chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Pain; Headache; trouble breathing; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, headache and difficulty breathing. On an unknown date, the outcome of the influenza-like symptoms, pain, headache and difficulty breathing were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, pain, headache and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient had very bad achy pains and very flu like symptoms. The patient had headaches and was having trouble breathing. The patient had these problems for over a week and a half and they were just beginning to settle down. The patient was wondering if she should take the 2nd shot what would be the problems with not taking the second shot. This case has been linked to US2019GSK081836, reported by the same reporter for patient's husband.
COVID-19 Treatment; COVID-19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter (consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER2613), in left arm and on 12Apr2021 as dose 2, single (Lot number: EW0158) at the age of 31 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medications included: CITALOPRAM, start date: Oct2016; HYDROXYZINE, start date: Jan2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 5 days after testing negative; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient received COVID 19 Treatment which included Paxlovid from 02Oct2022 to 06Oct2022 (lot number: 1918538A). The patient reported Covid rebound 5 days after testing negative on 11Oct2022, not recovered. There was no treatment. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 21 year old female with a history of anxiety and depression who was vaccinated intramuscularly with a first and second dose of GARDASIL (Lot # 0250X) on 04-JUN-2008 and an unknown date respectively. Subsequently, the patient experienced pain in back and in both arms about 2 weeks after each dose. Unspecified medical attention was sought; no laboratory or diagnostic tests were performed. The patient recovered from pain in back and pain in both arms each time. Additional information has been requested
Headache, Myalgia, Arthralgia, NauseaVomiting, Localized pain; fatigue Narrative:  Other Relevant History:
Extensive rash spreading over entire abdomen and sides of body.  Rash also on face.  Rash consisting of large red lesions as well as individual pox.
This case was reported by a consumer and described the occurrence of fever in a 75-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included carotid endarterectomy, carotid stenosis, cholesterol, hypertension and irritable bowel syndrome. Concurrent medications included Diavan, Atenolol, LIPITOR, Aspirin and CO Q 10. On an unspecified date in 2008 and on an unspecified date in September 2009 he subject received a dose of Influenza vaccine (unknown). On an unspecified date in March 2009, the subject started generic product Isradipine (oral, manufacturer unknown) at 5 mg daily and discounted on an unspecified date in October 2009. On 17 October 2009, the subject started DYNACIRC CR, (oral) at 5 mg daily. In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced fever and chills. On an unspecified date in 2009, after vaccination with Influenza vaccine, the subject experienced "felt terrible with generalized feeling bad". At an unknown time after starting generic Isradipine, in March 2009, the subject experienced lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension. On 17 October 2009, within 24 hours of starting DYNACIRC CR, the subject experienced a "flutter type" headache with redness of her face and neck. Treatment with generic Isradipine was discontinued in October 2009, while therapy with DYNACIRC CR continued. At the time of reporting, the fever, chills, feel terrible, headache, red skin on face and neck,  lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension were resolved. She had a flu shot this year, about six weeks ago. She felt terrible with generalized feeling bad for about 24 hours then it went away. Last year was her first time for getting the flu shot. She got fever and chills for 24 hours then all went away. Caller reports that she takes DYNACIRC for her blood pressure. Back in the spring of this year, around March, she took generic for DYNACIRC because she was unable to get the brand product. While on the generic she reports lack of effect, anxiousness, palpitations, felt stressed out, tense, nervous, uptight feeling and hyped started on the name brand CR product. She reports that she initially had a flutter type headache, with redness of her face and neck within an hour of taking the product. These issues have since resolved and her blood pressure has lowered.
Vaccine administered 9/30 in afternoon. Immediate bump approx 1" from skin. No pain/burning. 6 pm - pt had flu-like sx and went to ER. Treated and released.
developed sciatica a week after booster dose. severe pain in right leg, foot and back. sciatica/back pain  resolved mid january but right foot started flaring: sense of coldness in foot, swollen, dark red/black color, numbness in toes with unbearable nerve pain. by mid February was unbearable. couldn't walk, couldn't have any clothing on it, even showering/water drops on it was painful. very sensitive. saw multiple specialists. tried gabapentin, topical anesthetic and found unhelpful. has taken lyrica and acupuncture once weekly and has started to resolve. started subsiding about mid april and now about 75-80% recovered. still hard to wear shoes. 3/10/22 dx complex pain syndrome considered.
