chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began sneezing and coughing within minutes of the shot, and began vomiting within 5 minutes of the shot. Vomiting continued at the doctor's office for 2.5 hours, occurring regularly every 10-15 minutes. Child was ver lethargic and fell asleep in between episodes of vomiting. Doctor administered rectal suppository "tebamide" to suppress vomiting. Vomiting continued for 12 hours at home ever 30 to 45 minutes.
MMR, HIB given on 1/31/11. Had OM at the time put on AUGMENTIN. Fever 101. 2 ax 2/9/11 -> febrile sz. OM resolved at ER.
Chills, nausea, headache, fatigue.  Side effects started approximately 24 hours after first injection.  Chills lasted approximately 8 hours.  Side effects resolved within 24 hours.  I had been diagnosed with Covid prior.  Tested positive on 1/6/21.  Symptom started 1/2/21.  Mild Case.  Fatigue, headache, nausea, dry cough, Acted like a real bad Sinus Infection.  Post Nasal Drip.  Loss of taste and smell.  No Fever at any time.  Blood Oxygen levels fine (96% - 99%).  Vitals fine and stable.  Doctor prescribed double dose (11 days) of azythromiacin.
My period will not stop. It has gone on significantly longer than it normally does. My period is typically regular and consistently 4-5 days. I?m on day 8 and have a migraine that won?t go away.
Extreme fatigue, arm sore and swelling at the site, fever, nausea, muscle aches,  spine ache, headache.
ELEVATED BLOOD PRESSURE; FAINTING; STINGING PAIN ALL OVER THE BODY/ BODY ACHES; BLURRY VISION IN LEFT EYE; PERIPHERAL VISION AFFECTED; HEADACHE; BREAST AREA SWOLLEN (LEFT ARM UNDERNEATH); BREAST PAIN (ON LEFT UNDER SIDE ARM BESIDE BREAST); DIZZINESS/ LIGHT HEADNESS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 43 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: asthma, and hypoglycemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: unknown) dose was not reported, 1 total, administered on left arm at 11-NOV-2021 for prophylactic vaccination  (Dose number in series 1). No concomitant medications were reported.  On 21-NOV-2021, the patient experienced low grade fever.  On 23-NOV-2021, the patient experienced breast area swollen (left arm underneath), breast pain (on left under side arm beside breast) and dizziness/ light headness.  On 24-NOV-2021, the patient experienced blurry vision in left eye, peripheral vision affected, headache.  On 25-NOV-2021, the patient experienced stinging pain all over the body/ body aches (in front part of thigh/right leg, behind the knee on right knee, pains in stomach meeting chest area, chest pain and elbow and mid forearm, pain in mid-back on right side). On 27-NOV-2021, the patient experienced fainting, could not look down to see floor, paramedics called and offered ride to hospital which the patient declined. On an unspecified date, the patient experienced elevated blood pressure.  Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 171/90 ELEVATED, and Body temperature (NR: not provided) 100.2 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breast area swollen (left arm underneath), and breast pain (on left under side arm beside breast) on 25-NOV-2021, and low grade fever on 23-NOV-2021, was recovering from dizziness/ light headness, headache, stinging pain all over the body/ body aches, blurry vision in left eye, peripheral vision affected, and fainting, and the outcome of elevated blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211201944-Covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a Medical Assistant regarding multiple unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On multiple unspecified dates from 18-JAN-2016 to 28-JUN-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details, lot# and expiry date not known). The administered vaccines experienced a temperature excursion of 51.1 degree Fahrenheit for 18 hours 30 minutes. There was no previous excursion. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.
First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices; First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices; First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices; This spontaneous safety report, was received by the partner on 22-JUN-2023 and forwarded to company on 22-JUN-2023. Additional information was received by the partner on 23-JUN-2023 and forwarded to company on 26-JUN-2023 from a nurse.  This case was originally considered non-valid due to no patient identifiers but is now a valid case due to gender being provided.  Due to the nature of the event, the causality between the event "First dose was given on 10/13/22. Mother informed HCP that Pentacel was given 11/22 and 2/23 at different practices" and Vaxelis was not applicable.   Further information is expected.
