chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 30 year old female, with allergic rhinitis and no drug reactions or allergies, who on 7/30/04 was vaccinated with a dose of varicella virus vaccine live (lot # 646673/0708N). Concomitant vaccine given on the same day included MMR. There was no other concomitant medication. On 8/15/04, the patient experienced myalgia, rash at site and lesions on chest and arms. On 8/23/04 the patient saw the doctor for conjunctivitis and on 8/25/04 she saw an opthalmologist who noted a lesion on her nose and eye. She was diagnosed with keratouveitis related to varicella virus vaccine live. The patient was treated with valacyclovir hydrochloride. Subsequently the patient recovered. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. The reporter felt that the patient's keratouveitis was related to therapy with varicella virus vaccine live. The myalgia, rash at the injection site, lesions on chest and arms, and keratouveitis were considered by the reporter to be other important medical events (OMIC). Additional information has been requested.
Bruising and reddness at the site of injection. Reddness that spread to almost the entire upper arm. Warms at the site of injection reported by the patients. Pt came in yesterday 8/19/17 to report the event. Followed up with patient this morning, 9/20/17 and was told the area looks much better.
BROKE OUT IN HIVES  ALL OVER BODY; SORE ARM; This spontaneous report received from a patient concerned a 57 year old male. 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: 1802070 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced broke out in hives all over body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 06-MAR-2021, and was recovering from broke out in hives all over body. This report was non-serious.
Patient presented to us on Sunday 10/15/23   injection site reaction on RIGHT upper arm, measuring roughly 4-5in x 4-5in, surrounding the site of the injection -- raised, red, very warm to the touch, & patient reported it was also itchy and that symptoms began the day before (Saturday 10/14/23)  recommended patient to be seen by her PCP and/or Urgent Care to be evaluated
Patient is under 18 years old and received Janssen J&J Covid-19 vaccine. Patient had a reservation under the Janssen vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (been non stop vomiting as a side effect/not able to hold anything down at all) and NAUSEA (took Compazine for nausea but she can't keep it down.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced VOMITING (been non stop vomiting as a side effect/not able to hold anything down at all) and NAUSEA (took Compazine for nausea but she can't keep it down.). The patient was treated with PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, VOMITING (been non stop vomiting as a side effect/not able to hold anything down at all) and NAUSEA (took Compazine for nausea but she can't keep it down.) outcome was unknown. Not Provided. No concomitant products were reported.
On 04/24/21 around 11:30am , patient was getting her second Covid vaccine ( Moderna) . it was administered by Immunizing Technician under the pharmacist. Patient felt a bit dizzy after getting the shot , she stated she has history of getting a bit dizzy every time a needle been used on her ( getting shots or withdrawing blood ..etc) . Patient was responsive the whole time answering questions and stating she is feeling ok. we gave her some water and gave her time to rest , she was able to walk by herself to the waiting area and sit for an additional 15 minutes. Patient had her husband with her to drive her.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored ROTATEQ (lot#, dose and frequency were unknown). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Narrative: Patient received two doses of covid vaccine. Found deceased, no cause of death reported. PMH includes depression and substance use disorder. Reporting per instruction.
Swelling, redness, warmth, pain, limp (gait) left thigh.
I received the shot on 10/15/18 and the next day my right arm was paralyzed with tingling in fingers and toes on right side. The paralysis lasted about 4-5 hrs. On the third day I experience pain in left leg and ankle and could barely walk. I also had a very bad headache and felt very heavy to carry myself. Inside of my mouth on right side felt like it was closing up on me so I went to E.D with the bad leg. I was diagnosed with sciatica nerve! I went to see my doctor and she stated inflammation of tendons! My friend told her doctor about my symptoms and he stated GBS. Please help me because my pain in left foot is still there and now I'm starting physical therapy 11/13/18. I was fine til I received this flu shot!
