chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was diagnosed with stage 4 cancer after they got the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Patient was diagnosed with stage 4 cancer after they got the booster) 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.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Patient was diagnosed with stage 4 cancer after they got the booster) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Patient was diagnosed with stage 4 cancer after they got the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. Reporter wanted to know if the patient can get a third full dose. No treatment medications were provided.  Company comment.  This spontaneous case concerns a patient (unknown age and gender) with no medical history reported, who experienced the unexpected, serious medically significant event of neoplasm malignant. Timeframe between the event and the administration of the third dose of mRNA  1273 vaccine could not be assessed since the date of onset of the event was not disclosed. The report stated that the patient was diagnosed with stage 4 cancer after vaccination with booster. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (unknown age and gender) with no medical history reported, who experienced the unexpected, serious medically significant event of neoplasm malignant. Timeframe between the event and the administration of the third dose of mRNA  1273 vaccine could not be assessed since the date of onset of the event was not disclosed. The report stated that the patient was diagnosed with stage 4 cancer after vaccination with booster. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I received the COVID-19 Pfeizer (EJ1685) vaccine on Wednesday December 23, 2020 at 11am. Then at 3pm I ended up in the Emergency Room to be seen for numbness of lips, and difficulty to swallow and elevated BP. I was given 50mg Benadryl and observed for 4 hours then d/c home with instruction to take Benadryl as needed when symptoms arise again. It has been seven days and I am still having symptoms of feeling flushed, elevated B/P, upper lip numbness and severe anxiousness. Benadryl seems to now be working and this is scaring me. No one seems to care. I have reached out to my PCP, Employee Health and no one can give me answers other then give your 1-800- number who also informed it is just a sight to report only. Which I am doing now. In the Pfeizer trials where people experienced the adverse reactions what were they given? How long does this vaccine stay in our system?  Who can answer these questions and help us. I?m feeling so, scared and upset that I was pressured to take this vaccine.
This spontaneous report was received from a a consumer who also is a company representative concerning her family member, who is a 60 year old patient. The patient had no pertinent medical history or concomitant therapies. The patient's drug reactions or allergies were unknown. On 01-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX which was diluted in sterile diluent (manufacturer unknown), subcutaneously (the lot #, expiration date, and strength were not reported for any therapy) for shingles prevention (prophylaxis).  Soon after, on an unspecified date in 2017, the patient developed a rash at the injection site. Afterwards, the patient went to see a dermatologist about the rash, and the dermatologist confirmed that it was a slight shingles outbreak from the ZOSTAVAX injection. On 07-APR-2017, the patient was diagnosed with a vaginal infection that seemed to be an ulcerative infection, and her obstetrician-gynecologist (OBGYN) physician told her that the infection was the result of the vaccination. The patient received an unspecified treatment for the adverse events. At the time of this report, the patient was recovering from the events.  The reporter did not provided the causality assessment between the events and ZOSTAVAX. Additional information has been requested.
Dull headache, daily. Fatigue, daily, ongoing. Sleepiness, daily, ongoing. Limited arm movement, daily, ongoing. Deltoid muscle pain, daily, ongoing. Treatment: As per Dr.: antihistamines, OTC pain relievers.
Patient suffered syncopal event 10 minutes after vaccination; EMS called; Refused transport.  Patient is a nurse and post 13 hour shift at hospital.  Spouse picked her up after episode. VS Stable.  She was ashen and clammy initially but AOx4 after "smelling salts" utilized.
Patient was to receive Moderna BIVALENT booster but received a Moderna NON-BIVALENT booster.
pt recv vax 11JUL95 & on 12MAR97 pt devel a rash on upper & lower trunk & a low grade fever of 100.2;it was reported that the rash was more extensive on upper trunk & face;
migraine within hours of vaccine that lasted three days. Nausea that began during the night that I got the vaccine--I vomited approximately 4 - 9 am. The day after the vaccine I experienced a herpes outbreak, the first in over a decade. I am still dealing with that outbreak six days later. I think the immune system gets so stressed responding to the vaccine that anything else latent in the body has time to rear up. That is what seems to be happening for me and others.
