chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe joint and muscle pain.; Severe joint and muscle pain.; Sore arm were shot was administered; Sore and swollen lymph nodes in the right armpit; Sore and swollen lymph nodes in the right armpit; Low-moderate fever; Chills/shivers; Headache; Lethargy/exhaustion; Lethargy/exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 29Apr2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, anxiety / depression, eczema and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate (ADDERALL), intrauterine contraceptive device (MANUFACTURER UNKNOWN) and loratadine (CLARITIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received bupropion (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 30Apr2021 at 06:00, the patient had severe joint and muscle pain, sore arm where shot was administered, sore and swollen lymph nodes in the right armpit, low-moderate fever, chills/shivers, headache, lethargy and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe joint and muscle pain, sore arm where shot was administered, sore and swollen lymph nodes in the right armpit, low-moderate fever, chills/shivers, headache, lethargy and exhaustion was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Started with redness and swelling around injection site, and fever around 3:30-4pm, gave her Tylenol and Benadryl. She started having febrile seizures 2:30am 08/01/2015, contacted 911 they sent paramedics we were able to break her fever while paramedics were at our home. 08/01/2015 returned to the dr she had another seizure in the exam room. The Dr said that she had an ear infection starting so that it was a combination from the shots and the ear infection. He examined her ears before she got the vaccines the day before and they were clear. She had 2-3 more seizures after leaving the office and returning home. She was taken to Hospital where they did an EEG kept her overnight and they next day said that she had strep throat and again prescribed amoxicillin. 09/2015 my daughter started having partial complex seizures she had 4-5 in one day was again taken to Hospital another EEG was done they gave her Keppra before the EEG was done, they found nothing. She was discharged and the Dr informed us to call back and they would write a prescription for Keppra. She had many seizures from 09/2015-12/2015 each time she was taken to Medical Center, she continued to test positive for strep but no high fevers. 12/25/2015 she had 2 partial complex seizures that morning I called Dr. who informed me to give her Tylenol as she may be starting to develop a fever. She had a 40 minute grand mal, transported to hospital nothing found given keppra as a prescription and diastat for emergency use.
Severe shoulder pain began: restricted movement of left arm and weakness. Pain did not subside after reducing exercise, NSAID. Saw physical therapist 8/29/16 who though it was frozen shoulder. Saw orthopedic surgeon 9/29 who ordered MRI to r/o rotator cuff issue. Followed up with MD 10/5 and diagnosed with frozen shoulder (adhesive capsulitis) Received cortisone shot, EMG ordered, and will be starting physical therapy.
Patient was previously  given Moderna vaccine for 1st dose on 2/15/210and 2nd dose on 3/15/21 and was given Pfizer vaccine today in error. Patient was to be given flu vaccine today
Arm pit lymph nodes achy in left arm. Lasted one day. Fluid buildup in left arm pit down to breast. Fluid dissolved after 4 days.
flu-like sx-abd cramps-nausea & vomiting x 1 day; general aches-lightheadness & fatigue; subsquently devel chills over weekend & weakness of legs, felt hot but did not take temp;
Sore arm at injection site; Stomach cramps; Low-grade fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 18:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and sesame oil allergy. Concomitant medications included vitamin D nos (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), ubidecarenone (COQ-10) and prenatal vitamin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 17:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 at 03:00, the patient experienced sore arm at injection site, stomach cramps and low-grade fever with chills. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sore arm at injection site, stomach cramps and low-grade fever with chills was resolving at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
blood clot in the brain; still suffering with headaches; This is a spontaneous report from a contactable consumer. A "young" female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter called with questions regarding COMIRNATY and the reporter stated a young girl at their church who received the shot ended up with a blood clot in the brain and was still suffering with headaches. The clinical outcome of blood clot in the brain was unknown, the outcome of still suffering with headaches was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
C/O severe pain (8 on 1-10 scale) in biceps and triceps which began three days post receiving flu vaccine. Pain has interfered with normal ROH-no redness, swelling at any time. Ice provided short-term relief-has taken no medication. Not seen physician.
patient received Varicella vaccine as a child but developed primary chicken pox; after direct exposure; patient received Varicella vaccine as a child but developed primary chicken pox with first lesion appearing on 4/28/21 after direct exposure; This spontaneous report was received from a physician and refers to a 21-year-old female patient. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, she was on therapy included infliximab (REMICADE) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). On 28-APR-2021, the patient developed primary chicken pox with first lesion appearing after direct exposure to her boyfriend's shingles lesions. On an unknown date, she sought medical attention. The outcome of the events was not reported. The causality between the vaccination failure and varicella virus vaccine live (oka/merck)(VARIVAX) was assessed to be related. The causality assessment between the event of Varicella and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided. The causality assessment between the events and infliximab (REMICADE) was not provided.
