chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a child who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the child developed breakthrough chickenpox. It was reported that the pt's mother called the physician's office about her child being given the vaccine and then was exposed to another child with chickenpox and the child who was immunized developed chickenpox.  It was also reported that another child was vaccinated with a dose of varicella virus vaccine live and developed chickenpox like rash (WAES # 0308USA02579).  It was also reported that a 9 month old pt was inadvertently vaccinated with a dose of hepatitis A virus vaccine inactivated (WAES # 0306USA02947).  Additional information is expected.
PRESSURE ON THE HEAD (WOULD NOT CALL IT  HEADACHE); RED DOT ON UPPER THIGH; RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 25 year old female. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced pressure on the head (would not call it headache). On 04-JUN-2021, the subject experienced rash all over body. On 04-JUN-2021, the subject experienced red dot on upper thigh. The action taken with covid-19 vaccine  was not applicable. The outcome of the rash all over body, pressure on the head (would not call it headache) and red dot on upper thigh was not reported. This report was non-serious.
Extreme body aches, vomiting/diarrhea, fever, swollen and tender lymph nodes, headache, ongoing
I got the vaccine on Tuesday. I had terrible headaches Wednesday, Thursday and the start of a migraine Friday. Friday night I suffered a stroke.
Client received a flu and pneumonia vaccine in the same arm on the same day (12:30 pm).  At 7pm client noted extreme chills and aching. She went to bed and woke the next morning with a lump under her armpit, which was sore. Her arm also had a large reddened swollen area at the vaccine site. Over the course of the day she continued to feel "awful" with chills and aches. The next day she awoke with lumps along her clavicle and neck on the same body side as her immunizations. She presumed these to be enlarged lymph glands. She sought help at the local walk-in clinic. The physician diagnosed her with Shingles, even though she had no rash or skin eruptions in these areas. She was prescribed a drug costing $180 (name unknown) for shingles. She did not use it because she did not believe it was shingles. The lumps diminished over the next week and were gone by 8 days. The chills, aching, and malaise lasted 3 + days.
Acute fever @ 1AM on 2FEB92; generalized sz lasting about 4-5 min which occurred about 130PM on 2FEB92 (immun on 31JAN92 about 4 to 5PM); temp on admission 105.6;
Covid arm for several days. Wasn?t immediate. Didn?t notice until 12-14 days after vaccine. Directly at site of injection.
Fever body aches and fever Narrative: employee states he experienced 104 temp x 2 days and body aches x 2 days after second vaccine
Pt received his first and second COVID19 MRNA Vaccine on 2/4/21 and 3/4/21, respectively.  Patient was admitted to our facility on 6/17/2021 w/ symptoms of generalized weakness that had been worsening over the past few days.  His first symptoms began on 6/14/21 w/ nasal congestion.  He began to have cough and weakness on 6/16/2021.   Patient tested positive for COVID 19 on 6/17 via PCR on nasal specimen.   As of this report, 6/23/21, pt is admitted to a step-down unit at our facility requiring supplemental oxygen via CPAP. His current O2 requirements are 100 fiO2 and 60lpm w/ 15 cmH20 of PEEP.
Hypotension, patient felt lightheaded, but came back up. It got to 112/70 which was low for her, but it came back up after sitting for a while.
Pt recv vax on 10/7/98; on 10/8/98 pt exp indurated & warm rx on LA
Tried to wake up about 7-730 am, left eye very watery, constant blinking, or trying to blink, ate bowl of cereal, something didn't feel right inside my mouth, after eating brushed teeth, went to spit water and is dribbled out on the left side of my mouth, looked in mirror couldn't smile only on right side, left side paralyzed, suspected stroke, went to ER, all CAT, MRI tests show no stroke, it was diagnosed as Bell Palsy. Sent home with anti inflammatory, antibiotic and eye ointment.
I have a rash that is still present at the  injection site . It's red itchy and still sore. Headache and ocasional nausea.
Patient's Chief is a continuous pain to the upper left arm , affecting mobility of her extremity. No evident redness,  swelling or induration was noted on exam by primary provider on 5/07/2021. Limited ROM due to pain was noted  Please note patient was seen for an unrelated reason 5/07/2021 and made mention of her arm pain to the provider.