On Monday February 22, the lymph nodes in my right arm pit started to swell but not too much and is one of the side effects. Wednesday February 24 the lymph nodes in my right arm pit started to get sore and you could see lumps under my skin. Thursday February 25th I woke up with bad pinching pain in my right arm pit and the lymph nodes are about twice the size that they were yesterday and more painful. One feels bigger than pea sized.
This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a child male subject who was vaccinated with (Havrix, GlaxoSmithKline), (Varivax) for prophylaxis. In 2007 the subject received unspecified dose of Havrix (unknown) and unspecified dose of Varivax (unknown). Immediately following vaccination with Havrix and Varivax, the subject experienced an anaphylactic reaction. Adrenaline (Epinephrine) was administered, and the child was not admitted. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The reporter was questioning the incidence of adverse reactions with this particular lot number of Havrix, or when given in combination with Varivax.
Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and started CPR. 911 arrived and pronounced resident dead at 1:01 am.
Started feeling sick on Sunday 5/9/21. Stated his wife had similar symptoms for a week prior. He reported having rhinorrhea, body aches and sneezing for two days. Both he and his wife are fully vaccinated as of February 2/4/21 with the Pfizer vaccine. He is taking Cold-Eeze for symptoms.
Approx 24 hrs after injections and after karate practice child broke out in hives starting at back of neck, trunk then extremities. No other sx exhibited. Treated with BENADRYL. Still has a few hives or rash  like bump 2 days after.
3/7/2010 21 mo. female presented to ED in middle of febrile seizure: unresponsive with tonic movements of upper and lower extremities, not rhythmic in nature. Periorbital cyanosis - given 100% O2. Temperature elevated to 102.5. Initial exam positive for tachycardia, tachypnea, diffuse but symmetric hyperreflexia with clonus in bilateral ankles. Seizure broke with lorazepam; was also given fosphenytoin. Seized 30 min. total. Sent home with rectal diastat.
dose of pfizer covid-19 vaccine was drawn up at full strength/concentration and given to patient
Urticaria hives & angioedema developed 3 days after given both Varivax & Engerix-B vaccines.
About 5 minutes after receiving vaccine, patient experienced diffuse hives on upper torso (chest & back) and bilateral upper arms (more pronounced on injection site arm).  Patient did not have any signs of increased work of breathing, swelling, or respiratory distress.  MD was called to assess patient.  Per MD, 50mg Benadryl PO was administered.  About 30 minutes after Benadryl was given, hives had improved and patient also verbalized that she felt better.  In total, patient was monitored for close to an hour after Benadryl was given.  Vitals were stable, and patient was cleared by MD to leave.  Patient was instructed not to drive home, so her mother picked her up.
4/9   ( day 1)      fatigue, malaise,  sore arm at injection site 4/10 ( day 2)     sore arm at injection site , mild headache   (intermittent) 4/11  ( day 3)    mild headache   (intermittent),  4/12   ( day 4)   felt great  in AM , progressively worse  as day progressed:  strong  headache, fatigue, nausea, chills 4/13   (day 5)    felt great  4/14   (day 6)     PUSTULES on RT wrist (along same vein)   and RT thigh , swollen lymph node  RT armpit  ( injection arm) ,  very fatigued, chills , nauseous 4/15   (day 7)      Feel better overall, Pustules remain but smaller, no new ones
Patient reports extreme arm soreness/shoulder pain. Patient reports his arm was sore after his first injection, but the soreness is "three times worse". Patient reports a pain score of 8/10. No erythema, edema, or bruising noted. Full passive ROM. Patient instructed to apply cold packs, use anti-inflammatory medication as directed. Monitor symptoms and return if symptoms worsen or do not improve.