No additional adverse events; patient was administered an improperly stored Varivax; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-JUL-2020, the patient was inoculated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S036635, expiration date 14-NOV-2021 (dose, dose number, route of administration, anatomical site of vaccination were not reported) for prophylaxis.The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown).   The vaccine was stored at the temperature from -14 to -10 degrees Celsius (C) (-11.1) for 2 hours, at the temperature from -9 to 8 C (2.2 C) for 9 hours and 30 minutes, from -14 to -10 C (-9.8 C) for 2 hours and 30 minutes, and from -9 to 8 C (0.4 C) for 3 hours. The previous temperature excursion included temperature from -9 to 8 C (-6.1 C) for 8 hours. Digital data logger was involved. No additional adverse events were reported.
9/21/11 2100 - went to ER for tingling, numbness, weakness starting in feet, moving upward to hands and elbows. MRI obtained and EMG scheduled. No treatment provided.
Approximately 20 minutes after receiving Hep A vaccine, the pt described having palpitations, shortness of breath, sweating which lasted approximately 1-1 1/2 hours.
03APR04- right arm 10:30- felt nauseous, flushed, tired, maybe slight fever. 04APR04 local edema, erythema, 800 mg Advil taken. Still tired.
Flushing, heart beating  fast,  pulse ox 96% hr 13-114 .  kept for observation 45 min felt well when left  pulse ox 99% hr 110.
On  Sunday 2/14, pt notes that she experienced chills and "just felt out of sorts." On 3/15 at 1:30pm, she was scheduled for a wellness exam with her primary care provider. She notes that when staff took her vital, they were concerned because she seemed short of breath. Pt notes that she is overweight and does have dypsnea on exertion at times, but staff were concerned because she had been at rest for some time and they considered the shortness of breath unusual. Pt reports that her blood pressure was normal and her O2 sats were running 97-98% on room air. However, her pulse was 150. An EKG was done and the physician voiced concern over how long her pulse had been elevated. She was transferred to the ED,  where per her report another EKG showed that she was in  atrial flutter. Pt reports that she was treated with IV Cardizem and given and IV bolus of magnesium.  At approximately 4:30pm, a CT with contrast was completed to rule out blood clot or PE. A third EKG done in the ED revealed that she had returned to normal sinus rhythm. She was discharged home at 6:30pm.  Pt reports that she was seen for follow up on 3/20. At that time, her physician ordered repeat labs - CMP, potassium, magnesium, and thyroid - all of which were normal per her report. He changed her medication from baby aspirin 81 mg to Zarelto 20 mg, noting that she is at high risk for stroke. Cardiology has been alerted and she has an ECHO scheduled . Since her discharge from the ED, pt has been monitoring her pulse daily and it have ranged from 66-72 bpm/
32 year old pregnant Community member, During post vaccine observation felt ?cold thru body? & sweeting on/off, HR 100, BP 130/80's, 911 to ED, observed, labs WNL and discharged to home
Numbness and tingling of face unilateral on same side as injection, nerve like pain shooting thru neck, followed with bilateral reynauds of hands and feet. Started within 15 min on injection side and was bilateral within one hour.
This case was reported in a literature article and described the occurrence of vomiting in a child subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a month after receiving Meningococcal ACWY-CRM vaccine, the subject developed vomiting. Serious criteria included other: serious per author. The outcome of vomiting was unknown. It was unknown if the investigator considered the vomiting to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of vomiting in a child aged between 2 and 10 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the retrospective observational cohort study that summarized the occurrence of 26 pre-specified events of interest (EOI) and serious medically attended events (SMAEs) occurring up to 1 year after vaccination with MenACWY-CRM in children aged 2 through 10 years (inclusive-i.e., did not reach their 11th birthday) in routine clinical care. The study was conducted as part of a postmarketing commitment required by the regulatory authority at three medical centers within a particular healthcare system. In this study, most of the children had not received any prior MCV4 vaccinations. The patient was enrolled at healthcare system for 6 or more months prior to the first dose of MenACWY-CRM in order to have 6 or more months of observation time to identify preexisting diagnoses. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 September 2014, the patient received MENVEO (administration site and route unspecified; dosages unknown; batch number not provided). (It was reported, in January 2011, MENVEO, (GSK) was approved by the Food and Drug Administration for children aged 2-10 years in this country). [In this study, most children had not received another dose of MCV4 during their observation period (out of 327, 318 received 1 dose and 9 received 2 doses). The majority of children (n=236) received their index vaccination between 7 and 10 years of age]. The age of vaccination was not provided. On an unspecified date, within 30 days of vaccination, the patient was diagnosed with vomiting. (In this study, vomiting was considered as an SMAE). This case has been considered serious per author "SMAE". Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of vomiting and MENVEO. The authors concluded, "Data from this descriptive study do not suggest safety concerns associated with MenACWY-CRM vaccination when used as part of routine clinical care of children aged 2 through 10. However, the generalizability of the study results to the high risk child population with complement component deficiencies or functional or anatomic asplenia is more limited due to the small sample size of children with these medical conditions in our population". This is 1 of the 5 valid cases reported in the same literature article.
