chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry skin on her forehead, which spread to cheeks, eyes, ears, and neck; "very bad" sore throat; skin started to flake "badly"; her face started itching; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2021, 1 days after receiving Shingrix, the patient experienced dry skin. In September 2021, the patient experienced sore throat, flaking skin, and pruritus facial. On an unknown date, the outcome of the sore throat, flaking skin, pruritus facial, and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, flaking skin, pruritus facial, and dry skin to be related to Shingrix.  Additional details were provided are the case was reported by patient herself. The patient received a dose of Shingrix in right deltoid and next morning, she experienced dry skin on her forehead, which spread to cheeks, eyes, ears, and neck. A couple of days or a day later, her face started itching. She used a moisturizer, but no other new cleansing or moisturizing products. Less than 2 weeks after vaccination, the dry skin got worse, and her skin started to flake badly and also reported a very bad sore throat.  These events had not currently resolved.  The reporter was unable to provide lot or expiration of product. The reporter did not consent to follow-up.
Swollen and pain lymph nodes in left armpit still 1/22, injection site pain still 1/22, joint pain still 1/22, low grade fever ranging from 99.2-101 until only day after, headache still 1/22
Vasovagal response. Sweaty, light headed, hearing changes, change in vision. Felt back to baseline within 20 mins. Had patient lie down, hydrate with water, gave a sucker. elevated legs, cold cloth to forehead. Continuous monitoring.
Pt had swelling of the brain shown on CAT scan she is also requiring physical therapy. She is now being seen by neurologist.
On day 8 after the 1st shot my arm started to swell around the injection site. Within 24 hours it became red and inflamed. Started running a fever on day 10 and contacted my primary care. Diagnosed with covid arm/rash in which my muscle has a hypersensitive reaction to the vaccine. Prescribed steroids and antibiotics. Steroids were used to minimize the immune response and antibiotics were used incase there was a bacterial infection at the injection site. Steroids would prevent a normal response to bacterial infection even with antibiotics so it was precaution.
Sore left arm x3 days after 1st injection. Fatigue and uncontrollable sleep attacks; 1 hour after 1st injection slept 4 hours, 10 hours after second injection slept 1 hour. Period delayed by 4 days af; Fatigue; Uncontrollable sleep attacks; 1 hour after 1st injection slept 4 hours; Period delayed by 4 days after 1st injection; This is a spontaneous report from a non-contactable nurse (patient herself). A 25 years-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EL 8982, expiry date: unknown), via an unspecified route of administration in Arm Left on 25Jan2021 13:45 as dose 1, single (at the age of 25 years) for COVID-19 immunization. Medical history included Idiopathic hypersomnia, anemia, vitamin D deficiency, HSV1, HPV, bilateral sciatica, mononucleosis in adult, GERD with possible sliding hiatal hernia, PTSD, latex allergy. Concomitant medications included modafinil (MODAFINIL) 100 mg; famotidine (FAMOTIDINE); vitamin d3 (VITAMIN D3) 2000 iU all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. On 25Jan2021 at 02:45PM, the patient experienced sore left arm x3 days after 1st injection, Fatigue and uncontrollable sleep attacks; 1 hour after 1st injection slept 4 hours, period delayed by 4 days after 1st injection. No therapeutic measures were taken as a result of events. The outcome of the events was reported as recovering.   No Follow-up attempts are possible. No further information is expected.
