chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from the mother of a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with GARDASIL 9 (route, dose, and lot # not provided). The mother reported that her daughter experienced seizures after receiving GARDASIL 9 (she did not provide the onset date). The mother requested information on how long the seizures her daughter experienced with GARDASIL 9 were supposed to last and what she could do to reverse the effects. She also stated that it was unacceptable for children to be given GARDASIL 9 while knowing it can cause seizures and that it should be mentioned in the pamphlets and brochures. The mother stated she has contacted her lawyer. The outcome of the seizures was not recovered. Causality assessment was considered related. The mother commented on a potential lawsuit that she saw on television regarding "thousands" of patients who experienced seizures or died after receiving GARDASIL 9 (see case # 1807USA012762). This is one of two reports from the same reporter. Upon internal review, seizures were considered medically significant. The reporter did not provide any contact information or consent to be contacted for follow-up.
Okay so it started on the June 23rd 2021, I remember vividly because it was the day before I was supposed to take my sister out for her birthday and I could not. I first experienced a sore throat and aches throughout my body. Then on the 24th of June I continued developing the aches and checking my temperature, it got worse throughout the day. I canceled my plans on the 24th of June, the illness invaded me quite quickly. On the 25th of June I had the fever, was coughing up phlegm and was just not feeling well. I took my own cough syrup and such for the day and then it still continued, a lot of chills and headaches and even my neck was swelling a lot, my temperature got to about 101. I got a bit concerned because my neck was very swollen and under my neck I could feel my glands were very inflamed so I made an appointment to see my primary DR on June 30th 2021. He examined me and he said it seemed as though I had a cold, he put me on antibiotics, levofloxacin, and told me to rest and hydrate. He told me to alert him if anything got worse. I got better, but the neck inflammation and headaches are still present. I just wonder about the continued swelling and headaches so that keeps me concerned. I have a virtual appointment with my DR soon.
The day after his booster vaccine, he began to complain of his face not feeling right. His parents noted his face appeared asymmetric. He was seen in our office this morning and diagnosed with left-sided Bell's palsy.
no known adverse effects; On 17-APR-2019, a patient received a dose of proquad and a dose of varivax; This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 17-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) via subcutaneous route (strength, dose, lot# and expiry date not reported) for prophylaxis. On the same day, other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiry date not reported) for prophylaxis (inappropriate schedule of product administration). No known adverse effects (no adverse event). Product quality complaint was not involved.
Received a phone call from pt's mother concerned about red spotty rash at site of IPV and DTaP. Just appeared this am (IZ's given 11/27). No other problems stated. Rash is about 2x2 inches and ithcy; L arm.
Information has been received from a nurse practitioner concerning a female pt who in Oct 2006, was vaccinated IM with a dose of HVP vaccine. Subsequently in Oct 2006 she experienced lightheadedness, weakness, pallor and sweating. No medical attention was sought. The nurse practitioner indicated the pt was doing fine. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning a 76 year old male patient who "5 years ago", in approximately October 2010, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 05-OCT-2010, the patient was vaccinated intramuscularly with a second 0.5 ml dose of PNEUMOVAX 23 (lot # 665904/0866Z). Several days later, (onset also reported as 05-OCT-2010) the patient returned to the office with a very severe cellulitis from the injection site to below his elbow. The patient also experienced asthenia, malaise and fever. At the time of the report, the patient was recovering. This is one of several reports received from the same source. The office concerned for the lot. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question, 665904/0866Z, were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Pt states she awoke from sleep with head pressure, and a "weird crawling like" sensation down right arm and leg, "all the way to my toes", along with dizziness.