Patient has severe arm pain that limited mobility and severe pain was unrelieved by OTC pain relievers.
one of two pts who devel local react consist. of 8x6 cm erythema, induration, and edema w/ pain after injection
mild diaria from Sunday 25 of April, than evening 27 of April  diaria got very intens. The same evening I went to sleep and wake up at 2 am 28 of April with vomiting.  at 6.00 am I walk up with massive body ache, headache and fever was reaching 39. at 10 am I manage to take paracetamol but didn't feel any relief, fever was still 39. Later the same day I took paracetamol 2 more times. on the end of the day I took aspirin.  Fever decreased at 6 am 29 of April but body ache and headache are still present
Rash  on day 7 after injection that was itching and so read down upper . Itching   And warm for 5 days . Stil discolored on day 5 but no itching  anymore.
I woke up at 3:00am on December 1, 2023, with a hot flash but went back to sleep.  I had another one later that morning and then tested positive for COVID-19. I spoke with the doctor on the same day.  I took Paxlovid and began to feel better.  I had a low-grade fever and congestion.  It took about 6 weeks for the congestion to go away.  I did not test negative until the 16th day.
pt started 2x3 inch redness and swelling rash, starting second day of vaccination with a little bit of warmness in the area.  No fever reported, but arm is still sore.  So far, no oozing, discharge or blister.  Pt was informed to watch and report to md if any worsening symptoms or further concerns.
cold sweats; body aches like someone hit me head to toe; got the flu; Initial information received on 13-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who experienced cold sweats, body aches like someone hit me head to toe and got the flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient developed cold sweats (cold sweat), body aches like someone hit me head to toe (pain) and got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, Product name was not provided. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine.  I only got the flu once in my life and it was immediately after getting the vaccine. I was soooooo cold sweats and body aches like someone hit me head to toe  for 3 days.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events cold sweats, body aches like someone hit me head to toe, got the flu.  At time of reporting, the outcome was Unknown for the event cold sweats, body aches like someone hit me head to toe and got the flu.
Employee received FLU vaccination at 12:24pm, after waiting her 15minutes, she returned to her desk to complete work.   At 2:45pm individual stated that she had started to have severe itching to her bilateral upper extremities.  Denied SOB, difficulty swallowing, heart palpitations, tingling of mouth/tongue.  Vitals checked and were WNL.  Employee took Benadryl 25mg PO OTC . Vitals rechecked again at 3:00pm and 4:00pm which were WNL.  At 4:00pm individual stated that itching  had resolved.  Later that night, itching returned. States she took another Benadryl 25mg OTC and her symptoms resolved shortly after.  This afternoon (01/16/2021) employee states she is feeling better and has not experience any further symptoms.
Headache & general unwell feeling began 9/11/2015. Initial signs of shingles rash appeared on 9/15/2014.
Diarrhea/I took the first shot of the Pfizer on Friday (05March2021) and I had diarrhea for the next three days; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 05Mar2021 as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported, "I took the first shot of the Pfizer on Friday, 05Mar2021 and I had diarrhea for the next three days (from Mar2021). I have to take another shot I am afraid I am going to get it again." The outcome of the event was unknown. Outcome of the event, diarrhea was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Four days after 2nd dose of vaccine I started having "episodes", light head, dizzy, heat arrythemia and pain.
little bit sore on the arms; This is a spontaneous report from a contactable consumer (patient) A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3284), via an unspecified route of administration in right arm on 21Jan2021 15:00 at first single dose for COVID-19 immunization. Medical history included: diabetes, the patient was told his labs look really good, his diabetes was down around 100 when he pokes his finger, and his blood pressure was really good. He had no fever, only minor colds in the last year (2020). Last summer he had a minor surgery and colonoscopy and every thing was clear on that. The patient had not had COVID. Concomitant medication included amlodipine, acetylsalicylic acid (ASPIRIN), atorvastatin, glipizide for diabetes, lisinopril, pioglitazone, tamsulosin, all from 2014. The patient previously took flu shot and shingles shot for immunization. The patient got his first vaccine shot. He hadn't really had any reaction. When he took the Band-Aid off this morning there was no blood spot on the Band-Aid and it didn't really hurt when he got the shot. He had a little soreness in his arm, he was left handed but did a lot of things with his right hand and has done that today. The caller confirmed the shot was given in his right arm. This was not anything like the flu shot or the other shot he got a couple weeks ago, he can't remember the name of that shot but it is the one that made a person break out. He noted that he and his wife went through that with that shot. Caller remembered it was the shingles, the second shot he couldn't remember, that he hated. He was not looking forward to that second dose. He got it at a local pharmacy, the flu shot was first and about a month later he got the shingles shot. In 2-4 months got to get the second dose and he is not looking forward to that. The patient's second bnt162b2 dose is due 10Feb2020 at 8 am. Outcome of the event was unknown.
