chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an online article via a company representative. The article stated that a doctor said that the incidence of cervical cancer was very low and it was impossible for Merck's Human papillomavirus (HPV) vaccine to lower the already low incidence of cervical cancer. It was reported that the promotion of this vaccine to prevent cervical cancer was entirely groundless, although it was promoted as this. The study confirmed that the indication of this vaccine had nothing to do with cervical cancer, however, the way of promotion still ignored this fact. In fact, there was no evidence to support that this vaccine could prevent any cancer. According to Merck's labeling, this vaccine (the 1st generation) targeted four types of all the 40 types of HPV, which could be self-healing in short time. The article also concerned about the potential risks of this vaccine, as it indicated all the clinical trials were conducted among the females aged 15-year old or above, however, Food and Drug Administration (FDA) and Merck had extended the target users to girls of 9-year old and above, even boys. It was reported that so far there had been 15,037 cases of adverse drug reaction for this vaccine, and the statistics only included cases that met the very stringent validation criteria. There had been 44 girls that were confirmed to die of this vaccine. All kinds of adverse drug reactions included Guillain-Barre syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral palsy) (captured in MARRS# 1609USA012858). This report refers to the 44 girls who were confirmed to die of this vaccine. Upon internal review, die of this vaccine was considered to be medically significant. Additional information has been requested.
Began with stabbing pain in left shoulder that woke me up every 2 hours all night long. Progressed to massive migraine headache in a wide band across my forehead.  Found fluid pooling in a channel from my armpit past my elbow; rubbed on it and raise arm until it went away. Muscles in left arm stopped working; couldn't move my arm; put left arm in a sling.  Started feeling like I was burning up with fever, but body temperature was normal 98.8 degrees. Several hours later was having sudden chills and found body temperature had risen to 102 degrees F.  Developed high blood pressure for me. The lymph node in my neck were swelling, armpit tender to touch, and left breast tender to touch too.  Started icing the back of my neck to take down temp. Put ice on my shoulder to try to cool the pain.  I was very frightened and worried that: (1) got sepsis bacterial infection from shot (2) got bad lot of Moderna or (3) Moderna vaccine sat out at room temperature too long and had gone bad.  48 hours after the 2nd dose and after icing, symptoms started to ease.
Information has been received from a consumer with a history of chickenpox who in September 2006, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In October 2007, the patient developed shingles. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. Information has been received from a consumer with a history of chickenpox who in September 2006, was vaccinated with adose of ZOSTER vaccine live (oka/Merck). In October 2007, the patient developed shingles. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information was received from someone in the physician's office. It was noted that this 83 year old retired female was  on 12-SEP-2006 in the right arm with a first dose of ZOSTER vaccine live (Oka/Merck) (lot # 652965/0622F). Subsequently, on approximately 20-SEP-2007 the patient developed shingles. No further information was reported.
This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative reporting similar events for 3 different patients. This is the 3rd of three reports. A 17 year-old female patient of unspecified ethnicity received the first dose of TRUMENBA (lot number M37315, expiry date 01Apr2017) intramuscularly on 18Apr2016 at 16:00 at 0.5ml single in the left deltoid and the first dose of MENACTRA (Sanofi, lot number 45272AA) intramuscularly on the left arm on 18Apr2016 (time unspecified) at 1DF single. Relevant medical history was not reported. None concomitant medications. The patient experienced a local site reaction described as arm was red and swollen on 18Apr2016. The patient experienced numbness and left arm pain on unknown date. No emergency room, Physician visit, treatment or hospitalization was required for the events. The patient was recovering from redness and swelling arm. The outcome of the event numbness and left arm pain was unknown. The physician stated that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. The physician considered the Pfizer vaccine had a causal effect to the adverse events. Follow-up (16May2016): New information reported from a contactable Physician includes: patient's age and gender, details of vaccination with TRUMENBA and MENACTRA, concomitant medications none, onset date of the events, new events (numbness and left arm pain), outcome, causality assessment, confirmation that the patient provided to the physician information regarding the reported adverse events with the use of the vaccines.
