chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of salivary glands in cheeks - bilateral sialadenitis - started within days of first dose of vaccine and resolved, reaction was delayed with second dose - started that time about 7 days after second dose of vaccine given.
One month after vaccination I am left with the condition of chronic daily hives (since January 6th 2023)
Began itching within 10 minutes. Flu and pneumonia shots given in same arm. Red that evening. Next morning very swollen. By second morning a swollen red area 6 1/2" x 3" raised, red and very swollen. Dr. said reaction had to be treated like a staph infection. Dr. gave decadron and antibiotic for 10 days. When medication gone, still slightly red, itchy, and sore after 16 days
After second shot, covid arm, with swelling, itching and pain. Body aches, fever, chills, severe fatigue.  Even went  at day 12.  Symptoms lasted 13 days.  Took 1800 mg of Motrin a day for 2 weeks and 150 mg of Benadryl a day.   this was fine and to continue as needed.
This spontaneous report as received from a pharmacist (healthcare student) refers to a new 66 year old female patient with no known drug reactions or allergie. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapies included LEVAQUIN, doxycycline and vancomycin. The pharmacist reported the patient developed induration and urticaria at the injection site "that had rapidly progressed" after receiving PNEUMOVAX 23. The pharmacist also mentioned the patient stated she experienced "chills, increased dizziness, fever, body aches and pain" after receiving PNEUMOVAX 23. The patient contacted pharmacy. TICK panel and blood cultures were performed but the results were unknown. The outcome of increased dizziness, fever, chills, induration and urticaria at the injection site and body aches and pain was reported as not recovered. Additional information has been requested.
Mild reactions / Shingles break out; Reaction might be from the binders; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of illness (received Flu shot in 2016, for tolerance refer case- US2021AMR072602). Concurrent medical conditions included asthma, renal insufficiency (scared her right kidney), shellfish allergy and allergy to antibiotic (was allergic to sulfa antibiotics like Bactrim). Concomitant products included simvastatin.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and reaction to excipient. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the shingles and reaction to excipient were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and had mild reactions to it and shingles broke out. The reporter mentioned that, the reactions might be from the binders. The follow up dose was pretreated because of shingles break out. The patient had been taking Benadryl and steroids as a treatment medication. The patient also took versed which made her quit breathing. The patient was allergic to Bactrim and almost died at the hospital, went to acute renal failure and partial bowel blockage. The patient now had renal insufficiency that scared her right kidney. The patient had been taking ACE inhibitors and simvastatin which worked well and gave her lungs more protection. The patient could not have any contrast dyes that caused anaphylactic shock and could not take Doxycycline. The patient was asking if the vaccine contains iodine. The patient did not want to be contacted. The case had been linked with the case- US2021AMR072618 and US2021AMR072602, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072618:Reporter's case (Shingles vaccine) US-GLAXOSMITHKLINE-US2021AMR072602:Shingrix case
LIE DOWN FOR 24 HOURS; MEDICATION ERROR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included covid-19 vaccine for prophylactic vaccination. On JUL-2021, the patient experienced medication error. On an unspecified date, the patient experienced lie down for 24 hours. The action taken with covid-19 vaccine was not applicable. The patient recovered from lie down for 24 hours, and the outcome of medication error was not reported. This report was non-serious.
real bad stomach pain in lower Abdominal area /real bad lower abdominal pain; hot and cold; Chilks; irritable bowel syndrome aggravation; Stomach pain; This case was reported by a consumer via call center representative and described the occurrence of lower abdominal pain in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included irritable bowel syndrome.   On 19th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain. On an unknown date, the outcome of the lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain were unknown.   It was unknown if the reporter considered the lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain to be related to Shingrix.  Additional details were received as follows: The patient experienced real bad stomach pain in lower Abdominal area hot and cold and chills. The patient asked what are the side effects of the shingles vaccine. The patient was referred to the healthcare professional.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported), for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
The patient was given a 5-11 3rd dose when he was to receive a 5-11 bivalent booster
Psoriasis flare-up; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Patient had flare ups with Scaling and Itchiness and Experienced flu like  symptoms after receiving the second Moderna vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in underarm area. acetaminophen 1000mg every 8 hours was effective for pain relief . bed rest
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101733546 same reporter/drug/event with different patient.
Severe headache (on day 2 now) Fever up to 101 for 12 hours Chills
Patient stated lymph nodes swollen on right side of body, the one on his neck he says is still swollen.  Said his arm was sore for over a week which is not typical compared to other flu vaccines he has received.
