chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 02-APR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In or around April 2017 the patient was inoculated with the ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX the patient suffered endotheliitis and herpes keratitis. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expensed; the loss of accumulations; and other economic and non-economic damages. Upon internal review herpes keratitis was considered medically significant. Endotheliitis and herpes keratitis were reported to be disabling. Additional information has been requested.
Felt warm sensation in arm. Worsening to severe swelling, pain, hot to touch, limited ability to articulate arm.
Fainted after giving shot. Had sweating, nausea, paleness, visual disturbances. Called 911. Recovered. Took ADVIL.
redness & swelling in lt shoulder & warm to touch begin @ about 9PM 21JAN98;
rash inside of mouth, upper and lower inside lip.  Enanthem like lesion.  "Dry" sensation/no moisture.  Slight atypical tissue
There were no adverse events. The patient insisted on receiving the vaccine. The patient turned 18, three days after vaccine was administered.
Visit today for a whole body rash. Received Moderna vaccine booster 1/10/22 - that night had chills, fever, fatigue.  Went away by the end of the day. Yesterday he woke up with itchy spots all over. Tried showering, didn't go away. Now raised bumps within the itchy spots. No fluid that patient has noticed. Tried Benadryl - seems to have helped a little.  Causes drowsiness though.
Bilateral arms ache; Ache from low back to back of both thighs, to the knees; Ache from low back to back of both thighs, to the knees; Muscles are weak; Hard time going up or down the stairs; Ache from low back to back of both thighs, to the knees; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Ache from low back to back of both thighs, to the knees), MUSCULAR WEAKNESS (Muscles are weak), MOBILITY DECREASED (Hard time going up or down the stairs), PAIN IN EXTREMITY (Ache from low back to back of both thighs, to the knees) and MYALGIA (Bilateral arms ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced BACK PAIN (Ache from low back to back of both thighs, to the knees), MUSCULAR WEAKNESS (Muscles are weak), MOBILITY DECREASED (Hard time going up or down the stairs), PAIN IN EXTREMITY (Ache from low back to back of both thighs, to the knees) and ARTHRALGIA (Ache from low back to back of both thighs, to the knees). On an unknown date, the patient experienced MYALGIA (Bilateral arms ache). At the time of the report, BACK PAIN (Ache from low back to back of both thighs, to the knees), MUSCULAR WEAKNESS (Muscles are weak), MOBILITY DECREASED (Hard time going up or down the stairs), PAIN IN EXTREMITY (Ache from low back to back of both thighs, to the knees), MYALGIA (Bilateral arms ache) and ARTHRALGIA (Ache from low back to back of both thighs, to the knees) outcome was unknown.            No concomitant medications reported.  After 3 months, the symptoms are not better, and now the patient also had bilateral achy arms. The patient had visited her HCP once about this and was given an order for physical therapy.
10/25/12 Pt. reported / rash at the injection site. 10/26/12 2P examined / Rash / urticaria / cellulitis-like reaction size approx 5 cm dia.
THOUGHT OF GOING TO DIE; FEVER; MASSIVE AND PAINFUL HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On AUG-2021, the patient experienced thought of going to die. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced massive and painful headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive and painful headache, and the outcome of thought of going to die and fever was not reported. This report was non-serious.
On 10/22/09 came to ER w/flu symptoms. Chills, increased HR, DB, lethargy and altered mental status. 10/29/2009 Dc summary for 10/22-10/25/2009. Patient with sx of cough, nasal congestion, fever, diarrhea, sore throat, disorientated and lethargic. PE was normal, for observation with neuro cks, rehydration. Tx: Flu A +, Tamiflu given. Dc Dx: altered mental status, Influenza A+, dehydration. 11/3/09 Vaccination records received.  bhp 11/3/09 Medical OV records received from dates 10/24/08 to 10/21/09. OV DX:  mosquito bite lesion(10/24/08) asthma(09), ADD(09), learning disabilities(09), eczema(09).
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with non pertinent medical history. The patient drug reactions included Neomycin allergy. On 18-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L027322, expiration date: 21-OCT-2016, dose and route of administration were not reported), in the left arm, as the patient's husband had shingles. There was none concomitant medications. In December 2015 (reported as a couple days later), the injection site began to get red. On 21-DEC-2015, the patient went to her primary doctor's office, who told her that the rash was normal after receiving the ZOSTAVAX. On 28-DEC-2015, the patient went to the pharmacist, because the rash was spreading to both arms, her stomach, to more areas of her body and it was not getting better, and it was starting to welt. None lab diagnostic studies were performed. The patient was using unspecified, over the counter cortisone cream, but it was not helping the rash. The outcome of the events was unknown. The patient sought medical attention via visiting the primary doctor's office and the pharmacist. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Patient reported she felt dizzy immediately following injection. Her vitals were taken and blood pressure was 81/48. Patient was provided water to drink and monitored. Twenty five minutes after the injection (about twenty minutes after the initial blood pressure)  her blood pressure was rechecked  at 96/58. This reading was comparable to other readings the patient has had in the recent  past, and she said she felt good. Patient was lively and very chatty again at this point.