pt recvd vax 23AUG95 & 1SEP95 broke out in varicella-like lesions;had over 300 lesions over entire body;@ time of report had been broken out for 20 days, & was starting to scab over;reporting NP felt was natural outbreak
pt and daughter returned to pharmacy approx 15-20 minutes after admin of Fluad, Pt was reporting she was having chest pain that was radiating to back. She did not believe it to be related to Fluad admin.
Starting 12/04/2021, I got hives all over my body after exercising and getting hot. I was eventually diagnosed with cholinergic hives. I did an urgent visit, saw a dermatologist, saw my regular doctor and now going to see an allergist on Friday 06/03/2022. I take antihistamines, PEPCID and LEXAPRO (due to increased anxiety caused by the event). Its affecting me doing anything. Before the booster, I was able to go on long walks, exercise and do house work. However, now I can be in the middle of cleaning the house and break out in hives all over.
Patient was given undiltued form of peds pfizer per pfizer patient received 30mcg dose received
he could hardly walk. He would have a difficult time walking and standing still; Tested Positive for COVID; Tiredness/Fatigue; Achiness; slept a lot on Thursday; not feeling well; sinus sneezing issues; Sneezing; This is a spontaneous report from a contactable Nurse. This nurse reported that a 69-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL9262 and expiration date were not reported), dose 1 via an unspecified route of administration, administered in left deltoid on 08Feb2021 at 15:15 as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing Blood pressure, which is under control; back pain; nerve issue; stated he sneezes a lot with seasonal allergies; patient fell and broke his wrist (over a month ago the patient fell and broke his wrist); lack of sleep at night (A nap was common for him due to lack of sleep at night due to the facture); her husband had a sinus infection (with a negative COVID-19 test back in November); Prostatitis and blood disorder. Concomitant medication(s) included Metoprolol 25 mg, daily for blood pressure, Irbesartan 150 mg, once a day for high blood pressure, Gabapentin 300 mg twice a day morning and evening for Back pain/nerve issue, Vitamin D 2,000 units daily, Tamsulosin 0.4 mg once daily at night for Prostate, acetylsalicylic acid (BABY ASPIRIN) 81 mg once a day for circulation, magnesium 400 mg daily, Calcium 600 mg, Vitamin C 1000 mg daily and sometimes twice daily for sinus infection which were all ongoing. On 11Feb2021, the patient experienced a sinus sneezing issues, not related to the vaccine. He sneezes a lot with seasonal allergies also had negative COVID-19 test back in November. However, they thought it was due to the indoor activities occurring at that time then Thursday on 18Feb2021, started to have a sense of being tired, achiness and fatigue on 11Feb2021. He was could hardly walk. He would have a difficult time walking and standing still, achy, tired, and slept a lot on Thursday. His whole attitude/behavior was one that would reflect someone not feeling well. On Friday, 19Feb2021, he was not so bad. Feeling a little better. On Saturday 20Feb2021, went to urgent care and got a Rapid COVID Test done and his came back positive for COVID and requested a PCR test be done, but where they are it's only done in 3-4 different locations. A PCR test has been done, but they are currently waiting on the results for this report. On 21Feb2021 went to another testing facility for the PCR and it also confirmed positive for him. He is feeling better. He is not achy. He is resting and isolating himself. The outcome of events for sneezing was recovered on 21Feb2021; for achiness was recovered on 20Feb2021; for tested Positive for COVID, slept a lot on Thursday, sinus sneezing issues was unknown; for Tiredness/Fatigue, not feeling well, he could hardly walk/He would have a difficult time walking and standing still is recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021218283 same reporter/drug, similar event, different patient
Immediately post vax, the pt developed soreness, redness, and tenderness at the injection site.
