chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 12 month old male who on 04-MAY-2009 was vaccinated with VARIVAX (Merck) (lot# 663819/0336Y, subcutaneous injection, dose and site of administration not reported). On 04-MAY-2009 the patient had an injection site reaction, which included had swelling, redness and induration at the injection site after VARIVAX (Merck) was given. The patient visited the office for some unspecified medical attention. Subsequently, the patient recovered from injection site reaction on an unknown date. This is one of several cases from the same source. Additional information has been requested.
Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of varicella virus vaccine live. In July 2004, the patient experienced rash. The reporter also indicated that the patient's uncle had an adverse reaction (WAES0408USA01286). Additional information has been requested.
I received the vaccine around 10:45 AM on 11/16/15 at Public Health. Around 7:45 that evening I was struck with a sudden feeling of weakness, dizziness, nausea and I became clammy (sweating around forehead). I laid down immediately and within an hour I developed a body ache from head to toe. The body ache lasted for several hours. The nausea and light headedness seemed to go away after I laid down.
Redness at injection site, fever, mood change, behavior change, relapse in progress of understanding/grasp/mood/behavior. We're 2 weeks post shots, and he's still in a relapse. He's not the same person he was before he had his shots...like his autism is worse.
Patient had check up on 5-9-07 at 2:00 PM and received vaccines. parents took him to ER that evening for questionable seizure activity. See attached records.
A nurse reported that a 5 year old female with mild bronchitis, received her 1st dose of Prevnar on 5/15/01. On 5/16/01, she developed an injection site reaction characterized by redness and swelling that extended from her shoulder to her elbow.
Got COVID/Nasal Swab:Positive; Got COVID/Nasal Swab:Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 18:00 (Lot number: FH8027) at the age of 35 years as dose 1, 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) with onset 21Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 21Jan2022, outcome "recovering" and all described as "Got COVID/Nasal Swab:Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Additional information: The patient was not Covid prior to vaccination and tested after the post vaccination. The patient was not taken other vaccine with in four weeks and no other medication was taken in two weeks.  No follow-up attempts are possible. No further information is expected.
feverish; flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "feverish"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "flu-like symptoms".  Additional information: she and her husband had received the Pfizer COVID vaccine yesterday at (Facility name withheld), and everything was good. She said she had experienced flu-like symptoms last night and was feverish, and her husband was fine and golfing today, and he was good. She had a question about whether she can take Tylenol or Motrin and does not want to interfere with the vaccine if she takes a painkiller in case her fever goes up tonight with that. She wants to know if there was one better than the other: Motrin versus Tylenol. Creating an AE Form since the caller had experienced flu-like symptoms last night and feverishness after receiving the Pfizer COVID vaccine yesterday  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash in her biceps; some allergic reactions to the vaccine to her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Cancer patient with lymphoma and leukemia; "lymphoma" (unspecified if ongoing); "leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "some allergic reactions to the vaccine to her arm"; RASH (non-serious), outcome "unknown", described as "rash in her biceps".  Additional information: She had her 2 shots vaccine from Pfizer and she had some allergic reactions to the vaccine to her arm.  The reporter reported that she had a rash in her biceps.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 46 month old immuno compromised female with ulcerative colitis and an allergy to sulfamethoxazole + trimethoprim (Septra) who on 5/12/2003 was vaccinated SC with a dose of Varicella virus vaccine live (Lot 643532/0601M). Concomitant therapy included mercaptopurine and others. On 3/27/2006, the patient developed chickenpox and a fever, and was treated with oral acyclovir for 5 days. Subsequently, she was hospitalized and received IV acyclovir. While hospitalized, she developed stridor and received budesonide (Pulmicort). A CBC was obtained. The outcome was reported as recovered. There was no product quality complaint involved. The reporter considered the events to be other important medical events (OMIC). Additional information has been requested.
Day 1 of vaccine got typical body aches, fever, chills, etc which resolved within 24hrs. Day 2 after vaccine (Wednesday) I got severe nausea with vomiting. Vomiting lasted less than 12hrs. Nausea into friday.  Friday had nausea, lightheadedness and Bilateral feet "heaviness". Nausea resolved after ER visit due to inability to function due to nausea and lightheadedness. From Saturday-Current still experiencing bilateral leg weakness, and heaviness and sensation of being "pulled to ground with magnets". Had PCP visit and neurology visit. Needing labs and imaging.
Patient reported shortness of breath and tightness in chest that started around 4pm on June 26, 2021 during volleyball game that led to patient not being able to continue activity. On June 28, 2021 at 11am to 1pm, pt reported the same shortness of breath that led to patient not being able to continue strength and conditioning activity. Patient has been advised to contact primary care doctor for further guidance and evaluation.