Initial report received from a healthcare professional on 07 November 2014. A female patient with no medical history and unknown concomitant medications, had received an intramuscular dose of FLUZONE QIV (batch number, expiry date not reported), in left arm, on 09 October 2014. The patient had received a previous dose of FLUZONE QIV. The patient had previously called on 05 November 2014 and reported that on an unspecified date 3 weeks after aminotransferase. The patient called back on 07 November 2014, to state that she had further testing done and her scan of gall bladder indicated blockage. The patient stated that she believes that gall bladder blockage was what actually caused elevation of her liver enzymes and not the Flu vaccine. The patient declined to provide any contact information for herself of her HCP. Corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none. This case is linked to case# 2014SA153498 (cluster case).
73 Y female with a past medical history of  CAD with stents, DM2 with hyperlipidemia, HTN, osteopenia, atherosclerosis of aorta, PAD presents with progressive shortness of breath and cough with sputum production and declining O2 sats, admitted for acute hypoxemic respiratory failure 2/2 likely COVID Pneumonia   COVID PNEUMONIA // ACUTE HYPOXEMIC RESPIRATORY FAILURE Patient fully vaccinated with two doses Pfizer. Patient attended wedding 10/2 and noticed mild symptoms shortly after. Developed a cough 10/6 managed by Robitussin. Tested positive at home 10/8, and tested positive again 10/9. 10/14, symptoms worsened considerably with productive cough with green sputum, and home pulse ox showed SpO2 in high 80s. Used supplemental O2 at home which mildly relieved symptoms and was told to present to ED by PCP. In ED, patient comfortably speaking on 2LNC. 6mg Decadron x 3, Remdesivir 200mg in ED, and Remdesivir 100mg x1. Patient oxygen requirements improved from 2L NC to 1L NC to RA.    HYPONATREMIA On presentation, patient with Na of 134 10/15, decreased to 132 10/16 and improved to 136 10/17. Stable at time of discharge Reason for Hospital Admission (Admitting Diagnosis):  COVID Pneumonia
About 3-4 hours after injection, patient began to have a cough and not feel well. Later in the afternoon and into the evening, she reported body aches, fever of 101.2 and a headache. She slept "fairly well" and woke up the next day feeling ok. No redness or swelling at site of injection.
Rapid antigen test was performed and it came out positive for Covid-19; Rapid antigen test was performed and it came out positive for Covid-19; chills; fatigue; sore throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from quality group.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18May2021 (Lot number: EW0168) at the age of 29 years as dose 2, single and intramuscular, administered in arm left, administration date 26Apr2021 (Lot number: EW0176) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Dec2021 17:00, outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021 17:00, outcome "recovering" and all described as "Rapid antigen test was performed and it came out positive for Covid-19"; CHILLS (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 21Dec2021 17:00, outcome "recovering", described as "sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, chills, fatigue, oropharyngeal pain.  Clinical course: The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The reporter was Pfizer employee and also a pharmacist. He was reporting for his wife. She did not experience an AE for first or second dose of the Pfizer Covid vaccine. But on 21Dec2021, she experienced chills, fatigue and a sore throat. Rapid antigen test was performed, and it came out positive for Covid-19. She will follow up with a PCR test to confirm Covid-19 diagnosis. No known allergies were reported.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
My arm feels broken and I can't move it at all, I'm going on day 3 and still feels painful; My arm feels broken and I can't move it at all, I'm going on day 3 and still feels painful; fever; dizziness; tiredness; headaches; joint pain; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Mar2021 at 09:30 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), hyperhidrosis, and hypothyroidism. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination on an unspecified date the patient was diagnosed with COVID-19. The patient had an allergy to pineapple. On 08Mar2021 at 11:00 the patient experienced arm felt broken and could not move it at all. She was going on "day 3" and still felt painful. She had fever, dizziness, tiredness, headaches, and joint pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of arm felt broken, could not move it at all, painful, fever, dizziness, tiredness, headaches, and joint pain were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 11-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.  Index number was reported .   Reporter did not allow further contact
This non-serious spontaneous case, initially received from other healthcare professional (nurse) on 11-Oct-2018, concerning a 40-year-old, adult, female patient. The patient had no medical history and concomitant medications. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [batch number: 252663, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported]. On the same day, after vaccination, the patient experienced body aches all the night and nothing helped (as reported), and the patient developed a giant cramp from head to toe which remained still painful. At the time of this report, the patient had not recovered from the events.
Patient had anxiety with vaccination and passed out after receiving vaccination. Patient was having difficulty conversing and self identified as a panic attack.  Patient had difficulty regulating breathing.
