chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One day following second dose of vaccine, patient developed chest pain. Was admitted to the hospital with concerning ECG features and high troponin elevation. No wall motion abnormalities, so less concern for STEMI. Likely diffuse myopercarditis. Full workup still pending
Swollen L arm at injection site, reddened and swollen area with minimal tenderness, tiny cluster of vesicles in center. This is in follow-up to report (s) previously submitted on 5/16/2007. Information has been received from a physician concerning a 9 year old male who on 11-JUN-2007, at 14:00 was vaccinated subcutaneously into the left arm with a second dose of VARIVAX (Oka/Merck) ( Lot # 556990/03340). Within days after being vaccinated with the second dose of VARIVAX (Oka/Merck) the patient developed a local reaction, with a large area or erythema, warmth and swelling surrounding the injection site, as well as mild tenderness and a tiny cluster of vesicles at the needle site. It is unknown if medical attention was sought. The patient recovered on 13 JUN 2007. There was no product quality complaint. Additional information is not expected.
After 7 days my arm began to swell and hurt.  Raised rash started to form and arm became warm to touch.  Each day after the initial discovery,  the rash grew larger and the pain and heat grew in  intensity.  I iced my arm and took 3 Advil.  As of today the swelling has subsided.  The redness now  is across the entire front of my arm but the pain no longer prevails.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-DEC-2010, the patient was inoculated with the 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 ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-MAY-2013, the patient was treated by a physician at a healthcare facility/clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed BACTRIM for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for 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.
In her right arm she has a similar popping in the shoulder; She cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull.; Severe pain in the shoulder and arm; Severe pain in the shoulder and arm; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164; Expiration Date: Aug2021), via an unspecified route of administration, administered in right arm on 07May2021 (age at vaccination: 46 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included hypertension and overweight. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150) an unspecified route of administration, administered in left arm on 17Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date in May2021, the patient in her right arm had a similar popping in the shoulder, she cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull, severe pain in the shoulder and arm. She thought it was a side effect of the vaccine. She went to see the doctor on 27May2021. She cannot use the arm to get dressed, shower, lift arm in certain angles, or push and pull. The patient did not require emergency room visit. The patient did not have any prior vaccinations within 4 weeks. The patient on an unknown date in 2021, underwent x-ray which showed no fracture or dislocation. The outcome of musculoskeletal discomfort was recovering; Loss of personal independence in daily activities was unknown; Arthralgia and pain in extremity was recovered on an unknown date in 2021.
did not return within the recommended time frame to receive the second dose; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2020, between 3 and 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 76 or 77 years. The patient received the first dose on Shingrix, however did not return within the recommended time frame to receive the second dose. On an unknown date in April 2020 the patient developed a case of shingles that was reported as resolved. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The consented to follow up.
Pneumovax recommended by MD at school physical exam. History of asthma. PPD also administered a the same time, approximately 3 PM on 04/11/01. By the evening the patient developed generalized itching, and hives, covering most of his body. Physician unavailable that evening. The patient was seen at neighboring clinic, where he was given Benadryl IM, then oral Benadryl every 4 - 6 hours. The hives were present on 04/12/01 in the AM,but reportedly resolving.
PATIENT RECEIVED AN EXPIRED FLUMIST QUADRIVALENT; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number MH2201) 0.2 ml once/single administration, via nasal route, on an unknown date.     The report described a medication error for Flumist Quadrivalent. The reported term was "patient received an expired flumist quadrivalent" (Preferred term: Expired product administered).     Treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal) was not changed.     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Product As Reported: FLUMIST QUADRIVALENT  Product Role: Suspect  Operator of device: Health Professional
VARIVAX #2 given on 3/21/08.  Patient developed vesicular rash on right arm and injection site and down dermitose on 3/24/08.
Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 06/17/2021. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated. Pregnancy information is unknown
Tired; headache; vertigo; Feeling hot; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 at 11:15 (at the age of 56-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:1470) via an unspecified route of administration in the arm left on 30Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor, hashimoto's hypothyroidism (hashimoto's disease), and asthma. The patient had known allergies to sulfa and gadolinium MRI contrast dye (contrast media dye allergy). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), tamoxifen (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), ibuprofen (ADVIL) and meclozine (MECLIZINE) ; from an unspecified date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, the patient felt tired and spicy (feeling hot) for a couple of day following injection then one day with headache, followed by vertigo until date of second vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures taken included self-medication  with meclizine hydrochloride. The clinical outcome of the events tired and spicy, headache and vertigo were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Red rash along front and back, left side. Blood pressure 201/110 in doctors office. Placed pain patch Lidoderm over affected areas. Given prescription for Acyclovir, Methylprednisolone.
