chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, improperly stored doses of PROQUAD lot # M038862 with expiration date 13-MAR-2018, lot # M044718 with an expiration date 07-MAY-2018, or lot # N002915 with an expiration date 24-JUL-2018, or lot# M036159 with an expiration date 12-FEB-2018 (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. No adverse effects were reported. It was reported that the products were exposed to temperatures between 6 and14 degrees Fahrenheit for 174 hours. No previous temperature excursion was reported. Digital data logger was involved. No product quality complaint was reported. This was one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013643: US-009507513-1706USA010087.
Neuropathy exacerbation in the bilateral arm, each early morning getting progressively worse with burning,  decreased feeling, tingling, pins, and needles, extreme, severe pain.
Next day experienced Fever, nausea, headache, achy body, fatigue, Sore throat, cough and diarrhea
deathly sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received dose of Shingles vaccine and felt deathly sick for a couple weeks. For 2nd dose, refer case US2021AMR176128, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176129:Same reporter US-GLAXOSMITHKLINE-US2021AMR176128:Same reporter
12 Blisters on palm left hand and 1 on 5th digit 4 blisters to right knee
Am extremely unstable getting out of bed; Chills without high temperature; Extreme fatigue; Instantly sleepy, slept for 3 hours upon return home (afternoon naps not normal for me); Sleepless night; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN60262) via an unspecified route of administration in the right arm on 06Mar2021 at 13:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 mellitus, epilepsy, anxiety, osteoporosis, vitamin D deficiency, vitamin B complex deficiency NOS (B deficient), high blood pressure, thyroid function decreased (low thyroid) and high triglycerides. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR), ibuprofen (IBO) and multivitamin (unspecified); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 06Mar2021 at 14:30, the patient experienced extreme fatigue, was instantly sleepy and slept for 3 hours upon return home (afternoon naps were not normal for the patient) and on the same day, the patient was sleepless at night. On 07Mar2021, the following day morning (AM) the patient was extremely unstable to get out of bed and slept in a chair and had chills without high temperature. The events did not result in doctor or other health care professional office/clinic visits, and the emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, instantly sleepy and slept for 3 hours upon return home, sleepless night, extremely unstable to get out of bed and chills without high temperature was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
extreme itching, redness and heat profuse over trunk, arms, thighs, hands, feet, back of neck over 4 days,Difficulty sleeping at night due to extreme itching,; required visit to Urgent Care physician,   Prednisone dose pack consisting of total 15- 10 mg tablets over 10 days; Benadryl 25-50mg HS, Zyrtec bid, Aveeno colloidal oatmeal baths (sr citizen with reduced mobility)  Currently finishing first 10 Prednisone (bid X5 days) sx reoccur each afternoon
Arm welted up; Arm turned to blisters; Arm  itched; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Arm welted up), BLISTER (Arm turned to blisters) and PRURITUS (Arm  itched) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Arm welted up), BLISTER (Arm turned to blisters) and PRURITUS (Arm  itched). At the time of the report, URTICARIA (Arm welted up), BLISTER (Arm turned to blisters) and PRURITUS (Arm  itched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 at 16:00 as dose 1, single (Lot number: ER8729), in left arm and on 01May2021 at 12:00 as dose 2, single (Lot number: ER8736) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 24Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 939902), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression and anxiety" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; BUPROPION; BUSPIRONE; ACETAMINOPHEN; PSEUDOEPHEDRINE. Past drug history included: Cefaclor, reaction(s): "known allergies: Cefaclor". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19.
booster out of date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster out of date) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A, 010M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster out of date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster out of date) had resolved.            No concomitant medication provided. No treatment medication provided. Booster dose was expired on October 2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up received on 28 dec 2021 included patient demographics.
Urticana @ vaccine sites 0 anaphylaxis, 0 emesis, 0 resp distress, supportive care only.
Initial unsolicited case received from a healthcare professional on 25 November 2014. A 60-year-old male patient with no reported medical history had received a dose of Flu vaccine on 03 November 2014 (manufacturer, lot number, route and site of administration not reported). On 23 November 2014, i.e. 3 weeks post vaccination, he experienced pyrexia, headache and cough. A quick view nasal swab test indicated "Flu B". The events required ER/doctor visit. No further details were provided. Patient's outcome was unknown. Documents held by sender: None.
