chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 65 year old female patient with drug allergies to EFFEXOR XR, simvastatin (MSD), LIPITOR and ezetimibe (MSD), who on 07-MAR-2008 was vaccinated intramuscularly into the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 658449/0989U). There was no concomitant medication. On 07-MAR-2008, the patient developed an injection site rash. The rash was described as a large, round 4X4 area of redness, was swollen, with minimal warmth to touch at the injection site. The patient called the office three days after the vaccination to report the reaction. The patient stated she received the ADACEL vaccination on 07-NOV-2007 and had an identical reaction. No diagnostic laboratory studies were performed. At the time of this report the patient recovered from the redness and warmth. The outcome of the rash and swelling was unknown. It was reported that no previous vaccination with pneumococcal 23v polysaccharide vaccine was noted. No product quality complaint was involved. Additional information has been requested.
(MANUFACTURER UNKNOWN) in the past and experienced vaccine allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 20Mar2021, the patient experienced facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness. No therapeutic measures were taken as the result of adverse events. The adverse event resulted in visit to the doctors or other healthcare professional office/clinic visit. The clinical outcomes of the events facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient came in January of 2021 to report she still has a sore arm and range of motion possibly affected and wanted reported to vaers.
Difficulty breathing, chest pains, racing heart, panic attack feelings with inability to regulate and pace breathing, extreme hot flashes and sweating, low grade fever or 99-100 degree every other day for 4 weeks, extreme fatigue and "brain fog", dizzy, nauseous for 4 weeks, blood pressure has risen, daily menstrual spotting to this day when there was no previous menstrual activity for nearly 2 years due to IUD placement.
Shingles; Pain was excruciating in the same way that my shingle pain was 3 years ago; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number: FF2589), via an unspecified route of administration, administered in arm left on an unspecified date at 20:00 (8 o clock pm) as DOSE 2, SINGLE for covid-19 immunization at pharmacy/drug store. Patient medical history included High cholesterol and had shingle pain (3 years ago) from an unknown date and unknown if ongoing. Patient concomitant medication included rosuvastatin (ROSUVASTATIN) 5 mg once daily, taken for high cholesterol, start and stop date were not reported. Patient historical vaccine included received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: FF2588), via an unspecified route of administration, administered in arm right (upper right arm) on 01Sep2021 as DOSE 1, SINGLE for covid-19 immunization. On 04Oct2021, the patient developed shingles and thought it was re occurring and the pain was excruciating in the same way that patient's shingle pain was 3 years ago. The pain started about 12 hours after had her second dose, the pain started and intensified for about 24 hours. 24 hours later, the pain was almost gone. It was reported that patient took olives, and she did not know what olives are. The outcome of events was unknown.
Patient reported nervousness prior to receiving vaccine. Patient reported blurred vision, possible vertigo, slight nausea. Patient never lost consciousness. Patient was moved to fresh air, given ice pack, bottle of water. Left without issue.
My symptoms starting the night I got the vaccine and lasted for 2 weeks after. I had a fever, chills, severe headache, nausea, shortness of breath, muscle aches, fatigue, and pain in my left leg. We ended up going to the emergency room the week after because of fear of blood clots.
Got the shot around 6:40PM on 3/26.  Woke up with severe headache at 6:30AM on 3/26.  By 9:30AM had a temperature of 101 which increased to over 102 within an hour or two.  Experienced nausea and fatigue.  On 3/27, headache continued, fever was over 101.  Arm had redness around injection area and became swollen.  Arm slightly sore, but not bad.  3/28  had low grade temperature in the morning, but it went up to 101 at night.  3/29-present have had a low grade temperature which sometimes went up over 100, but most of the time was around 99.9.  Arm redness worsened on 3/28 (spread over larger area) and continued to get worse over next few days, including becoming very swollen and itching a bit (very mild itch). Swelling started going down on 3/30 and by 4/1 was mostly gone, as was redness.  Arm more or less normal by 4/2, though slight blotchiness around injection shot. Fatigue and headache, sometimes severe, ongoing.  I am prone to migraines, so possibly that this is a migraine that may or may not be related to the injection.  Have experienced mild vertigo from about 3/30 through the present.  Sensation of pressure on head (weigh on top of head or squeezing), accompanied by feeling of motion coming to an abrupt stop when I turn my head (like slamming on the brakes in a speeding car).  I used cold compress and exercise for arm, when it was painful the first few days (much less painful than with first shot, fairly mild), and cold compress on head for the headache.  Still experiencing fatigue.  Tempreature today is down to 99.3.
