chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her daughter (a 21 year old female) with diabetes as well as allergies to heat and penicillin who at 3:15 pm on 04-FEB-2009 was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL. Concomitant therapy included ATARAX, ADDERALL, NEXIUM and insulin. The patient had an anaphylactic reaction on 05-FEB-2009 (after 12:00 am). She was recovered on 05-FEB-2009. The patient received the first dose of vaccine on 03-FEB-2008. There was no reaction after the first dose. The patient did not seek medical attention. Additional information has been requested.  3/31/09 Office note received dated 2/5/09. Pt reported to MD that ~12 hrs s/p Gardasil pt developed ? tight throat and ? difficulty breathing. HPV series D/c.
Received Pfizer vaccine @ 10:00 am in my left arm.  Heart palpitations and headache started about 2 hours after vaccine. Took Tylenol around 3:00 pm because headache worsened.  Around 7:00 pm, I broke out in a red bumpy and very itchy rash around both ankles, with the worst being on my left ankle.  I took Benadryl and rubbed Cortizone 10 on the rash. Rash did not spread any further overnight, but heart racing continued throughout the night.  By 03/12/2021, I was no longer itching, but still had the rash.  Heart palpitations/racing was gone.
Vaccinee rec'd 3 doses Engerix-B or "RECOMBIVAX" so far titer is low; "may re-vaccinate.";
Started the day after the second injection.  Feeling very tired, most of the day.  Fall asleep on my couch. Flu like muscular pain in back and legs. Sometimes my legs feel very weak.  I will call my Doctor if I am not feeling better by tomorrow the 20th of April.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 30-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS-LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F -2.777777778 Celsius) for 672 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
It was a flu shot. I have been sick for 3 days. Heavy coughing, dizziness, headaches runny nose.
Rash and pruritic macular rash on chest, upper neck/back, axillae and. Diphenhydramine 25mg once, hydrocortisone 1 dab once.
3" x 5" red, swollen  and hot arm  (much more than any other vaccine).  After 3 days, still red, a little itchy.
Strong Headache, Strong Body Aches, Pain while urinating, heavy congestion and discharge, pain in various areas of my body which moved throughout the day (jaw, arm, etc), upset stomach
Woke up on 4/10/2022 (one day after receiving Janssen COVID-19 vaccine) feeling  mild to moderate Nausea,  mild fever,  moderate headache, muscle soreness (around injection site, upper back (left), and left side of neck). Lastly, experiencing a loss of appetite and mild anxiety.
(R) deltoid warm to touch, red began 10/7/08, 5 cm. Family reports area smaller today (note, found out client had pneumococcal vaccine in 12/16/04).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions were not reported. On 22-AUG-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Concentration, dose and route were not reported), lot # K020214, expiration date 25-MAR-2016. Patient's concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The outcome of welt associated with ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
6/6/2023 - 6/7/2023 (19 hours) Presented to the hospital generalized weakness. Patient elected to leave against medical advice.   030L20A 1/22/2021 039K20A 2/20/2021 939905 11/2/2021 FM7553 6/17/2022 generalized weakness and fatigue for the last 2 days with associated loose stools.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-APR-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
PERICARDITIS; This 65-year-old, Male, subject was participating in study.  The subject's medical history, as provided by the investigator, included intraocular lens implant (bilateral), skin cancer- squamous cell (left tonsil), tonsillectomy (left tonsil), and cataracts (bilateral). Concomitant medications reported included naproxen and naproxen sodium.  Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3) for SARS-CoV-2 vaccination on 04 Oct 2021, approximately 11 months, 29 days before onset of the event.  On 02 Oct 2022, the subject experienced pericarditis. It was reported that the subject was admitted and diagnosed with pericarditis. Per reporter, the diagnosis was not secondary to receiving the Moderna covid-19 vaccine. Treatment information was not provided.  The subject received all scheduled doses of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.   The event, pericarditis, was reported as resolved on 04 Oct 2022.  The investigator assessed the event, pericarditis, as not related to study drug and not related to study procedure.  Company Comment: This case concerns a 65-year-old, Male, subject with medical history of intraocular lens implant (bilateral), skin cancer- squamous cell (left tonsil), tonsillectomy (left tonsil), and cataracts (bilateral), who experienced the expected serious adverse event of special interest (AESI) pericarditis. The event occurred 2 years 1 month 19 days after the first dose of mRNA-1273 and 11 months 29 days after the third (booster) dose. The event was reported as resolved and was assessed as not related with study drug in accordance with the investigator´s assessment noting the long latency to onset. Further information was requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a Family Medicine facility for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Patient and parents presented with an email from the school nurse with a list of immunizations required for school admission with foreign transfer and foreign vaccine logs. The temp. MA reviewed the list of immunization required by the school nurse which appeared to be appropriate Pre-K vaccines, DTaP, IPV, and Varicella and administered them. When the VFC report was filled the vaccine was inappropriate for the age of the child as she was 7 and the error was discovered. All parties involved were informed and while the dose does not need to be repeated, VFC noted a report should be filed.
