems, general sleepy feeling and tiredness. I've been feeling really good so this took me down it has been 6 days and I'm feeling better but still sluggish and feel a bit like lead in the blood.
Severe Rash/hives, itchy ...thighs, knees, ankles and feet. Treatment from physician: prednisone shot, prednisone 2 tabs once a day for 5 days, pepsid, zyrtec
Moderna 2/10/21, 3/15/21, Pfizer 11/24/21 He came to the ER w C/o Worsening fatigue and exertional dyspnea for the last several weeks progressively worsening.  With occasional fever, chills and cough.  He mentioned that he was (+) for COVID a few weeks back.  (+) on 01/25/2022. COVID-19 infection-seems like long COVID in the setting of immunosuppressed state..  Received vaccinations including the booster.  Currently no indication for acute therapy with steroids or antivirals or immunomodulators.  Based on clinical status if patient requiring any supplemental O2-to initiate IV steroids.  Supportive care for now
Rash on upper left arm, bicep area, approximately 8 cm x 10 cm., with a red visible raised area.  The rash started about 24 hours from the vaccine time, and went away by about 56 hours from the vaccine time.  I also had mild body aches, starting about 2 days after the vaccine, and continuing for another 2-3 days.