Head starting feeling  funny, started to sweat and became dizzy an hour after vaccine. Went outside into cold air to relieve the symtoms, took about 1/2 to subside. Now have slight headache.
pt recv 2 doses of varicella vax & lab eval 6-7wk post vax revealed 11 neg titers (WAES95101160 through 95101166 & 95110424 through 95110427) & 6 equivocal titers (WAES 95110428 through 95110430 & 95111163 through 95111165);
Pt received the Pfizer Bivalent when she should have received the second dose in the primary series.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling seemed to be lymphatic; shoulder swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 12Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included nasal sinus allergies (otherwise healthy), some shellfish sensitivities and mouth swelling with some spices allergy from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN). The patient previously took codeine and experienced itching reaction. The patient stated, "The night of the vaccine I awoke at 1am with moderate amount of swelling in shot arm, swelling in left side of neck and facial swelling on 13Jan2021 01:15 AM. No breathing problems so I did not go to hospital. Some swelling went down with Benadryl. On the second night, swelling came back in same places with neck/shoulder swelling being worse." The patient called her doctor who set up an appointment for 15Jan2021. Sweeping is some better on the third day have continued to take Benadryl, Motrin seemed to make it worse (as reported). The patient further stated, "My doctor has advised me not to take the second dose of Pfizer COVID 19 vaccine due to the swelling going beyond just arm swelling. The arm, neck, face swelling seemed to be lymphatic." all on 13Jan2021 01:15 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given to the patient for the event, over the counter medications - Benadryl and Motrin. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events ware considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The patient was not pregnant.
heart fluttering happening several times a day lasting around 20 seconds; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart fluttering happening several times a day lasting around 20 seconds) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030b21 and 024m21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced CARDIAC FLUTTER (heart fluttering happening several times a day lasting around 20 seconds). At the time of the report, CARDIAC FLUTTER (heart fluttering happening several times a day lasting around 20 seconds) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the srtat date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the srtat date of the event a causal relationship cannot be excluded.
Approximately 45 minutes post vax, the mother states the patient's face became very red and swollen. There was also redness and swelling on the patient's arms and legs. The patient was seen at the ER and treated with Benadryl.
Received 2nd Dose on 04/02/2021 in the evening. I woke up with a swollen, painful right upper arm; from the top of the shoulder to the elbow on the right arm. Pain scale   6/10 I took Motrin 800mg and Tylenol 1000mg twice a day for 3 days.  Pain with movement/ range of motion of right upper arm. Painful if bumped or touched. Pain decreased to about a 4/10, 04/04/2021.  Day three 04/05/2021 pain was a 2/10 On the fourth day,04/06/2021 the swelling had gone and there was no longer pain to touch.  Pain scale 0/10
Moderna 0.25ml given instead of Pfizer 0.5ml for 2nd dose of Covid vaccine; 17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently; 17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 0.25ml given instead of Pfizer 0.5ml for 2nd dose of Covid vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently) and ACCIDENTAL UNDERDOSE (17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included ADHD since 06-Oct-2015, Social anxiety disorder since 30-Oct-2019 and Clostridioides difficile infection (Treated with 2 courses of Vancomycin and probiotic) since 23-Sep-2021. Concomitant products included METHYLPHENIDATE from 03-Sep-2021 to an unknown date for ADHD, ETHINYLESTRADIOL, LEVONORGESTREL (LEVONORGESTREL AND ETHINYL ESTRADIOL) from 29-Sep-2021 to an unknown date for Birth control, VANCOMYCIN from 12-Oct-2021 to an unknown date for Clostridium difficile infection.   On 22-Sep-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Nov-2021 at 4:15 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 0.25ml given instead of Pfizer 0.5ml for 2nd dose of Covid vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently) and ACCIDENTAL UNDERDOSE (17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently). On 17-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 0.25ml given instead of Pfizer 0.5ml for 2nd dose of Covid vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently) and ACCIDENTAL UNDERDOSE (17 year old received 0.25 ml of moderna vaccine/but Moderna was given inadvertently) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided. Reporter stated that patient took Vancomycin 125 mg 4 times daily for 10 days, then 125 mg twice daily for 7 days, then 125 mg daily for 7 days, then 125 mg every 2 days for 4 weeks  Reporter also stated that the patient was waited the appropriate 15 minutes and was monitored, no adverse symptoms noted.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Patient's demographics, medical history and concomitant medications were updated.