Fever. Confusion. Got up to go to the bathroom but did not need to go. Then said he went in his depends. Next morning he asked me what all that was about. I said I don't know. It was not his normal state if being. I attributed it to the flu vaccine. Dad started getting weaker and weaker and having trouble walking. He could not get out of bed. He was finally confined to bed and needed 100% assistance. He had to start using the commode only. With help. Also depends undergarments  all the time. Dad was bed bound and could do nothing. We had the tv on for him and music but he did not watch. Dad was having a harder and harder time of it. Everyday he got worse. I called Dr and he recommended hospice. Dad got weaker and could not talk anymore. He understood but could not speak. I could not understand why dad went downhill so fast could not move and could not speak. I called hospice knowing they help with the last 6 months of life if someone is dying. Hospice cake. Dad did not rouse when they pushed on his sternum. He was very hot. Hospice said he would be dead in 3 days. I was astounded. Why was my dad dying like this? I thought he would have 6 months at least. Dad could not talk but did waken somewhat when I had family say goodbye to him in the phone. I know it was the flu vaccine that made dad go downhill like that in one month and a half and die. The flu shot killed him. Dad wasn't like that before. Dad could walk and talk. No more after the flu vaccine. The heavy metals in the flu vaccine like mercury could have given him heavy metal poisoning and also made his Parkinson's worse. Dad was 90 years old. Your form keeps telling me he was 89 he was 90. Flue vaccine: influenza PF Quad ped/adol/Adult psat type t or vial dosage .5 milaliters right side. Dad died unexpectedly October 29th 2016, a month and 2 weeks after the flu shot, at the age of 90 years old.
wet cough, sinus congestion, runny nose, headache, loss of smell, some faitgue. Loss of smell just happened last night. starting 10/31/21
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 03-MAR-2014, the patient was vaccinated with M-M-R II. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
diarrhea; reoccurring extreme fatigue; some body ache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation, reaction(s): "some fatigue ", "Headache", "swelling in my arm ". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "reoccurring extreme fatigue"; PAIN (non-serious), outcome "unknown", described as "some body ache"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: The patient stated, "I just got the vaccine, the second dose. Sometime in, I think it was last week on Thursday. So, I that was a second dose, that was the last dose I needed for the Pfizer vaccine and I know this that I have been experiencing diarrhea and reoccurring extreme fatigue and some body ache and chills and I was just wondering about the common side effects that uses have reported." After second dose, you know I was experiencing some weird symptoms. I was not experiencing fever or seizure anything like this and I was just shocked and how they escalated."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Came for 2nd dose 15 months after 1st; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 02nd October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix on 02nd October 2020 and came in pharmacy on 16th February 2022 for his 2nd dose, 15 months later instead of 2 to 6 months as outlined in PI.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked if the patient needed to restart the series or needed a third dose. Call center representative provided information as per content and CDC guidelines.  The reporter did not consent to follow up. VAERS details pertained to 1st dose of Shingrix.
Heart was racing; even at rest my heart rate was over 100". Caller reports that the highest it went was around 130; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a female of unspecified age received the first dose BNT162b2 (solution for injection; batch/lot and expiry information reported as not available) as a single dose via unspecified route on 10Mar2021 at around 3:30 - 4:00pm, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. On 11Mar2021, the morning after receiving the vaccine, the patient experienced her heart was racing. The patient explained that morning after the vaccine she noticed that her heart was racing and even at rest her heart rate was over 100. The patient stated that at the highest it was around 130. The patient reported that on 15Mar2021, five days later, it is still happening; her heartrate is still around 110. The patient stated that she went to her doctor where an electrocardiogram (EKG) was performed which was normal. The outcome of the events heart racing, and even at rest my heart rate was over 100". Caller reports that the highest it went was around 130, was not recovered.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
"COVID arm"  - redness, firmness at injection site First noticed on day 9, larger on day 10
Janssen on 6/10. Positive on 8/8 admitted 8/8-8/9
20 minutes after the shot driving home with my mom I started feeling funny couldn't describe it my mom said it was probably anxiety I got home remove the Band-Aid and there was a rash under the Band-Aid my arm was completely red and swollen and still swollen you can see a indent where it meets on the arm started itching everywhere my throat was acting up it was hard to swallow so I took a bunch of Benadryl for 3 days I was sick so I was told I can't get the second vaccine which is very frustrating but my doctor and the pharmacy said no CDC when I called said they can't say yes or no but they gave me the warnings is there anything else I can do to get that second shot I'm getting desperate I have no immune system
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Over weight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2 weeks and had no known allergies. The patient was being treated for COVID-19 with Paxlovid from 26Jul2022 to 30Jul2022. After taking a dose of Paxlovid, the patient would have horrible taste in her mouth. The patient would lesson as time went on and would come back when she took the next dose and took almost 5 days for it to be completely gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
FEELS LIKE FLU; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feels like flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels like flu was not reported. This report was non-serious.