Two droplets rolled down the arm of the patient/not receiving the complete dose; A spontaneous report was received on 03 FEB 2021 from a pharmacist concerning a 54-year-old, female patient, who received  Moderna's COVID-19 vaccine (mRNA-1273) and when the needle pulled out, two droplets rolled down the arm of patient and not received the complete dose.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 28 JAN 2021, patient received their first of two planned doses of mRNA-1273 (LOT number: 010M20A) with expiration date 19 JUL 2021, intramuscularly for the prophylaxis of COVID-19 infection. The Pharmacist reported that when the vaccine administrator gave the shot, and pulled the needle out of the patient's arm, two droplets rolled down the arm of the patient and a band aid placed over the injection site.   On 31 JAN 2021, The consumer called the pharmacist back and expressed concern about not receiving the complete dose. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The event, two droplets rolled down the arm of patient and not received complete dose was considered resolved on 28 JAN 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 010M20A. There were no reported AEs associated with this case of Incorrect dose administered.
rashes on his hand; swelling of his eyelid; Itching; redness of his eyelid; "covid toe" blisters; chill; This is a spontaneous report from a Pfizer sponsored program by two contactable consumers (one of them was patient's wife and the other was patient self).   A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm on 31Mar2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 57-year-old) for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medications included ibuprofen; acetylsalicylic acid, ascorbic acid (ASPIRIN).  The patient previously received BNT162B2 (at an unknown age) for COVID-19 immunisation as dose 1 and no reaction reported.  The patient did not take any vaccination 4 weeks prior to COVID 19 Vaccine.  Vaccination Facility Type was a set up clinic.  The patient received his second dose of BNT162B2 on 31Mar2021 and had been experiencing AEs. The patient's wife was wondering what they should do about the AEs. The patient had been having rashes on his hand and swelling of his eyelid. The patient has been diagnosed with the "covid toe" blisters on his toe that keep coming back and getting reinfected, and rashes on his hand that keep coming back and redness of his eyelid for which they had used hydrocortisone. Right after his second dose of BNT162B2, he experienced chill, struggled for a day and that the blisters on his foot and rashes on his hands and then his eyelids appeared 3 or 4 days later.  The consumer wanted to know how long will these AEs last.  Treatment included the patient went up to Podiatrist, they had the patient on some antibiotics for some days or so and then he used hydrocortisone for the itching and he had also taken the Benadryl time to time. Anatomical location of administration was in the arm.  Outcome of the events was unknown.  Information on Lot/Batch information has been requested.
Non-severe allergic reaction, face swelling around mouth, itchy face and neck.  Took Benadryl to relieve symptoms.
very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself.  A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021.   Information about lot and batch number was requested.
Patient was given Tdap instead of DTaP at age 15 months. No adverse effects noted. Patient is now 30 months.
0925 Patient experienced hives 10 minutes after administration of Pfizer COVID-19 vaccine located on bilateral UEs and on back. Denied SOB, tongue swelling, difficulty breathing. Denied numbness or tingling in UEs. 0941- 50 mg Diphenhydramine given. Improvement @ 1005 B/P 152/50  Pulse- 60bpm, o2-98%, RR-18 Lungs + clear, Heart-RRR, Skin-red. hives on BLEs, chest, back.  mouth-moist, membranes no evidence of swelling
increase temperature 99.6-103, elevated Blood Pressure 196/128, Heart Rate 115, mild light headedness, no shortness of breath, alert and oriented
Broke three fevers the night of the second  vaccine. First one started around 9pm. Tylenol taken. Next fever started around 2 am. Ibuprofen taken. Next fever 7 am next day. No meds taken.   Was very lethargic next 24 hrs following vaccine.
pt recvd vax;mom had pt down for an afternoon nap;when checked on pt,found him dead;to er; possible SIDS; no oth; sxs were reported;
Heart rate racing, pulse 126, blood pressure 150, Dizziness, sweating, chills
s/p shingles vaccine to the right shoulder, the patient developed a large area of inflammation with warmth and skin coloring changes.  He denies any fevers or pain (so no apparent infection).  This has lasted x at least 3 weeks and was noted by his wife a few weeks after his shingles shot.
arm pain; possible administration of 2nd dose after >36 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (possible administration of 2nd dose after >36 days from 1st dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had not diagnosed or tested positive for Covid. Patient had no other vaccine given within one month prior to Moderna vaccine.  Concurrent medical conditions included Disability, Drug allergy (Lisinopril), Allergy to NSAIDs (Aspirin), Adhesive tape allergy (Adhesive) and Congestive heart failure (10 years ago. Recent change in status: Worsening) since 2012.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (possible administration of 2nd dose after >36 days from 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CELECOXIB (CELEBREX) for Adverse event, at an unspecified dose and frequency. In 2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (possible administration of 2nd dose after >36 days from 1st dose) outcome was unknown.            Patient was on concomitant medications but declined to provide the names. Patient reported that arm pain was nothing compared to what patient experienced events after the 3rd dose. Patient did not have access to her vaccination card and therefore could not provide Moderna lot numbers or accurate dates of previous administrations. Patient had a similar reaction compared to 3rd dose of Moderna. However, it wasn't as bad as the 3rd dose and did not last for a week.   This case was linked to MOD-2022-566830 (Patient Link).