Thu Jan 13 - vaccine given Fri- Fever + fatigue Saturday - Headache Sunday night - Chest pain radiating to jaw Monday - presented to medical care, ultimately diagnosed with myocarditis and admitted to inpatient floor
Mild transient flushing Vital Signs 0900 - BP 124/79, HR 110, RR 22, Temp 98.2, SPO2 98% Vital Signs 0915 - Blood Glucose 78 - crackers given with drink Vital Signs 0935 - Blood glucose 87 10 min post crackers, BP 118/75, HR 80, RR 18, SPO2 100%
administration with 5/8 needle instead of  1inch; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect needle gauge used in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29th November 2024) for prophylaxis.   On 27th November 2022, the patient received Boostrix. On 27th November 2022, unknown after receiving Boostrix, the patient experienced incorrect needle gauge used. On an unknown date, the outcome of the incorrect needle gauge used was unknown.   Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comment: The reporter reported that the patient received a dose of Boostrix and administered with a 5/8 needle instead of a 1 inch needle.  The reporter consented to follow up. Additional Supportive Information: The patient received Boostrix with 5/8 needle instead of a 1 inch needle, which led to incorrect needle gauge used.
Information has been received from a physician concerning a 5 year old patient who had been vaccinated with a dose of VARIVAX (Merck) in the past, and had been diagnosed with shingles. The physician was not interested in VZV analysis by PCR (Polymerase Chain Reaction) as the patient was completely recovered. The patient sought medical attention at the office. No lab diagnostic studies were performed. Additional information has been requested.
Erythema, swelling, warmth, feeling of heaviness and pain at injection site. Patient experienced headache, dizziness, palpitations and SOB. After several days patients arm felt like it had a bruise. Had a lump.
Throwing up; Fever 102.4 F; Could not urinate; Back pain was so bad after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up), PYREXIA (Fever 102.4 F), URINARY RETENTION (Could not urinate) and BACK PAIN (Back pain was so bad after the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up) (seriousness criteria hospitalization and life threatening), PYREXIA (Fever 102.4 F) (seriousness criteria hospitalization and life threatening), URINARY RETENTION (Could not urinate) (seriousness criteria hospitalization, medically significant and life threatening) and BACK PAIN (Back pain was so bad after the vaccine) (seriousness criteria hospitalization and life threatening). At the time of the report, VOMITING (Throwing up), PYREXIA (Fever 102.4 F), URINARY RETENTION (Could not urinate) and BACK PAIN (Back pain was so bad after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Aspartate aminotransferase: 90 (Inconclusive) inconclusive and 7000 (abnormal) after being transported to hospital. On 29-May-2021, Liver function test: 1000 (abnormal) in emergency room, 2000 (abnormal) 2000 when admitted in the local hospital and 2500 (abnormal) 2500 after being transported to hospital.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included an unspecified antidepressant for an unknown indication and an unspecified medication for backpain.  Caller stated that his wife received the first dose of Moderna vaccine 1 month ago in her Primary Care Provider's Office as of 31st May 2021 it was reported that she had felt very tired and had vomiting for a day. Caller also mentioned that his wife could not urinate and in the hospital was given 3 liters of fluids and still could not urinate.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
On Friday morning approx. 7:30 AM, I woke up dizzy and nauseous. I tried to walk to the restroom, but almost fell into the wall. I took 2 24mg of Meclizine HCl. It helped but the dizziness kept coming back. I had to take 4 days off of work. Nausea, difficulty breathing, dizziness.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L032184 with expiration date of 24-NOV-2016 or lot # L034736 with expiration date of 09-DEC-2016 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. No adverse event was reported due to vaccination with ZOSTAVAX. Furthermore, no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
first dose was administrated on June 24 2019 / 2nd dose was no administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, a patient is late for the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. No patient's identifiers provided. No lot number and expiration date provided for 1st dose.  The reporter did not consent to follow up.
Along left side of back, she was getting itchy. Also on scalp, arms and legs. Red spots started appearing on these areas as well as torso and back. No pain associated with this.
Patient received 0.2mL of undiluted pediatric COVID-19 Pfizer-BioNTech (5 - 11 years) vaccine.
