chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 42 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the patient became aware of loss of smell and tested positive on 03-JUL-2021 (confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: COVID-19 (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210720833.; Sender's Comments: V0: 20210718648-COVID-19 VACCINE Ad26.COV2.S-  confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Fever, Nausea, Headache, Swollen lymph nodes in armpit, Fatigue, Redness in toes, Chills
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # was not reported) for prevent shingles. On an unknown date, 18 months after being vaccinated with ZOSTAVAX. The patient developed shingles on her face and contacted pharmacist. She was treated with an unspecified antiviral medication. The outcome of shingles on her face was reported as recovering/resolving. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: En6295), in left arm and on 19Apr2021 as dose 2, single (Lot number: Er8731) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Lot number: 033f21a), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dose:4, 3 Moderna/Dose:2, 1 Pfizer" (unspecified if ongoing), notes: Dose:4, 3 Moderna/ Dose:2, 1 Pfizer. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Negative; (11May2022) Positive; (10May2022) Inconclusive; (11May2022) Positive; (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Other medication in 2 weeks: No.  No follow-up attempts are possible. No further information is expected.
1) Experiencing delayed period. My cycle is fairly regular and should have started within a couple days of getting vaccinated. As of 3/30/21 I have yet to start my period. Experiencing bloating, swollen breast, fatigue. Pregnancy test taken today was negative.  2) Suffered a fracture of upper left humerus, neat vaccine site. Injury was sustained during a fall while downhill skiing and may be unrelated to the vaccine, but the fracture was at the same spot as my vaccination.
about 3 hours after injection, began feeling nauseous.  the next day at about 8 am temp went up to 102.4. took ibuprofen and temp finally broke about 4 pm that day. had injection site soreness for the first 48 hours then developed large red wheal that covered 3/4 of upper arm. still with red area when this report was filed on 12/28/2020
she had a terrible reaction to the 1st shot; Fever; Fatigue; Headache; Muscle pain; Chills; Vomited; Slept for 36 hrs; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 36 hrs), VACCINATION COMPLICATION (she had a terrible reaction to the 1st shot), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunoglobulins decreased (Immunoglobulins deficiency). Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPERSOMNIA (Slept for 36 hrs), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and VOMITING (Vomited). On an unknown date, the patient experienced VACCINATION COMPLICATION (she had a terrible reaction to the 1st shot). At the time of the report, HYPERSOMNIA (Slept for 36 hrs), VACCINATION COMPLICATION (she had a terrible reaction to the 1st shot), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and VOMITING (Vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication reported was Tylenol, but patient was unsure if she actually took it. PCP advised that she should be woken up frequently to drink water.   This case was linked to MOD-2021-250729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Updated information of one new adverse event, medical history and reporter contact details are added.
This spontaneous report was received via field employee from a female nurse in her 50's, referring on herself. On an unknown date, the patient was vaccinated with ZOSTAVAX (vial) dose reported as "standard" single dose, route reported as "injection" (lot number was not provided). No concomitant medications were reported. On an unknown date, reported as "within one day after receiving ZOSTAVAX", the patient experienced rash, redness and soreness around the injection site. Treated with acyclovir, the "anti-viral medication", the reaction improved "within a few days." On an unknown date, the patient was recovered. Additional information is not expected.
Information has been received from a physician concerning a 16 year old female with a history of humoral bone tumor who on 15-JAN-2008 was vaccinated with Gardasil.  On 16-JAN-2008 the patient experienced influenza-like symptoms.  She also presented with a painless nodule at the injection site measuring a few centimeters.  Subsequently, the patient recovered from influenza-like symptoms.  Neither fever, nor general signs nor adenopathies were observed.  The patient had not yet recovered from injection site reaction.  Additional information is not expected.
pt claims red & inflamed over whole bicep, & increased blood pressure (pt says she went to ER)
12 hours after the shot, extreme soreness in arm that felt like swelling and then numbing, extreme nausea and vertigo and chills, diarrhea, and blacking out. Felt like dying. Possible mild concussion. Had head wound for next few weeks. Felt okay within a day after.
probably killed my wife; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received bnt162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "probably killed my wife". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Pfizer is a nasty; vile; foul company that probably killed my wife since she was the only one in the household who had the Pfizer covid shot; but she died. We all lived. Reporter consider event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: probably killed my wife
swelling and pain at injection site, fatigue, headache, nausea, muscle pain, teeth chattering chills
Day 1 - sore left arm (anticipated) Day 2 - enlarged left axillary lymph nodes (anticipated) Day 3 - area of petechiae measuring 3 X 3 cm to medial aspect of right forearm (not anticipated) Note - Both parents experienced petechia which resolved on its own, following second dose of the Moderna vaccine.