Reports lt arm swelling, knot came up, stinging & hot to touch;reports chills 5FEB99 PM;red by 6FEB99;went to urgent care 6FEB99 PM; was prescribed pred & cephalexin;
History of Present Illness: This is a 17-year-old male with history of asthma brought in by his mother who presents to the ED after an allergic reaction. The patient was receiving his first dose of the Pfizer vaccine at the vaccine clinic here approximately at 1:15 PM. He then started to develop left-sided neck tightness, throat pain, and tongue swelling 30 minutes afterwards and brought here. Currently, the patient's symptoms are constant, moderate in severity, and has no alleviating or aggravating factors. The patient has significant allergies to cats, grass, and dust but no known drug allergies. The patient also received a meningitis vaccine 1 month ago. The patient's parents are both fully vaccinated.
This case was reported by a other health professional via call center representative and described the occurrence of visual disturbance in a 51-year-old male patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th December 2018, less than a day after receiving SHINGRIX, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown. It was unknown if the reporter considered the visual disturbance to be related to SHINGRIX. Additional details were reported as follows: The physician assistant reported that she administered SHINGRIX on left arm within the last 3 hours. He contacted her to report seeing a white line in one eye while working on his computer. The line did not move and there was no pain. The physician assistant did not know which of the patient's eyes was affected.
Day 1 post injection: severe headache, severe pain, inflammation and swelling to left deltoid, pain in all joints, incapacitating fatigue, loss of appetite. Day 2 post injection: moderate headache, improvement in joint pain, fatigue, appetite improved, not yet normal,  left deltoid inflamed and swollen, less painful (could touch it) Day3  post injection: headache resolved by end of day,  improved appetite, improved energy, though still not normal, left deltoid area pink, swelling diminishing
p/vax c/o tingling around eye;w/in 8min began itching on neck;DPH given;throat closing;911 called;
Patient stated she had severe muscle aches. "bone crushing", severe headache, extreme lethargy, and difficulty swallowing/throat closing. Had similar symptoms the year before but much more severe this year. Lasted approximately 2 1/2 days.
Persistent, reproducible arthralgias after each anthrax vaccination. Currently stationed in Qatar. Joint Pain, multiple joints Start: 5/22/2004 comment: has not gone away.
This spontaneous report was received from a pharmacy technician and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M018958 with an expiration date 03-MAR-2018 and lot# M035455 with an expiration date 22-APR-2018, orally for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced the temperature excursion of 1 degree Celsius for 93 hours. There was no previous temperature excursions. A digital data logger was involved. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012989: US-009507513-1703USA013108: US-009507513-1703USA013106:
COVID-19 Breakthrough case. on 8/24/21: Patient arrived to ER due to generalized weakness.  Per EMS, patient tested positive for COVID on 8/19/2021.  EMS reports the pt has been experiencing decreased appetite and weakness over the past 5 days. EMS states the patient received Regeneron treatment today at 0930.  He is on 4 liters of O2 at baseline and his O2 saturation was 77% when found by EMS. EMS states the pt's O2 saturation was 100% on 15 liters NC.  He reports fever, cough, SOB, myalgias, and diarrhea.  Admitted 8/24/21. Diagnosed and treated for covid-19 pneumonia and acute hypoxic respiratory failure. Condition did not improve. Moved to hospice on 8/27/21.  Patient received first dose Pfizer vaccine on 2/13/2021 Lot # EN6201 and the second dose on 03/06/2021 Lot # EM9810
Fever, nausea, vomiting, and blisters on the inside of his mouth.
Redness and swelling at site in deltoid muscle area and in a large area encompassing most of the upper arm. She developed sepsis symptoms and marked leukocytosis - wbc 21,000.  8/13/2008 MR received for DOS 7/19-21/2008 with D/C DX:  Cellulitis of the Right upper arm sequela of recent Pneumovax injection with sepsis syndrome. Dehydration and pre-renal azotemia.  Persistant right shoulder pain limitation of range of motion of right shoulder.  Anemia of uncertain etiology.  Pt presented to the ER with hx of feeling poorly since recent Pneumovax injection. Pt developed redness, swelling and pain of the right arm with decreased ability to move the arm 2' to pain. Pt has also felt weak with decreased appetite. Admitted for sepsis syndrome with marked leukocytosis. Tx with IVF and abx with improvement in all but shoulder ROM.
The next day, I felt light headed and very tired. I felt that way for about three weeks. I had loose stool for those three weeks - it wasn't diarrhea but loose stool. And then 11 days after vaccine, I had a rash on my thighs and my lower torso. And that rash lasted for four days and it went away. Rash looked like measles or chicken pox - red dots. I went to the dermatologist as I have never had a rash in my life. Dermatologist  did a Biopsy.  The rash lasted for four days and cleared up.
ER visit on 10/20/2016. Diagnosed with viral syndrome discharged the same day. Cleared to return to work on 10/23/2016 by physician.