pt recv vax 29JAN96 & 12APR96 pt devel shingles, described as lesions on the rt side of sacral spine, rt buttock & rt leg;18APR96 pt recovered from shingles, which resolved on their own w/o tx;
her throat feels scratchy; allergic reaction; itchy dermatitis baby hives on the inside of her left elbow; itchy dermatitis baby hives on the inside of her left elbow; felt a strange sensation throughout her body; This is a spontaneous report from a non-contactable nurse (patient herself). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (left deltoid), on 20Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the first dose of the COVID vaccine yesterday, 20Jan2021. She experienced an allergic reaction two hours after receiving the vaccine and also experienced itchy dermatitis baby hives on the inside of her left elbow all on 20Jan2021. The vaccine was administered in the left deltoid muscle. Furthermore, when she walked away from the vaccination site, she felt a strange sensation throughout her body on 20Jan2021, but she was able to drive herself home. Her throat feels scratchy today 21Jan2021. With all this, she was concerned about receiving the second dose. She wanted to know if her symptoms have been reported and; if she should receive the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Right arm redness, swelling, itching, "welting"; treated with ibuprofen and Benadryl, looking a little better per mom on 09/06/2012.
Onset on 4/20/2021 of flank pain the day after his 2nd moderna shot. Was seen in office on 4-22-2021 with his wife for same and had early blisters in a dermatomal distribution on his right trunk - flank and RUQ.   Patient and wife hadn't seen the rash that morning when got dressed. Was treated for shingles.
Prior to dose being given, immunizations record was blank when reviewed in the electronic health record by the vaccinator. After dose given, while attempting  to make the next appointment, the electronic health record indicated that the patient had already received 2 Moderna doses previously (2/11/21, 3/11/21). Patient does not recall having received a vaccine previously.
T102F x 3 days p/adm; swelling fr hip to knee x 3 days pain & redness leg also; tx DPH & Duricef x 5 days by ER MD;
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Huge bright red rash. Itching that got worse over the next 24 hours. Painful to touch. Rash approximately 5 inches in diameter at injection site.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-SEP-2016, the patient was vaccinated with improperly stored dose of VAQTA lot number reported as: LN749, expiry date: 26-AUG-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
The day following vaccination the patient called the pharmacy to report the injection site area was warm, red, and swollen with injection site pain.  Patient was advised to ice the area, take an oral pain reliever/fever reducer if possible, and to call the pharmacy or seek medical attention if the symptoms worsen or do not improve over the next couple of days.
patient reported feeling itchy on the neck, back, and down the arms approximately 15 minutes after injection.
The next morning I woke up and my arm  at the injection site was a little sore which lasted about 36hrs and subsided on its on.  On 1/11 I thought I was developing a sinus infection because I began feeling real lousy.  I took a COVID test at home as protocol but it was negative.   Because I still wasn't feeling well I went to an Urgent Care and had another test and various other test performed but it too was negative.  I was prescribed a Z-pack and treated with Antibiotics and released.  At 10am the next morning the Urgent Care called back and advised I was in fact COVID positive, but was not a candidate to go to the hospital because my symptoms weren't bad enough to admitted so I am currently quarantining at home at this time.  This morning I woke up with a 101.9 fever and my blood O2 sat was at 84.  I reached out for assistance and two local reps came out  to my residence  this morning and check my vitals and theirs 02 sat read at 94.   I just received a call that I have now I am currently advised to take the GSK treatment and is currently awaiting to be transported to the Hospital to have that treatment as we speak
Injection site pain; throbbed/Ache; Chills; Joint pain; Muscle pain; Unable to walk; Feeling unwell; arm still tender; This is a spontaneous report from a contactable consumer reported for herself. An 83-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot Number EN6202, Expiry date not reported) via unspecified route of administration, administered in left arm on 01Mar2021 at 10:15 (at age of 83-years-old) as dose 1, single for COVID-19 Immunisation. Patient medical history include COVID-19 in Aug2020. It was unknown that patient had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient concomitant medications include ferrous ascorbate, folic acid (I 100) used for unspecified indication start and stop dates not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. On 1Mar2021 at 23:00 (12 hrs 45 min after vaccination), patient experienced Injection site pain, throbbed/Ache, chills, joint pain, muscle pain, Unable to walk, Feeling unwell for 2 days. Now 1-week later arm still tender. Patient did not receive any treatment for the events. The Outcome of the events was recovering   No follow up attempts are possible. No further information is expected.
experience itching on the left side of her abdomen; First BP was taken with a cuff that was too small; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a 62-year-old female patient that.  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration on 22Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that During her 15-minute waiting period after the injection, the patient began to experience itching on the left side of her abdomen. She denied rash, hives, difficulty breathing, difficulty swallowing and wheezing. Patient complains of itching of skin Treatment included: Had patient take her at home dose of Clonazepam 0.5 mg and Metoprolol 50 mg. She usually takes these at 5pm. Her BP improved with home medications. She denied itching on discharge, discussed taking antihistamine at home if needed for itching if it returns. First BP was taken with a cuff that was too small. BP greatly improved with larger cuff use. Follow up response to treatment: good. It was reported that patient discharge: Stable to go home and follow up with PCP. The outcome of events was recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.