On January 20, 2022 (1 week after his booster shot), he woke up and his arms and legs were shaking severely. His legs were weak and he had difficulty walking.  He was taken to Hospital ER.  He had a blood work up, EKG, CT of the head and nothing was found.  He used to get up and work on things around the house.  Now he just sits in the chair and his arms and legs continue to shake.  According to his wife, he shakes so badly that it is very hard for him to eat or drink. She reports he has lost 20 pounds in a week. He saw his PCP today and was given lorazepam. He has an appointment with a neurologist on February 2nd.
Pt stated starting to feel dizzy shortly after administration.  She continued to sit in the administration area.  Approximately 27 minutes after administration patient vomited and stated her stomach has hurt all day and she doesn't know why she got sick now.
a sore arm; he felt weak; he felt tired; a headache; a fever for 20 minutes; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak), HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea). On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak) and FATIGUE (he felt tired). On 03-Mar-2021, HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea) had resolved. On 04-Mar-2021, PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak) and FATIGUE (he felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative. On 13-Mar-2021, SARS-CoV-2 test negative: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that he was exposed to someone positive for Covid.  Concomitant medication is not given. The treatment information was unknown.  Patient states that he was exposed to someone positive for Covid.  Treatment information was unknown..   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received and contains non significant information.
Extreme back ache during a period exceeding three hours. Emergency room visit and subsequent admittance for treatment. Treatment included a battery of lab test, with antibiotic administration and anti-imflamatory medication
limpness, cyanosis requiring mouth to mouth resuscitation approx 4 hrs p/vax given; period lasted 1 1/2min; pt had temp of 101.4;
This spontaneous report was received from a medical assistant via a company representative and refers to a 16-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unspecified date in approximately 2015 (reported as "approximately 2 years ago"), the patient was vaccinated with GARDASIL injection (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. On an unknown date, after receiving the GARDASIL, the patient collapsed and then experienced lack of sense of balance and some loss of hearing. At the time of this report, the patient did not recover from the adverse events. The causality assessment between the events and GARDASIL was not provided. No product quality complaint was involved. Upon internal review, the event of collapsing was considered to be medically significant. Additional information has been requested.
Infection of left deltoid following Influenza vaccination on 11/4/08. 11/5/08 increased soreness, fever and chills; 11/7/08 went to primary care diagnosed allergic reaction and prescribed pain medication. 11/8/08 went to urgent care diagnosed with cellulitis prescribed cephalexin 500 mg TID 11/8/08 and 1/9/08 fevers of 102 degrees F 11/10/08 went to family practice labs done. 11/12/08 WBC 19.5 per lab on 11/11/08. Clindamycin 300mg TID x 15 days Doxycycline 100mg TID x 15 days prescribed . negative 11/12/08 all symptoms abated-patient finally recovered.
CRAZY CHILLS; EXHAUSTED; A TERRIBLE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced crazy chills, exhausted, and a terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy chills, exhausted, and a terrible headache. This report was non-serious.
Admitted to hospital 8/30 c/o Can't breath. Started on Nasal cannula at 4 L/min. 9/2 60 L/MIN heated high flow.  9/3 BIPAP. Expired 9/12
Was seen in clinic 8/27/09 red, warm flat area right arm.  Advised cool pack & antihistamine & follow up if worsening symptoms occur.
bedridden; aches; sinus problems; curled up like a baby; chills; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 62 year old male patient who experienced bedridden, aches (pain), sinus problems (sinusitis), curled up like a baby (posture abnormal) and chills, while he received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Past vaccination included he realized that Tetanus vaccine was what had made him sick in 1988 as well.  Medical treatment, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing allergic to Penicillin and sulfa drugs.  In 2006, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date: not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious bedridden, aches (pain), sinus problems (sinusitis), curled up like a baby (posture abnormal) and chills, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was also reported that   Details of laboratory data not reported.  His doctor has given him an epipen to bring with him when he receives the COVID (coronavirus disease) vaccine.  At the time of reporting, the outcome of events was reported as unknown.