No adverse effects reported; One 15 year old patient received one dose of PROQUAD.; This spontaneous report was received from a nurse referring to a 15 years old male patient. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On 06-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot # R030803, expiration date 22-APR-2020; vaccine dosage detail and route of administration not reported) subcutaneous inject for prophylaxis which was reconstituted with sterile diluent (drug use in unapproved age group).  No adverse effects was reported. No product quality complaint (PQC) was involved in this case.
dizzy spells; Feelings of vertigo; itching at injection site; fatigue; redness at injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells), VERTIGO (Feelings of vertigo), VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo (During peri-menopause patient experienced occasional bouts of vertigo. These disappeared after menopause). Concurrent medical conditions included Drug allergy (Sulfa drugs), Penicillin allergy and Hypothyroidism since 01-Jan-1978. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (dizzy spells), VERTIGO (Feelings of vertigo), VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site). On 18-Mar-2021, DIZZINESS (dizzy spells) and VERTIGO (Feelings of vertigo) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Reporter Email Address was added patient race Height and weight was added allergy medical history and current condition was added Outcome of the events was added from unknown to Recovered concomitant drug added 2nd dose info was added
Information has been received from a nurse practitioner concerning an 18 year old patient, who in approximately 2009 (at the age of 15) was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). It was reported that the patient has now (date unspecified) been diagnosed with cervical cancer with severe dysplasia. It was stated the nurse was wondering if the product had been handled properly in the office where it was given. Unspecified treatment was given for the patient's symptoms. At the time of the report, the patient's outcome was unknown. Upon internal review, cervical cancer was determined to be an other important medical event. Additional information has been requested.
I had a breakthrough infection in January 2022. I was advised by a VAERS rep who called me at 1:44 PM on March 31, 2022 that this qualifies as an "adverse event" and that I should report it via this form. To be clear, I had NO adverse reaction to ANY of the three shots in my series and merely had a mild breakthrough infection in January. If this is not useful, feel free to delete this report, but I was asked to make it and want to do my part by putting in the effort to report this to you. Thank you for your hard work and for making this lifesaving vaccine available to me.
Dr. spoke to parent on 11/29/21 and they reported patient has had no known reaction to receiving the incorrect COVID vaccine per patients age.  Parents will follow up with office if any further concerns or questions
I was feeling sick; Kind of chilled; My second shot my arm hurt me extremely bad; Little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I was feeling sick), CHILLS (Kind of chilled), VACCINATION SITE PAIN (My second shot my arm hurt me extremely bad) and FATIGUE (Little bit tired) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (I was feeling sick), CHILLS (Kind of chilled) and VACCINATION SITE PAIN (My second shot my arm hurt me extremely bad). an unknown date, the patient experienced FATIGUE (Little bit tired). At the time of the report, MALAISE (I was feeling sick), CHILLS (Kind of chilled), VACCINATION SITE PAIN (My second shot my arm hurt me extremely bad) and FATIGUE (Little bit tired) was resolving.            Concomitant medications were not provided. Treatment information was not reported.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Pt received 0.5ml instead of 0.25ml of Moderna 6m - 11yrs covid vaccine
Swelling, redness, heat L arm.  Started 1 day after vaccine administered.
4/18/03 - Injection of Td given to pt in left deltoid. No reaction. At approx 12:00 on 4/19/03 stated he was SOB, had chest pain and rash from nipple line to face. Wife called 911. Pt given IV fluids, monitor, Benadryl, Decadron, Vistaril and Allegra.
