chrisvoncsefalvay/vaers-outcomes huggingface dataset:
admitted on 9/5/21 and found to be positive for COVID; prescription given for prednisone; dc'd the following day; 9/19/21 pt to ED with increased confusion; never got prescription filled; bradycardic, hyponatremia, UTI; CT showed old MCA stroke; DNR/comfort care; pt's condition worsened and she died in the hosp
At 11:20 am, I felt like I felt like when I get chocolate - my tongue kind of swelled. It felt funny. They person there walked me out. I slept all afternoon; felt tired. When I got ready to go the bed, my heart felt like it was racing some. Around 2:00 am my heart was really pounding - my watch was going off and telling me that it was at 130 to 150. The highest was 152. I called my doctor's after hours phone number. I took my blood pressure - it wasn't that elevated but it was the racing heartbeat. About 03:30, I went back to sleep. It was about 100 for about next  12-18 hours. It seems to be back to normal now.
It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/5/99. The vaccination "was given SQ instead of IM". Reportedly, that same day, the pt experienced a mild to moderate reaction at the injection site. The pt reportedly recovered from this experience. "Reviewed, no additional information at this time, 11/17/99.
On 11/10/2021 I was dizzy and lightheaded. On 11/15/2021 I was very weak and felt faint. I thought I was going to pass out so I called the ambulance and they took me to the ER hospital. I was given a heart catherization that was normal. I had shortness of breath on 12/30/2021. On 12/31/2021 I was told by my doctor that I should get a lung scan because one of my blood test was slightly elevated. I did a lung scan and it showed that I had an aneurysm of the aorta.
Left thigh noted redness and swelling PM 01/14.  No fever, complained of pain, no limp.  Itchy.  P/E: Erythematous swelling left lower thigh.  No tenderness.  Site of injection 1 inch above rash.
Temp 102 w/in 1 hr p/vaccinated, climbing to 105F in next 10-12 hrs; Given APAP & called MD;
passed out and almost broke her arm; started salivating really bad/it's lot of drool; Heart rate started pounding; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date May2021), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunisation.  Medical history included: Allergy.  Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for Birth control, chlorphenamine maleate (PIRITON) for Allergy.  The patient was perfectly fine up until about the 3 hours after the vaccine, she started salivating really bad, she was not throwing up or nauseas or anything, it's just that it's lot of drool, like she even had just go over sink as just salivating so much it was weird, and her heart rate started pounding and she passed out and almost broke her arm, so and then she kind of like blacked out and don't remember anything for rest of the evening. The events onset date was on 26Jan2021 08:30. No treatment was received. The outcome of events was recovered in Jan2021.
Patient came up after about 15 minutes and stated her arm felt numb and tingly. She stated she was not having any other symptoms and felt okay. Her arm just felt asleep.
Very large swelling around the injection site. Swelled to about 1 inch in diameter and 1/4 inch height. Swelling did go down to normal after 15 min.
Red at site.- T high 102 degrees, Heart rate high 140- 160 - BP high 146/94 - TYLENOL ES tabs 2 po - SV started, BENADRYL 50 mg QV sent to ER
Information has been received from a consumer referring to her 27 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. There was no concomitant medication. On an unspecified date in March or April of 2016, the patient was vaccinated with VARIVAX (subcutaneous; dose was unknown) for prevention of varicella. The patient presented with redness at the injection site on the next day or two after the VARIVAX injection. The area turned into a red splotch and was still present as the date of this report. The patient visited an unspecified physician on 15-JUL-2016. The physician diagnosed her with ringworm as a result of the VARIVAX injection. An unspecified treatment was given for the event. No lab test was performed. Additional information is not expected as the reporter refused to provided HCP's contact details.
muscle pain in left are lasting about 5 hours after vaccination chills starting about 10 hours after vaccination 101 degree fever overnight, 12-15 hours after vaccination temperature normal 20 hours after vaccination
This is a spontaneous report from a contactable Pharmacist. A 72-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose in 2014 for pneumonia, immunisation. The patient medical history and concomitant medications were not reported. The past drug history included pneumonia shot received in 2008 and another in 2013 for immunisation. The patient experienced pneumonia twice afterwards on an unspecified date with outcome of unknown. She was recommended to get another shot of PREVNAR 13. Consumer wanted to know what is the recommendation in this case. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Sore arm; the fatigue started 24 hours after the injection. The fatigue lasted for about five days. Abdominal pain came that seemed to be coming from the region of my liver and I had been having some problem with that previously (in a mild way) and the injection seemed to make this flare up more. About 4 days after injection, I went to ER and they did blood test and liver tests. And over time it seemed to resolved itself in a few days. The pain in my SI joint flared up about 24 hours after the injection - the extreme pain lasted for about 24 hours and then it slowly tapered off after a couple of days.
panic and anxiety increase/ panic attack; panic and anxiety increase/ panic attack; panic and anxiety increase; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunisation on 16Mar2021. Medical history included: anxiety and panic attacks. He stated he had been free of anxiety/panic attacks for 6 years. Concomitant medication was not reported. The first week he felt fine, then the second week (Mar2021) he began to feel his panic and anxiety increased and he had a panic attack in which he was admitted to the emergency department. Outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
ITCHING RASH ON THE RIGHT TIGH, AROUND THE VACCINATION SITE  NO TREATMENT DONE RECOVERED AFTER 10 DAYS
Pt c/o "hard lump" - painful to touch that developed in the area of her Tdap administration on 12/6/07.
