chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash longer than 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter enquired if it was normal to have a rash longer than 4 days after the shingles vaccine. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Initial report received from a non-healthcare professional (patient's son) on 11 JULY 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of ADACEL (lot number, route and anatomical site of administration were not reported) on 06 JULY 2013, morning. On an unspecified date, after vaccination, the patient developed fever of 101.6 F, fatigue, redness and swelling from elbow to shoulder. Relevant laboratory tests were not reported. The patient took Benadryl every 6 hours as corrective treatment on unspecified dates. At the time of this report, the outcome of events was not reported. Documents held by sender: none
patient was given a covid vaccine instead of the regular flu vaccine, with no reported adverse event; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  The case is linked to case 2021SA331684 (cluster).  This case involves female patient (unknown age) who was given a coronavirus disease (COVID-19) VACCINE instead of the regular INFLUENZA VACCINE (wrong product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect COVID-19 VACCINE (not produced by Sanofi Pasteur) instead of INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual case of medication error due to wrong vaccine administered (same day latency).  It was reported "They have and gave a 4 year old the covid vaccine adult dosage supposed by mistake and a lady was given a covid vaccine instead of the regular flu vaccine."  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  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 of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
Develop a blood clot on their left knee; Left leg kept swelling up; A spontaneous report was received from a physician concerning a 83-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a blood clot on her left knee and left leg kept swelling up.  The patient's medical history included cholesterol unspecified. Products known to have been used by the patient, within two weeks prior to the event, included vitamin D and medications for cholesterol.  On 26 Feb 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly  in the left arm for prophylaxis of COVID-19 infection.  On an unspecified date after the vaccination patient developed blood clot on left leg, leg also kept swelling.   Relevant treatment for the event included blood thinners and aspirin.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, blood clot on their left knee and left leg kept swelling up, was unknown.; Reporter'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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 30Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Sep2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Jun2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 01Sep2023 to 05Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Mom reported on 2/11/03 that after vaccine given on 11/11/02 one hour after shot developed hives then fever that pm taken to hospital was given steroid injection. Hives and fever off and on next two days.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 1 dose (lot # M001578, expiration date: 21-NOV-2018; route was not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Vaccine error: Vaccinator administered COVID 19 vaccine however some of the liquid of vaccine splashed onto the patients arm and thus the patient did not receive full first dose. The vaccinator likely did not secure the needle to the syringe well enough. Incident was filed on the date of occurence. Patient did not have any symptoms.
I gave the above vaccine on 4/14 at 1:45pm.  After giving the vaccine,  I discovered that the vial was opened (punctured) on 4/12 at 4:45pm and had been open for greater than 12 hours. When I gave the vaccine the vial had been open for a total of 20 hours and 45 minutes.  It was refrigerated the entire time.  It had only been removed from the refrigerator to draw up the previous dose for a total of 5 minutes.
Pt was here to receive their third COVID vaccine. They were supposed to get the bivalent Pfizer dose, and received the monovalent dose on accident.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 06-year-old child of an unspecified gender. On an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and it continued for 2 weeks (explicitly coded as incorrect product storage). On 19-Feb-2018, the patient was administered with FLUCELVAX QIV (dose: not reported, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018 that was stored out of recommended temperature for an unknown indication (explicitly coded as drug administration error). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Patient experienced tingling sensation in the fingers and hand immediately after receiving shot. Patient reported numbness in the arm and cold sensation in the hand.
On 1/7/2021 Received vaccine in L Deltoid and arm started twitching within a few minutes of receiving shot.  Twitching had stopped by time that client completed 30 minute observation.  On the evening of 1/8/2021, client reported that twitching of left leg above knee area began.  Client able to fall asleep and when client awoke the next morning twitching was still occurring.  Twitching still occurring on 1/9/2021 and 1/10/2021.  Twitching was occurring less frequently on 1/11/2021.  1/12/2021 client stated that twitching no longer noticed.