I started having muscle spams in my legs especially on the left side. I had sciatica in my buttocks that radiated to the side of my leg to my ankle. It tires me out to walk from one part of house to the other part. It wakes me up in the middle of the night because I was in so much pain. I couldn't even walk because of the pain it was causing. I went to a masseuse about 4 or 5 times because it helps with the pain. The masseuse said I had knots all over my body. I cant stand still for too long because the pain would start. It has improved. I don't have the excruciating pain as I did before. I haven't been out to the mall or store because of it being too big to walk around so I am stuck at home. I took a medical leave for short term disability since January 2022 from my job. When I went to the doctor I found out that I have bone degenerative disease. The doctor said it's probably what's causing the pain. I was prescribed cyclobenzaprine and gabapentin. He is referring me to a neurosurgeon.
Vaccine dose #1 Moderna 03/01/2021 041L20A  pt currently has covid 19
Information has been received from a immunization coordinator nurse concerning a 26  year old female nurse in her office who on 18-JAN-2007 was vaccinated in the arm with a second dose of HPV vaccine (yeast). Subsequently the patient experienced "general achiness" throughout her body and swollen lymph glands.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  It was reported that the patient "did not respond like this" after her first dose of HPV vaccine (yeast).  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/24/2007. On 19-JAN-2007, the patient was diagnosed with strep throat. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. It was reported that the patient "did not respond like this" after her first dose of GARDASIL. The registered nurse reported that the patient's strep throat was not related to GARDASIL. No further information is available.
Information has been received from a healthcare worker concerning a 68 year old female patient with no pertinent medical history and no known drug allergies who on 21-MAR-2011 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667914/1067Z, expire date 28-FEB-2012), 0.5 ml, intramuscularly. The healthcare worker reported that on 23-MAR-2011s, the patient developed a 2 cm area of redness and swelling at the injection site after administration of the first dose of PNEUMOVAX 23. The patient also experienced low grade fever, chills, and achiness. The healthcare worker mentioned that the patient was examined by the physician via office visit on 25-MAR-2011 and 01-APR-2011. No treatment was given to the patient. There were no laboratory diagnostics studies performed. On 01-APR-2011, the patient recovered. This is one of two reports received from the same source. Additional information has been requested.
Patient admitted to hospital with Covid-19 detected PCR test. Per provider discharge statement, "This is an 83-year-old female who is a resident of skilled nursing facility.  Patient was sent to emergency department for evaluation of changes in mental status and behavior along with nausea, vomiting and diarrhea for last 3 days.  Patient recently tested positive for COVID at the facility.  She has had a generalized decline in her overall ability to care for herself and has reportedly been quite at her cognition and with development of the nausea and vomiting she was sent to emergency department for evaluation.  Arrival to emergency department patient was noted to be tachypneic with a respiratory rate of 24 and noted to have abnormal lung sounds on exam (rhonchi).  Patient was febrile with a rectal temperature to 101 ° F. repeat COVID testing resulted positive.  During the course of her stay in the emergency department patient's SpO2 dropped into the mid to upper 80s.  Patient was placed on supplemental oxygen.  Chest x-ray did not show obvious infiltrates.  Given her need for supplemental oxygen and meeting sepsis criteria hospitalist service is asked to see for further evaluation and management.    Hospital Course: No notes on file Sepsis due to COVID with hypoxic respiratory insufficiency- Back on RA. Continue remdesivir and steroids. Check CTA given rising ddiimer. Contine ppx dosed lovenox -She is vaccinated but has not had the booster.  -Continue Singulair and PRN albuterol. -she has improved clinically. Ok for discharge home in stable condition.    Suspected metabolic encephalopathy due to COVID-   Improved. Suspect exacerbation of her mild dementia by COVID."
When the needle was  being removed started shoulder pain from top of shoulder to the elbow. Got hot  all over from inside out, nausea , weakness,  chills  within first 2 minutes.  headache,  fast heart beat,  and tiredness.   Still chilling  and a small headache after 3  days.
patient experienced rash post vaccination. patient also has raised red welt on arm that is still present 1 week post vaccination and has not improved.  patient does report pain in the area but states that it is warm to the touch. patient continue to monitor for resolution and will update staff.  patient stated she took advil - for headache but did not see improvement in arm redness. patient declined medical attention from the emergency room today.