Patient was administered Moderna vaccine, age 17 years and 4 months. No adverse reaction
6:45AM- blurred vision and chills upon getting out of bed followed by loss of consciousness for ~30 seconds. Vomiting upon regaining consciousness. Fever of 38.5C. Took Tylenol, drank water, and slept from 7AM-8AM. At 8AM, chills and blurred vision had resolved. Was able to eat, drink, and take medication without further vomiting. Fever persists. New mild headache starting around 8AM.
Diarrhea, dehydrated, nausea, vomit, dizzy.
Pt complained of rapid pulse, weak, shaky and slightly dizzy, hot and flushed. Pt went to ER and had MD exam when she left the Health Dept. Pts skin diaphoretic.  Pt refused BP check. Pt advised to take antihistamine.
numbness of tongue pressure around the chest dizziness nausea was given Benadryl at ER
flushed face, facial swelling, lips and tongue swelling, elevated HR, elevated BP , light headedness,  after vaccine I waited for 20 min with no symptoms, once I left the facility I immediately felt symptoms of  face flushing  and swelling and elevated heart rate .  I immediately turned around and went to the ER,
The next day I developed a serve asthmatic cough treated with inhaler 40mg prednisone and doxycycline were prescribed for 7 days. Cough remains.
Facial swelling around sites of prior facial filler injections.  Angioedema under eyes
Information has been received from a physician and a registered nurse (RN) concerning a 16-month-old female with no known drug allergies, who on 24-FEB-2006 at 14:00 was vaccinated subcutaneously in the left arm with a first dose of Varivax (lot# 650388/0914R). On 22-JUN-2006 the patient developed lesions, on 23-JUN-2006 she was seen in the physician's office and was diagnosed with chickenpox (mild, < 50 lesions). The patient was seen back in the physician's office on 07-JUL-2006 and was recovered. Additional information has been requested.
FLUZONE HD vaccine from last year, which expired with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 89-year-old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which  was expired (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA, expiry date:30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day)  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  At 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 holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. 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.
she doesnt feel well; diarrhea; chills; headache; she was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: MALAISE (non-serious), outcome "unknown", described as "she doesnt feel well"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; ILLNESS (non-serious), outcome "unknown", described as "she was sick".  Additional information: Caller (name) was calling because she had an appointment today (02Apr2021) for her 2nd dose but she was sick and wanted to reschedule. Also, she added what happens if she will not show up for her 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A week after she developed a rash in both of her elbows.; Her arm still hurts though. Her whole left arm hurts.; both elbowsredness burning itching three days later pain and inflamation; both elbowsredness burning itching three days later pain and inflamation; both elbowsredness burning itching three days later pain and inflamation; both elbowsredness burning itching three days later pain and inflamation; both elbowsredness burning itching three days later pain and inflamation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): PR-PFIZER INC-202200291775 (Pfizer).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2022 16:45 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 15Feb2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Jan2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), BURNING SENSATION (non-serious), PRURITUS (non-serious), ARTHRALGIA (non-serious), INFLAMMATION (non-serious) all with onset 07Feb2022 12:00, outcome "recovering" and all described as "both elbowsredness burning itching three days later pain and inflamation"; RASH (non-serious), outcome "unknown", described as "A week after she developed a rash in both of her elbows."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm still hurts though. Her whole left arm hurts.". Therapeutic measures were taken as a result of erythema, burning sensation, pruritus, arthralgia, inflammation.  Additional Information: No other vaccine in four weeks. Patient called in about receiving her booster dose on 01Feb2022. A week later, she developed a rash in both elbows. After 3 to 4 days, her left elbow where she got vaccinated became inflamed and hurt. She currently uses a topical cream to help the redness and burn on that arm. She stated that her arm still hurts. She mentioned taking Panadol or Tylenol but did not confirm if she was currently taking it. She wanted to know if this would be a problem and if it will go away. She also wanted to get treatment recommendations. Had covid prior vaccination. Had not tested covid post vaccination. No known allergies and other medical history. She did not have a prescribing doctor.   The lot number for bnt162b2 was not provided and will be requested during follow up.