On October 12 2022 Pfizer COVID -19 Vaccine Pediatric 5-11 Year Lot FL2757 the pharmacy received that the expiration date had changed been changed from to September 30 2022. We administered a pediatric vaccine on October 6 2022. No adverse  effects/symptoms reported from patient
Extreme pain in left shoulder joint, reduced range of motion, weakness in muscles, pain radiates down arm to elbow joint, wrist. NSAIDs don?t alleviate pain. Warm compresses help relax other muscles but no impact on shoulder pain.
Nose bleeds; This is a spontaneous report received from a non-contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in right arm on 03Feb2021 09:00 (at the age of 70-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included lymphoma. No known drug allergies (NKDA) and no COVID prior vaccination reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in 4 weeks. On 19Feb2021 the patient experienced nose bleeds. No treatment was received due to the event. The patient was not tested for COVID post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & devel sinus & ear discomfort & depression, being more pronounced p/2nd dose; sinus & ear discomfort resolved in about 1 wk; lightheadedness w/nausea & dizziness; seen by MD 14AUG92; tingling in lt hand & foreaarm; twitch
Booster shot. Patients mental health provider noticed hemiparesis to the patients face in group. It was reported to the medical unit and the patient was sent to the ER and diagnosed with Grade VI Bells Palsy. The patient did not self report any changes, so onset is hard to determine. Patients do not have mirrors. Patient currently has complete hemiparesis of RT side of face and numbness to posterior scalp and tingling to his neck.
Vaccine looked cloudy milky,vial was still frozen or not thawed properly; iInitial discomfort in the left arm after receiving vaccine; A spontaneous report was received from a consumer concerning a 57 --year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced initial discomfort in the left arm and vaccine appeared to be cloudy milky in color and was not thawed properly.   The patient's medical history and relevant concomitant medications were not reported.   On 13 Jan 2021, the same time as the onset of the events, the patient received their first of two planned doses of mRNA-1273  (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced initial discomfort in the left arm after receiving the vaccine. The patient also felt the vaccine appeared cloudy milky. After removing the vaccine vial from the freezer, the pharmacist only warmed the vial in his hands for a couple minutes prior to administering the dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events initial discomfort in the left arm and vaccine appeared to be cloudy milky in color were not reported.; Reporter's Comments: This report refers to a case of a 57-year-old female patient who experienced non-serious events of experienced initial discomfort in the left arm and vaccine appeared to be cloudy milky in color and was not thawed properly (Product appearance cloudy) during administration of mRNA-1273 (lot # 25J20A, Exp date-unknown). There were no reported AEs associated with the events of experienced initial discomfort in the left arm and vaccine appeared to be cloudy milky in color and was not thawed properly
Patient passed out shortly after receiving the vaccine.  He lost consciousness for a minute and seemed to be twitching in his eyes and his mouth.  He regained consciousness after a few minutes and we monitored him for 30+ minutes.  We referred him to urgent care to be monitored further.
This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of an unknown gender. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 14-OCT-2013, at the age of 11, the patient was vaccinated with a dose of GARDASIL (dose, route and site of vaccination, lot number and expiration date were not reported). Subsequently, on 23-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 lot number L037554 with expiration date on 25-DEC-2017 (dose, route and site of vaccination were not reported). No adverse events were reported. Additional information has been requested.
Hep-B #3, 0.5cc, right thigh, IM; DTAP #3, right thigh, IM; Hib #3, left thigh, IM; Prevnar #1, left thigh, IM on 3/24/03. Mother called on 3/25/03 at 11:00, stating pt had swelling, warmth and redness at the site of injections. Mother spoke with PA and was told to come in. Pt was examined on 3/25/03 at 14:00. Pt had redness and induration in 5cm right upper, outer thigh.
This spontaneous prospective pregnancy report as received from a consumer mother refers to a 17 year old female patient with pregnancy. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with the dose of GARDASIL 9, intramuscular in the left deltoid (lot #, expiration date and dose were not provided) for prevent HPV. Other suspect therapies (reporter was not sure which one was administered) included GARDASIL intramuscular in the left deltoid (lot #, expiration date and dose were not provided) for prevent HPV. The patient became pregnant with LMP of JUN-2017. On 02-OCT-2017 the patient performed a positive pregnancy test. At the time of initial exposure to GARDASIL 9 or GARDASIL patient was about 15 weeks pregnant. The exposure to vaccine occurred in the second trimester of patient's pregnancy. The pregnancy outcome was pending at the time of the report and the fetal outcome was unknown. The outcome of the vaccine exposure during pregnancy was unknown. The patient did not seek any medical attention.