Large area of redness, swelling, warmth, and itching at site of injection starting 7 days later.  Treated with a 5-day course of cephalexin, oral antihistamine, and topical cortisone cream.  Slight pinkness remains 1 week after onset; all other symptoms have resolved.
After the first dose I had a lot of the typical symptoms such as a sore arm, etc; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "After the first dose I had a lot of the typical symptoms such as a sore arm, etc".  Additional information: The patient later received second dose and booster dose of BNT162b2 for covid-19 immunisation. She received the booster dose of the Pfizer-BioNTech COVID-19 Vaccine on an unknown date in Dec2021 and it knocked her out, she experienced increased urination ever since. After the vaccine all night long, every 45 minutes, she had to go to the bathroom. It was not a big stream, but it was constant. She woke up dehydrated, it was such an excessive urination. She was not taking meds or anything like that.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200555679 Same pt/drug, diff event sep in time
Pt received her Covid vaccine and within the first 5 minutes of observation period she fainted.  We immediately activated 911.   She was pale and clammy to the touch.  Her pulse was normal  and her breathing was steady during the initial observation.  She slowly regained consciousness within the next 5 minutes and told us her chest hurt, her right hand hurt and she couldn't move her right arm or hand.   The fingers on her right hand were white.  EMT arrived shortly after and immediately took over.
High fever of 106F, wheezing, upper right quadrant pain and lower right quadrant pain. It lasted for 8 months. Treatments were antibioctics.  5/26/09 Hospital records received ED and inpatient DOS 9/18/07 to 11/19/08. FINAL DIAGNOSIS: Focal acute colitis. Post vaccination presented with abdominal pain all quadrants, fever, headache, nausea, hepatosplenomegaly, polyuria, polydipsia. Additional visits for sore throat, congestion, runny nose and cough.   8/7/09 ICD-9 Codes: 789.00 abdominal pain unspecified, 789.01 Right upper quadrant abdominal pain, 793.6 Nonspecific radiologic abnormality of the abdomen or retroperitoneum, 309.24 Adjustment disorder with anxiety, V15.09 Other allergy other than to medicinal agents, 462 Acute pharyngitis, 465.9 Acute upper respiratory infection unspecified sites, 079.99 Viral infection unspecified in condition classified elsewhere, 571.8 Other non-alcoholic chronic liver disease.
"pt recv vax 28JUL97 & devel t100-101;31JUL97 pt fussy, sleeping only fitfully & crying;irritable;pt cried & pitched a fit for 5-6 days;saw MD;thinking had an ear infect;"
Information has been received from a 68 year old female on 13-NOV-2007 was vaccinated with ZOSTAVAX (Merck). On 14-NOV-2007 the patient experienced a sore on her lower lip that looked white and painful. At the time of report the patient said "the sore on her lip has improved a little bit but its still there." The patient is recovering from the sore on her lower lip. The patient sought medical attention by calling the physician. Additional information has been requested. Follow-up information has been received from the patient with no known drug reactions/allergies reported. The sore on her lip went way after one week (approximately 21-NOCV-2008). No additional information is expected.
Sweaty; hot; Fever; Headache; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweaty), FEELING HOT (hot), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Shivering) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERHIDROSIS (Sweaty), FEELING HOT (hot), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Shivering). On 01-Apr-2021, HYPERHIDROSIS (Sweaty), FEELING HOT (hot), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Shivering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt entered dates on all four lines of Covid consent form. It was then thought that this was her booster does. Once the imm was given, it was noted this was pt's first dose.