tient ID:   82 y.o.       Admit Date:  8/30/2022     Discharge Date: 9/1/22     Principal Dx/ Final Dx:  COVID     Relevant Inpt Dx:  Principal Problem:    COVID  Active Problems:    Chronic obstructive pulmonary disease with acute exacerbation    Type 2 diabetes mellitus with diabetic polyneuropathy, without long-term current use of insulin    HTN (hypertension)    Tobacco abuse    Chronic kidney disease, stage III (moderate)ckd3a    Acute hypoxic respiratory failure        HPI:     Hospital Course:    This 82 year old man was admitted with covid and copd exacerbation.  He was hypoxic and required oxygen on admission.  He has improved.  Today he has no wheezing and his oxygen saturation is 92% on room air.  Follow up with pcp.  Complete steroids orally.                  Consults:    IP CONSULT TO SEPSIS NURSE NAVIGATOR  IP CONSULT TO SOCIAL WORK           Disposition:  home     Discharge Condition:  fair
Pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   No treatment information for the events was provided.   This case was linked to MOD21-13175, MOD21-13172 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-13175:Crosslinked: Same reporter MOD21-13172:Crosslinked: Same reporter
Patient reports 2 hours after getting her first pfizer vax in her right deltoid she began having constant right sided head and upper  extremity weakness. Reports intermittent dizziness, palpitations
This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 27-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degree F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F. On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. Patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of ZOSTAVAX lot # L024999, expiration date 26-OCT-2016, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
localized redness and swelling exuding from shoulder to elbow. Chills and generalized muscle aches.
only Shingrix diluent used; diluent only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: A pharmacist reported that several months ago, a patient may have had received just the Shingrix diluent only. The reporter was sure that 2 patients received diluent only but believes this may have happened before since they have 2 extra lyophilized vials. The reporter had no details or information on this 1st patient. The reporter consented to follow-up. This case is for 1 of 2 patients. Additional supportive information: The patient received just the Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022111741:Same reporter. Patient 2
There was not an adverse event.  The patient was given an dose of expired  Pfizer vaccine as a booster. The patient was  contacted about the event and scheduled to come in and receive an additional Pfizer vaccine on Nov 3.
Notice hard area around injection site about the size of a tennis ball. Site was hot, hard, painful.  Started getting chills on and off thru-out the next two days.  Size grew to approx. a grapefruit, hard, hot, painful.  Myalgias started and continued x 48 hrs. Started having runny nose and cough Saturday.
From initial information received on 05/20/2004 from the patient regarding an adverse event occurring in the USA, it was reported that the 38 year old female received a dose of TD ADS Adult, lot number U1014AA, administered in the left deltoid on 03/22/2004.  The route of administration was not reported.  Four days later, on 05/26/2004, the patient developed bilateral muscle aches and cramps in her legs, as well as pain and swelling in her left arm.  On 03/29/2004, she experienced a muscle constriction in her right leg and was barely able to walk.  On 03/30/2004, she was placed on prednisone and a medrol pack, which relieved the symptoms temporarily.  She was seen in the emergency room on 04/01/2004 for blood work and was administered baclofen for muscle spasms.  The patient was also seen by a neurologist and was placed on Klonopin and continued on 10mg of prednisone.  At the time of this report, the patient had not yet recovered, but had recently returned to work.  From additional information received on 08/18/2004 from the responsible physician, the patient was taking Zyrtec D at the time of vaccination.  The patient's recovery status was unchanged.  From additional information received on 04/21/2004 from the initial reporting facility, it was reported that the patient was last seen on 04/04/2004.  He has since been lost to follow up.  No further information is anticipated, this case is considered closed.
Nausea; Vomiting; Loss of appetite; Severe stomach cramps; Severe abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes type 2, HTN (hypertension) and obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received codeine (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medication within two weeks of vaccination. On 23Feb2021, the patient experienced nausea, vomiting, loss of appetite, severe stomach cramps and severe abdominal pain. The events resulted in doctor or other healthcare professional office/clinic visit. 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 nausea, vomiting, loss of appetite, severe stomach cramps and severe abdominal pain were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Cold chills, weak, extremely tired, pain from injection site across my back and into the other arm , light headed and light sensitive
I initially developed left arm soreness in the evening of administration of the injection. The following day I developed chills and myalgias. On 1218 2021, I developed shooting pain down my right leg.  Later that evening I developed persistent tingling and numbness in my hands, both, as well as tingling and numbness in both my feet. Since that time I have had persistent tingling and numbness. These symptoms have persisted since this time. They are worse with cold weather. Not associated with any weakness however I do have some increased fatigue ability in my right forearm, which may be unrelated.
fever almost 12 hours after injections. Highest was 99.8. Body aches & chills. Headache. Side Effects lasted until 4pm the following day.
Felt hoarseness within 2 hours and the hoarseness got progressively worse, eyes got very red, was difficult to take full breaths, head hurt, arm very sore. Called Pharmacy at 8:30 PM, was advised to take 2 benadryl and could take both ibuprofen and acitomenaphen.  Took 2 Benadryl and 2 ibuprofen. Still felt hoarseness in morning and eyes still red and did not feel well. Took 1 more Benadryl and 2 ibuprofen. Slept most of the day and by evening felt 80% better. The next morning 10/4/2019, felt all better.
Chest Pain; Left side chest tightness for few days. Patient also c/o cough and hot flash. Denies SOB, HA. PMH of Afib.  Cough