101.5 fever, body aches, joint pain, headaches, chills.  From 2 am February 1-February 2nd 3pm
Technician thought the dose looked funny in the syringe but, didn't notify the pharmacist until she gave the vaccine and the next one pulled funny too.  Then she notified me about the vaccine looking funny and upon inspection, there was no vaccine in the syringe.  We pulled the rest of the shots in the vial and found that there was an extra shot.  We concluded that this patient must not have actually received any vaccine in her dose and called her back to give her another dose.  Patient was fine at the time of the incident and I followed up with her n 48 hours and she is still fine and no side effects to her arm. She did say that she had a headache but, that could have been due to the weather and not necessarily the vaccine and otherwise she feels fine with no other side effects or health issues.
after 4th dose antibody level was 0.1/ no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from the  consumer/non-healthcare professional.  This case involves a 80 year old male patient who received 4 doses of RABIES (HDC) VACCINE [IMOVAX RABIES] and received IMMUNOGLOBULINS and after 4th dose antibody level was 0.1 (antibody test negative).  Other Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was bitten by a bat on 30-Dec-2019. The patient had been suffering from hypogammaglobulinemia.  On 01-Jan-2020, the patient started taking IMMUNOGLOBULINS dosage unknown via an route unknown (with an unknown batch number) for animal bite.  On 01-Jan-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot number not reported) via an unknown route at an unknown administration site and than received the next injections for day 3,7,14 respectively lot number not reported) via an unknown route at an unknown administration site for post-exposure immunization.  It was reported that after 4th dose (unknown latency) titer was done and the titer was 0.1 (antibody test negative).  Case details: Caller states he was unaware he was bitten by a bat on 30-Dec-2019 and saw his local doctor on 31-Dec-2019 but the bite was not noticed until 01-Jan-2020 when he saw the clear bite mark so he went to the emergency room and started his injections and they gave him Immunoglobulin on that visit.   The patient received last dose on 28-Jan-2020.  Lab data included titer was 0.1.  It was not reported if the patient received any corrective treatment.  The event outcome was not applicable.
Patient (13 years old) fainted at the vaccination table after receiving his first dose of the Pfizer vaccine, while waiting for his mother as she was getting vaccinated. Patient saw his mother bleed after the vaccine and fainted in the chair, as he began to fall, the vaccinator was able to catch him and assist him to the floor. Patient was turned on his side. EMS was called at 0912 and arrived at 0919. Patient was assessed by paramedics and found to be stable. Patient?s mother reported no PMH and the he doesn?t usually faint after injections. Patient left accompanied by his mother.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
pt recv vax 17FEB97 & diffuse hair loss started w/in 2 or so weeks;progressed to 80-90% hair loss to present NOV97;during this hair loss period used Kenalog inj, Rogaine, PUVA immuno therapy w/CYP;
Initial report received from healthcare professional on 18-JANURY-2013. A 65-year-old female patient had received an intramuscular dose of ADACEL (batch number UT4421AA) in left deltoid and an intramuscular dose of PNEUMOVAX (manufacturer unknown, batch number was not reported) in right arm, both on 18 DECMBER 2012. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Concomitant medications were not reported. On 26 DECEMBER 2012, the patient experienced rash of tiny blisters around the injection site, reddened and hot to touch and had severe muscle ache. There were no laboratory investigations/relevant diagnostic tests performed. Corrective treatments were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: None.
Day 1-2 post injection:  Severe body aches (whole body - hurt to even try to pick up cell phone), visibly swollen left armpit painful to touch and with arm movement, severe rigors, fever ~101, rapid temperature changes (burning up to freezing), sweating, headache, nauseousness, dizziness, exhaustion/low energy, no appetite, brain fog  Day 3:  above started to slowly subside  Majority of symptoms have gone away.  Still get nauseous and dizzy at some point every day.  Low energy, lethargic still, no real appetite, still have brain fog.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
next day p/vax exp nausea, fatigue, h/a, abd distention;will see MD again today;
Swollen lymph nodes along collarbone of same side as injection (left). They grew to the size of grapes and while they dissipated after about 8 weeks, they were also tender to the touch.
she was driving home from being vaccinated and said she blacked out and hit car in front of her   checked by paramedics and released
Paresthesia of the right leg/thigh after getting the vaccine; This is a spontaneous report received via Pfizer sponsored program from a contactable physician (patient). A 60-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 9231) via intramuscular route in left arm on 29Dec2020 01:00 AM (at the age of 60-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID- 19 (nasal swab and Abbott Antigen) on 14Feb2021 and resulted negative. On 09Jan2021 13:00, the patient experienced paresthesia of the right leg/thigh after getting the vaccine. The patient did not receive any treatment for the event. The outcome of event was not recovered/not resolved.
