chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2006, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and 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. During 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. 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.
Information has been received from a physician concerning an approximately 79 year old female was was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently the patient complained of injection site pain, redness and swelling toward the elbow. Medical attention was sought and the patient was treated with compresses and ibuprofen (Advil). The AE's resolved after 5 days. No product Quality complaint was involved. It was also reported that within the same week tow other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) and developed AE,s (WAES0411USA00719, WAES0411USA00720). Additional information has been requested.
Patient is a 10yr old female who came to a pediatric flu shot clinic that was held Wed., 11/18/2009 from 4-7pm.  They waited in line ~1.5hrs prior to getting vaccinated.  While waiting in line patient kept herself busy doing homework.  They did not have supper prior to coming to clinic. Immediately post vaccination while they were leaving, patient told Mom "I cannot see". She then dropped to the floor. Her eyes were rolled back in her head and she was twitching. After a few minutes she came to and was very confused and panicky. She was put on a stretcher to lie down for about 40 min. to an hour.  Then Mom slowly got her up and let her feet dangle before standing up. Patient also complained that the injection site arm (as well as her spine) was tingling. Mom describes patient as a very hypersensitive child who is very in tune with her body.  We question whether this is a true adverse reaction to the vaccine vs a vasovagal response to the injection itself.  Mom has herself also passed out post injection. Patient has not had any problems with previous routine vaccinations.  Her most recent vaccincation was varicella 2/2007 (7yrs old) and prior to that would've been her pre-KG shots in 8/2004 (5yrs old).
On 9/10/21 this individual died.  Beginning on 9/2/21 he began complaining of not feeling well and he informed a friend that he had a positive COVID-19 test.  The whereabouts of this test and actual results have not been verified.  Shortly prior to his death he informed his friend that his throat and chest felt tight.  An autopsy performed at the Medical Examiner's Office on 9/10/21 revealed an infection of his larynx; his lungs shows some focal fibrinous deposits with mononuclear cell infiltrations but not classic hyaline membranes.  A postmortem COVID-19 test was not performed; however, paraffin blocks have been submitted to the CDC with the assistance of the DOH Laboratory for COVID-19 testing.  The CDC recommended this case be reported to VAERS.
experienced a golf ball size lump at the injection site; the swelling; the wrong needle size was used for the patient (5/8" needle, 25g syringe); medication was essentially given subcutaneous versus intramuscularly; the injection site is red; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-OCT-2023, the patient received Shingrix (subcutaneous, unknown deltoid). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: the injection site is red). On 17-OCT-2023, the patient experienced injection site lump (Verbatim: experienced a golf ball size lump at the injection site), injection site swelling (Verbatim: the swelling), wrong technique in product usage process (Verbatim: the wrong needle size was used for the patient (5/8" needle, 25g syringe)) and intramuscular formulation administered by other route (Verbatim: medication was essentially given subcutaneous versus intramuscularly). On 18-OCT-2023, the outcome of the injection site lump and injection site swelling were resolved (duration 1 day). The outcome of the injection site erythema was not resolved and the outcome of the wrong technique in product usage process and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site lump, injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site lump, injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 Healthcare professional was the reporter. The reporter stated that a patient was vaccinated with the wrong needle size (5/8" needle, 25g syringe) although the medication was injected into the deltoid muscle due to the length of the needle the Healthcare professional stated that the medication was essentially given subcutaneous versus intramuscularly (Medication Error.)  The patient immediately experienced a golf ball size lump at the injection site. On 18th October 2023, the swelling has resolved however, the injection site was red. The patient administered Shingrix vaccine with the wrong needle via subcutaneous route, which led to wrong technique in product usage process and intramuscular formulation administered by other route. The reporter consented to follow up.
Patient stated his arm became red and swollen.He says he took antihistamine and was OK.
sore arm with raised, warm, red, itchy bump at injection site measuring 1in wide by 2in long lasting 10 days (site still discolored on 11th day). No treatment. Chest tightness, difficulty breathing, asthmatic cough starting a few hours after injection and lasting 4 days. Used albuterol rescue inhaler four times a day (2 puffs each time) for all 4 days. Extreme fatigue and inability to stay awake the day of injection and the day after. No treatment other than sleeping more.
Initial unsolicited report received from a consumer (patient himself) via other company (manufacturer report number: 2017TAR00369) on 30-May-2017. This case involves a female patients (age not reported), who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient previously received ENOXAPARIN SODIUM (Lovenox) for three months prior to starting WARFARIN SODIUM (Taro Warfarin) which started from an unspecified date of Oct 2016. Patient's medical history included diabetes, high blood pressure, kidney stones, GERD and cancer. The patient had a port placed in right shoulder and developed a clot post port insertion. Patient's concomitant medication included Irbesartan, glimepiride, sodium bicarbonate and omeprazole all from an unknown date. On an unspecified date, following the vaccination, the patient experienced muscle spasms. Patient's laboratory investigation and corrective treatments were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Woke up with pain on my left arm/ inside left elbow/forearm. Intense pain as if it was an internal injury.  No bruising or outside the skin injury.    Then it started to have redness & feel warm to the touch. I?ve had similar symptoms with shingles in 2010, so I went to the urgent care clinic earlier this week and they started me on medication for shingles and/or cellulitis.