No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 22-AUG-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S010702, expiration date 16-JAN-2021; strength, route, dose and frequency were not reported) for prophylaxis (improper storage of product in use)and no adverse effects. The outcome of the event was unknown.
January 5, 2023, I tested positive for COVID-19, I called my physician to let him know I was positive for COVID-19. I was unable to take the Paxlovid due to medications I was taking at the time. I went in on March 1, 2023, to have my routine high intraocular eye pressure test. The doctor made aware that the pressure in my eye was a lot higher than it has ever been, 31. I would need to start using medicated eye drops for glaucoma, Latanoprost. I do have a follow up visit with my eye doctor this Friday to see if the eye drops are helping.
Narrative: Pt is a 74 year old male with PMH of HTN and Afib. He received COVID-19 vaccines (Moderna) 3/23/21 and 4/20/21 at the facility. He reported to PCP on 12/27/21 that he got his COVID-19 booster (Moderna) 12/20/21 at facility and experienced erythema and induration locally encompassing entire deltoid (which deltoid not documented) and surrounding tissue.
24 hrs post inject lost voice; lasted x 6 days; afebrile; no loss of appetite; no lethargy;
she felt as if she was incapacitated; her joints started to hurt / Her right hip and joint felt locked up and hurt; vaccine "made everything in the body hurt"; Her right hip and joint felt locked up and hurt; tooth also was hurting; couldn't stand or walk; This spontaneous case was reported by a consumer and describes the occurrence of JOINT LOCK (Her right hip and joint felt locked up and hurt), TOOTHACHE (tooth also was hurting), GAIT DISTURBANCE (couldn't stand or walk), ASTHENIA (she felt as if she was incapacitated) and ARTHRALGIA (her joints started to hurt / Her right hip and joint felt locked up and hurt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced JOINT LOCK (Her right hip and joint felt locked up and hurt), TOOTHACHE (tooth also was hurting), GAIT DISTURBANCE (couldn't stand or walk), ARTHRALGIA (her joints started to hurt / Her right hip and joint felt locked up and hurt) and MYALGIA (vaccine "made everything in the body hurt"). On 21-Mar-2021, the patient experienced ASTHENIA (she felt as if she was incapacitated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, JOINT LOCK (Her right hip and joint felt locked up and hurt), TOOTHACHE (tooth also was hurting), GAIT DISTURBANCE (couldn't stand or walk), ASTHENIA (she felt as if she was incapacitated), ARTHRALGIA (her joints started to hurt / Her right hip and joint felt locked up and hurt) and MYALGIA (vaccine "made everything in the body hurt") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.   This case was linked to MOD-2021-083688 (Patient Link).
Patient was given six doses of the Pfizer Sars-Cov-2 Vaccine do to incorrect measurement during medication prep. Patient had no obvious symptoms of adverse reactions up to 48hrs after administration and was scheduled to follow-up in one week.
Raised, Red , Warm, Swollen area on right posterior side of upper arm (between elbow and shoulder) , effected area measured 145 mm in L x 140 mm in W, more solid and differently colored center of effected area measured 35 mm L x 55 mm W, began with discomfort while sleeping the night after receiving it, the next day it warm and red, 2nd morning after vaccine area presented as documented above.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 20-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Abdominal pain, nausea, fever, seeking at injection site, pain at injection site, itching at injection site, swelling at injection site, sweating, flushing, fatigue, malaise
Breakthrough case admission after 2 vaccines Pfizer 7/1/22 lot# FP7135;  Pfizer 7/28/22 lot# FP7139
Within one day of receiving the covid vaccine I had dizziness/lightheadedness and a mild headache. Within 14 days the headache grew into Chronic migraines. I either have a migraine or headache everyday  with a dizzy feeling in ,my head. I did not have this prior to vaccine. I am still dealing with these adverse reactions and am having a hard time doing my job as an RN.
Fever, body aches, headaches, vertigo, lack of appetite, GI distress.
Pt had a cluster of pink papules around injection site, about 24 hrs after imm. more clusters are at underwear line of right buttocks cheek, right outer ankle.