Extreme tiredness which lasted about 12 hours and anxiety and edginess which lasted two to three weeks.
Fully vaccinated with moderna. Second dose administered on 11/12/2021. Tested positive for COVID 19 on 12/24/2021. Was admitted to Hospital in 12/23/2021 and expired on 01/02/2022 while still hospitalized.
Patient record in immunization registry shows he completed the Pfizer primary series on April, received Janssen on May and Pfizer was administered for booster on 12/4/21
A non-serious spontaneous report of received full dose of FLUMIST in one nostril, there was no clip on the syringe was received from a physician concerning himself, an adult male. Neither patient's medical history nor concomitant medications were reported. The patient received the full dose of the FLUMIST dose in one nostril on 21-Sep-2011. There was no clip on the plunger. FLUMIST was present only in side of the vial. There was no adverse event with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 06-Oct-2011 and incorporated in the narrative: Term changed from "one half sprayer in one nostril as total dose" to "received full dose of FLUMIST in one nostril, there was no clip on the syringe." The patient stated that he received a full dose of FLUMIST and explained that there was no clip on the syringe. The patient stated that he had no side effects.
5cm red, hot, itchy, swollen area to right thigh. Pain with touch and ambulation. Given Keflex, ibuprofen and desenex cream.
sensed/tasted metallic; sensed/tasted metallic; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot EK9231) solution for injection in the left arm on 05Jan2021 at 16:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included hypertensive. Concomitant medications included metoprolol; ascorbic acid/herbal nos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc (AIRBORNE); and an unspecified diuretic. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 at 16:30, the patient experienced sensed/tasted metallic. The patient stated, "Immediately after the vaccine was injected, I sensed/tasted metallic. It has been four days since the injection and I still have the metallic taste." No treatment was provided for the event sensed/tasted metallic. The outcome of the event sensed/tasted metallic was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
one child received the ActHIB powder only from Pentacel vaccine, the ActHIB was diluted with another diluent because the diluent was not used/No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves one patient of an unknown demographics, who had been given the ActHIB powder only from vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL].  No information regarding past medical history or concomitant drug was reported.   On an unknown date, the children received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL], lot number and expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to wrong solution used in drug reconstitution.  It was reported that one patient received the ActHIB powder only. ActHIB was diluted with another diluent because the diluent was not used. The Reconstitution Guide Site was given to the caller.  At the time of reporting, no adverse event was reported.  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 2001/83/EC 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.  Information on the batch number was requested.
This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atopy (the patient carries an EPIPEN). Concomitant products included EPIPEN. On 27th June 2018, the patient received the 1st dose of SHINGRIX. On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness and nausea. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness, nausea and headache were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness, nausea and headache to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she was vaccinated with the initial dose SHINGRIX vaccine as recommended by her primary care physician. The patient asked the nurse, that if the vaccine would hurt and the nurse said no. The patient also stated that, she was very active 73 year old female and also later on same day after vaccination she swam her usual laps. She realized then that she could not raise her arm that had been injected without a lot of pain, but she kept on thinking that the pain would work its way out, however it didn't. After carrying out a 40 min swim she felt dizzy and was thankful that she had not fallen onto the cement. Thereafter she felt slightly nauseous, headachy and lethargic. By the next day of the vaccination most of her symptoms were resolved, but the site of the injection continued to be very painful, red and somewhat swollen for three days. The patient was handed with a flyer at the time of injection and she warned that side effects could be mild to moderate. Whereas, the patient described the side effects as moderate to severe. The patient never had that degree of pain after vaccination. She went online and read a lot of reports of the same side effects that she had, which reassured her that the reactions that she had experienced were normal for the vaccine. The patient had two questions towards GlaxoSmithKline that were stated as, why don't you warn patients about the moderate to severe side effects in your flyer? Also, as the patient was atopic and she carried a EPIPEN, so the patient inquired that is it recommended for her to take the second part of the immunization which she was scheduled to receive in a few months, before the date of reporting.