chrisvoncsefalvay/vaers-outcomes huggingface dataset:
noticed that she no longer experienced pain;  the vaccine to help with Fibromyalgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Jan2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2016 (unspecified if ongoing), notes: I had something called Fibromyalgia I was first diagnosed in 2016. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 28Jan2021, outcome "unknown", described as "noticed that she no longer experienced pain;  the vaccine to help with Fibromyalgia". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Age: 83; Unit: Unknown. Consumer stated, "I took the Pfizer Covid Vaccine on 27Jan and I just wanted to report to them that I had a very unusual reaction to it, it was a positive reaction. Patient had Fibromyalgia, which was first diagnosed in 2016, patient had it before but they couldn't diagnose it. Patient had been on all kind of drugs (Unspecified Medications), all kinds of acupuncture and Medical marijuana and nothing had helped. Patient took the Pfizer Covid vaccine, on 27Jan and woke up next morning and haven't had the Fibromyalgia like it was. Patient went from the pain level of 8 to 10 or 12 everyday but now the pain level was down to between 1 and 2 and in a lot of days, patient had zero or between 0 and 2 but most of the time its zero. I don't know what is in the vaccine or it is just a coincident. I just felt that Pfizer should know about it because there might be something in that vaccine that could help fibromyalgia patients." Patient had second dose on 17Feb2021, Lot number "E19267." ( not appropriately clarified further, hence LOT# for the first shot captured in tab).  No follow-up attempts are possible. No further information is expected.
Bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical history information was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, MELATONIN for Insomnia, BIOTIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CONTUSION (Bruising). At the time of the report, CONTUSION (Bruising) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, White blood cell count: (Low) WBC being slightly below normal range.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Other concomitant medication include: Multivitamins. Treatment information was not provided. Tested negative for Von Willebrand disease.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient height and weight updated. Concomitant medications Lexapro, biotin, multivitamis, melatonin added. AE Outcome updated as recovered.
extremely ill/horribly ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: Having covid three times. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Illness"; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "Illness". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "extremely ill/horribly ill". Additional information: Event Description: How sick the covid vaccine and booster made me. Having covid three times was a better reaction than I had to having the covid vaccine times two and one booster. Made me extremely ill and I am having long-term covid effects. The covid vaccine times two and the booster times one made me horribly ill.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300175426 same patient, drug and event with different dose;
I received the Vaccine on Wednesday, and my symptom's started Thursday early morning.  Friday morning my fingers were numb for hours (around 5 hours)
This spontaneous report as received from a consumer via Clinic refers to a currently 75 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
no adverse reaction --- patient received Moderna vaccine instead of Pfizer --- we didn't receive the guidance for vaccine errors until 11/29 --- the patient received the second dose of Moderna as well.   NO ADVERSE REACTION with either dose.
myocarditis; pericarditis; This is a spontaneous report from a non-contactable consumer (patient).  A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Sep2021 10:00 (Batch/Lot number was not reported) as single dose (at the age of 33-years-old) for COVID-19 immunization. Medical history included none. The patient was not pregnant. No known allergies. Not diagnosed with COVID prior to vaccination. No other vaccines in four weeks. Concomitant medications included metoprolol and piroxicam (PAXIL [PIROXICAM]). The patient reported that, "On Sunday night I was diagnosed with pericarditis but was unconfirmed. Went to the ER and was confirmed with myocarditis." The event started on 12Sep2021 04:15 AM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 1 day. The patient underwent lab tests and procedures which included investigation: pericarditis on 12Sep2021, SARS-CoV-2 test: negative on 12Sep2021 (Nasal swab). Therapeutic measures were taken as a result of the event which included Tylenol and colchicine and indomethacin. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the second shot of Moderna on 11/1/21, my menstrual cycle started after being in Menopause for 1.5 years, where I did not have a menstrual cycle.  The bleeding lasted for 7 to 8 days (ending on 11/10).  Saw Dr on Nov 10th to determine what the root cause.  The outcome of the visit was to schedule an ultra sound of the uterus to determine the root cause. (echography, transvaginal).  On 12/21 the ultra sound was completed no abnormalities were found and there was no evidence of why the bleeding occurred other than the vaccination on 11/1/21.
THIS PATIENT RECEIVED HER FIRST DOSE OF SHINGRIX ON 9/27/19, SHE CAME IN ON 10/7/19, AND INFORMED ME THAT SHE WAS VERY SICK FOR ABOUT 1 WEEK AFTER THE SHOT, HER ARM WAS VERY SORE AND SHE DEVELOPED SWELLING INTO THE HAND, SHE STATED THAT AFTER 7 DAYS IT ALL RESOLVED AND SHE IS NOW OK.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Pt given Tdap in (R) arm and immediately after IPV in (L) arm. Pt became pale with cyanotic lips, became rigid and unresponsive for approx. 10 sec. Pt. became responsive but pallor and lip discoloration remained for approx. 1/2 minute.