Feeling lethargic; Body aches; Sweats; Chills; Headache; fever of 101; A spontaneous report was received from a consumer concerning a 50 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lethargy, body aches, sweats, chills, headache and fever of 101.  The patient has a medical history covid. No relevant concomitant medication was reported.  On 22nd Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 23rd Jan 2021, the patient experienced feeling lethargic, body aches, sweats, chills, headache, fever of 101 thought out the day. Symptoms of body aches, headache, fever of 101 ended on 24th Jan 2021 and symptoms of chills and sweats ended on 25th Jan 2021 but feeling of lethargic remained.  Treatment for the headache included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, body aches, headache, fever of 101, chills and sweats was resolved and feeling lethargic is not resolved.
The patient called in around 1:00 pm on 5/25/21 to report symptoms after vaccine. She said that she had pain in the right side of neck and in the back of the head and felt dizzy after the 15 minute wait when she stood up to leave after receiving her vaccine. She said that she felt tired later and slept well all nigh. At 6 am she said that she had cramps in calves, legs, and arms. At 9:30 am she woke up and felt tired and had a strange sensation in the back of the neck and numbness in the mouth and jaw.  She said she is feeling a little better now.
Information has been received from a certified medical assistant (CMA) concerning a male patient who was vaccinated intramuscularly in left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 651319/1007P).  Subsequently the patient developed a red , blotchy arm and fever.  The CMA also stated that he developed a red, warm, swollen arm at injection site.  The patient sought medical attention and was recovering at the time of this report.  Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu vaccine on left arm. The patient received the Flu vaccine (unknown manufacturer) in October 2018. The patient states that her left arm was a little sore after receiving the vaccine, and this soreness lasted for a couple of days. The patient stated that the soreness was minor. The reporter did not consent to follow up. The reporter did not wish to provide any additional information.
Flu like symptons ..  headache, nausea, shivering.  Pain and rash at injection site.
injection site (day 1 and day 2): pain, redness, swelling  injection site and 2 inches each way surrounding the area (days 3 - 11) : tenderness, swelling & hardness, redness, area is hot; rash on upper left arm
PT FELT DIZZY AND LIGHTHEADEDNESS. HAD A LITTLE BLEEDING ON INJECTION SITE AFTER REMOVED NEEDLE (WHICH WAS EXPLAINED IS NORMAL), PUT BANDAID OVER LOCATION AND INFORMED PT TO SIT DOWN FOR 10-15 MINUTES. OFFERED PT WATER AND OFFERED TO CALL AMBULANCE. PT WAS FEELING FEELING BETTER AFTER 10 MINUTES AND WALKED AWAY AFTER 20 MINUTES INFORMING ME SHE WAS FINE.
On day one: Pain Injection site. Pain eased after 5th day. On day 6 after the vaccine, discomfort on left armpit that progressed to strong Pain on Lymph Nodes (Left armpit).  Some swelling but not much.  Applying cold compresses.  Day 8 after the vaccine, pain continues and not lessens.
Patient developed some complications of inflammation in the shoulder/arm and patient thinks because the injection was given too close to the shoulder joint instead of deltoid muscle.
Weak, high fever (103.7 on its way down, don't how high it had gotten to), head ache, body aches, chills, nausia, dizziness, fast heart rate (122 at the hospital ER), hard to breath, pale.
Headache, Myalgia, Fever, Chills, Back pain Narrative:
Narrative: 72yo male patient with hx of lung and liver cancer died on 10/9/21 at home in home hospice care. Pt received covid vaccines on 2/14/2021 & 9/21/21. Pt's death is not related to covid vaccines.
Pfizer BioNTech COVID-19 Vaccine EUA: Fully Vaccinated Expired Patient received Pfizer Vaccines on 3/5/2021 and 3/26/2021. Patient had a history of ESRD secondary to diabetes and hypertension, renal transplant on 7/13/2021, and was admitted on 7/26/2021 through ED for worsening shortness of breath, weakness and dyspnea.  Patient found to be positive for COVID-19 and pneumonia. Patient was treated with remdesivir, dexamethasone, and piperacillin+Tazobactam. Patient continued to decline and expired on 8/11/2021
Started with pain and soreness. The swelling began to spread and was told to see the MD.
Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinephrine (patient thinks 2 doses) and Benadryl administered in the field. Patient brought to hospital by ambulance where she received IV SoluMedrol, Pepcid, Benadryl, and fluids scheduled throughout hospitalization. Patient improved and was discharged the following day (3/27/21).