Severe migraine; body aches; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 32-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Er8736 and Expiration date was not reported), via an unspecified route of administration in arm left on 23Apr2021 at 15:45 (at the age of 32-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included asthma. Past drug event included morphine and experienced known allergies: morphine. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Historical vaccines included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Ep7533 and Expiration date was not reported), via an unspecified route of administration in arm left on 02Apr2021 at 09:00 (at the age of 32-years-old) as a dose 1, single for COVID-19 immunization and patient experienced severe migraine, body aches, cough that got worse, slight fever, nauseated, diarrhea, just wanted to sleep and made her asthma worse using her rescue inhaler more frequently on the same date and time and the patient received gardasil vaccine (GARDASIL), via an unspecified route of administration on an unspecified date as an unspecified dose for an unspecified indication and experienced known allergies: gardasil vaccine. On an unspecified date in Apr2021, the patient experienced severe migraine, body aches both the times. Treatment was not received for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse and described the occurrence of injection site swelling in a 5 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 08Aug05 the subject received the 5th dose of Infanrix in the left thigh (lotAC14B002AA). On an unspecified date on or after 08Aug05 and on or before 15Aug05, less than one week after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling. The subject was seen at a physician's office. The nurse described the injection site swelling as about the size of a grapefruit, about 8 to 10 cm. The subject was treated with steroid and antihistamine. The events resolved on an unspecified date on or after 08Aug05 and on or before 15Aug05. The nurse considered the events to possibly be related to vaccination with Infanrix.
Patient turned pale after 5-10 min of receiving the vaccine. He felt dizzy, his vision got blurry for a few seconds. He felt nauseous but did not vomit. His heart was hurting. EMTs arrived approximately 15-20 min after vaccine was given. At that time, patient seemed to lose consciousness but was responsive when spoken to. He was taken to the hospital.
p/vax pt devel an inj site rxn characterized by a 2.5mm area of redness & swelling & a 4mm area of induration @ the inj site;pt seen by MD;
Patient states that she developed severe pain in the shoulder after the vaccination. She didn't notify us back then and she mentioned it today when she came to get a bivalent shot. She went to the MD right after receiving the vaccination as the pain was not going away and the MD said it was Bursitis possibly caused by the vaccination. She tried different things and nothing helped the pain relief. She ended up going to an accupuncturist and after getting several months of accupuncture therapy, took a herbal pill per accupuncturist recommendation. She thinks the pill had helped her after taking for 2 months. She is fine now except she has a slight achy feeling in her arm all the time.
This spontaneous report as received from a registered pharmacist refers to a 65 years old female patient with no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # 672607/1716AA expiration date 02-FEB-2013) on 23-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 24-JUN-2012, the patient developed a red rash at the injection site. The patient also developed black colored rash above the injection site. The patient saw the pharmacist. The patient did not revealed treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. The relatedness for red rash at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
High fever 101 degrees F -> 103 degrees F.  Headaches-severe and positional- can't stand up or sit up, nausea, dizziness, vomiting- lasted 3 days, now still have headaches .  Spinal tap, fluid replenish, got measles, still having headaches, blood lab, spinal tap.
Patient fainted briefly after covid vaccine administered by pharmacy technician.  Patient was sitting down. EMT arrived, vitals were normal, patient refused transport to hospital.  Patient referred to PCP for evaluation. No anaphylaxis or other symptoms.
Had TD vaccine on Saturday AM at health fair and that afternoon, started having muscle pain in back, hips and legs and felt feverish. These symptoms lasted 36 hours. Much improved today except for sore arm at site of injection.
I did not have an adverse reaction to the vaccine. I started feeling symptoms on 01/29/2023. I tested positive for COVID-19 on 02/01/2023. I contacted my doctor and got the prescription PAXLOVID. I tolerated the medication well without any issues. As of today, I do not have any lingering COVID-19 symptoms. Also, I slipped and fell on 03/01/2023.
On 03/23/2021 - I woke up in the morning with a headache that stayed all day long. I had fever, and throughout the day I had chills. Elevated temperature that went up to 99.1. I treated it with Tylenol and I was fine the next day.
Two hours after vaccination- client felt burning-oozing and "deep pain" at site. He (R.A.) removed band aid (non-latex) and discovered 2 small blisters. He cleaned the area and applied ointment. Today 01/26/2005 scab has formed area looks clean and free of infection.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 3, intramuscular. The patient received an improperly stored dose of GARDASIL (lot K010574, expiration 04/08/2017). The patient received her dose, which was her third in the series, on 04/08/2015. No adverse effect reported. No additional information provided. This is one of two reports from the same reporter. Additional information has been requested.