The day after i received pfizer bio booster I developed whole body hives. The same thing happened with the prior booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 02:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZ [AZITHROMYCIN]; FLONASE [FLUTICASONE PROPIONATE]; HYDROCHLOROTHIAZIDE; LISINOPRIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: All cefalasporins, reaction(s): "Allergy to: Cephalosporin"; Tetracycline, reaction(s): "Allergies to: tetracycline"; Ketamine, reaction(s): "Allergies to: ketamine". Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufactured unknown), for Covid-19 Immunization; Bnt162b2 (Dose 3), for Covid-19 Immunization, reaction(s): "The day after i received pfizer bio booster I developed whole body hives. The same thing happened with the prior booster.". The following information was reported: URTICARIA (non-serious) with onset 05Nov2022 at 01:45, outcome "recovering", described as "The day after i received pfizer bio booster I developed whole body hives. The same thing happened with the prior booster.". Therapeutic measures were taken as a result of urticaria.  Additional information: Adverse event treatment: The patient took Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Flu like symptoms; Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient reported events of non-serious lack of effect / humira was no longer working and flu like symptoms with HUMIRA (ADALIMUMAB).  On unknown dates, the patient experienced lack of effect/humira was no longer working and flu like symptoms. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of lack of effect/humira was no longer working and flu like symptoms was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a medical assistant concerning a 31-year-old male with no pertinent medical history, who was vaccinated with a second dose of hepatitis B (lot # 637982/1749K) (date, route and dose unspecified). There was no concomitant medication. In 2001 the patient complained of weakness in both hands, soreness in the biceps and forearms bilaterally; unspecified medical attention was sought. The patient was subsequently diagnosed with a mild case of Guillain-Barre Syndrome and was hospitalized. Pulmonary function tests were performed (results unspecified) and a spinal tap revealed mild elevation in protein. The time frame between the dose of hepatitis B and the onset of the symptoms is unknown. It was reported that the patient recovered. Medication taken by the patient as of 06-FEB-2006 included "baby aspirin" and multivitamins. No product quality complaint was involved. The reporter considered the patient's adverse experience to be life threatening. Additional information has been requested.
FATIGUE FOR 3 DAYS POST VACCINATION MENTAL FOG FOR 3 DAYS POST VACCINATION HEADACHE ON 3RD DAY POST VACCINATION
A non-serious, report of administration of TIV and 1 week later FLUMIST in a 24-month-old female patient was received from a nurse. On 04-Sep-2009 the patient received a "flu shot" and on 11-Sep-2009, received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMISTS.
COUGH, SOB, CHILLS, FATIGUE, SORE THROAT, HEADACHE
Bilateral pneumonia; strong reaction; A spontaneous report was received from a consumer concerning a female patient of unknown age , who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced bilateral pneumonia and "strong Reaction".  The patient's medical history was not provided by the reporter. Concomitant product use was not provided.   On unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection.   On an unspecified date the patient experienced bilateral pneumonia and a "strong reaction". No treatment medication was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The events bilateral pneumonia and strong reaction were considered not resolved during the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Patient received BOOSTRIX first, then FLUZONE second. Within 1 minute of flu shot, pt stated that she felt dizzy and then listed over, but rph was able to support her while seated. She managed a sip of water from a water bottle, stated she was still dizzy and nauseous, and laid down on the floor. Patient showed signs of rapid breathing, reported nausea, sweats, and tingling feeling in arms (like vasovagal syncope). Symptoms didn't abate, 911 called. She threw up (minimal and saliva-like) and stated that she had not eaten anything yet that day. 911 ambulance arrived and monitored pt vitals, tried to regulate patient breathing, but with no improvement after 15 minutes, was taken to ER/hospital.
From telephone contact received at manufacturer on 07/31/2002, it was reported that a 19-year-old female received her last dose of the post exposure rabies series (Imovax Rabies) on 07/24/2002. The pt's mother called to report that her daughter had just completed her post exposure rabies series. Schedule was started on 06/26/2002, 06/29/2002, 07/03/2002, 07/10/2002 and last dose was on 07/24/2002. Mother stated that pt worked in office handling animals and had been exposed to a rabid raccoon. According to mother, pt did not wear gloves and probably did not wash her hand as she should have. Also reported that it took the office personnel at least 2 weeks to begin treatment if not as long as a month. On 06/30/2002, pt went to the ER with severe pain, rated a 10 on the scale of 1-10, in her legs and lower spine. Pt also had a fever. Physician in the ER gave her Motrin and antihistamine. Mother reported that a lot of blood work including test for rabies were done at the ER before discharged her to home. Mother asked, from what has read about rabies, does her daughter have rabies because of her signs and symptoms. Mother does not have any lot numbers and was too upset to ask more info.
One week after initial vaccine injection, patient has had continuing headaches that do not stop.  Patients sts he has not taken any medication to alleviate px and has not seen his PCP.  Patient believes headaches are a normal part of his day now and is otherwise not impeded by the constant px.  Just wants documentation.
after pt recv 2nd dose of vax pt devel welts on her feet w/itching.
tested positive the week after; sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's daughter) reported that a 69-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, solution for injection) via an unspecified route of administration on 14Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date it was reported that patient got the first shot on 14Apr2021 and tested positive the week after. They got COVID and have been sick for 2 weeks. patient was now getting out from the disease, patient would like to know the appropriate amount of time when to receive the second dose. The outcome of COVID-19 (PT) was recovering while for other event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
30 min after immunization patient had chills & hot flashes then fainted. She got up and then fainted a 2nd time.
