chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ashthma" (unspecified if ongoing); "severe allergies" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "brain issues" (unspecified if ongoing), notes: brain issues treated with Lamotrigine.; "autoimmune thyroid" (unspecified if ongoing). No known allergies reported. Patient received other medications within two weeks of vaccination as concomitant medication(s) included: THYROID; ARMOUR THYROID, start date: 01Dec2018, stop date: 06May2022; LAMOTRIGINE, start date: 01Jun2021, stop date: 06May2022; DULERA, start date: 01Jul2020, stop date: 06May2022; XOLAIR, start date: 01Jul2021, stop date: 06May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: COVID infection confirm with both rapid and PCR; (26Apr2022) Positive, notes: COVID infection confirm with both rapid and PCR; (02May2022) Negative, notes: Rapid test Negative on Day 7; (06May2022) Positive, notes: today again on Day 11/ Slight line on positive rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient took Paxlovid last around Day 2 of COVID infection confirm with both rapid and PCR. Felt wonderful after about a day, finished series. Rapid test Negative on Day 7. Started having symptoms today again on Day 11 that feel just like the beginning of the infection, chills, headache, nasal drips, slight sore throat. Slight line on positive rapid test. It feels like it was coming back, she have severe asthma and autoimmune thyroid and really scared.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A report was received from a health care professional on 11/19/03 concerning a male vaccine of unknown age who experienced total body aches, malaise, and fever after receiving Fluvirin on an unknown date. On an unknown date, the vaccinee experienced total body aches, malaise, fever, and was bedridden for 4 days after receiving Fluvirin. This was the first time the vaccinee had been exposed to the influenza vaccine. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/23/03: An update report indicated that the vaccinee was a 56 year old male who experienced severe muscle, ligament and bone pain, a temperature of 102 degrees, extreme pain in the eyes with headache which lasted for 5 days and muscle pain, fatigue, and weakness which lasted for 4 days after receiving Fluvirin on 10/10/03. No follow up pending.
ERRONEOUSLY ADMINISTERED 1 ML DOSE; This spontaneous report received from a health care professional concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced erroneously administered 1 ml dose. The action taken with covid-19 vaccine  was not applicable. The outcome of erroneously administered 1 ml dose was not reported. This report was non-serious.
Fever of 101.8, Chills, Nausea, Body Aches, Right side of head and face hurt, Arm red and sore.
This spontaneous report as received from a pharmacist refers to a 75 year old patient of unknown gender without known drug allergies. On 13-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L026033 exp 27-MAR-2017, intramuscular. At an unspecified time post vaccination (November 2015), the patient experienced muscle pain in arm and was unable to lift their arm. At the time of this report, the outcome of paresis and myalgia was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
7/15/03 at 11:10 rash, hives no fever no other symptoms given Zytec 2.5mg po at 11:15. Pt sent home.
C/O weakness, dizzyness, nausea, and heart pounding ~30 minutes after shot given.  Shot was given at outside clinic.  Client presented to Public Health office 2 hours later were PHN took vitals.  BP and Pulse above normal range.  Advised to see Primary MD.
Dizziness, fatigue, worsened tinnitus.  Dizziness and fatigue lasted continuously for about 5  days then lessened but still recurs occasionally.  Pre-existing tinnitus has become more pronounced after receiving vaccine.
PATIENT DEVELOPED GIANT HIVES BILATERALLY ON LEGS AND TORSO, SIX HOURS POST INJECTION OF DOSE NUMBER TWO OF INFLUENZA VACCINE.
48 hours after vaccines, child developed redness, mild swelling and small area sloughed skin at injection sites on left thigh. Redness extended to lower leg and many pinpoint vesicles were present over entire leg. This was non-tender and patient was afebrile. Placed on Keflex PO then 12 hours later on IV Kefzol with significant resolution after 2 doses IV. The follow up states cellulitis of both legs.
Generalized (L) arm discomfort after vaccination on 10-15-10. Nov 6th noticed lump to (L) posterior Humerus. Went to MD Nov 17th - X-ray revealed nothing. Ultrasound on 12-3-10 of lump to (L) Humerus. States that difficult dressing and (L) arm. Pain causes her to "go to her knees". No treatment from MD. Dx with residual swelling from flu shot.
Arrhythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Arrhythmia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took  vaccine in March and experienced an Arrhythmia. Patient reported to VAERS and all the information needed was in VAERS.  Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.  This case concerns a male patient with no relevant medical history, who experienced the unexpected event of arrhythmia. The event occurred in March 2021 after vaccination with Spikevax, it is unknown if it is first or second dose. . The rechallenge was unknown, as there is no information that states vaccination date or dose number and there is only one dose reported. The benefit-risk relationship of Spikevax is not affected by this report. Event arrhythmia was automatically upgraded as a Serious event as per RA list and kept as serious as per medical judgement, despite it was reported as non-serious. No further information is expected as the patient did not authorize follow-up.; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected event of arrhythmia. The event occurred in March 2021 after vaccination with Spikevax, it is unknown if it is first or second dose. . The rechallenge was unknown, as there is no information that states vaccination date or dose number and there is only one dose reported. The benefit-risk relationship of Spikevax is not affected by this report. Event arrhythmia was automatically upgraded as a Serious event as per RA list and kept as serious as per medical judgement, despite it was reported as non-serious.No further information is expected as the patient did not authorize follow-up.
headache body ache fever tight chest for 4 days, and dull headache that will not go away now three weeks later.