Hives. Starting on arm, spread to extremities, chest, neck, face within 24hrs.
In less than 24 hours of receiving the Spikevax vaccine I began to experience very high glycemic excursions, despite having been stable on my insulin pump and Metformin. My blood sugar would go over 325 and remain there for several hours without warning or cause. No ketones developed. This has been persisting over the past 10 days since receiving the vaccine.  The increases in blood sugar occur randomly and are not related to food intake, insulin bolus, or activity levels.
Information has been received from a physician concerning a 59 year old female with chronic obstructive pulmonary disease who on 11/4/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). Subsequently, on 11/05/05, the pt experienced a severe local reaction. The pt then experienced chills, a fever of 102 deg F, pain and redness at the injection site, and presented to the ER on 11/6/05. the pt was released and treated with antibiotic. On 11/7/05, it was noted that the symptoms persisted. The outcome was reported as not recovered. It was also noted that the pt received a previous dose of Pneumococcal 23V polysaccharide vaccine in approximately 1995. There was no product quality complaint. It was noted that the physician did not feel comfortable using the remaining doses in the vial and would like an investigation in to Pneumococcal 23v polysaccharide vaccine (lot 650648/0957P). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
On the same day of vax in the afternoon, the pt noted itching at injection site. The next, the are became erythematous and swollen. The pt presented himself the the ER, once on the 22nd and again on the 23rd of March. He was given Benadryl and Tylenol. On the 23rd the swelling was worse and extended to elbow covering a 15cm in diameter area.
Patient's mother called in today and states that she had an allergic reaction to the MCV4 vaccine. States that patient's throat started swelling, eyes started bulging, and she developed a rash, this did not occur until Saturday.
The day of the shot I had a headache that lasted days. I have no history of grinding or clinching my jaw. I?ve now begun that later on that night of the shot.
This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration, administered in left arm on 09Apr2021 (at the age of 40-year-old) as dose 2 , single for covid-19 immunization. Medical history included asthma, high blood pressure, pulses, mitral valve prolapse from an unknown date and unknown if ongoing. Patient was allergic to mild eggs, dairy, peanuts, severe mushroom from an unknown date and unknown if ongoing. The patient did not received any other vaccines within 4 weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications, in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, flecainide (FLECAINIDE) taken for an unspecified indication, valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication, hydrochlorothiazid (HYDROCHLOROTHIAZID) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (solution for injection, lot number: ER2613) via an unspecified route of administration, administered in left arm on 17Mar2021 (at the age of 40-year-old) as dose 1 single for COVID-19 immunization and experienced Lymphedema. On an unspecified date in Apr2021 the patient experienced with in 8 hours chills, fever, nausea, diarrhea, body muscle aches, low energy, swollen lymph node. The patient underwent lab tests and procedures which included body temperature (reported as temps): 99.1, 99.7 and 100.9 on an unspecified date in Apr2021. No treatment received for the events. Outcome of the events were resolving. No follow up attempts are possible. No further information is expected.
Pain at injection site starting one day after 2nd pregnancy (first was miscarriage), due date November 12
I developed a severe headache, left underarm pain, back pain on left side and felt feverish starting about 15 1/2 hrs after my 2nd vaccine.  I took 1 gm acetaminophen but symptoms lasted about 6 hrs.  I was fine after that with no further symptoms.
Edema, erythema and hard lump on right lower upper arm area. Diagnosed with cellulitis right arm, Treated with doxycycline 100mg every 12 hours.
Erythematous area about the size of a grapefruit. Warm to touch, not tender. Pt's mother denies fever or pt complaining of pain. Pt's mom denies vomiting or diarrhea. Has had similar reaction when received 2 year shots.
Patient began to experience numbness and tingling on the left arm the day after the injection. The following day the patient was unable to get out the bed due to the complete numbness of the left leg. The patient fell out the bed due to "not feeling" her leg. The patient eventually was able to walk; however, the numbness and tingling sensation to left leg continued. She went to the ER. Her physical exam showed a reflexia of all extremities. She was shipped to Neuro ICU. She was discharged after 2 days with the diagnosis of mild Guillain-Barre' syndrome.
The next day I woke up feeling like I have a flu I had body ache, and felt fatigued and loss my appetite. I could have had a mild fever but did not have a thermometer that time to take my temperature. The 2nd day after my vaccination I woke up with a severe headache and it lasted till about supper time I took a nap and then the symptoms subsided. By the 3rd day I felt normal again.
Client rec'd VFC varicella-states he has had chick pox as a child. Needed vaccine for nursing classes. 24 hour later had redness, swelling, warmth 8 cm diameter redness with more red center with itching.
Patient received expired medication. confirmed with manufacturer that dose maintained its efficacy. no follow-up needed. no adverse outcome.