CHEST PAIN; LEFT SIDE HAND AND FOOT BURNING PAIN; SHAKING; HEART RACING; FEEL HORRIBLE; JOINT PAIN; CHILLS; NAUSEA; FEVER; SEVERE HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced left side hand and foot burning pain. On 07-APR-2021, the subject experienced shaking. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced feel horrible. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced severe headache. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and fever on 08-APR-2021, had not recovered from severe headache, chest pain, fatigue, joint pain, left side hand and foot burning pain, nausea, and heart racing, and the outcome of feel horrible was not reported. This report was non-serious.
Received Vaccine on Thursday the 16th approx 3:30 pm. Started having jaw clinching around dinner time that night., Arm was sore,  was taking Claritin and Tylenol. Friday had pain in shoulder around shoulder blade jaw not working properly felt like it wasn't working smoothly.  trouble chewing, felt like she was having ringing in ears and pulsating in the other ear  CAlled MD, around 5 pm, told could last 24-48 hours. Call health dept on Monday.  Saturday felt tired , legs and knees weak.  felt like the Claritin helped knees. felt feverish, never took temp.  Sunday felt better, took 3 hour nap. feeling better today.
Information has been received from a licensed practical nurse concerning a 30 month old female who on 10/26/1999 was vaccinated with one dose of varicella vaccine. On 05/05/2001 the pt developed 20 papules, lesions in different stages on scalp to feet, and pruritus. It was also noted that the pt was afebrile. The event was reported as varicella. The pt was seen in the physician's office on 05/05/2001. The pt was treated with Benadryl and Aveeno bath. It was also reported that the pt's sister had similar experiences. No further info is expected.
Patient had an increase in chronic headache frequency and had a near-syncopal episode on 1/21/21. She stated that the near-syncopal episode lasted for about 10 minutes. She has had one prior episode that was caused by hypotension and dehydration.
Six days after the shot she had very severe rash on both arms across the neck and on her right thigh that lasted for a month and half. Made an appointment with her doctor a day later and they prescribed Neosporin and it still didn't get better.
BP went up to 210/111 the day after vaccine was administered. On 4/24/2021 patient went to ER for double vision. BP was 200/100's again. Given IV BP meds, did CT scan that showed no abnormalities noted. K+ was 2.9. On Sunday, 4/25/21 back to ER for double vision again. BP 160/90's. Observed, given more BP meds and sent home again. Went to PCP, clinic 4/26 who referred to Ophthalmologist.  Opthalmology, found optic nerve damage and believes related to mini stroke possibly from Covid vaccine.
Information has been received from a registered nurse concerning a 16 month old male patient with no medical history and no drug allergies or reactions who on 27-JAN-2010, was vaccinated with a 0.5 ml SC dose of MMR II (rHA, lot # 663796/0423Y). Concomitant therapy included PREVNAR and H1N1. On 13-MAR-2010, the patient experienced negative mumps titer. At the time of reporting, the outcome was unknown. The patient sought medical attention via office visit. Additional information has been requested.
Patient came in to get HPV vaccine Gardasil with his father, who's also getting his Shingrix. Pt. was accidently given Shingrix instead of Gardasil on his left arm.  We called and talked to his father; patient didn't complain of any adverse event at the time we called. We consulted father for any allergic reaction, and adverse event at  injection site. We also left message for his primary doctor.
