chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 26Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: 381308A) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of cancer (Hodgkins lymphoma)", stop date: Aug2019, notes: History of cancer (Hodgkins lymphoma), NED since Aug2019; "Known allergies: Shellfish" (unspecified if ongoing); "History of asthma (childhood + allergy" (unspecified if ongoing), notes: History of asthma (childhood + allergy, induced); "chronic muscular pain" (unspecified if ongoing), notes: chronic muscular pain; "TMJ" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: 01Sep2021; BUPROPION(MFG Lupin), start date: 01Feb2022; SPIRONOLACTONE, start date: 01Aug2021; CETIRIZINE HCL, start date: 01Jun2022; ACETAMINOPHEN, start date: 26Jun2022, stop date: 03Jul2022; IBUPROFEN, start date: 26Jun2022; ALBUTEROL SULFATE HFA( inhaler, Prasco), start date: 27Jun2022, stop date: 28Jun2022; SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;VITAMIN B12 NOS;VITAMIN E NOS], start date: 01Apr2022; COQ10 [UBIDECARENONE](Nitrigold), start date: 15Mar2022; Mini Multi vitamin, start date: 01Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient started Paxlovid on day 1 (the day after symptom onset) and completed it on day 6. The patient's symptoms resolved on day 8, she tested negative at home on an antigen test on days 7 and 8. The patient began experiencing symptoms again on day 11, symptoms progressed and she tested positive at home on an antigen test on day 12. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: day 12; Negative, notes: day 7; Negative, notes: day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid(lot number: GA2851) from  27Jun2022 to 01Jul2022.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no pertinent medical history and no drug reactions or allergies. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000436, expiration date 10-APR-2014) 0.65 ml, once, subcutaneous for prevention. Concomitant therapies included PLAVIX and COZAAR. The pharmacist reported that on 13-MAY-2013, a few hours after receiving ZOSTAVAX in her left arm, patient developed a spot at the site of injection. Pharmacist stated at that time, the spot was just a localized reaction. The patient then went to see her unspecified primary care provider on an unspecified date, at which time the red spot had grown to 5-6 inches in length and 3 inches in diameter. Pharmacist reported that the patient's primary care provider referred to an unspecified reconstructive skin surgeon who diagnosed her reaction as an outbreak of shingles. Pharmacist reported that patient was currently still experiencing the outbreak of shingles. Treatment was not given and laboratory tests were not performed. At the time of the report the outcome of outbreak of shingles and localized reaction was reported as not recovered/not resolved. Additional information has been requested.
Information has been received from a nurse practitioner, via a company representative, referring to two female patient of unknown age. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (strength, dose, lot #, expiration date and route were not reported). It was reported that while on ZOSTAVAX, the two female patients experienced large amounts of swelling, pain and rashes near their respective injection sites. There was no lab diagnostics tests performed. The patient sought medical attention. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Slight fever started at about 10:30 pm on 8/7/17. By 12:00 midnight the fever (went to 104), nausia, dizziness & sore throat. Acetamenophen tablet with lots of cold water were given and, ice & cold wet towels were applied all over the body especially on forehead, armpit, chest & legs. At 7:45 am on 8/8/17patient was taken to Dr. where he was given medication & blood samples for testing & x-ray were taken. It was believed that the illness may have been caused by the HPV vacine.
Case number PHEH2012US013840 is an initial spontaneous report received from a medical assistant on 12 Jul 2012: This report refers to an adolescent male patient. He was given only the CYW-135 liquid conjugate component of MENVEO (batch number: X11071) on 11 Jul 2012. No other adverse reaction was reported following this administration error.
pt recv vax 9SEP96 returned 12SEP w/swelling, erythema around arm surrounding inj site;
She has pain to the point where she can not lift her arm above her head. Tylenol does not help. Informed her to ice it also.  Due date 9/19/2019, currently 29 weeks and 4 days. She was 150 lbs at time of injection.
Patient received 1st dose on 01/28/21 and 2nd dose on 02/24/21-both at age of 16 years.