Chills, drenching sweats, severe muscle and joint pain- started 12 hours after vaccine and continued for 48hrs Headache- ongoing for 6 days; Rash (itchy with some hives) on face, arms and shoulders- showed up on day 5 post vaccine and resolved with benadryl; Hot flashes- ongoing for 6 days; Fatigue- severe for 48hrs and moderate ongoing still on day 6 post vaccine; Diarrhea- day 5 has since resolved; Arm pain- moderate for 48hrs and resolved by day 4 Lack of appetite- ongoing for 6 days; Generally I just do not feel good and am surprised many of these side effects have lasted so long.
States she woke up this morning at 09:30am and she is covered in a red, raised hive like rash over her entire body and extremeties.  The rash is now starting to spread to her face.  She denies swelling in her tongue, throat, scratch throat or difficulty breathing.  She has had previous Flulaval vaccine last year without a reaction.  She called her PCP and was instructed to go to the ED.  She was seen in the ED and given prednisone and Benadryl.  They gave her an Epi pen for home.  She is better.  She still has injection site soreness and a rash, but the rash has not gotten worse.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vials was 07-May-2021 No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
Pt COVID + 10/16/22 - Received Pfizer vaccines x3 BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/16/2022 Discharge Date: Oct 18, 2022   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Dizziness [R42] Weakness [R53.1] Chest pain, unspecified type [R07.9] COVID-19 [U07.1]   HOSPITAL COURSE:  67 y.o. male with past medical history significant for coronary artery disease, hypertension, hyperlipidemia, paroxysmal atrial fibrillation, hyperlipidemia, right hip arthroplasty and on March 22. Patient presented to emergency department with approximately 1 week of fatigue, malaise, weakness, chest discomfort, shortness of breath.  Upon arrival to emergency department patient was hemodynamically stable.  Labs unremarkable except for mild hyponatremia.  He did test positive for COVID.  Due to vague complaints of chest pain, troponin was obtained and was normal.  EKG revealed sinus rhythm with first-degree AV block, known left bundle branch block.  Chest x-ray is negative for acute process.  CT head is negative for acute process, there is mild disproportionate ventriculomegaly.  Patient was unable to stand or walk when evaluated in the emergency department and thus admitted for further care.  Initially patient had relative hypotension and home Toprol-XL dose was decreased to 25 mg daily and Cozaar Lasix held.  Blood pressures improved Cozaar  restarted.  Patient remained on room air.  Decadron was discontinued secondary to this.  PT OT consulted and recommending home.
the husband is positive for Covid; the husband is positive for Covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 16Mar2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Reporter stated that the mother-in-law had her first vaccine on 14Mar2021 and the mother-in-law's husband (patient) had his vaccine on 16Mar2021. Patient received first dose 16Mar2021 and tested positive for COVID, 2 days ago (05Apr2021). Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Injection site red; Injection site hot to touch; Injection site itchy; Injection site soreness; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 72 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. After the 2nd dose, injection site was red, hot to touch, itchy and sore.
Pt's mother called and reported half-dollar sized redness/raised area. No SOA, fever, rash, etc. Treated at home with OTC BENADRYL and ice.
Pt vaccinated with DTP/OPV developed lip swelling. Rxd w/ice. Resolved after 1 hr. No furthe reaction.
Body broke out in hives arms, chest and back.  Child displayed chronic memory loss, bizarre behavior and frustration.  Highly unusual behavior for patient. Dr.was notified about this.
Temp up to 106.0; Uncontrollable shaking; Headache; body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809, Expiration date not reported), via an unspecified route of administration on arm left on 20Feb2021 11:00 at single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, bp issues, hypothyroid and covid; all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had known allergies to morphine.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has received unspecified other medications in two weeks. On 20Feb2021 20:00, the patient experienced uncontrollable shaking, temp up to 106.0, headache and body aches. The patient underwent lab tests and procedures which included body temperature: up to 106.0 on an unspecified date. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved
After my second dose of Pfizer BioNTech, I have flu-like symptoms within 90 minutes and hormonal symptoms within 24 hours. These symptoms have been communicated to numerous western and functional doctors and included: fatigue, headache & severe cognitive issues, intense muscle pain (feeling like my entire body was getting paralysed), joint pain, mild fever, intense ongoing pain at the injection site, severe pelvic pain and sensations, adverse changes to my hair (greasy and straw-like), late/ missed menstrual cycle, locking of my left hand, and occasional numbness and tingling in my feet. Within 90 minutes of the vaccine on the afternoon of June 2, 2021, I was holding my head and not feeling well enough to work. The symptoms intensified around 3-8 weeks with intense muscle aches and fatigue. It has been almost 12 months and I still have severe cognitive issues, belts of intense muscle aches, fatigue and energy issues, and occasional pelvic pain. Symptoms continue to prevent me from performing my regular work, exercising, and during 'flares' from undertaking basic daily activities. The vaccine has taken a year of my life and still counting.