warm to the touch (feverish) of the injection site; injection site itchiing; soreness; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch (feverish) of the injection site), VACCINATION SITE PRURITUS (injection site itchiing), VACCINATION SITE PAIN (soreness) and VACCINATION SITE RASH (injection site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch (feverish) of the injection site), VACCINATION SITE PRURITUS (injection site itchiing), VACCINATION SITE PAIN (soreness) and VACCINATION SITE RASH (injection site rash). At the time of the report, VACCINATION SITE WARMTH (warm to the touch (feverish) of the injection site), VACCINATION SITE PRURITUS (injection site itchiing), VACCINATION SITE PAIN (soreness) and VACCINATION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Reporter did not allow further contact
Severe fatigue starting two days after the second Pfizer COVID vaccine  lasting three  full weeks.  Fatigue was so intense that I had a difficult time standing and walking.
Itchy and redness (4 inches in length, 2-3 inches width) around injection site. Occurred 8 days after injection
After getting each vaccine my arm would hurt then it would go away. After the third dose the pain was there in my arm from my shoulder at the injection site to the forearm and lasted a month. My pain management doctor gave me a steroid shot to get the pain to away. Whenever I try to use my arm to pick up anything a pain will shoot down my arm and I will drop what it is I am trying to pick up. The pain is back, it is like a dull achy twingy pain that is always there, if I try to use my left arm the pain shoots throughout my arm.
Influenza A; This spontaneous case from the United States was received on 28-Mar-2022 from other non-healthcare professional (patient's parent) and concerned a 5-year-old, female patient.  The patient's medical history and concomitant medication were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On 27-Mar-2022, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient was tested positive on antigen test for Influenza A. Differentiation of H1N1 and H3N2 was not performed.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of 'influenza A virus infection' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 5-year-old patient was tested positive on antigen test for Influenza A an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. Due to lack of information regarding temporal relationship, causality for the reported event is unassessable.; Sender's Comments: A 5-year-old patient was tested positive on antigen test for Influenza A an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. Due to lack of information regarding temporal relationship, causality for the reported event is unassessable.
moderate deltoid swelling blotchy redness & mild ecchymoses @ site of inject;
Information has been received from a 22 year old female patient, for GARDASIL, a Pregnancy Registry product, concerning herself who on 16-JUL-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Last Sunday, the patient conducted a home urine pregnancy test and it was positive. Patient reported that she went to her gynecologist and they confirmed her pregnancy and she was told that she was 7 weeks pregnant. Lot # was not available. Patient reported that around the time that she got pregnant, she had been experiencing nausea but she was recovering from nausea at the time of reporting. The patient's date of last menstrual period was approximately on 10-JUN-2009 and the estimated delivery date is 17-APR-2010. Information also has been received from a medical assistant reported that the patient on 16-JUL-2009 was vaccinated intramuscular with the first dose of 0.5 ml GARDASIL (lot # 662300/0100Y). The patient called the office on 29-JUL-2009 to report she was pregnant. The patient did not provide a last menstrual period date. No problems reported. Follow up information has been received which reported that the patient's estimated delivery date was March 2010. On an unspecified date in March 2010, the patient had a normal infant with no congenital anomaly. No further information is expected.
A few weeks after initial vaccine, I developed vitiligo across my body. Arms, back, legs, hands, feet.
Temperature of 100.6 with chills, fatigue and  sore arm; Adverse reactions have gone away by 9:00 am Friday, Feb 12,  2021