chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per email from Customer Care, patient stated -  ?I received my COVID booster shot at the Pharmacy on Sat, Nov 13. I've just returned from the doctor and have been told that I have SIRVA (Shoulder Injury Related to Vaccine Administration) due to the vaccine being given improperly. I don't know the full extent of the damage yet but will be seeing an orthopedist for a prognosis and course of treatment. Some action needs to be taken with the Pharmacist at the this Cub. At the very least, she needs to be retrained on how to properly give a vaccine shot in the arm. Mine was given too far up on the shoulder. I'm sure I can't be the only one who received the shot incorrectly.?
5 minutes after patient got his J$J vaccine he lost consciousness and fell down on the floor. The pharmacist(myself) run to him.  Patient started to seize. I turned him to his side and tried to keep his mouth open in order for him to not bit his tongue. Meanwhile 911 was called. Patient had seized about 15-20 seconds, then suddenly he became calm and conscious. 911 dispatcher told us to keep him laid down on the floor till they get to the store. One of our coworker asked patient few questions to see if he remembered things. Paramedics came about 7 minutes later and took care of him. They let him go after evaluation. I called him later & he had recovered.
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. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about November 2013, the physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 04-SEP-2014, the patient was treated by a nurse practitioner for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pt arm swelled up, throat swelling, went to ER. Benadryl given at hospital. Pt discharged with prednisone RX.
Flu vaccine was injected IM too high into my left shoulder. Site pain became intense and woke me from my sleep at approx 1am on 10/7/17. After approximately 10 days, I noted no improvement in pain, radiation, numbness, tingling fingers, and limited painful range of motion. I saw an orthopedic MD specializing in shoulder pain on 10/19/17.
12:25 PM administered the Pfizer Booster shot.  01:40 PM Patient reported numbness of right side of face, neck and arm and lips. BP  160/90  HR 91  SPO2 96% Resp.=20 01:50PM    administered 1 shot of EPI 01:55PM  BP  110/100  Resp=20  HR=90 SPO2 96%  Symptoms relieved no neck, arm lip pain  Some blurred right eye visions Patient transported by EMS to hospital.
dizziness/severe dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent (Mother).  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:30 (Lot number: EW0150) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 31Mar2021, outcome "not recovered", described as "dizziness/severe dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: There was no PQC present. Caller said that her daughter received the first dose of the Pfizer-BioNtech Covid-19 vaccine yesterday. Her daughter experienced dizziness after receiving the injection. Caller would like to know if that was normal or they should take something or go to the ER and how long it was supposed to last. No treatment done yet. Caller stated that she believes it is EW0150 but had difficulty reading the card writing. Severe dizziness was started ten minutes after leaving the facility. Received at 3:30 pm yesterday 31MAR2021. AE(s) did not require visit to Emergency Room or physician office. None were prior vaccination within 4 weeks. There were no AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
wrong diluent used for the reconstitution of Hiberix and Rotarix; wrong diluent used for the reconstitution of Hiberix and Rotarix; Rotarix vaccine was injected and Hiberix was given orally.; Vaccine Administered at Inappropriate site/ Hiberix given orally; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis.   On 18th October 2021, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Hiberix (oral). On 18th October 2021, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Hiberix, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered, inappropriate route of vaccination and intramuscular formulation administered by other route. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered, inappropriate route of vaccination and intramuscular formulation administered by other route were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter called from medical facility to report that a Medical assistant at the facility used the diluent for the Rotarix vaccine to reconstitute the Hiberix vaccine and the diluent for the Hiberix vaccine was used to reconstitute the Rotarix vaccine, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered for both the vaccines. Then the Rotarix vaccine was injected and the Hiberix vaccine was given orally, which led to inappropriate route of vaccination and intramuscular formulation administered by other route respectively. The patient did not experience any adverse effects. The reporter asked for recommendations on what she should do. The reporter consented to follow up.
It started off with extreme body pain, palpitations, and body tremors for a few days. Felt a little better after a few days but less then a few weeks later started having chest pain, palpitations, tremors, neuro issues,  high blood pressure and heart rate, and blurry vision. Went to the hospital three times and have seen a neurologist, cardiologist, and pulmonologist. Cardiologist diagnosed me with a mildly stiff left pump and am currently on a beta blocker.
Low grade fever for 48 hours, starting about 2 hours after vaccines. On her right thigh, an area about the size of a quarter became red and inflamed, stiff to the touch and seemed painful. Area developed about 2 hours after vaccines and was still there 72 hours later. She experienced extreme gas pain in the middle of the night about 8 hours after vaccines and lasted about an hour.