Patient describes, soreness in arm where Fluzone HD was given; achy hot to touch, daily fever just over 100 F late in the day for 8 days, diarrhea for 8 days; uncomfortable feeling in arm that received the Zostavax.
teeth chattering; soreness in arm; fever; nauseated; muscle aches; soreness at injection site; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of teeth chattering in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of pain in extremity (received on an unknown date, refer case US2019AMR131657).   On 10th July 2019, the patient received Shingrix. On 10th July 2019, several hours after receiving Shingrix, the patient experienced teeth chattering, pain in arm, fever, nausea, muscle pain, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the teeth chattering, pain in arm, nausea and muscle pain were recovered/resolved and the outcome of the fever was not recovered/not resolved and the outcome of the injection site pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the teeth chattering, pain in arm, fever, nausea, muscle pain, injection site pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On 10th July 2019, in the early afternoon, the patient received the vaccine in left deltoid and experienced teeth chattering a couple of hours after receiving the vaccine.  The Last night before the date of reporting, the patient she felt feverish and took her temperature was registered 102.2 degree F. Less than a day after receiving Shingrix, the patient also felt nauseous and had muscle aches like the flu. The patient also had slight soreness at the injection site following the vaccine.  No additional details provided. The reporter consented to follow up. This case has been linked with and US2019125960 (husband's case), reported by the same reporter
Received 2nd dose moderna vaccination at 7am 1/26 in the left arm. Had mild pain at injection site and some itchiness at the injection site a few days later. I had chin and facial itchiness thinking it was windburn for the next few days and on evening of 2/2 felt upper extremity itching, bilaterally near the elbow. Mostly on the upper left arm. I woke up on 2/3 with itching on both upper and lower extremities with external ear pain and redness and swelling on the same side as my injection. I also had 3-dime to quarter sized hives on the contralateral (right) medial knee and faint rash on other areas where I was experiencing itching throughout my body. No markings notes on trunk. I took cetirizine and symptoms mostly resolved within 30 minutes. I still have mild itching, but no new hives. Seeing provider today in case follow up is required.
Vertigo; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL9265) via an unspecified route of administration in the right arm on 18Feb2021 at 17:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, Lyme disease syndrome, and gluten allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL) from an unknown date for thyroid, vitamins from unknown dates for unknown indications and herbs from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 05:00 the patient experienced vertigo, which was continuing Monday, 22Feb (2021). The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The outcome of vertigo was reported as not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Woke up Saturday afternoon and noticed 6 red dots on chest. Went to work that night and started to feel pain in chest at approx. 05:00. Relieved of duty at 06:00. Went home and couldn't sleep. Went to ER about 09:00 Sunday. Seen for chest pain 1-10 scale "7". Admitted to ward for generalized vaccinia with possible pericarditis vs costochondritis. Treated with 1 overnight stay at hospital. Motrin and Toradol given. Discharged with Motrin. Follow-up with cardiology for echo.
On 06/21/2022 I tried to get out of bed to go to the bathroom and could not move. My legs were not working. I attempted to crawl to the bathroom and was unsuccessful. I called 911 and was transported by ambulance to the local hospital where it was determined that I had COVID-19. I remained in the hospital for 8-10 hours. I requested a prescription for PAXLOVID which I was provided. Before I even left the hospital, I was beginning to feel better. By the end of my 5 day course of PAXLOVID, I was feeling much better. I began testing myself at home for COVID-19 and was positive until  07/05/22. When I finally tested negative at home, I went for a PCR test which was also negative.
This spontaneous report as received from a other health professional (healthcare worker) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. On 29-NOV-2014, the patients were vaccinated with (Oka/Merck) VARIVAX injection lot number K003414, expiry date 06-MAR-2016 (dose, route and frequency were not reported). Concomitant medications were not reported. Starting on 24-NOV-2014, the doses of (Oka/Merck) VARIVAX were exposed to a supported temperature excursion of 17.8 F for 93 hours. According to the Prescribing Information for (Oka/Merck) VARIVAX, the (Oka/Merck) VARIVAX should be stored frozen between-58 f (-50 C). Based on the information and assessed data, these (Oka/Merck) VARIVAX to temperatures colder than-58 F (-50 C). Based on the information and assessment data, these (Oka/Merck) VARIVAX should be used within three months. No adverse effects were reported. The outcome was unknown. Product quality complaint was not reported. No additional information was provided. This is one of the 2 reports received from the same reporter. Additional information has been requested.