First day , Jan. 27. in the afternoon serious headaches began lasting for several days.. took Tylenol to alleviate.  Feb. 3. Very serious itching began at the injection site, on my left arm, width of my arm and down to just above the elbow and the area was very red. I used cold pack to alleviate the severe itching and redness. This lasted for  approx. three days.  Feb. 8.  In the early afternoon my entire left arm began to ache, becoming painful as the day wore on. Then also went down into my armpit. The pain was very intense. I started having heart palpitations so totally Rested. Took a Tylenol for the pain.  Took another Tylenol before bedtime and was able to sleep through the night.  The pain and ache was better the next morning. By later in the afternoon I felt better,
Pt has had no adverse reactions to speak of yet. His doctor called us after we administered the vaccine and stated that he had already received the vaccine at their office 2 weeks prior. He has problems with his short term memory and did not remember.  Md said to cancel his 2nd dose appt.
Roughly 15 hours after receiving the vaccine, I started to develop muscle aches. Within 30 minutes of the aches, they became severe. Aches were primarily located in the lower back, shoulders, hips, and calves. 30 minutes following,  I started to feel very fatigued and had labored breathing. Another 1.5 later, I developed chills and had flu like symptoms. By the afternoon, I had broken into a fever and had mild nausea. Besides the muscle aches, as one symptom onset, the others seemed to fade away. By 5:00 in the evening, (roughly 25 hours after receipt of vaccine) the symptoms quickly subsided. The only residual side-effects within the rest of a 48 hour period were soreness in the area of the injection, and mild headache.
This spontaneous report as received from a registered nurse (RN) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored temperature: 21.6 degrees Fahrenheit (F), time frame: 1 hour and 55 minutes previous temperature excursion: 28 F, time frame: 6 hours and 15 minutes; total cumulative temperature and time: 28 F for 8 hours and 10 minutes; the vaccine was back in range) doses of ZOSTAVAX lot # L011533, expiration date: 03-JUL-2016 (dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
Information has been received from physician, concerning a patient who was vaccinated with second dose of varicella virus vaccine live (Oka/Merck) and developed zoster. The physician noted that this was reported to him by a colleague at another practice. Additional information has been requested.
Pt experienced malaise, fever, URI symptoms for 24-48 hours post 1st vax. Could not rule out post vaccination syndrome.
After about a day my sore left arm cleared up and I was feeling fine, but just about a week after my shot I started noticing: -a sore spot under my left armpit that is maybe an inflamed glad or something, not visible or felt from the outside -joint pain, most acutely in my left shoulder, elbow and wrist, but other joints too -surface skin pain around the shot area -a small rash below where I was injected, as well as the sides of my face -a cold sore came out on my lip that usually only happens when my immune system is weakened -chills
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284725, 2018SA284730, 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284726, 2018SA284728, 2018SA284729, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735 and 2018SA284736, from same reporter. This case involves child patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1997AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to incorrect product storage. It was reported that patient was given vaccines that were outside of the recommended temp range (below 32F). It was unknown whether patient experienced any adverse reaction after the injection. This suspected  adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
I got flushed after shot, the nurse had me wait longer. I experienced my normal aura nausea and panic, loss of brief consciousness. I'm fully aware stress can trigger a seizure. In July I had a major episodes about two months after I ended up with a major episode ended up in ER July 7 & 9th. Ativan was administered to stop the clusters and I was sent home and saw my Neurologist shortly after.