Extreme headache on 04/06 and 04/07 followed by a bloody nose on 04/08. I haven?t had a bloody nose in 25+ years. Not sure if this is a one off or an actually side effect.
Shortly after receiving his Janssen covid vaccine, client complained of lightheadedness and felt that his blood pressure was high. VS assessed: 0925 am: 164/100  98%  84 pulse and very anxious.   Talked with client while drank water and snack. 0938 am: 172/100  97% 71 pulse and less anxious. 10:06 am:  164/82  98%  75 pulse and complaining of ringing of ears but dissipating.  Was able to leave recovery area after 30 minutes.  Contact information was given if further problems or side effects encountered.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild, Additional Details: swelling and redness at injection site has gone down had shoulder/neck pain and headache night after injection. redness and swelling has gone down and headache has gone away.
It caused cellulitis in my arm.  Even after taking and completing  an antibiotic, cellulitis developed in a different part of my arm.  The same arm that the vaccine was given.  Now I'm taking round 2 of an antibiotic.
I RECEIVED A ZOSTER VACCINE FOR SHINGLES ON NOV27. SHORTLY AFTER (A WEEK OR TWO?) I NOTICED I WAS ADDING MORE AND MORE SUGAR TO MY FOOD, OVER THE NEXT MONTH, ABOUT JAN 1ST I NOTICED I COULD NOT TASTE SALT OR SUGAR, ONLY SOUR ITEMS.
Extreme headache, 102 degree fever lasting less than 24 hours.  Lethargy and headache lasting 2 days.
dizziness; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizziness) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported.  No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Patient complained that the redness and swelling started few hours after she received the flu vaccine. She reported it to me on 10/1/14 @ 1200 pm.  The R deltoid area still had some redness and swelling (6.5 cm), slight warm to touch.  NO other complaints.
FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
Primary vaccination 02 FEB 03 without incident. Eleven day s/p primary vaccination patient presents with 2-day h/o erythemic macular/papular rash of chest and back. All lesions in same stage of development. No other complaints. Consultation with Dr. & concurs that this rash is c/w generalized vaccinia reaction . -- When MD saw patient on Thurs (2/13), he had generalized macular papular type rash on his trunk and on his post neck. MD has not seen him since. Another provider reports he has "a couple of areas that looked pustular" on Friday (14 Feb 03).
day before getting the first vaccine, a medication she took and to which she had not reacted in the past was increased; rash persisted and worsened after the second dose; crazy itchy rash travelling on [her] body; feels like a "deep sort of pain"; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included rash from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, via an unspecified route of administration from an unspecified date (Lot: unknown) to an unspecified date, as a single dose for covid-19 immunization. Reporter reported patient took Shingles at a younger age. The patient experienced day before getting the first vaccine, a medication the patient took and to which the patient had not reacted in the past was increased. On an unspecified date the patient experienced rash persisted and worsened after the second dose, crazy itchy rash travelling on her body, deep sort of pain and rash after each dose of the vaccine. The reporter reported that after each dose patient developed a rash, but it was worse after the second dose, stated patient had a deep pain like shingles, not readily going away, crazy itching traveling on her body, has been 4 weeks that she has had the rash. The doctors decided to stop the medication. The reporter reported regardless, the rash was worse after the second dose of the vaccine. Doctors determined the rash was due to the vaccine and may be starting medication for shingles as the rash was persisting. The outcome of the events of Rash aggravated, Itchy rash, pain and Potentiating drug interaction was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Client felt rush after vaccine. 5 min post vaccine felt numbness under eye +upper jaw-L side. Client waited 30 min. reports s/s subsided.
Thyroid function decreased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Celiac disease" (ongoing); "Soy allergy" (unspecified if ongoing); "Milk allergy" (unspecified if ongoing); "Thyroid function abnormal" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown", described as "Thyroid function decreased".  The lot number for bnt162b2 was not provided and will be requested during follow up.