chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having overall exhaustion March 8, 2023 followed by a low fever with some extra congestion. Over the next few days my symptoms progressed till I didn't have any energy at all. The severe congestion persisted for five days. The low fever lasted for ten days. Around March 20,2023, I started feeling better. On March 21, 2023, I started having a fluttering sound in my right ear. My doctor said I had a virus that attacked the nerve that attacked my ear drum. That lasted about three weeks. Accompanied with the fluttering, was a low fever that would happen only during the evenings. I still had extreme exhaustion that lasted till April 9, 2023. I took over the counter treatments such as Tylenol, Mucinex, and Ibuprofen.
3 weeks after I got the PCV 13 shot I was in the hospital 6 days with streptococcus pneumoniae. I coughed up thickened blood for about 30 min. before going to emergency room. They didn't diagnose it immediately and ready to send me to Hospice care!
pt recv vax & approx 24hr post vax pt exp welts, then stiffness, some form of kidney impairment & subsequently jaundice as of 19OCT95;MD visit was required;treated w/a steroid cream;sx persist;
Chills, fever, numb hands, tiredness. All started about 12:45 same day as the vaccine.
Dizziness and Extreme weakness (to the point walking was difficult) Numbness Burns Muscle pains Mental foginess
HPV vaccine ((L) deltoid) administered as well as influenza vaccine ((R) deltoid) on 1/21/13. Reported (L) arm soreness and generalized fatigue within hours of administration. Positive vomiting episodes 1/22/13 am, positive nausea. Mother recalls vomiting episode after HPV dose #1.
Dysautonomia symptoms that I have not experienced in over a year have been triggered once again. The Moderna booster shot seems to have re-triggered the dysautonomia symptoms. I have been quite sick since the booster. I have headaches when upright, fast/high heart rate when upright, dizziness, cannot catch breath/shortness of breath, some neuropathy (in legs and left hand) and fatigue.
Patient received 3rd dose of twinrix on 08/26/2023 after receiving their 2nd dose on 08/16/2023. Patient has not reported any adverse events at the time of submitting this form.
inadvertently given 0.3ml of 5-11 vaccine (50% additional dose) followed 2 weeks, no adverse events
Headache, Myalgia, CoughWheeze & UrticariaPruritus Narrative:
pt.recvd. vax & developed lymphadenopathy,arthritis,& petechial rash.
"Moderna 042L20A Exp 7/5/21, First dose, L arm  Administration time 08:30 Reactions start time 08:35 Symptoms: Hot, Flushed, Nausea, Burning sensation to shoulders, back of neck.  No rash or redness noted at that time.  Previous reactions/allergies: Avocados, Pistaccios however did report with last flu vaccine had redness, warmth and swelling.   08:40 122/82, 100, 98% Increased nausea   08:50 121/79, 95, 98% Nausea improved   09:00 110/75, 83, 100% No nausea, continued burning to upper shoulder, back of neck.   09:15 145/91, 100, 99% Increased burning up back, neck, pt sat up and had increased dizziness, slight frontal Headache, Rash noted to R inner arm and L arm. Slight sensation of tightness in swallow.   09:18 25 mg Benedryl PO  09:30 135/85, 85, 100% Palmer surface of hands flushed. Increased nausea, increased dizziness.   09:45 Up to the bathroom.   09:50 126/84, 88, 100% No change   10:00 125/85, 86, 100% Continued bilateral upper extremity rash and dizziness. Benedryl 25 mg PO given  10:15 124/82, 77, 95%  Increased warmth at back of neck and shoulders. Contacted primary care provider and arranged for appointment today.   10:25 124/83, 85, 100% No change   10:40 Waiting for spouse in Waiting area with RN at side, increased heat sensation to back of neck and shoulders. Stated that she just did not feel right.   10:45 Ad Rep and Lead RN to evaluate.   10:50 Transport to the ED with RN and Rep.
left deltoid injection site pain, reports of not feeling well, chills, body aches, fatigue
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 112 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
soreness @ inj site that has, not gone away;cont to be sore & spreading to entire arm, chest, & legs;all over body soreness;occasional fever, flu like sx;hard time walking now;
PERSISTENT COUGH; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (Pfizer) concerned a 35 year old female. Initial information was processed along with the additional information received on 23-DEC-2022.  The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. Patient had no other illnesses. The patient had not received any other vaccines within 4 weeks or any other medications within 2 weeks prior to the covid-19 vaccine. Patient had never before prior to the vaccine had an issue getting over a cough. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 15-DEC-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 34 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient also received dose 2 with non-company suspect vaccine Pfizer Biontech Covid-19 Vaccine (tozinameran), (Dose number in series 2), (batch number: GJ6665 expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 06-OCT-2022 to left arm deltoid for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 2). On 04-NOV-2022, Since getting booster shot patient had developed a cough (persistent cough), (Dose number in series 2) and had been treated with antibiotics, advent inhaler, albuterol, breathing treatments, and cough medications and her cough was not going away. On 09-DEC-2022, Laboratory data included: COVID-19 virus test Negative. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from persistent cough, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000264514.