Light headedness/ dizziness; Wobbly; Heavy limb feeling; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease and coil in carotid artery for aneurysm from unknown dates. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and triamterene (MANUFACTURER UNKNOWN); both from an unknown date and for unknown indications; unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 08Feb2021 at 14:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. 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 vaccination. On 07Mar2021 at 00:00, the patient experienced light headedness/ dizziness, wobbly and heavy limb feeling after second shot and had not gone away. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events light headedness, dizziness, wobbly and heavy limb feeling were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had the Typical muscle ache, extreme fatigue but 2 days later my neck on the left side inflamed and it lasted 24 hours and  today the right side of my neck  is swollen but it's going down (12 hours). The day after the vaccine I noticed that gallbladder swollen, and then Sunday was quiet swollen feeling and Monday too, that prompted to call the doctor, I saw the doctor and today I am getting an ultrasound.
Syncope. Patient fainted at the check-out counter. She was with her mother. She gained consciousness right away. She stayed for 15 minutes then walked out with her mother.
Extreme pain immediately after injection. Cannot raise arm above shoulder height.  Pain continued through out the night, patient couldn't sleep. Pain has continued though the next day with no improvement.
First injection:  sore arm (up to shoulder and down to elbow), tiredness/fatigue, diarrhea Second injection:  tiredness/fatigue  Breakthrough COVID case:  coughing, fever, runny nose, stuffy nose, approx 3 days
COVID-19; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. Vaccination date of dose 2 was reported as 28Dec2020 (pending clarification). The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hyperuricemia" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2015; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2015; ALLOPURINOL, start date: Jan2015; VITAMIN D3, start date: Jan2015; ROSUVASTATIN, start date: 01Apr2022; ACETAMINOPHEN. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID-19"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Mar2023) Negative, notes: Negative antigen test 25Mar2023 and resolution of symptoms. Symptoms recurred 28Mar2023 (headache) and antigen test again became positive; (28Mar2023) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2.
Pt given saline injection only. Pt was asked to come back to be revaccinated the same day.
Lethargic, unresponsive ( in and out), hives on face and chest, body tics on left side of body ( head to toe), nausea, heavy pressure on chest as well as chest pains, shortness of breath, headache, stomach cramps, dizziness, weakness, tightness of throat - All within 15-30 of injection. She was taken from the Health Clinic by ambulance to hospital ER at 2:45pm 08/06/2021.  She was in ER for 5-6 hours then was released.
Dizziness, HYPERtension & Tachycardia  Narrative: within 5 minutes after vaccine experienced chest tightness,  lightheadedness. On examination BP 190/110, pulse 112. Ear flushing. A&O x 3.  No cardiac or respiratory distress. 25mg of Benadryl orally was given. Escorted  to the ER in wheelchair. Discharged from the ER diagnosed as HTN and Anxiety.  Discharged home in stable condition.
arthralgias progressive over 2 wks; dec voltage on ECG; echocardiogram pricardial effusion; tx w/Pred;
This spontaneous report as received from a nurse refers to a 60 year old female patient. The patient's medical history and current conditions were not provided. On 19-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L017139 expiration date 13-AUG-2016. The nurse reports that the patient was inadvertently administered a dose of ZOSTAVAX intradermally. Nurse reports that immediately upon administration "local reaction" was seen described as "a lump where you could visibly see the medication under the patient's skin". There was no treatment given for skin lump. The outcome of skin lump was reported as recovered on an unknown date approximately in 2015. The relatedness between skin lump and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-AUG-2017, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
A rash that turned out to be Gianotti-Crosti that is still waxing and waning, but mostly resolved.  Never uncomfortable and never treated with anything.
pt w/nonspecif myoclonic-like shakes (1-2 shakes, startles the child) crying occurred; 20 hrs p/vax had a fever spike & witnessed by nurse a full tonic-clonic sz w/post ictal; also noted to have fever & OM;
Muscle aches and pains and a fever of 103.3 that only went down to 99 degrees after taking two aleve.
Hearing loss in left ear progressing by the next am to extreme dizziness nausea and vomiting.
Mom states arm red swollen with hard knot in center states she took child to ER and MD told her it was allergic reaction to DTaP and that forms needed filing.
Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; worse around lymph nodes (axillary, neck, and inguinal). No rash, fever, shortness of breath, swelling of tongue/throat/lips, eye redness, palpitations, fever. Erythematous skin.
Expired vaccine was stored in refrigerator; No adverse event; gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Dose 1), Covid-19 vaccine (1st booster dose), Covid-19 vaccine (Dose 3) and Covid-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine and Covid-19 vaccine.    On 06-Sep-2022 at 2:33 PM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 2:33 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). The vial did not undergo any temperature excursion.   No treatment details were reported.
I started itching on the face, chest and it was swollen and red. I started feeling very agitated. I then went to health clinic. I had an elevated blood pressure. I ended up going to ER, monitored me for a while. next morning, I felt fine for a few mins, then I started feeling really bad and passed out. I went back to ER, I waited or 2 hours and ended up leaving. BP ended up normalizing.
Itching all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Hives (Hives/urticaria). Concurrent medical conditions included Hypertension (Hypertension (Essential)) since January 2017, Drug allergy (Fluticasone caused nasal swelling and sores in nose.), Food allergy (beef, rice (itching)) since 2006, Allergy to molds and Insect bite allergy (dust mites). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, LISINOPRIL for Hypertension.    On 25-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRURITUS (Itching all over). On 25-Mar-2021, PRURITUS (Itching all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: allergy medication Symptom text: Patient stated that within 10 minutes of receiving first dose  her nose and scalp began mildly itching which spread to forehead, face and skin throughout the day. Face felt prickly. Itching lasted until the last dose of Xyzal (resolved within 10-15 minutes of Xyzal).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Patient demographics, medical history, concomitant medication, vaccination facility details added. Reporter information, dose details updated.
Information has been received from a health professional concerning a 9 year old male pt who was vaccinated with a dose of varicella virus vaccine, live. Subsequently, on approximately 02/11/04, the pt developed breakthrough chickenpox with 50 to 500 lesions. Follow up information indicated that " there was not a single report of adverse reaction following vaccination". The reporter indicated that 49 other people developed breakthrough cases of chicken pox ( WAES # 0404USA02615, 0405USA00578, 0405USA00579, 0405USA0580, 0405USA00585, 0405USA00590, 0405USA00591, 0405USA00592, 0405USA00593, 0405USA00594, 0405USA00595, 0405USA00596, 0405USA00597, 0405USA00598, 0405USA00599, 0405USA00600, 0405USA00601, 0405USA00602, 0405USA00603, 0405USA00604, 0405USA00605, 0405USA00606, 0405USA00607, 0405USA00608, 0405USA00609, 0405USA00610, 0405USA00611, 0405USA00612, 0405USA00613, 0405USA00614, 0405USA00615, 0405USA00616, 0405USA00617, 0405USA00618, and, 0405USA00619. No additonal information is expected.
I received the vaccine and approximately  5 minutes after the injection I began sweating profusely and passed out. While I have passed out in the past, I have never done so after receiving a vaccine or while sitting down (which I was). After I "came to" I felt an all over tingling sensation throughout  my body.   As noted, I have never had any reaction to a vaccine and my most recent previous vaccine was a tetanus booster in 2020. Not history of fainting or any adverse reactions to a vaccine.
Less than 24hrs after receiving the booster I had the onset of  floating threads and spots in my right visual field. None present in my left eye.  It is persistent. I also experienced. headache and body aches at the same onset, but these symptoms subsided by the morning of 12/12. I?ve never experienced having these floaters  before.
age indication; This non-serious case was reported by a other health professional via call center representative and described the occurrence of product prescribing error in an multiple number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patients received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced product prescribing error (Verbatim: age indication).  The action taken with Kinrix was unknown. The outcome of the product prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-SEP-2023 The health care professional (HCP) motioned that in the past doctors have been prescribing Kinrix in the catch up series to children under 4 whom never received the Dtap.  HCP wanted to verify if this was okay.  No adverse event details provided. The physician had prescribed Kinrix under 4 years children, which led to product prescribing error. The reporter consented to follow up.
pt recv vax 29JAN98 & 7FEB98 pt devel approx 26 lesions on face, neck, trunk & diaper area;pt also devel a fever off 102.9;
Information has been received from a 75 year old male consumer referring to himself. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD), arthritis and many other unspecified conditions he did not want to list. Concomitant therapy included 25-30 different unspecified medications. The patient did not have drug reactions. In approximately 2014 (reported as about two years ago) the patient was vaccinated with ZOSTAVAX (one shot, lot# and expiration date and route were unknown). On approximately 20-AUG-2016 (reported as two months ago) the patient experienced shingles twice "back to back". On 10-OCT-2016 the patient was admitted to a hospital and stayed there for 8 days. The outcome of the event was reported as not recovered. Causality was not provided. Additional information is not expected since there is no consent to contact the physician.