chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 14-JUN-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX vaccine (lot #, expiration and dose not reported) subcutaneous on or about 23-MAY-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-JUN-2015, the patient was treated at a medical center for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMVIR) for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
102.5 fever with sudden onset and severe chilling relieved by TYLENOL over a period of six hours. Recurrent low grade temp of 99.5 on 1/7/2018 at 4:00pm also relieved by TYLENOL.
TESTED POSITIVE FOR COVID; This spontaneous report received from a patient via a company representative concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced tested positive for covid. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000211543.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Headache, Fever  PAIN LEFT ARM. BODY ACHES, FATIGUE,  NASAL CONGESTION
Information has been received from a nurse concerning a 61 year old male with high cholesterol, hypertension and allergy to LIPITOR (muscle aching), pravastatin (muscle aching), colestipol (muscle aching) who on 02-JUL-2010 was vaccinated with ZOSTAVAX (Merck) S.C. 0.65ml (therapy site unknown). Concomitant therapy included atenolol, aspirin, omega-3 marine triglycerides, chondroitin sulfate sodium (+) glucosamine sulfate and vitamins (unspecified). On 06-JUL-2010 the patient experienced shingles and a vesicular rash on his right forearm. The patient sought medical attention. At the time of this report, the patient's shingles and vesicular rash on his right forearm persisted. Additional information has been requested.
Rash, Facial flushing. Stabbing head pain Diarrhea (1-09-2021), Fever 100.4,Headache Took Loratadine and Benadryl - symptoms resolved
Info has been received from a health professional concerning a female pt who on 10/09/2002, was vaccinated in the arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy on 10/09/2002 given in the opposite arm included a dose of influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to pneumococcal vaccine 23 polyvalent . Subsequently on approx 10/09/2002 the pt developed "severe" pain in arm and under arm, and she was unable to lift her arm for 3 days (approx 10/12/2002). It was noted, the arm was warm and a little swollen, but felt better by Tuesday, 10/14/2002. It was noted the pt rated the pain "8" on a pain scale, and took ibuprofen (ADVIL) for the pain. The reporter requested a lot check. The records of pain testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested. The health professional 13 other pts who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 021USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, and 0211 USA02251.
I did not have an adverse reaction to the vaccine. In 12/2022, I was diagnosed with pneumonia. I saw my doctor but I only remember taking MUCINEX for the cough.
18 Hours after dose, came on super fast, achy; shaking; freezing; Slept for a couple hours; headache; flattened; Eyes hurt; Guzzling water; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: ER-8732), via an unspecified route of administration, administration at Arm Left on 06Apr2021 (vaccinated at the age of 51 years) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The previously received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administrated on left arm on 18Mar2021 as dose 1, single for covid-19 immunization. The patient did not received other vaccine in four weeks and not received other medications in two weeks. The patient not had covid prior to vaccination and had not tested for covid post vaccination. On 07Apr2021, 18 Hours after dose, came on super-fast, achy. Then started shaking and was freezing. Slept for a couple hours and still flattened and headache. Eyes hurt and guzzling water. The patient did not receive any medication for the events. The patient was recovering from all the events.  No follow-up attempts are possible. No further information is expected.
Patient received original Pfizer Covid- 19 vaccine instead of requested bivalent Pfizer Covid-19 vaccine
Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2022, the patient received the 2nd dose of Shingrix. On 25th February 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient reported this case for himself. He had pain at the injection site in the left arm. The reporter reported that this did go away after about 24 hours. However, on 3rd March 2022, the pain at the site had started again and stated it was worse. The reporter consented to follow-up.