Started taking Paxlovid 18Jul for 5 days. Tested negative 25Jul Tested positive 28Jul; Started taking Paxlovid 18Jul for 5 days. Tested negative 25Jul Tested positive 28Jul; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose number unknown, single (Lot number: EL9264) and on 07Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve repair" (unspecified if ongoing), notes: Other medical history: Mitral valve repair 20 years ago.; "High BP" (unspecified if ongoing), notes: Other medical history: High BP. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Started taking Paxlovid 18Jul for 5 days. Tested negative 25Jul Tested positive 28Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (25Jul2022) Negative, notes: Tested negative 25Jul; (28Jul2022) Positive, notes: Tested positive 28Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date. Antibody testing completed.
Case number PHEH2014US022762, is an initial spontaneous report received from a pharmacist on 07 Nov 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on unspecified date (reported as year ago). It was reported that, she presented with hives or spots all over her body, including throat. It was also reported, that her body was totally in pain and ached all over. The outcome of the events was not reported. Reporter did not assess the seriousness. Seriousness assessment of the event urticaria was upgraded based on information available in source document. Causality of the events was not reported.
Pt recv vax on unknown day; post vax pt exp transient numbness and could not walk for a few hr This is a follow-up to report (s) previously submitted on 1/25/99. Informaiton has been received form a physician concerning a 11 month old male patient with recent otitis and BACTRIM allergy who on 01-DEC-1998 was vaccinated with a third dose of COMVAX vaccine IM. Concomitant vaccination that same day included the first dose of VARIVAX vaccine (MSD) SC. That same day, the patietn experienced "transcient numbness and couldn't walk for a few hours." There was no locala tenderness, erythema, or swelling noted. Later that day the patient awoke crying from his nap. The patietn sought unspecified medical attention. On 02-DEC-1998 the patient recovered form his experiences. It was reported that another patient had a similar experience (WAES#98121251). No further informaiton is available.
starting on 2nd day after the shot, right side of torso become soar and the skin in that area became somewhat tender as if there was a rash.  Then on the 3rd day, a few small pimples showed up in that area, near the belt line.  Then on the 4th day, the pimples started to look more like a rash.  Then on the 4th day the rash became raised and looked more like boils.  On the 6th day, I went to the doctor and they believe it is shingles.  Started antiviral treatment for shingles on the sixth day.  This entry is being made on the 7th day, one day into the shingles antiviral treatment.  Never had shingles before.  Also, migraine headache started on the 7th day, but this is not uncommon for me.
This spontaneous report was received from a registered nurse refers to a 4-year-old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the four year old patient was possibly vaccinated with one dose of GARDASIL 9 (lot# and expiration date unknown) (product administered to patient of inappropriate age). This was not a product confusion. No adverse effects were reported.
1. left arm soreness, started ~8 hours after injection, lasted 48-72 hours after injection. Treated with tylenol, message 2. left axillary lymphadenopathy, started about 24 hours after injection, lasted about 5-6 days after injection 3. muscle aches, started about 16-24 hours after injection, lasted about 36 hours after injection, treated with tylenol, rest 4. nausea (mild), started about 16-24 hours after injection, lasted about 36 hours after injection, treated with bland diet, hydration
Patient developed rash on hands and feet one hour after vaccine administered. Benadryl 25 mg po and Tylenol 650 mg po given.
had both shingle shots and he got it anyway/ Suspected Vaccination failure; had both shingle shots and he got it anyway /it wasn't a real bad case; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient received both doses of Shingles vaccine and got shingles. The reporter stated that at least it was not a real bad case. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Covid-19; mild discomfort from the injection site; tired; fever of 102F; headache; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program,. A male patient of an unspecified age (age: 55; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history included exposure to COVID-19 on 26Feb2021. Concomitant medications were not reported. On 26Feb2021, a week prior to the patient's first dose he was in contact with someone at work who tested positive for Covid-19. The patient received the first dose of the vaccine 1 week ago on Friday, 05Mar2021. He had mild discomfort from the injection site, was tired, and slight fever Sunday 07Mar2021 figured it was from the vaccination. The patient had fever of 102F on 08Mar2021, and headache (date unspecified) and was taking ibuprofen but it only helps until he has to take the next dosage. The patient tested positive on 10Mar2021. The reporter (patient's wife) asked if the patient should get the 2nd dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
TTP (hemolytic anemia , thrombocytopenia with negative Coombs , high ldh and retic counts ) all testing rules out everything else and alluded to the vaccine . Confirmed by oncology clinic.
Redness around injection site 27mm x 30mm.  Right thigh lower - no treatment received.  Physician advised and looked at it.