Fever, crying, thirst, constant urination.  Diagnosed with Type 1 diabetes mellitus one week later on 4/6/2018
SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT. Initial case was retrieved from the scientific literature on 08 June 2011.The agency was established in 1986 in response to the vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing Td, DPT and DTaP, MMR II, IPV, and HBV. In 2009, the agency charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute's review, we undertook a systematic analysis of the agencies anaphylaxis case experience. The agency administrative database was queried for all cases submitted to the agency alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A pediatric male patient (age not reported) with medical history of 30 weeks premature, cataracts, lens replacement, latex allergy and IgE positive to gelatin, received the following vaccination on an unknown date with unknown manufacturers and unknown lot numbers: an injection (route and site not reported) of DTaP vaccine, an injection (route and site not reported) of IPV, an injection (route and site not reported) of Hepatitis A virus, and an injection (route and site not reported) of MMR II. On an unknown date within 2 hours after receiving the vaccines the patient developed anaphylaxis with symptoms of cough, sore throat, welts, shortness of breath, wheezing and urticaria. The patient was treated with diphenhydramine and oral steroids. The outcome was reported as recovery to previous immunization state. The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03328, 2011-03329, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Asthma exacerbation started about 24 hours after administration of 1st COVID vaccin
Swollen large area, red at site - after swelling went down - left dark brown area at site.
Initial report received from a healthcare professional on 01 June 2012, who provided information on this case of one unidentified patient out of a cluster of 10 unidentified patients (previously reported as approximately nine unidentified patients), in case number 2012-05660. Information on the remaining nine patients is captured in case numbers: 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06073. The reporter for this case is also the same reporter as case numbers 2012-05658 (six elderly patients) and 2012-05659 (two adolescent patients). The reporter stated, of the cases reported as vaccine failure, one unidentified patient received an injection of FLUZONE, sanofi pasteur Inc., lot number reported as UT434AA in dose form 0.5 mL syringes, single dose syringe (route, site and date of administration were not reported). An unspecified amount of time later, the patient tested PCR positive for influenza A/H3 at the state laboratory, since January. The patient's outcome was not reported. There was no additional individual patient information available. Followup report was received from a healthcare professional on 15 October 2012. The case now met the criteria for an expedited report since receiving patient identity. The patient received the FLUZONE on 04 October 2011 and the approximate treatment date was 08 May 2012. The patient tested positive with PCR for influenza A/H3N2 on 08 May 2012. Within four weeks of vaccination with FLUZONE, the patient received an intramuscular injection of PNEUMO-PS, lot number 0631AA, in the left deltoid on 12 October 2011. The patient's outcome was reported as recovered. Documents held by sender: None.
Received Pfizer vaccines on  3/3, 3/24, 9/9/21 COVID-19 positive by PCR on  1/5/22 admitted to hospital 1/13/22 to ICU for pneumonia d/t COVID 19 pt s/p lung transplant May 19, 2019; h/o DM, CAD
High Blood Pressure that was not previously high, heart arrhythmia and racing heart, heart palpitations at times
Extreme dizziness; Extreme chills; Overall muscle pain; Joint pain; Bone pain; Extreme fatigue; Extreme site pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 05Apr2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure that was controlled by meds (medications). The patient had no known allergies to medications, food or other products. Concomitant medications included medications for high blood pressure, amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and estradiol (MANUFACTURER UNKNOWN); from unknown dates for unspecified indications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 14Mar2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021 at 18:00, with in six hours the patient experienced extreme site pain. On05Apr2021 at 19:00, the patient experienced extreme chills, overall muscle pain, joint pain, bone pain and extreme fatigue. On 09Apr2021, the patient experienced extreme dizziness which set in after 4 days and continued. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme site pain was resolved by 48 hours on 07Apr2021 at 18:00. The clinical outcome of the event's extreme chills, overall muscle pain, joint pain, bone pain and extreme fatigue was resolved by 48 hours on 07Apr2021 at 19:00. The clinical outcome of the event extreme dizziness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recv vax; severe local rxn; high fever, swelling, redness up & down leg of vax site; large knot from hip to knee; limping; no pertussis;
Irregular menstrual bleeding, onset of severe migraines and GI isssues. Hospitalized twice for sudden abdominal cramps and pelvic pain
No additional AE reported; a patient received a dose of PROQUAD and a dose of MMRII; This spontaneous report has been received from a registered nurse regarding a 1-year-old female patient. The patient's concurrent conditions, pertinent medical history, and drug reactions/ allergies were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) (lot number: W000452, expiration date 23-JUL-2024).  On 12-AUG-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA)) lot #W010527, expiration date: 25-SEP-2023 (strength, dose, route of administration, and anatomical location were not provided), and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot #U039906, expiration date: 16-DEC-2023 (strength, dose, route of administration, and anatomical location were not provided) for prophylaxis (overdose). There was no additional adverse event (AE) reported.