Stated one of the ladies wasn't feeling well so I had her bring back to me. Patient c/o right arm tingling, sweating, itching, dizzy, confused ashen in color b/p taken 145/92; 11:30 .5 ml (500 mg) epinephrine given by right thigh 911 called b/p 165/112 hr 86 ems arrived 11:50 b/p 145/92 hr 82 patient said she had not  taken her B/P metformin this am random bld sugar 225 (she had a biscuit and coffee at 6:00 am. Patient refused and signed AMA consent to be taken to ER.
Blotches on arm and stomach area.  Macular/Papular rash over chest/back/arms and neck.
pt recv vax 730PM-8PM 9OCT98 approx 2-230AM 10OCT98 woke wife PM w/diff breathing to hosp )@ given approx 3hr of care in ER:
Seizures, starting on 5/3 with focal seizures occurring all day although I didn't realize that was what was happening, 2 tonic clonic seizures the following day. Symptoms may have started as early as 4/27 with some of the focal seizure symptoms. No head trauma, no family history of epilepsy, no illicit drug use. Seizures resolved with treatment with Keppra, one dose increase required to resolve all symptoms.
When pt awoke the next morning, she was developing fever and headache.  Fever got to 102. Pt then developed rash on the underside of arm and some swelling.  She went to the ER and was given IV Benadryl to alleviate the symptoms.
The patient was nervous about the shot, we asked her multiple times but she decided to get it. During waiting she started feeling nausea and like her heart was beating fast. We checked the HR and it was between 115-120 beats per minute. She then stated she was having trouble speaking, shaking, sweating. We called 911 and she was taken to local er where she had a panic attack.  Pt called later about asking to return to work and the manager on duty told her no.
Pt. felt weak, muscle soreness for 3-4 days two weeks after administration of Hep A and Hep B vaccines. Advised to see his healthcare provider.
Daughter was given TdaP,Hep B, Flu vaccine, Meningococcal, this same day at night developed huge hives. My daughter was put on Prednisone, I gave liquid BENADRYL,alternating ZYRTEC, BENADRYL cream and hydrocortisone cream.
pt recv vax 9MAY97 pt devel more serious rash 12JUN97 w/bumps growing together like hives around neck;
No adverse event; received expired doses of the Moderna COVID19 vaccine bivalent from the same vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided. This case contains information for the 1st patient out of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735212 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735212:Patient 2
Patient got itchy red rash 2 days after vaccine which has continued to todays date. 11/17/14- says it is improving now.
This spontaneous report was received from a physician refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was "presumably" vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) for hepatitis b vaccination (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient had hepatitis b titers drawn on which exhibited "low or non-existent level." The outcome of the event was unknown. The relatedness between the event and hepatitis b vaccine (recombinant)(manufacturer unknown) was not provided. Additional information has been requested.
About 2 weeks after shot, my back became covered with extremely itchy blister-like eruptions.  The same thing happened to me back in April of 2021 when I received my second Moderna shot.  I was uncertain then that it was connected to the Covid vaccine, but since it has happened again with the booster, and in the same time frame (2-3 weeks after receiving shot) I thought I should report it. It has been 2-3 days now since onset, and the blisters and itchiness seems to be receding.  As I recall, it took about 5 days for this reaction to go away back in April.  Anecdotally, when I mentioned this to my sister, she said her husband had a similar reaction to the Moderna vaccine.
It started with fatigue, headache, and sinus pressure. The symptoms gradually progressed over the course of two weeks until I had fever, racing heart, extreme fatigue, chills, and swollen lymph nodes in my throat.
Did not received another dose; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of incomplete course of vaccination in a 15-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (1st dose received on January 2023) and Pediarix (2nd dose received on 9th February 2023).   On an unknown date, the patient did not receive the 3rd dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incomplete course of vaccination (Verbatim: Did not received another dose).  The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter reported that the 15 months old patient missed a dose of Pediarix due to his or her mom no showed at a 1 year old appointment. The reporter stated that the patient did not had any symptoms. Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
for first 48 hrs. I was bedridden feeling: - Headache - Chills - Fever 100.8 - Nausea - Weakness  - Little pain at the injection , but nothing  - Weird part: little nose bleed after 24hr.  after 48 hrs-no symptoms