got the shot, got shingles/suspected vaccination failure; shingles off and on for five years; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had bout with shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles off and on for five years). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 5 years).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received form the patient via interactive digital media. The patient got the shot and it caused him or her to had shingles off and on for five years. The physician  said that he had never seen it happen before. The patient had learned throughout his or her decisions to pray, talk with your physician and make the decision you feel it was right for you. The patient stated that shingles were horrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, dose was not reported (lot# K010222, expiration date: 12-MAY-2016; lot # reported as K009753, expiration date: 28-APR-2016; lot# reported as K007247, expiration date: 17-MAR-2016). The temperature excursion was supported with in-house stability data. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Headache; Chills; Muscle ache; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Dec2020 10:30 at single dose for preventive measure of COVID. Medical history included hypertension.  Concomitant medication included atenolol at 50 mg for hypertension.  Consumer stated, "It is Pfizer! I am having side effects, I started this morning. I am having the headache, chills and muscle ache, just feel like I have a flu but I don't. I have received the vaccine yesterday from my job, yesterday at 10:30. I think I got all the symptoms like the dizziness, fatigue, headache and muscle ache." Consumer stated, "I just took some Aleve" as treatment. The outcome of events was unknown.  Information about lot/batch number has been requested.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/24/2023 FAILURE TO THRIVE SYNDROME, ADULT CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/24/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/24/2023 CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Patient had injection site reaction to Pneumovax. Had a big lump of 4 inches possibly infected. Patient also had nausea, fever, chills.
Received COVID vaccines on 4/2/21 and 4/23/21 and was admitted to the hospital on 8/26/21 for COVID-19.
Blurry Vision, tingling hands, Dizziness, Sweating. BP 102/69, Pulse 70. Few mins after lying down patient were in stable condition. gave 500 ml water oral, discharged after the patient was  stable and advised to seek medical help if needed.
The patient was given an expired vaccine. The patient was contacted and advised to return in 2-4 weeks per recommendation of our Chief Medical Officer to get the current flu vaccine.
On Sat 9/10/11 arm started itching. Area became red and swollen. Observed a red, warm area around vaccination site approx. 1 inch wide and 4-5 inches long. Pt. took BENADRYL and APAP. Pt. saw doctor on 9/13/11 was given a prednisone shot and oral taper. Pt. states she is fine.
Pt developed sporadic flat erythematous macular lesions on chest with itching.  I diagnosed as non viral pustulosis and treating with oral antihistamine and topical steroid to chest rash.
Following the second I had irregular heavy bleeding that was not ending, so we came to the conclusion of Perimenapause. I went on natural progestrine, which brought it under control, my cycles ended. I did not associate these issues to the vaccine. On the 8th of December I received the 3rd shot/ 2nd booster, a little over a week later I started a cycle after not having one for 4 months.   My daughter after her 2nd vaccine (same day as mine) had hormone/cycle issues, the doctor switched her birth control, to try different hormones. The day after her 3rd shot , while on birth control, started av14 day cycle, that was  a week early and it was extremely heavy (which is not normal), after 14 days it fell back in line with her cycle again, but she is having hormone issues again.   I would still get a vaccine to protect others, but I am worried for my daughter, she does want to have kids one day and we need to continue to make sure these are safe for the younger people. I am done having kids, so I am not worried for myself. I do believe our hormone issues are now being caused by the vaccine. All our vaccines have been Moderna
Pt developed a red, raised itchy rash at the injection site and on his back, chest, and shoulders.
3/25/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Anxiety .   Assessment : Time of assessment 1200. Alert and oriented.   Actions taken:  Bp- 139/83. P- 77, O2- 100%       Medications administered: none   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/25/2021 11:45 AM 0.3 mL 12/11/2020 Intramuscular
Reaction on right arm, swollen lymph nodes, bruising on right breast.  Patient reports no fever and does not feel ill.
This case was reported by a physician via call center representative and described the occurrence of unwell in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced unwell and injection site cellulitis. On an unknown date, the outcome of the unwell and injection site cellulitis were unknown. It was unknown if the reporter considered the unwell and injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the reporter on behalf of the patient. The age at vaccination was not reported, but the patient was 70 years old at the time of reporting. The patient was very ill after and also developed a localized reaction at the injection site (suspected cellulitis). The reporter stated that the patient called her to report the event but she had not physically seen the patient. No additional details were available. This is one of the three cases reported by the same reporter.
headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report from a contactable healthcare professional. This 66-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot EL3247) on 24Jan2021 at 11:15 AM at left arm for COVID-19 immunization in hospital. Historical vaccine included first dose for BNT162B2 (lot EK5730) on 02Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Medical history included hypo thyroid, parox afib, high blood pressure (HBP), obesity and allergies: bupropion hydrochloride (WELLBUTRIN), soy. Concomitant drugs included metoprolol, apixaban (ELIQUIS), fluoxetine hydrochloride (PROZAC), losartan potassium (COZAAR), thyroid (ARMOUR THYROID) and more. On the day of injection on 24Jan2021 at 04:00 PM, the patient had low blood sugar symptoms, weakness, which resolved in a few hours. On second day, symptoms of low Blood sugar, sweats, feverish, chills, on third day feverish symptoms of low blood sugar, sweats, feverish, headache.  No treatment was received. The outcome the events was unknown.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 01-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L013284, expiration date: 07-AUG-2016), which was improperly stored for 19 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient described feeling numbness & sharp, shooting pain from injection site (over right deltoid) to elbow and then proximally again towards right shoulder (from elbow), immediately after injection of vaccine started. Also describes weakness from elbow to fingers (hand and arm flexor muscles mostly) & numbness in right hand, palmar & dorsal surfaces, & upper arm, especially over anterior, medial biceps area. Approximately 3 hrs after vaccine, swelling developed in right hand also. She described pain & discomfort in upper arm as worsening in the 2 hrs after vaccination & later included wrist also. Patient went to urgent care & was told her symptoms were beyond their scope and to go to ER. Patient said that she did not feel that symptoms were related to needle stick and instead felt they started once she felt the vaccine fluid being injected, though much of what she described initially sounded like it may have been, at least partially, related to the needle stick. Most of the information recorded on this form was obtained on 5/22/18, though the form is being submitted on 5/29/18. We were waiting to receive information from patient's visit to the ER as she said she would return with the ER paperwork afterwards. However, she has not communicated with us again since 5/22/18.
severe headache, body aches, chills, fever - all symptoms began around 8 hours after receiving the vaccine. Symptoms lasted about 10 hours and then began to reduce. By 24 hours after receiving the vaccine, symptoms were gone.
Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient received Shingrix and experienced sore arm. The reporter did not consent to follow up. The reporter declined to provide any HCP information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202284:wife's case
Patient reported symptoms of "COVID arm" with redness and swelling around the injection site on 4/21/21.
My arm began to hurt at the vaccination site, with a red spot. It was like a knot and itchy. By today my whole upper arm is tight and swollen and a very large red spot around it like the size of a credit card.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Afib" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid on 21Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Yesterday at 11am I began to experience severe, high (under rib cage) abdominal cramping and a headache. I fell asleep at approx 1pm and woke up around 4pm with less cramping and a dull headache. The headache continued throughout the evening. I had diarrhea on and off. Each time I stood up I felt faint and lethargic, leading me to spend the rest of the night in bed. Today, my body feels sore and lethargic and my mind feels foggy and tired.
None reported at this time; received MenQuadFi by mistake (had only asked for MMR)
cough, wheezing & tight chest, very slight SOB used proair inhaler, & took 2 Duo nebs, Dr was in facility & listened to lungs & requested the nebulizer X 2
ITCHING RASH ON ARMS AND BELLY, AND AT VISIT WITH PCP 5/7/15 PT STATES HER NECK AND FACE ARE STARTING TO ITCH AS WELL. RASH APPEARED LIKE PAPULAR RED PRURITIC SCATTERED TYPE OF RASH.
Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.
This case was reported by a consumer and described the occurrence of adverse event in a male patient who received SHINGRIX. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient suffered from severe side effects after vaccination. The patient wondered if one do had the side effects on the first shot, would they be more likely to have it again on the second shot.
11/14/2007 At approximately 6 pm.  2.5-3 hours after receiving the Hepatitis vaccine, the patient experienced onset of body aches, nausea, headache, diarrhea, fever.  Symptoms persisted  throughout the night with patient awakening every 2 hours due to symptoms.  11/15/07 @ 12:30 pm (21 hours after receiving the vaccine, the patient contacted RN to report the illness.  The patient was referred to a health care provider of her choice.  Per patient verbal report11/16/07:  Patient was seen in the afternoon of 11/15/07 by Dr.  No treatment administered. Advised illness probably adverse reaction  to vaccine.  11/16/07 11:00 am.: patient continuing to experience body aches and head aches, but symptoms less severe and "not as sick as yesterday".
Pt recv vax on 10/7/98; on 10/9/98 pt exp swelling &bubbling of LA; tx=Benadryl. On 10/13/98 pt imp.
Three to four days post vax the pt developed apnea and was taken to an ER where she received unspecified treatment. Please note that second report was submitted documenting a AE following second vax where she developed apnea and coughing.