One hour after injection:  Left arm local reaction tenderness + 1.5x2.5cm erythac indurated accompanied by chest/abd pain-costochundral irritation by examination.  Pain with any rib cage mout.  No SUB, CXR: Normal limits, EKG: Normal limits.
Sore arm, body aches, migraine, stiff lower back, chills, tiredness, smell/taste affected.
Information has been received from a physician concerning a female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on approximately 13-AUG-2009 was vaccinated with a third dose of GARDASIL (lot # not reported) 0.5ml intramuscularly. There was no concomitant medication. In August 2009, the patient developed swelling and pain at the injection site of the left deltoid area. The patient was seen in the office on 19-AUG-2009. No treatment was prescribed. At the time of the report on 20-AUG-2009 the patient was recovering. There was no laboratories diagnostics studies performed. Additional information has been requested.
Covid booster; Her arm that she received her injection in, is painful; She has an area of redness where her injection site is; The redness is continuing to get enlarged or get bigger and the area is hot to touch; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program (004756). The reporter is the parent. A 24-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included: METFORMIN; BUSPIRONE; CYCLOBENZAPRINE; CYMBALTA; and FISH OIL. Vaccination history included: Covid-19 vaccine (dose 1 (Manufacturer unknown, lot# not provided), for COVID-19 immunization; Covid-19 vaccine (dose 2 (Manufacturer unknown, lot# not provided)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Covid booster"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2021, outcome "not recovered", described as "She has an area of redness where her injection site is"; VACCINATION SITE WARMTH (non-serious) with onset Dec2021, outcome "unknown", described as "The redness is continuing to get enlarged or get bigger and the area is hot to touch"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Her arm that she received her injection in, is painful". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site warmth, vaccination site pain which included BENADRYL. Additional information: The patient had no prior vaccination (within 4 weeks) and no lab test performed.  The lot number for bnt162b2 was not provided and will be requested during follow up
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Pt came to ER 7/27 with CP and 7/28 with difficulty breathing.
Apparent reaction to flu shot Got shot on 10/28/14. 10/29/14 redness at injection site and swollen was prescribed prednisone by nurse practitioner on 10/30 and is fine. Followed up with patient on 11/2 swelling and redness gone.
Nausea, vomiting, dizziness, vertigo, migraine? two weeks plus physical therapy
Multiple Sclerosis; hands didn't work too well; This is a spontaneous report received from a contactable consumer (patient) and a consumer from a Pfizer sponsored program. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 24Mar2021 at 09:05 (Batch/lot number: ER8727; Expiration Date: Unknown) at the age of 62-year-old as single dose since the patient had Multiple Sclerosis and didn't want COVID. Medical history included ongoing multiple Sclerosis from 24Dec1982, ongoing asthma from 2007. Prior Vaccinations (within 4 weeks), other vaccinations was not received. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Investigation assessment was none. Concomitant medication included fingolimod hydrochloride (GILENYA). The patient previously received Hepatitis B vaccine and experienced extreme itching on back, but no rash. The patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 03Mar2021 in the morning (Lot number: EN6202) at the age of 62-year-old as single dose for COVID-19 immunization. On 15Jul2021, the patient had an antibody test but did not have any antibodies. On an unspecified date, the patient hands didn't work too well and had Multiple Sclerosis and taken immunosuppressants. The patient wanted to know if she were to stop the Gilenya, would those antibody cells be re-activated and whether she needed to receive a booster dose of the Pfizer-Biontech Covid19 vaccine. The patient was at her doctors office and they chose to do that test. Doctor mentioned there was some problems and other patients tested negative for antibodies after their COVID-19 Vaccines. The patient wanted to known how long it takes for the booster shot to give her antibodies. The patient didn't get sick after her COVID-19 Vaccines. Caller states she called the company who manufactures her medication, and they suggested if she were to stop her medication for two weeks with her doctor's guidance, she may be able to get an additional dose of the Pfizer BioNTech Covid-19 Vaccine during that time and develop an immune response. The events did not required a visit to emergency room and physician office. Nobody can tell her how many days it takes to develop antibodies after the third shot. She discussed this information with transfer agent. Relevant tests was none. The outcome of events was unknown.
A headache that gradually increased in intensity until it was very intense, during this time some nausea started. I barely had any appetite at dinner time, and after esting a few bites vomited repeatedly, until after my stomach was empty and there was no more to throw up.