This is my second pregnancy and at the time of my vaccination, I was 32 weeks 6 days gestation with an estimated delivery date of 2/15/21.  I tolerated the vaccine well initially with only a very minor sore arm the day after the vaccine. On 12/31/2020 (4 days after vaccination), I felt muscle fatigue around my hips and buttocks as well as significant fatigue. It seemed to improve over the course of the day and was not very noticeable for the next few days. On 1/4/21 (8 days after vaccination), my muscle fatigue in my hips, buttocks, thighs, and hamstrings bilaterally became very significant, preventing me from doing some activities that I had planned. I also had generalized fatigue. On 1/5/21, I had similar symptoms, but the muscle fatigue also began to include my shoulders bilaterally. 1/6/21, the muscle fatigue also included my neck and I was physically exhausted. 1/7/21 I started to note some improvement, and I also saw my OB who did bloodwork but also did suspect a possibly delayed reaction to my vaccine. Today (1/9/21) I am still experiencing muscle fatigue, but it does seem to be improved from several days ago.
mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a spontaneous report from a contactable Physician reporting for herself. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration, in left arm, on 07Jan2021 at 11:15 at single dose for COVID-19 immunisation. Age at vaccination was 32 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) was received via an unspecified route of administration on 21Dec2020 at 09:00 in left arm at single dose. Medical history included major depression, and generalised anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) and daily fusion multivitamin. On 08Jan2021 at 01:00 AM the patient experienced injection site soreness, feverish, headache, insomnia, restlessness, mild muscle aches. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.
62 year old patiet was accidentally given the high dose fluzone for those over the age of 65. No adverse events or outcomes known.
Pt developed several small hives on body approximately 2 hours post influenza vaccine. 1 on foot, 2 on knee, 1 on side of right hip. All approx  cm across with 5-7 cm red rash surrounding.
Information has been received from a physician concerning a 15 year old male who on 15-MAY-1995 and 24-AUG-1999 was vaccinated with the first and second dose of MMR II (LOT# not reported). On 13-NOV-2009, the patient experienced R parotitis, dizziness and was afebrile. On 18-NOV-2009 the patient experienced mumps. The blood work was done on 13-NOV-2009 and the results indicated IgM <1:10, IgG 4.31, and serum amylase 74. Follow up information has been received concerning a 15 year old (also reported as 14 year old) male who on 15-MAY-1995 and 24-AUG-1999 was vaccinated with the first and second dose of MMR II (LOT# not reported). On 03-NOV-2009 (previously reported as 18-NOV-2009) the patient experienced mumps. On 05-NOV-2009, the patient was afebrile and diagnosed with mumps. The patient had left parotitis. The blood work was done on 09-NOV-2009 and the results indicated IgM <1:10 and IgG 8.11. The results of the blood work on 24-NOV-2009 indicated IgM <1:10 and IgG 8.2. At the time of the report, the patient's outcome was unknown. No further information is available.
I don't know which flu shot I got, nor the lot number. As far as I know it's just the one shot, not a series. I don't know the Shingrix lot number. As far as I know, it's just the one shot, not a series. Very manageable pain at both injection sites. Pain began in back, in kidneys areas, then included chest, shoulders and neck. Most pain in central chest area. It feels muscular because acerbated by movement. No difficulty or pain with breathing, including deep breaths. Slight, occasional dry cough.
Information has been received from a Physician's Assistant concerning a female patient who in approximately November 2007, was vaccinated with her first dose of GARDASIL. After receiving her first dose, the patient experienced itching all over body for about a week. Medical attention was sought and the patient recovered. In January 2008 the patient received her 2nd dose of GARDASIL, and no reaction occurred. Additional information has been requested. 02/12/2010 Follow-up indicated that the office was unsure if the patient actually had a reaction to the vaccine. The patient did develop a rash but was still vaccinated with the second dose with no problems. Additional information is not expected.
1 of 9 pts immunized from same lot# 366949; not the same vial; who exp induration & poss erythematous nodule approx 2 inches in diameter @ the inj site; nodule persisted 6-8wks;
The medical assistant only admin. the liquid part of the shot not the powder . Medical assistant did not mix the two together.
Swelling, redness, inc warmth of the L upper arm (from shoulder to elbow). 1st noticed Fri. 3/28/03 (DTaP, IPV given in L arm on 3/27/03).
Rash with urticaria 1 1/2 x 2 cmm scabbing. Rash also macular papular on arm.
I95.9 HYPOTENSION 3/27/2023 BPH (BENIGN PROSTATIC HYPERPLASIA)
Child was given Flumist instead of injectable flu vaccine for 6-36 months; There were no adverse effects, but the wrong kind of flu was given for the wrong age, doctor said to report
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 05-SEP-2016, the patient was treated for a vesicular outbreak, which were diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Shortly after leaving the vaccination clinic my face felt hot and swollen and looked red across my nose. My throat felt swollen and itchy very quickly. I could breath fine so I did not seek medical attention. It lasted 15-20 minutes.