Vaccine was given at 11:30AM. Approx. 5 minutes after dose given, patient was lightheaded, broke out into a sweat, pale,  cold, and fainted twice in the course of 15 minutes. 911 was called and arrived at 11:45AM.
30 minutes following injection the patient began experiencing tingling of the lips and sensation of swollen tongue. no shortness of breath, wheezing, chest tightness, lightheadedness or syncope. She was given 25 mg po Benadryl and monitored for 45 minutes. her symptoms resolved completely.
This spontaneous report was received from a register nurse referring to a 6 month old patient.  The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 04-SEP-2018, the patient was vaccinated by oral route with ROTATEQ lot # R003111 expiration date 12-SEP-2019, (dose was not provided) for prophylaxis. On the same date,  the nurse reported she administered an improperly stored dose of the vaccine(medication error), no adverse effects were reported. Temperature: 47 Fahrenheit to 77 Fahrenheit (47.1 Fahrenheit)  for 20 minutes, the call was due to a "data logger".
Fever, chills, joint aches, dizzy, lightheaded, nausea, ringing in ears, almost fainted. Took ibuprofen. 10 am on the 24th, feel better but still dizzy and shaky.
A few minutes after vaccination the child fell, hit her head on the floor and had a seizure lasting less than 1 minute.  The child then sat up and climbed into her father's lap, BP 120/70 left arm, child alert and oriented, father was offered emergency treatment/assessment of child through 911 but father declined.  Encouraged father to bring the child to facility for assessment, father stated he would do that.  Child ambulated out of the office independently, accompanied by her father.
A non-serious spontaneous report of H1N1 administration to 8 individuals under 2 years old was received from a registered nurse concerning two patients under the age of six months, and six patients between the age of six months to two years old. Seven patients have no medical history, only one patient had a previous history of respiratory syncytial viral (RSV) infection. All patients were not on any concomitant medication. The patients received H1N1, Intranasal on 20-Oct-2009. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved. Additional information was received on 11-Nov-2009 and incorporated into the narrative: Information about medical history and concomitant medication of eight patients has been added.
ringing and buzzing in her ear nonstop; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm (upper arm, unknown which arm) on 23Feb2021 around 11: 00 AM (Batch/Lot Number: EN6202) as single dose for COVID-19 immunization. The patient previously received first dose bnt162b2 (BNT162B2) via an unspecified route of administration, administered in Arm (upper arm, unknown which arm) on 02Feb2021 (Batch/Lot Number: EM9810) as single dose for COVID-19 immunization.  The patient medical history and patient's concomitant medications were none. Family Medical History Relevant to AEs was none.  The patient had her second shot already on 23Feb2021. She was not really good if something was bothering her to know if it was really bothering her. She had had this ringing and buzzing in her ear nonstop. She was sure that it has been going on for at least a week. She had also gone to the dentist. She clarified that she went to the dentist for just a routine cleaning.  She was not sure if it could have been going on longer. She asked if that was a side effect. It was kind of just a nuisance. It was kind of like when you hit your ear and it pops and then you get a buzzing. It was annoying. When she was listening to TV, she didn't notice it, but she definitely noticed it when in the bed and when it was quiet. Vaccination Facility Type was Pharmacy Department. Vaccine was not Administered at Military Facility. No AE required a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. Relevant Tests was None. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
With both doses, eyes became swollen.  Saw primary care provider and was prescribed eye drops and oral antibiotics which cleared the infection.  PCP stated the "eye infection and stye" was caused by the vaccine.
This case was reported by a consumer via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The age group was not reported, but was selected adult as per vaccine indication. The reporter's physician informed her that, some of the other patients reported to the physician that the SHINGRIX vaccine was painful. The reporter did not have any additional details. This case has been linked with the case US2018182771, reported by the same reporter.
Patient fully vaccinated (Moderna), but not boosted, admitted to the hospital on 1/21/2022 with COVID-19 and associated hypoxia. Patient was discharged on 1/25/2022.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 22Jan2022 as dose 3 (booster), single (Lot number: EL3208) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "higher BMI" (unspecified if ongoing); "Known allergies: chicken eggs" (unspecified if ongoing); "known allergies: Yeast" (unspecified if ongoing). Concomitant medication(s) included: ZINC COLD THERAPY, start date: 02Sep2022, stop date: 04Sep2022; AMPHETAMINE SALTS, start date: 01Aug2021, stop date: 02Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid (Lot no. GE4259) for treatment of COVID-19 from 04Sep2022 to 04Sep2022.