About two inches below the injection side, I have had a red mark on my arm that has grown in size over the last 3 days. The spot was dark red but has lightened in color. The spot is slightly warm, but not itchy or painful.
Immunizations given 12/16/2003.  12/17/2003, raised rash over entire body.  Looks like pimples.  Fever 99-100. Benadryl and to ER.
First shot I had a slight fever on and off of 100 degrees starting at 11:59pm and lasting approximately 24 hours. Second shot on and off I had a 101 degree fever, severe cold chills, severe tired feeling, nausea, and dizziness starting around 11:55pm and lasting approximately 36 hours.
Client was sitting in the observation room and c/o dizziness after receiving her second Pediatric Pfizer COVID vaccine Lot # FK5618 exp. 02/21/22 at 2:59 PM on 12/08/21. At 3:20 PM RN assisted client to sit in the anti-gravity chair in a high-fowler position for further assessment and RN took client?s vitals: B/P 112/86, P 100, 02 Sat. 100%. Client denies any c/o pain and denies any other symptoms. Client had lunch at approximately 1:00 PM and had a snack of some candy about an hour after that. The client has no history of any underlying medical conditions and no known allergies. RN took client?s vitals at 3:30 PM:  B/P 110/78, P 98, 02 SAT 100%. At 3:30 PM, client states "I feel the same" still c/o some dizziness and denies any new symptoms. RN took client?s vitals at 3:40 PM: B/P 112/80, P 90, 02 Sat. 100%. Client states ?I feel better" with no new symptoms, denies any c/o H/A or pain, and denies any further dizziness. Client and her father states ?we are ready to go". Client stands up independently and ambulate without difficulty. Client left clinic at 3:45 PM with a steady gait accompanied by her father. No s/s of distress noted.
Mild heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Mild heart palpitation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2A) for COVID-19 vaccination.     The patient's past medical history included Lung lobectomy (She had lung surgery, part of her lung was removed.) in July 2020. Concomitant products included LEVOTHYROXINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Mild heart palpitation). At the time of the report, PALPITATIONS (Mild heart palpitation) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient was taking Lipitor for a months before the first dose and stopped taking Lipitor before the second shot for a couple weeks.   Treatment information was not reported.    This case was linked to MOD-2021-428375 (Patient Link).
felt sick; chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had the first vaccination back in the day).   In MAR-2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: felt sick) and chills (Verbatim: chills). The outcome of the feeling unwell and chills were resolved.   It was unknown if the reporter considered the feeling unwell and chills to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell and chills to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2023AMR060509   Additional Information: GSK Receipt Date: 22-APR-2023 This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine back in the day, and felt sick with chills both times, but short lasting.  The patient was glad that it was over. The patient had seen first hand how bad shingles could be. Follow-up would not possible, as no contact details were available. For tolerance of 2nd dose, refer case US2023AMR060509.; Sender's Comments:  US-GSK-US2023AMR060509:Same patient
drug exposure via breast milk; This case was reported by a nurse via call center representative and described the occurrence of drug exposure via breast milk in a 2-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number 99CA4, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2019-2020 season. On an unknown date, unknown after receiving Fluarix Tetra 2019-2020 season, the patient experienced drug exposure via breast milk. On an unknown date, the outcome of the drug exposure via breast milk was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient demographic details were not provided. The nurse reported that, the Fluarix vaccine was administered to the patient who was breastfeeding to child. The reporter provided the details of the patients' monther who was breastfeeding to child.
Redness, approximately 4 inches in diameter with a 1 1/2 inch diameter center that was darker red. Pain and warmth injection area.
Patient was taken to the emergency room that evening and diagnosed with encephalopathy due to the SHINGRIX vaccine by the doctor she saw. Patient is now at a skilled nursing facility.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 6 (booster), single (Lot number: GJ3277) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 10May2021 as dose 3 (booster), single (Lot number: EW0178), in left arm, on 12Nov2021 as dose 4 (booster), single (Lot number: EW0191), in left arm and on 15Jul2022 as dose 5 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid  from 13Aug2023 to 18Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever of 101F with cold symptoms-runny nose. Call in 1-2 days. Take OTC Pediacare anti-pyrectics.
Cough; closed throat; swollen tongue; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route on 08Apr2021 at 09:45 (at the age of 56-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included known allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 10:45, the patient experienced cough, closed throat, swollen tongue. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for events with Benadryl. The outcome of the events was resolved on unspecified date of 2021.  No follow-up attempt are possible. No further information is expected.