Information has been received from a physician concerning a 3 year old patient who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the patient developed a varicella rash after being vaccinated a few weeks prior. The rash consisted of about 10 lesions. The reporter noted that the patient's day care requested a note from him regarding the child's contagiousness. Unspecified medical attention was sought. Follow up information was received from the physician indicating that he did not have the patient's name. The reporter also noted that he did not place this as adverse reaction, i.e. rash. No further information is expected.
Recieved Hep B #3 on 9-24-02 late afternoon.  Redness, swelling (shoulder to elbow), 1st noted around 3 AM on 9-25-02. C/O discomfort locally (R arm)
Patient requested her first Shingrix vaccination of the series, which led her to spike a 102 fever, redness and swelling of the arm, and muscle aches approximately 12 hours after. Patient also described tingling of skin when anything touched her. Patient contacted PCP who advised her to continue to hydrate and contact pharmacy where immunization was administered to report adverse event.
Last time I got the flu shot I was sick 5 days; Initial information regarding an unsolicited valid non-serious case received from a consumer via Social Media and transmitted to Sanofi on 10-Oct-2020.  This case is linked to case 2020SA294157.  This case involves patient with unknown demographics who reported last time i got the flu shot i was sick 5 days (illness), while he/she received vaccine influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose  of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On an unknown date, (latency unknown) the patient reported last time i got the flu shot i was sick 5 days (Illness) after the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
STARTED WITH RUNNY NOSE, COUGH WITH PHLEGM WHICH WAS YELLOW IN COLOR. BY 2 DAYS LATER, CONT. WITH FATIGUE, FEVER OF 101.6, THEN DOWN TO 92.4 F AFTER TAKING EX STRENGTH TYLENOL. WENT TO ER ON 11/17/16, HOSPITALIZED FOR 5 DAYS.
Very sore arm, low grade fever (99.8-100.8), aching all over, severe pain in armpit, pink blotches where pain is worst (but not at injection site). It's now 2 days later and no change.
Patient presented to medical provider to receive MCV4 and TDAP for school. Patient and mother were sent to the infusion center and he was given 1 vaccine and told to get the other one in the pharmacy. Mother brought patient to the pharmacy and stated that he had just gotten meningococcal vaccine but still need his TDAP. Adacel was prepared and administered. The next day another parent called asking if the pharmacy could administer MCV4 because the infusion center informed her they couldn't order. Pharmacist then realized that he may have received two doses of TDAP. Upon further investigation, it was discovered that he did indeed receive two Adacel vaccines. Pharmacy called the family practice manager and infusion center to confirm then proceeded to inform the patient's mother.
This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on unspecified dates an unspecified number of patients were administered more than the recommended doses of PNEUMOVAX 23 INJ in a shorter time period than recommended in the prescribing information. Additional information has been requested.
I had patient report that she had localized swelling and lymphadenopathy.  I confirmed this on physical exam.  She had localized increased warmth over the left upper outer arm where the vaccine was given at the deltoid.  There was a raised area of skin in a serpiginous pattern circumferentially 3.5 across and 4.5cm in length.  It was blanching and not firm. She had 1 soft lymph node palpable at the left axilla, tender and 1.5cm in size.  She has had no other symptoms other than pain at the injection site for 2 immediately days after the injection was given.  I advised that she fill out the information for v-safe and asked that she report any further program to both v-safe and our office.
On July 17 in the middle of the night I woke up with severe pain under my belly, I went to the restroom and I had flood coming out instead of urine. I went to the ER where they did a CT scan, administered antibiotics, took a urine sample. The results came out as a mixed culture. They had given me Keflex which I finished. The symptoms returned within a week after Keflex was finished, this time I contacted my OB/GYN andThey wrote another urine test and gave me Nitrofurantoin. The results were the same as last time and there was no clear sign of a UTI at all. After 2 weeks that the antibiotics were done, My skin started to get severe rashes All over and I also got hives. I went to see my dermatologist and he said that It?s because of my body?s reaction to an infection that I?m getting this. So he?s put me on three anti-histamines.
On 10/23/15, patient received influenza vaccine in the left deltoid area. The vaccine was given in the left deltoid. Patient reports (via translator) that a few hours after the vaccination she developed the following symptoms: persistent pain in her left arm radiating up and down from elbow to neck. Denies numbness or tingling in arm or hand. Denies similar pain in the past. Pain is "bone-like" in nature and not relieved with OTC pain meds. Also reports left middle finer is flexed towards palm of hand every morning. Patient returned to Wellness Program on 11/20/15 to report the above symptoms. She states that pain is limiting her ability to perform her daily personal and work activities. She reports a history of back pain due to an accident and also history of arthritis "throughout her body". Patient received the Vaccine Information Statement on day of vaccination and signed a consent form as per Wellness Program's standard policy. On 11/20/15, patient was examined by RN. There was no visible redness, swelling, lumps or striations at left arm injection site. Left forearm did have 2 nickel-size bruises (patient reports she gets these bruises spontaneously on arms and legs). Active ROM of left arm limited to 45 degrees. Patient was referred to Hospital for evaluation of left arm pain with the plan for Wellness Program to call her next week for follow-up. Follow-up call to patient 11/24/15 was made. She reports she went to ER on 11/20/15. She states she received an injection for pain but it did not relieve the pain in left arm. The ER staff referred her to specialist for further evaluation.