Slight headache, but fine the next day. This slight reaction  is being reported at the suggestion of the nurse because my first shot was J & J but  my booster was Pfizer and more data is needed in cases where two different vaccines were given.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 01-DEC-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
throbbing pain in arm right after injection and low grade temp by feel. Then about 7-8 days later developed a deep cervical chain lymph node swollen.
Expired vaccine given; 0.3ml given as booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and ACCIDENTAL OVERDOSE (0.3ml given as booster) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 038B21A and 042B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and ACCIDENTAL OVERDOSE (0.3ml given as booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and ACCIDENTAL OVERDOSE (0.3ml given as booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (0.3ml given as booster).    No concomitant medications were reported.  Expired vaccine given with no adverse events reported.  It was unknown whether patient had tested positive for COVID-19.  No treatment medications were reported.
Provider ordered the Hep A/B vaccine for this patient. Provider did not realize that it was only for adults and a warning for this did not pop up on Epic as it did for another patient later in the morning.  The MA also did not catch this and administered the vaccine to the child.  No reactions were seen while child was in the clinic.  Mother of patient aware and will monitor him.
Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23.  On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Fatigue in the afternoon and aches and pain throughout the night, the morning I vomited and nausea and weakness the next few days.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (2 other patients had a similar rash) in a female patient of an unknown age 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 RASH (2 other patients had a similar rash). At the time of the report, RASH (2 other patients had a similar rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medication were provided. This case was linked to US-MODERNATX, INC.-MOD-2021-155384 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow Up received on 30-JUN-2021 contains TCR form with No New Information; Sender's Comments: US-MODERNATX, INC.-MOD-2021-155384:Case of patient.
The sequence of events begins approx. 3:30pm on 12/23/20.  12/23/20 ? headache, nausea with vomiting, brief itching, chilled feeling, temp of 99.9, body/bone aches all over with legs hurting the most, very sore injection arm, husband and I debated on going to the ER, cried  12/24/20- headache, nausea without vomiting, body/bone aches, didn?t take temp, sore arm.   12/25/20- same as 12/24   12/26/20-body/bone aches but not as intense, headache, arm sore, neck was tad stiff. When I put on deodorant it hurt then felt pea sized lump painful to touch in left arm pit. Also felt lump on left side on my neck the size of thumb pad but not painful. Cold sore appeared on bottom lip 12/27/20- sore armpit- lump smaller, neck lump smaller non painful, nauseous 12/28/20-armpit feeling better lump almost gone still painful if I press on it otherwise not an issue, neck lump smaller -pinky pad finger size non painful  June 2020 tested positive for COVID was moderate in symptoms
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (pain on the injection site) and myalgia (muscle pain in the right thigh) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031A21A) for COVID-19 immunization. No medical history reported. On Mar 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 24, 2021, patient experienced vaccination site pain (pain on the injection site). On Mar 25, 2021, patient experienced myalgia (muscle pain in the right thigh). On Mar 27, 2021, vaccination site pain (pain on the injection site) resolved. At the time of the report, myalgia (muscle pain in the right thigh) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
chills alternating with hot spells at night painful injection site headache for several days generalize fatigue
Pt presented  four days  after vaccination stated rash had started on feet and spread all over body, upon visit 4 days later rash had resolved to all areas except  injection site R deltoid, Order noted Decadron 6mg IM was administered.
Fever, aches, headaches, dizziness,  hands shaking, wobbly, walk into walls
Patient stopped by pharmacy 3 days later to show localized skin reaction. She said it was slightly painful to the touch and a little warm but it was not bothering her. She has no systemic reaction and did not feel she needed to seek medical attention, but wanted to show the reaction. She does plan to follow up and get 2nd dose in 2 months.
My mom had a stroke on 6/17/2021 and was hospitalized. A week or so before the stroke, my mom lost feeling in the fingers of her right hand and didn?t feel well...but she didn?t feel sick, just not her normal self.  The stroke spidered out over both sides of her brain. Mom is off balance, her mouth droops on the right and that side of her face is numb. The doctors in hospital could see what happened to my mom but were puzzled why because she?s so healthy with no prior issues which would cause a stroke.  We saw mom?s primary care doctor after release from hospital. She was very surprised that mom had a stroke as nothing in blood work, her health or family history would indicate that this would happen. Doctor said it was probably the COVID-19 vaccine.
Headache, lower back pain, severe pain to my left arm, dizziness, fatigue, persistent feeling that something is in my chest
A small ball came out between the nape and neck and it hurts a lot, I can hardly move my neck from the pain