7NOV91 t102 oral, lethargic, slow to respond, would not walk; MD called-told to give APAP, this lasted 2 hrs slowly improved p/APAP;
Patient received flu shot Saturday 10/17/2015 at 10AM. Mom states child came to her Saturday noc c/o arm soreness. When she looked left deltoid area was red, warm to touch and swollen. Gave dose of BENADRYL. Mom reports arm less swollen today but still red. Appt made to see Doctor. Red localized reaction to (L) arm 7 inches long by 4 inches wide. No antibiotics prescribed.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild arthritis, irritable bowel, lower back pain and drug allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) dose was not reported, 1 total, administered on 01-APR-2021 at right arm for covid-19 prophylaxis. No concomitant medications were reported.  The patient received two doses of non-company suspect vaccine (Pfizer biontech covid-19 vaccine) tozinameran (Dose number in series 2) (form of admin, route of admin were not reported, batch number: FF 2593 expiry: UNKNOWN) dose was not reported, administered on 24-OCT-2021 at right arm and (form of admin, route of admin were not reported, batch number: FJ 4989 expiry: UNKNOWN) dose was not reported, administered on 29-APR-2022 at right arm for covid-19 prophylaxis.  On 19-JUL-2022, covid symptoms started and tested positive for COVID-19 PCR test (coronavirus disease-19 polymerase chain reaction) which led to confirmed covid-19 infection (Dose number in series 2) and hence confirmed clinical vaccination failure (Dose number in series 1).  The patient received non-company suspect drug: (Paxlovid) Nirmatrelvir/ritonavir (form of admin, route of admin were not reported, batch number: unknown and expiry: UNKNOWN) dose was not reported, therapy started from 20-JUL-2022 till 24-JUL-2022 for covid-19 treatment.  Covid symptoms greatly improved after 48 hours. Patient finished full five day course.  On 25-JUL-2022, first negative rapid test. On 28-JUL-2022, patient felt fully recovered and rapid tested negative again. On 30-JUL-2022, patient started feeling sick again. Rapid test was positive. On 03-AUG-2022 (day of reporting), patient was still sick and testing positive. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and with paxlovid was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220820818-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure.The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Injection site swelled on right forearm injection site. Injection site started itching really bad. I itched the injection site around the swelling. I became severely dizzy with an internal nausea feeling. My wife thought I was having a heart attack. I tried laying down and started getting sicker so I sat back up and wondered what in the world was going on. My wife took me back to the doctors office 15 minutes after I received the injection. They placed me in a wheel chair and placed some cold paper towels on my forehead, took vitals. The cold paper towels started reducing my severe dizziness so I refused the ER at this time fear of another injection and affordability of ER. My spine hurts worse. Diabetes feels worse 25 days later my liver enzymes are up.
My tinnitus symptoms have been raging since I have received my second dose of phizer covid-19 vacination.   I can not say 100% that the vacine is the the sole reason for the extreme symptoms  but can tie nothing else to the change. The ringing, screeching and high pitch sounds are louder than I have ever e,peri encased in my 15 years with tinnitus.   I TS constant,  unnerving,  stressful,  and never ending.  Difficult to impossible to sleep  and if I do happen to fall asleep the symptoms wake me up within an hour.  Kinda at my wits end at this piint.
only received 2 out of 3 doses; This case was reported by a nurse via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received HPV 16-18 (Cervarix) for prophylaxis.   Co-suspect products included human papilloma type 16 + 18 vaccine + as04d pre-filled syringe device (Cervarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Cervarix (received 1st and 2nd dose on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Cervarix and Cervarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Cervarix and Cervarix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, 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: 08-AUG-2022 Reporter's Comments: The nurse reported that the patient initiated HPV series with Cervarix while traveling but claimed that the patient only received 2 out of 3 doses in series. No additional information was provided. No additional adverse event or product quality complaint was reported at the time of call. The reporter consented to follow up. Additional Supportive Information: The patient received 2 out of 3 doses in series which led to incomplete course of vaccination.
(Sore, swollen  arm 8/29/2021). (muscle aches 8-31-2021)
Nausea starting around 5 or 6 in evening.  Normal remedy of ginger makes it worse.  Vertigo upon waking, clears up in a few minutes.  Both getting worse in days 4, 5, 6 since vaccine
Patient experience severe pain in the left arm and passed out twice and was taken by ambulance to the hospital, patient was told possible reaction to PREVNAR 13, patient known to have had arthritis in the shoulder, patient was advised by MD at the hospital to excercise arm and take ADVIL.
arthralgias;rash suggestive of E. multiforme though to be serum sickness;