Approximately 9:45 am employer of patient came to our medical window reporting patient had returned back to work after immunization and reported he had blacked out and woke up in the field across the street from here. Employer bought patient back here and this nurse along with another RN went to parking lot to assess patient. Patient noted to be in passenger seat of truck with head reclined. Patient alert and oriented. Color good. Skin/lips pink. C/O nausea. Patient tearful. Patient states he felt fine after immunization was given. Had reported that he has history of passing out when giving blood with last episode 2-3 years ago. Patient reports he never had any episodes with immunizations. Patient declined going to private room with a bed for immi. Patient given Tdap in left deltoid with no issues noted/reported. Patient stayed in facility after immunization approx. 5-6 minutes with no complaints. Stated that that "was the easiest shot I have had." Patient left denying issues/complaints. Patient reported to this RN that after he walked out of here, he jogged to his truck, got inside and became nauseated and sweaty. He said he sat in truck and drank a pop. Patient states he thought he was in park, but the next thing he remembers is "coming to with his head bumping left drivers window and he was in field across the street from us, behind the radio station. Patient states, "I should have come back into the office when I started feeling bad." Patient states he drove back to work (close to here), but doesn't remember doing so. Employer states he saw patient lying back in truck and patient told him what happened. No injuries noted or reported by patient. No injury to head noted/reported. Patient states he ate prior to immunization. Patient instructed to go to ER/Urgent Care for evaluation. Patient states he wasn't going to go. Told patient this RN would call tomorrow for follow up. Patient verbalized understanding. No damage to vehicle noted/reported. Employer to drive patient back to work site and wife meeting patient there.
pregnant patient was administered Fluzone QIV, with no reported adverse event; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from consumer/non-health professional.  This case involves a 28-year-old pregnant female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] on 30-Sep-2021 (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported pregnant patient was administered Fluzone QIV and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 23 weeks of pregnancy, during second pregnancy trimester.  The date of last menstrual period was 22-Apr-2021.  The estimated due date is 30-Jan-2022.  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 medications and family history were not provided.  On 30-Sep-2021, the patient received a dose 1 (0.5ml) of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: VT7325JA; expiry date: not reported; form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-SEP-2016, the patient was vaccinated with properly stored expired dose of PROQUAD (lot # L009209, expiry date: 17-SEP-2016), (route: subcutaneous) (expired product administered). No adverse reactions reported. The outcome of the events was unknown. Additional information has been requested.
No adverse event. I am reporting a vaccination error. Moderna vaccine was accidentally given instead of Pfizer as second dose. On 7-19-21, two patients came in for COVID vaccines. The technician did the paperwork for both while I was on the phone with patients and gave the consent forms to me (the pharmacist) while she went on to help other people. I called the name for patient 1, but patient 2 answered. Confirmed name and date of birth of patient 1 with patient 2, and he acknowledged both. Believing him to be patient 1, I went over information on the second dose, confirmed I would be giving the Moderna vaccine, and gave him the vaccine. After the vaccine was given, patient 2 had a question on the name of the vaccine given. Went over the paperwork and vaccination card of patient 1 with him thinking he is patient 1, confirmed with him that he is getting the same medication as last time while pointing out the vaccination card to him showing both doses as Moderna, and he continued to agree. Gave patient 2 the receipt and vaccination card of patient 1 after going over them with him and he left. Did not realize until called patient 2's name and patient one said that was not him. Apologized to patient 1 and informed him of the situation, as well as telling him that patient 2 does have his receipt and vaccination card. Gave patient 1 his vaccine and a new receipt and vaccination card. Spoke with the technician, who agreed she had overheard me confirm name and medication with who we now know is actually patient 2. We had believed that patient 2 could speak well enough, but just to be sure I had the technician call patient 2 to have him come back and then translate for him in Spanish and explain to him the situation as well as apologize for the misunderstanding. Patient 2 acknowledged his understanding but said in Spanish that the printed name on the vaccination card was too small so he didn't realize it was not his. Had patient 2 return patient 1's documents. Did some research and explained to him that even though now we know that his first dose was Pfizer and he was given Moderna for his second dose, the CDC does not recommend repeating the dose. Explained to him possible side effects to watch for with getting the second covid vaccine, and discussed with him that if more data comes out in the future on booster vaccines he might consider getting it. Patient said that it is okay and left with his updated vaccination card. No adverse effects that we know of.
Patient developed fever, decreased appetite and lethargy the day after vaccination. Eventually, was admitted for IVVD and fever.
Case number PHEH2014US025103 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 75 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46049 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.