It appeared to be too quick. They squeezed my arm/the shot appeared that they did it much too quickly and they pushed the plunger in very fast. It felt like it was in there only a second; shoulder pain a little bit/Sore shoulder; I had a sore arm; little soreness where the needle went in; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9262, expiration date was not reported) via an unspecified route of administration, in left arm, on 28Jan2021 08:00 (at the age of 72-years-old), at dose 1, single for covid-19 immunization from school/student health clinic. The patient had no medical history. There were no concomitant medications. Historical vaccine included flu shots (INFLUENZA VACCINE), shingles vaccines (VARICELLA ZOSTER VACCINE), Pneumonia shot (PNEUMOCOCCAL VACCINE) and never had any events. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No additional vaccines administered on the same date of vaccination. On 28Jan2021, the patient experienced shoulder pain a little bit/sore shoulder, had a sore arm, little soreness where the needle went in and the patient concern is that when he got the first vaccine the individual who injected the shot appeared that they did it much too quickly and they pushed the plunger in very fast; felt like it was in there only a second/ felt like it was not administered correctly. No treatment was received for the events. The patient underwent lab tests and procedures which included: tested 6 times for covid and always negative on 3 days prior to first vaccine (25Jan2021) and 3 days prior to second shot (15Feb2021) and took it again on an unspecified date. The patient received the second dose of vaccine (Lot number EN6200) in the left upper arm on 28Jan2021 and had a sore arm and shoulder pain a little bit. The outcome of the events shoulder pain and sore arm was recovered on 28Jan2021 and outcome of other events other events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366630 same reporter/drug & different patient/events
Patient received vaccination. Later that night, she couldn't move her arm. She was experiencing 9/10 pain. The pain lasted 3 weeks, now it is better. Her shot was 3 inches from her rotator cuff, which was most involved with the pain.
R clavical lymph node became very swollen and tender. Flu like symptoms on day prior to lymph node reaction, which was a day after shot (4-11-injection, flu symptoms 4/12, Swollen node 4/13. Went to personal physician, had chest X ray and blood work. Which were all normal. Still slightly swollen on 4/25
Body pain; Extreme muscle weakness; Night sweats; Headache; Chills; Nausea; Temporary loss of hearing in her right ear; Stiffness in both upper arms and upper legs; This spontaneous case was reported by a health care professional and describes the occurrence of DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in both upper arms and upper legs). On 19-Apr-2021, the patient experienced DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear) (seriousness criterion medically significant), PAIN (Body pain), MUSCULAR WEAKNESS (Extreme muscle weakness), NIGHT SWEATS (Night sweats), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear), MUSCULOSKELETAL STIFFNESS (Stiffness in both upper arms and upper legs), PAIN (Body pain), MUSCULAR WEAKNESS (Extreme muscle weakness), NIGHT SWEATS (Night sweats), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started with dry cough and then moved down into my chest. Then pretty significant fatigue the first two days. Then just croopy cough and runny nose and fatigue. I never had a fever. My symptoms April 26th, a Tuesday. The worst was about the 30th and then I began to feel better. As of today I am completely recovered.
Local reaction 4 1/2-5 in from shoulder down arm, pinkness, swelling, firmness and warmth.
Severe delayed skin rash/hives-- itching, bruising. Beginning 12/8 and ongoing. Treating with prednisone, antihistamines, hydrocortisone creams.
Given flu shot on 11/2/10 at 122 pm. That night she reports her "ribs were hurting", hard to take a deep breath. Believes she had a fever, felt warm, temp not checked. Didn't seek medical treatment. Didn't feel better until 4pm the next day. Reports on 11/4/10 of feeling fine.
First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia since 17-Aug-2020, Type II diabetes mellitus since 17-Jul-2019 and Essential hypertension since 05-Dec-2019. Concomitant products included ATORVASTATIN, EZETIMIBA and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.   On 05-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Jun-2021 at 11:04 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 05-Mar-2021 and second dose received on 02-Jun-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included lyumjev kwikpen 30 units injection TID. No treatment medications were reported.   This case was linked to MOD-2022-503289 (Patient Link).
Burning began in the center of my chest that increased in area and intensity.  It spread to my back and the pain became a level 9.  I was taken to the ER and treated for suspected heart attack.  The diagnosis was finally made at esophagitis.  I spent 5 days in that hospital.  Three days later I experienced severe heart palpitations that caused dizziness for two hours to such a degree that I could not stand up.  Over the course of the next six weeks, I continued to have daily episodic attacks of this nature with a lessening degree of symptoms each time.  As of today, the symptoms have not recurred.  Additionally, I began to experience significant hair loss at the same time as the onset of the other symptoms to such a degree that when brushing my hair I would get a fistful of it in my brush.  The hair loss has slowly diminished, and as of today, the excessive hair loss has ceased.
Diarrehia; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 53-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), with first dose (lot number: EJ1685) at 10:00 on 18Dec2020, with second dose (lot number: EJ1686) on 05Jan2021, both via an unspecified route of administration at site of right arm at single dose for COVID-19 immunization. Medical history included hypertension, cholesterol and known allergies: latex, pencillin and ACE inhibitors. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ) and simvastatin, both received within 2 weeks of vaccination. The patient experienced diarrehia at 14:30 on 05Jan2021. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date. The case was identified as non-serious by reporter. The outcome of event was recovering.