This case is linked with case: 2013-05765 and case number: 2013-06247 (reported by the same reporter). Initial misuse report received from a healthcare professional on 24 April 2013. An adult patient was given DAPTACEL instead of ADACEL. (No more information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Information has been received from a physician concerning an 18 year old female who on 18-JUN-2009 was vaccinated IM, 0.5 ml with the first dose of GARDASIL (lot # 661954/1131X). On 18-JUN-2009 after being given GARDASIL, the patient "fainted and had shaking episodes and seizure like reactions. She regained consciousness and the shaking and seizure like activity stopped, but then started again." The adverse effect "stopped and started over a 3 hour period before she was ready to leave." The mother said that the patient was "fine" by then, but also said that the patient had "similar reactions" to "other vaccines" in the past. The doctor did not specify which vaccines the patient had the reaction to. The patient sought unspecified medical attention. The patient had recovered on 18-JUN-2009. Additional information has been received from a medical assistant on 22-JUN-2009 who reported the patient had no pertinent medical history other than the fact that the patient had "similar reactions" to childhood vaccines (no specifics available). The patient had no known drug allergies (NKDA). Concomitant therapy included SOLODYN and unspecified oral contraceptive. No other vaccines were administered at that time. Seizure like symptoms included twitching and eye rolling. The patient also had mild nausea. Blood pressure (B/P) at start of incident was 90/60; later it was 118/60. The patient did not go to the emergency room (ER). Event not considered as life threatening. Upon internal review, it was determined that eye rolling/twitching (convulsion) were serious as an other important medical events. No further information is available.
I had a swollen arm and unable to lift my arm for about 24 hours. I was on a trip and on the third day, I started not feeling well. I was diagnosed with atrial flutter and AFIB. My first episode occurred on 03/23/2021. I went to the emergency room and got the help I needed. As of today, I feel better after starting new medication, and I have a follow-up appointment in two weeks.
30APR irritable & crying & poor diet all day; mom didn't take temp but pt sleepy all day; large reddened area @ inject site started about 12PM chest pain 1MAY92 redness under arm;
This is in follow-up to report (s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 24 year old female with no medical history of drug reactions/allergies who on 25, Jan 2007 was vaccinated with the first IM 0.5 ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 04, Feb 2007 (1 1/2 weeks after the first injection), the patient experienced lesions/"vaginal bumps" on the external vaginal area. The patient contacted the physician on 26, Feb 2007 regarding the "rash" and 'vaginal bumps" . A vulvar biopsy of the left labia and posterior fourchette revealed condyloma. No treatment was provided at the time of reporting.  Cultures were obtained ad HPR, Hep B, Hep C, HSV 1 and 2 HIV tests were performed and were all negative. The patient had not recovered. It was noted in follow-up tht the patient ws vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL on 27-MAR-2007 (Lot # "00844"). As of 05-MAY-2007, there was no report of an adverse experienced with this second dose. No further information is available.
Severe shivering, slight fever, pain at injection site and in left armpit and clavicle, fatigue, loss of bladder control
arm aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm aching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm aching). At the time of the report, PAIN IN EXTREMITY (arm aching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  No relevant Lab Data was provided.  No relevant medical history was provided.   This case was linked to MOD-2021-072551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contains non-significant information.
We had a 17 yr old female that came to the health department with her grandmother and teenage brother for the seasonal flu vaccine. The grandmother did not come to the exam room with them. I asked both of them if they were allergic to eggs or latex or if they had ever had a problem with the flu vaccine. Their answer was no. I asked if they had asthma or any other underlying condition, diabetes, heart disease, cancer, etc. They said no. The 17 yr old female said that they wanted the mist. I returned to the exam room with the seasonal flu mist and after I administered it, the 17 yr old told  me that her doctor would not give her the flu shot. I asked why not. She said that she was pregnant. She was 18 week gestation.
pt recv vax 5JAN98 & a few hr p/ vax pt devel pain, redness 7 swelling in lt arm;tx w/med;
Redness and swelling at injection siteon right arm, low grade fever, emesis X1 beginning 06/20/2007 AM.  Treating with Tylenol and cold pack to site.
1wk p/vax pt devel itchy blister type rash @ inj site 4" diameter was given DPH w/relief;had no problem p/DPH for 3 days;
increasing in episodes of A-Fib strong enough where she was aware of them; peripheral neuropathy was greatly worsened; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Lot Number: EW0172) as 1st dose, single dose for covid-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing Peripheral neuropathy from chemo, asthma, ongoing A-Fib, Known allergies: Yes. Concomitant medications included unspecified drugs that the patient received within 2 weeks of vaccination. On 23Apr2021, the patient experienced increasing in episodes of A-Fib strong enough where she was aware of them. She slips into and out of it many times daily but am usually not aware when it occurs. Since the vaccine these episodes are such that she was well aware of them. Her electrophysiologist had others reporting same. Also, peripheral neuropathy was greatly worsened. No treatment received. The events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The second dose of BNT162B2 was on 14May2021 03:00 PM (lot number: EW0167, Vaccine location: Right arm) for covid-19 immunisation. Outcome of the events was not recovered. The case was reported as non-serious.
Patient states the next day after her injection she developed diarrhea, felt short of breath and felt palpitations and had a productive cough with yellow sputum