I administered a high dose flu vaccine to a patient this morning around 11:59am. The patient does have a history of prior stroke. The patient's wife just called to report that she believes he may have had some sort of TIA event after the shot. She stated he had symptoms of numbness in his left arm, slurred speech, and confusion. She stated she understood the importance of seeking emergent medical care within the first hour of symptoms; however, when I asked her if she had her husband evaluated she stated that she was "headed that way earlier" but felt like he had improved so she took him home and got him something to eat. I strongly advised that she seek emergent medical care due to the symptoms he was having. She stated he is napping. I advised her that I felt very strongly that he should seek immediate medical care. She stated she understood. I followed up with the patient's wife about an hour later. She stated that she woke the patient up and she believes he is okay now. I reiterated that I strongly believe she needs to seek emergent medical care (call EMS, take him to the emergency room, etc). Wife reports that patient has had ~3 similar events this year already, one as recent as August 2020. She reports she has previously called EMS and they have evaluated him and held him for observation. She stated again that she does not believe emergent medical care is necessary. She stated she understood that I advised her to seek emergency medical care; however, she does not feel it is necessary given his history of similar episodes.
I woke up 12 hours after my booster with chills, a fever, headache and body aches. I took Tylenol and went back to bed. I woke up at 8 feeling the same. It?s 3:19pm on 12/2 and my fever and chills are back. I still have a headache and body aches.
I want to report a miscarriage. I got the vaccine when I was 5 weeks and 1 day pregnant. I didn't know I was pregnant when I got the vaccine, but I got a positive pregnancy test 2 days after.  It was a "missed miscarriage" because I had my 10 week ultrasound on May 10 and it showed that the embryo had died at 6 weeks and 2 days. I started miscarrying that day on May 10.
Vaccine recipient complained of "some left-sided numbness in her ears and arms" almost immediately.  Report received second-hand from the vaccine clinic director.
PT to the hospital for c/o Sob and DIB and wheezing per his wife. Patient used his inhalers at home but with no relief. Per wife, he began grunting, moaning, and then stopped breathing. He arrived unresponsive. In the ED, patient was intubated, He was noted to go into v fib twice and required defibrillation. He did have ROSC after about 20 . Found COVID +. CT scan of head shown generalized cerebral edema. Placed on assist-control ventilation and unresponsive. Was managed for acute respiratory failure secondary to asthma exacerbation and S/P cardiopulmonary arrest and acute renal failure. The patient has suffered massive cerebral edema and is thought to have an anoxic brain injury. Pt expired.
He experienced, severe fatigue myalgias, chills with rigors, ear pain, lymphadenopathy, ear 'echo', tinnitus, cough, rhinorrhea and diarrhea with symptoms starting day 2 after IIV receipt. He reports preexisting symptoms with acute exacerbation after IIV receipt in addition to notable systemic symptoms highly suggestive of alternate infection.
first dose approximately 14 months ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 14 months ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter stated that, the second dose was late due to the patient residing in different states throughout the year and not due to supply issue.  The reporter was calling from home and did not have patient details or lot number and expiration date details. The reporter consented to follow up. Healthcare professional gave permission for follow up, but declined to provide mailing address. This case is linked with US2022027784, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027784:same reporter, diffrent patient
About 15 minutes after the shot I felt a slight tingling feeling in my tongue and throat.  About 30 minutes after the shot I experienced a rapid heartbeat and felt light headed.