Twenty-five minutes after H1N1 vaccine administration, while at home, patient developed itching eyes, progressed to forehead, back, legs. Took Benadryl, called free clinic office. Symptoms gone  within 1 hour.
pt recvd vax;on phenobarbital for afebrile szs;no sz since start of phenobarbital in apr94;had afebrile sz 24 hrs p/ vax; no fever,no local rxn;
This spontaneous report has been received from a registered nurse referring to an unspecified patient of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On 02-FEB-2017, the patient was vaccinated in a local hospital with PROQUAD, intramuscularly rather than subcutaneously (dose, frequency, strength, lot#, and expiration date were not provided) for prophylaxis. No adverse effect were reported. Product quality complaint was not involved. Additional information has been requested.
It is what I would call severe tinnitus.  Like billions of crickets and also an additional "zoom" sound whenever I move, or particularly move my head.   I have had tinnitus before this, but never this bad.  Some days are worse than others.  It has lessened somewhat since the injection.   I am afraid to get the second shot.
experienced tenderness on the left side of her face/the left side of her face is tender around the jaw and underneath her eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Lot number: ER8732) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: diagnosed at least 10 years. Concomitant medication(s) included: TOPAMAX taken for migraine (been taking at least 10 years). Vaccination history included: Bnt162b2 (Lot number:EN6207, Anatomical location: Right arm), when the patient was 49 years old, for COVID-19 Immunisation. The following information was reported: FACIAL PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "experienced tenderness on the left side of her face/the left side of her face is tender around the jaw and underneath her eye". Therapeutic measures were taken as a result of facial pain.  Additional information: Got vaccine on 16Apr2021, stated for about a week now, the left side of her face was tender around the jaw and underneath her eye, stated she has not hit face or had any incidents. Does not know the exact date of the start of the event. Treated the tenderness with Motrin and ice and it got a little better. Reporter informed that tenderness of the face is not listed, but this list does not include all possible side effects, just commonly reported ones. Referred caller to HCP for further guidance  No follow-up attempts are possible. No further information is expected.
Patient falsified DOB when registering for vaccination, stating the minor was 05/16/2017.  Guardian, consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 05/16/2017 which made the vaccine a contraindication.  No known adverse reactions noted.
Racing of heart; Swelling of hand/fingers & feet/toes; Burning sensation in veins; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 19Feb2021 10:15 (Batch/Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin, vitamin D3 and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. Prior and post to vaccination, the patient was not diagnosed with COVID-19. On 20Feb2021, the patient experienced swelling of hand/fingers & feet/toes, racing of heart; burning sensation in veins and dizziness. It was reported she felt better now. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Started with tingling on tongue. Spread to lips (but more mild), inside of cheeks, and roof of mouth. Odd sensation on small patch from mouth to nostril on left side of face (not really numb, but maybe some pressure).
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information has been received from nurse providing information VARIVAX temperature excursion such affected lot numbers, expiration dates and patient ID. Two patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration) (lot# J012384, exp. date: 27-MAR-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one several reports received from the same source. Additional information has been requested.
Patient may have received Pfizer vaccine instead of Moderna for 2nd dose in series. Patient completed observation period without incident.
only received the Dtap- IPV portion of the Pentacel; second dose at age of 6 months and third dose at age of 12 months; Initial information received on 12-Jun-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 12 months old female patient who was vaccinated with a second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on an unknown date of Dec 2018 at age of 7 months (doses with unknown batch number, route and site of administration) and received a 0.5 ml third dose (at 12 months and also reported as 13 months) of same vaccine with lot number UI953AAA, Exp. Date 30-JUN-2020, via intramuscular route in the left leg on 11-Jun-2019 (Exterior Box: Lot- UI953AAA, expiry date: 30Jun2020 , and NDC: 4928151005; ActHIB: LOT: UI953AA expiry date: 30Jun2020, and NDC: 4928151005; and Dtap- IPV: LOT: U6138AB, expiry date: 30Jun2020)  Patient recieved first dose DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on an unknown date of JUL-2018 at age of 2 months.  The patient's medical history.   Concomitant medications included Hepatitis A vaccine.  It was an actual medication error case due to inappropriate schedule of vaccine administered and inappropriate reconstitution technique. It was reported that, for the third dose of pentacel, patient only received the Dtap- IPV portion of the Pentacel. Patient visited doctor on 11-Jun-2019.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
From 5pm on the date of vaccination through the following two full days (01/13 and 01/14) I had an elevated resting heart rate from 20-40 beats higher than my usual resting heart rate. I had one instance of tachycardia (up to 130 beats per minute) on 01/13 that was not caused by activity - it resolved within 30 minutes.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site nodule. On an unknown date, the outcome of the fever and injection site nodule were unknown. It was unknown if the reporter considered the fever and injection site nodule to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had fist size knots at injection site and fever. Because of adverse reaction, the patient was advised by the reporter's office that not to get 2nd dose. This case linked to US2018GSK137728, reported by the same reporter.
pt recvd vax & devel a fever of 103-105 10 days p/vax; No further details were provided; MD reported 15 similar pts;