In April of 2023, I had a cold and on day 4 I had a sinus infection and ear infection and then it moved into my lungs.  I didn't really feel 100% for over a month.  I went to urgent care on April 3, 2023.  I was prescribed antibiotics for 7-10 days.  My symptoms got better but not completely better.  In May, I had symptoms again for my sinuses and then my lungs were affected.  I was tested for pneumonia with an X-Ray and it was negative.  As of today I feel like my ears are still messed up because my hearing is not right.  I also had a cough that took a few weeks to go away because of mucus that I was unable to cough up.
pt recvd vax 22SEP94 & 23SEp94 pt presented in sick call w/ either fever &/or a local or systemic rxn;sxs resolved p/several days;
Feeling very sick then had trouble walking. Died of a deep vein thrombosis and pulmonary embolism.
injection site itchy; injection site red; injection site rash; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE RASH (injection site rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, FUROSEMIDE, ALLOPURINOL, LEVOTHYROXINE, POTASSIUM, FAMOTIDINE, CLOPIDOGREL, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and LABETALOL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE RASH (injection site rash). At the time of the report, INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site pain, injection site erythema and injection site pruritus are consistent with the product safety profile.
SEVERE chronic hives. Require multiple doses of Benadryl and Zyrtec to subside. Still persistent until today.
Drug dose administration interval too long; Fever; Chills; Cough; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 11th February 2022, the patient received the 2nd dose of Shingrix. On 11th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced fever, chills and cough. On an unknown date, the outcome of the fever, chills and cough were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, chills and cough to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient reporter that it has been more than six since his first dose of Shingrix vaccine. The patient received his second dose of Shingrix vaccine and experienced fever, chills, and a cough that lasted about four months. AE (adverse event) filed. The patient reported that he was about to go on a trip and would probably wait until he returns next month and then get his second dose.  The reporter was given medical disclaimer. Referred to HCP (Health care professional). Spoke per PI (package insert) and content. Offered after call survey.  The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Approx. 8 hours later vaccine site started to itch, almost like getting a mosquito bite. Itch spread to other parts of the arm, (both) neck and some leg areas
PATIENT WAS ADMINISTERED MENVEO INSTEAD OF BEXSERO. PATIENT HAD NO REACTION, SHE WAS NOTIFIED IMMEDIATELY AND SHE WILL RETUN TO OFFICE TO GET RIGHT VACCINE.
On 2/7/03, 3 spots on his chest for 3 days. No fever.
Partial 6th cranial nerve palsy, causes double vision. No prior history of eye issues in 33 years.
Arm became very painful for about 2 days.  Then as the pain subsided it swelled up into a knot over the tricep area of the Left arm.  Grew red and began itching.  is starting to lighten up and not itch as much 7 days out.
Fever up to 103 starting 3 days after vaccinations. Decreased sleep; decreased appetite. Parents report heart beating harder. Called to be seen 6/8/06. While in office pt noted to have new onset heart murmur and hepatomegaly. Diagnosed with pericardial effusion. Pneumonia Rx with Rocephin then Augmentin.
lab values for HSV-2 were less than 0.9 values which is negative value; the male patient received ZOSTAVAX, then had oral sex with wife (unspecified date) and wife thought she had Herpes Simplex 2.; Herpes Simplex 2.; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unspecified date in 2019 (reported as recently), her husband was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, unit, batch/lot#, expiration date and route were not reported) for prophylaxis. On an unspecified date in 2019 (reported as recently), her husband had lip swelling and hives after received zoster vaccine live (ZOSTAVAX) (captured in MARRS# 1908USA008686).   Then She had oral sex with her husband on an unspecified date (Exposure via semen) and she thought she had herpes simplex 2. The patient was treated with valacyclovir hydrochloride (VALTREX). The patient's lab values for herpes simplex viruses (HSV)-2 were less than 0.9 values which was negative value. It was unknown if her lab values for HSV-2 were negative before or after treatment with valacyclovir hydrochloride (VALTREX). The outcome of events was not reported.  Causality between the events and zoster vaccine live (ZOSTAVAX) was not reported.; Sender's Comments:  US-009507513-908USA008686:
Chest pain, difficulty breathing, constricted throat, nasal congestion, dizziness, red skin, slightly elevated temperature and heart rate, hives, rash.
This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date about 12 months later, the patient received the second dose of GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as there was no consent to contact the reporter.
Child administered 0.5ml Afluria PFS (recommended for 3+ years) - child tolerated dose well, waited in clinic 20 minutes after vaccine administered with no reaction; vaccine administered at 1:36pm, mother contacted at 3:45pm of incorrect dose administered and child still tolerating well
just received my first vaccine shot yesterday today I'm starting to feel bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (just received my first vaccine shot yesterday today I'm starting to feel bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 FEELING ABNORMAL (just received my first vaccine shot yesterday today I'm starting to feel bad). At the time of the report, FEELING ABNORMAL (just received my first vaccine shot yesterday today I'm starting to feel bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.