Heavy uterine cramping inconsistent with cycle phase, light to moderate spotting inconsistent with cycle phase
Patient send to the ED with worsening shortness of breath.  Patient admitted to the hospital with Covid and treated with remdesivir.
Developed runny nose, body aches, fever, sore throat.  Telehealth called clinic on 7/8 and received paxlovid and finished it.  Still have runny nose and a bit of fatigue.  Still a lot better.
Developed a metallic taste in my mouth/ Foul taste; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 18:45 (Lot number: EW0513) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure. I do not know it has been couple of years.; "Cholesterol little elevated" (unspecified if ongoing), notes: I have a cholesterol little elevated but I am on medication for that. Concomitant medication(s) included: LIPITOR [ATORVASTATIN] taken for blood cholesterol increased; HYDROCHLORTHIAZID, start date: 2020. Vaccination history included: Bnt162b2 (First Shot, Lot number:LOT#: EP7534, Anatomical site of vaccine administration (first shot): Left arm, Time of Vaccination of first shot: 6:45 pm, No events reported.), administration date: 20Mar2021, when the patient was 61 years old, for Covid-19 Immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 24May2021, outcome "not recovered", described as "Developed a metallic taste in my mouth/ Foul taste". The event "developed a metallic taste in my mouth/ foul taste" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Patient already went to his primary care physician for consultation. Patient wanted to know if anything was being reported that any other, any side effects coming up after a week. Patient took Hydrochlorthia 12.5 mg tablet once a day (not clarified further, hence not captured in tab), Patient was trying to see if it is related to the vaccine because like I said, it happened almost a month or two months after I received it.  Follow-up attempts are completed. No further information is expected.
chills; dizzine; breathing was fast; her face was pale; blood pressure high measured at 158/98; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergic reaction to bee sting.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98). On 22-Jan-2021, CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: blood pressure elevated mmHg (High) 158/98. On 22-Jan-2021, Respiratory rate increased: breathing fast abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Sore arm with vaccine; A bit of body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm with vaccine) and MYALGIA (A bit of body aches) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm with vaccine) and MYALGIA (A bit of body aches). In 2021, VACCINATION SITE PAIN (Sore arm with vaccine) and MYALGIA (A bit of body aches) had resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient received immunization on 09/16/2023. Patient reported to pharmacy on 09/19/23 reporting prolonged soreness/pain and redness in the area that immunization was given. Upon visual inspection, the shot was administered low on the deltoid muscle. Patient was advised to apply a cold compress to the area and take oral ibuprofen to assist with pain and inflammation. She was instructed to follow up with MD if no relief or if symptoms worsened by day 7 post-immunization.
Information has been received from a pharmacist concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently the patient developed fever, body aches, flu-like symptoms and large local reactions. The patient sought unspecified medical attention. It was reported that the patient had recovered. No additional information was provided.
Scratchy throat, swollen lymph nodes around neck, difficulty breathing, hoarseness, sore throat, throat swelling.
pain at injection site; her arm still hurts, not bad but it is still sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 24Mar2021 (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergic to coconut and mushrooms" (unspecified if ongoing). Concomitant medication included: EUTHYROX, start date: 2021.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "not recovered", described as "pain at injection site"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "not recovered", described as "her arm still hurts, not bad but it is still sore".  Additional information: The events did not require a visit to emergency room and physician office. There were no prior vaccinations within four weeks.   No follow-up attempts are possible. No further information is expected.
very high fever over 104 and sometimes it can't read and says (HIGH) on thermometer , chills, body/muscle aches, headaches, sore arm. after the few days runny nose.  went to Urgent care after couple of days and got some treats to such as lab work and IV.
Dull ache in right forearm and wrist area. Fatigue in right arm muscles occurred about 2 1/2 weeks after vaccine #4 administered. Arthritic feeling in shoulders and hips.
Erythematous spot RD area with pain and pruritus of this area. Approximately 4 x 3 cm.
Case number PHEH2014US002600 is an initial spontaneous report from the nurse received on 04 Feb 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1310301) intramuscularly on 28 Jan 2014. On the same date, 15 minutes after vaccination she experienced severe swelling and hives in and around mouth. It was reported that patient did not experience anaphylaxis and was not hospitalized. The outcome of the events was unknown. The seriousness and causality of the events were not reported.