8-6-10 day of injection pain at injection site. On 8/7/10 very painful swelling the color was red to purple and very hard to the touch. On 8/8 and 8/9/10 swelling and numbness that radiated down to the elbow. 8/10/10 swelling minimal no redness but still very painful and still experiencing numbness of upper arm.
no adittional AE; had missed Brand Name GARDASIL doses specific to the Brand Name GARDASIL dose series; This spontaneous report as received from a pharmacist refers to a 9-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.   Approximately in 2009 (reported as 12 years ago) the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (route and dosage information were unknown) for prophylaxis.   At the reporting time, the patient had not received the other doses for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (inappropriate schedule of drug administration). No adverse event was reported.
On 1/10/11 had immunizations. (R) leg at immunization site became red, edematous, and firm.
Patient felt pain at injection site. Pain has persisted for 2 weeks. Her PCP recommended a warm compress and that only provided little relief.  Pt has bruising and a "knot" at injection sie. Tingling sensations down the arm and above the shoulder. Patient also complains of stiffness in neck at both sides.
Right deltoid, red, warm to touch. Swollen, raised, 6cm x 3cm.
Patient felt like he was paralyzed. He could not move at all. His wife had to help to move him to bed. This lasted throughout the night. Even now a week later patient feels week and has no energy.
vial administered more than 12 hours after it was first punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial administered more than 12 hours after it was first punctured) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial administered more than 12 hours after it was first punctured). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vial administered more than 12 hours after it was first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  On 02-Sep-2021 at 1:20pm, The vial was first punctured. It was removed from the refrigerator two times for about 10 minutes each time. The vial did not undergo any previous excursion. The vial stored post puncture on Fridge.  Patient has not called to report any adverse effects  No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up information include secondary reporter, expiration date added and narrative updated.
Received call from patient parent. Patient died on Friday September 21st in the ER. Limited details available. Believe autopsy is pending.
Pt c/o itching and rash from neck down to thighs for 3 hrs. Itching subsided, redness still present 48 hrs later. BENADRYL relieved itching. Denies any respiratory problems.
This case was reported by a physician and described the occurrence of an injection site reaction in a patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The physician reported that 2 patients developed the exact same reactions following the administration of Infanrix, however, patient identifiers were not provided.  On 12/27/2004, the patient received a dose of Infanrix in the left leg.  The physician stated that the patient received a booster dose of Infanrix, however, the dose number was not provided.  Approximately 3 days following the administration of Infanrix, on 12/30/2004, the patient experienced an injection site reaction characterized as swelling and redness.  The patient was seen at the physician's office.  The physician recommended cold compresses and observation.  The injection site reaction resolved on an unspecified date on or before 01/03/2004.  The reporting physician considered the injection site reaction to possibly be related to vaccination with Infanrix.
Very large hive at the shot site.  Continued to grow in size until several doses of allergy medication were taken. Hive is no longer warm to the touch and has started going down in size.
6hr p/vax devel hives, throat, congestion, dizziness, diarrhea;rx oral claritin 10mg, DPH, prelone;
Tinnitus; continual loud buzzing in ears.  Continuing as I write today 6/10/2021.
2:30 am the next day, I woke up and I was shaking violently and I was freezing! I touched my cheek and I had a 104 temp. I couldn't move my limbs. I was immobile. Sick all night. Saturday I had diarrhea and vomiting and fever. Body aches. Large lump where I got the vaccine and it was hot and red to the touch at the injection site.
Initial unsolicited report received from a nurse on 19 October 2015. This case involves a [age 11 or 12] female patient who was vaccinated with a [route and dose in series were not reported] single dose of FLUZONE QIV MULTI DOSE VIAL (batch number, expiry date and site of administration were not reported) on an unspecified date. The medical history and concomitant medications were not reported. On an unspecified date, few seconds following the vaccination, the patient felt uneasy. On an unspecified date, few minute following the vaccination, the patient turned pale and had the sensation of passing out. It was reported that, after 30 minutes patient still felt like passing out and her face was tingly. Lab data was not reported. Corrective treatment was Benadryl and Solu-Medrol. The outcome of event was recovering (patient began to feel better). List of documents held by sender: none.
by mistake gave a female patient 17yr old Ipol 0.1ml instead of the Tubersol test, Patient has had 4 doses of polio vaccine as a child/ NO AE; by mistake gave a female patient 17yr old Ipol 0.1ml instead of the Tubersol test / NO AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old female patient who received 0.1 mL dose of vaccine IPV (VERO) [IPOL] lot N1K92, Expiry date- 14-11-2019 via unknown route in unknown administration site instead of TUBERCULIN TEST [TUBERSOL].  Patient has had 4 doses of polio vaccine as a child. No other vaccines administered. The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to Wrong product administered and extra dose administered. Nurse by mistake gave a female patient 17years old Ipol 0.1ml instead of the Tubersol test today.  No specific symptoms are being 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 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.  Documents held by sender: none.
Patient has experienced muscle and shoulder pain following the immunization. He has had to seek medical treatment from his primary doctor and now an orthopedic
Pt very lethargic for 48 hours after receiving PREVNAR 13. On third day developed rash. Swelling and erythema at injection site as well as hard nodule. Rash and itching continued down arm to elbow and continues for 7 days even with pt taking BENADRYL.