Small red area which spread to approx. 30% of my upper arm over next few days.  Faded within a week or so.  Hot and itchy (both minor).  Faded within a week to 10 days.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Seasonal allergies" (unspecified if ongoing), notes: Known allergies: Seasonal allergies; "Known allergies: tree nuts" (unspecified if ongoing), notes: Known allergies: tree nuts; "Carotid artery disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Familial high cholesterol" (unspecified if ongoing), notes: Familial high cholesterol. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Oct2021, stop date: 17May2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (28May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Antiviral Paxlovid was given from 18May2022 to 23May2022 for the Treatment of COVID-19.Patient finished the medication and tested negative. On 28May2022 she tested positive and got congested and fatigue again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
LOW GRADE FEVER; This spontaneous report received from a patient concerned a 66-year-old female of unknown race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included: crawling sensation, drug allergy to latex, abstain alcohol, and nonsmoker. The patient previously received covid-19 vaccine ad26.cov2.S (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown ) dose was not reported, frequency one total administered on 10-APR-2021 for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, frequency one total, vaccinated at left arm, administered on 19-DEC-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. On 20-DEC-2021, the patient experienced a low-grade fever. (Event occurred in Dose number in series 2). Laboratory data included: Body temperature (NR: not provided) 99 F.  Treatment medications (dates unspecified) included: paracetamol (Tylenol) overnight for the fever. Patient reported that while reading through the paperwork that they gave her at the facility, then mentioned that She had a strange sensation in the back of her neck when she was sitting by her computer that goes away when she stands but did not know how to describe it to her doctor. When she read the paperwork, she saw the crawling sensation in the skin, so that reminded her of that feeling that she had had but did not know how to describe it. She stated that she wanted to clarify that she did not have this crawling sensation after the booster. She had this strange feeling (Crawling/tingling) for more than 2 years from the time of reporting. It comes and goes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on 21-DEC-2021. This report was non-serious.
Pt developed blisters at the injection site (of MMR) two days after vaccine was given. She also had erythema/firmness at site. She was started on antibiotics pending culture.
Narrative:  79yo patient died on 9/24/2021. No info provided on pt's death. Pt had received covid vaccines on 2/14/21 & 3/13/21. Pt with med history of CAD, HF, AF CHADs2VASC 6 (age+2, TIA, HTN, CAD, DM), OSA, HTN, DM t2, History of esophageal strictures, & Remote History of TIA. Likely vaccines not related to pt's death given pt's age and length of time between date of vaccines given & date of pt's death.
1. Insomnia beginning 8 hours after injection, I was exhausted but could not sleep more than 20 minutes at a time, this went on for 48 hours. 2. Pain and hard disc of muscle at injection site, remained for 9 days, began 2/12. 3. Neck and trapezius muscles were hard for 7 days, began 2/12. 4. Stabbing pain under right shoulder blade for 9 days, began 2/12. 5. Right armpit lymph node swelling for 9 days, began 2/12. 6. Right breast tissue and adjacent lymph node swelling for 9 days, began 2/12. 7. Right armpit felt like sandpaper had taken off the skin, began 2/18 and still ongoing. 8. Could not raise right arm due to excessive pain for 8 days, began 2/12. 9. Shooting pain from shoulder to palm for 8 days, began 2/13. 10. Shooting pain from right elbow to palm became worse and more frequent 2/15 and lasted until 2/20. Intermittent periods of arm numbness and tingling. Could not use arm normally for 9 days. 11. Dull ache and throbbing from right elbow to palm began 2/20 and is still on going. 12. Right palm cramps and spasms began 2/13, ended 2/20. Dull ache in palm is still on going.  13. Chills beginning 2/12 and lasting for 48 hours with periods of intermittent sweating. 14. Excessive fatigue due to inability to sleep for 48 hours. 15. Headache beginning 2/12 and lasting 5 days. 16. Sore throat beginning 2/13 for 48 hours.  17. Lack of appetite beginning 2/12 and lasting for 5 days.
Course of time overall: 7 days Fever 101.4 degrees F: duration 30 hours Uncontrollable shaking/chills: duration 4 hours Body aches: duration 6 days Fatigue: duration 7 days Nausea: duration #1 lasted 4 hours within the first 24 hours. Duration #2 lasted 8 hours within the last 36 hours.  Dizziness: duration 6 days on and off.  No appetite: duration 7 days