J96.00 ACUTE RESPIRATORY FAILURE 3/10/2022 ACUTE RESPIRATORY FAILURE
Swelling on both hands - more so on left hand - small bumps like measles on hands and arms. Dry skin on face with cracking and peeling.
Patient received her shot at 5:20 PM.  Sat in observation area for 15 min. and felt fine. Drove back to her work bldg and about 15 min. later "felt hot, dizzy, nauseous, with thumping headache, and just not right". Got up to find waste basket. Began throwing up. Nurse was called and sent for and when she arrived patient said her "headache felt similar to when she had Covid in December, but worse". BP 193/117. Nurse called daughter to inform her, and EMTs  called. 6:22 P M BP-161/112. She had taken her BP meds at 3 PM. EMTs arrived 6:35 PM. Transported to  Hospital. She says she was "given 2 shots in ambulance, Phenergan and something for her headache?" Had a Cat scan of brain which was "normal". Discharged to home around 9:45 PM. Had appt. scheduled with Dr  on Monday, May 3 at 9:30 AM, but they called her and cancelled and rescheduled it for Monday, May 10.
This spontaneous report was received from a medical assistant, referring to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 with a Lot # L014415 and an expiration date of 25-JUL-2017 (dose not reported) intramuscularly for prophylaxis, however no adverse effects reported. It was reported that the vaccine was exposed to temperature of 32 Fahrenheit degrees (F) to 35 F for a time frame of 35 days and 4 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccine. There was no product quality complaint involved. This is one of the reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010738:
PATIENT DEVELOPED RASH AND AFTER SEEING HER PRIMARY CARE PHYSICIAN SHE WAS DIAGNOSED WITH SHINGLES.
On 4/07/2021 I had pains in my top arm down to my elbow
Burning tongue; Sores on sides of tongue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1605868-09765) via an unspecified route of administration in the left arm on 21May2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and unspecified reflux. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jun2021, the patient experienced burning tongue and sores on sides of tongue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events burning tongue and sores on sides of tongue was not recovered at the time of this report.
Prolonged fever 7 days. ER x 2. Headache viral etiology vs vaccine rxn.
aches, pains and fever for greater than one week --BUT-- also muscle twitching and 'brain fog' for over a week
Redness & swelling at injection site after shower at night. Next morning warm to touch. Looked like giant hive per parent. Swelling decreasing and not as warm to touch, per call to pharmacy on 10-13-20. Recommended contact Dr. Per mom: noted in pt. file @ Dr office.
No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a nurse, also the medical assistant, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 15-JAN-2020, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot number S004399, expiration date on 06-NOV-2020, as prophylaxis (concentration, dosage, and frequency were not reported), that had been improperly stored in a temperature below 36 Fahrenheit degrees (16.7 Fahrenheit degrees) for 2 hours and 30 minutes and below 24 Fahrenheit degrees (16 Fahrenheit degrees) for 1 hour and 30 minutes; 1 cycle. No symptoms and no additional adverse events were reported. There was not previous temperature excursion and the temperature was recorded by a data logger.
Rash, not painful or pruritic on left chest wall.  Preceded by one day of lip tingling and nausea. No medication prescribed.
After taking the vaccine when she was about to leave she had a hemorrhage stroke and fell unconscious  which cause her to be rushed to the ER. She later passed away.
Pfizer vaccine given 33 days after put in the refrigerator. Use by date 9/25/2021
Tingling and numb lips.  No swelling.  Loratidine relieved symptom. Did not reoccur.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 81.53  No concomitant medication was provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    No treatment medication was provided
Long red streak (not like blood poisoning) took week to go away. Just that/tired. No other adverse effects.
Some numbness in left portion of face, namely forehead down to jaw along hairline. Lasted close to three hours, and has not happened since.No treatment.
The right shoulder is observed a little bit red, swollen and a little bit hot to the touch. The child was evaluated by a physician on the 01/15/16 and had treatment and a prescription.
pt recv vax & exp malaise, joint pain, fever & eye burning; NO further details were provided;
Initial report received from a health care professional on 05-Nov-2013. A 66 year old male received FLUZONE HD (batch number U47878A, expiry date: unknown) intramuscularly in left deltoid on 04 November 2013). The patient's medical history and concomitant medications were not reported. On 04 November 2013, within 2 hours of vaccination the patient experienced some swelling in his hands, yellow drainage from his eyes, intense chills, shivering, fever, severe vomiting and feeling week. At the time of this report the outcome of the events were resolved.
This spontaneous report was received from health care professional regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, patients received improperly stored MMR II (therapy type, dose strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No Product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.