pt had pain @ site of inject for 13 days then on 13th day p/inject site became red, tender & pt was put on ATB & warm compresses;
After receiving the flu shot, Patient woke up around 3am the morning after the vaccine with "severe body aches?like my blankets felt too heavy my legs and arms and back were so sore. I also felt dizzy, fatigued and had awful heartburn all day?like radiating into my back kind of heartburn that made it hard to eat. I?m not sure how the heartburn fits but the rest felt much like the flu and I could write off to an immune response to the vaccine except I?ve never felt like that before. I ended up leaving work early that day, sleeping 3 hours in the afternoon, went to bed at 8:30 pm, slept all night and woke up 100% better the next day
SORE ARM; LOW FEVER; Laryngitis; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (Laryngitis), PAIN IN EXTREMITY (SORE ARM) and PYREXIA (LOW FEVER) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 12-Nov-2021, the patient experienced LARYNGITIS (Laryngitis). On an unknown date, the patient experienced PAIN IN EXTREMITY (SORE ARM) and PYREXIA (LOW FEVER). At the time of the report, LARYNGITIS (Laryngitis), PAIN IN EXTREMITY (SORE ARM) and PYREXIA (LOW FEVER) outcome was unknown.            No concomitant products were reported.  On unknown dates, the patient experienced sore arm and low fever. On 12/Nov/2021, the patient experienced laryngitis. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On Feb-2021, patient received 1st dose covid-19 vaccine manufactured by moderna, lot number unknown, expiration date unknown. On Mar 2021, patient received 2nd dose covid-19 vaccine manufactured by moderna, lot number unknown, expiration date unknown. On unknown date, patient received booster dose covid-19 vaccine manufactured by moderna, lot number unknown, expiration date unknown.  Causality for humira (adalimumab) The reporter's causality for the event(s) of laryngitis, sore arm and low fever was not provided.  No treatment information was reported by the reporter.  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.
Severe arm pain, 3 inch diameter redness and raised (day3). Fever, chills, malaise, arthralgia, skin tenderness, headache began day 2.
Patient was given flu vaccine this morning, could not breathe had anaphylaxis, O2 down to 58, Cyanotic, Oxygen administered, and epi was given By MD. EMS was called pt was stable when she left to hospital.
p/vax feeling queasy & then lost consciousness;became rigid & unresponsive x 2min;when awake was confused & lethargic;VS stable;transported by amb to ER;eval in ER rxn consistent w/vagal rxn;
Redness-dime sized area at injection site, noticed shortly after receiving injection.  By the AM of 10/30/2003, the redness had increased to 1 by 2 inches, slightly swollen, warm to touch.  Painful when touched.  Took 2 Tylenol this AM-still sore.  Able to function ok.
Tightness in throat, hypertensive, tachycardia, hives on face and upper chest, vomitting
No irritation noted after injection but the next morning had a red raised hard hot swelling at site 1 1/2" by 2" with orange peal texture with clearly defined margins. The following day lump same but surrounded with bright pink and swelling 5" by 8 1/2", also with clearly defined margins. Following day swelling and pink area extended by about 1/2" all around. Next day swelling and redness much reduced.
7 year old was given the Quadracel vaccine with no adverse event; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who received a 0.5 ml once fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Lot number- C5763AA, Expiration date- 26-Jul-2022) via intramuscular route in the left upper arm (Product administered to patient of inappropriate age) as prophylactic vaccination on 21-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  It was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: Same day). Reporter wanted to know that if the patient should revaccinate.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EF9231; Expiration date was not reported) on 11Jan2021 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer and hypertension. The patient's concomitant medications were not reported. On 18Jan2021, the patient had site pain; headache; and was nauseous. On 13Jan2021, the patient had cough. In Jan2021, after the vaccination, the patient had felt congested. In Jan2021, almost two weeks after the vaccination, the patient had no taste or smell. The reported events had resulted in the emergency room/department or urgent care. The outcome of the events, 'site pain', 'headache', 'nauseous', 'cough', 'felt congested' and 'had no taste or smell', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021, the patient had a nasal swab COVID-19 test, and was negative.
had a blood clot 9 days after receiving the vaccine; It turns your world upside down, she was perfectly healthy and it tips you upside down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had a blood clot 9 days after receiving the vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "It turns your world upside down, she was perfectly healthy and it tips you upside down". The patient underwent the following laboratory tests and procedures: blood test: no other reason, notes: no other reason why this would happen. Additional information: She had a blood clot 9 days after receiving the vaccine and she did not get her second dose. She stated she sees stuff on J&J. She stated nothing is going to prove what happened but she had no medical history and they have dose blood tests, and there is no other reason why this would happen. The doctor has noted it in the file that after looking at all her history and extensive testing and trying to rule out other things. She said it could be a blood clotting disorder that she did not know about but they think she may just be one of the ones that experience this after the vaccine. She said they are seeing more people have these types of things. It turns your world upside down, she was perfectly healthy and it tips you upside down.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine given 5/12, gradual progression of discomfort to area becoming significant by 9/12. NSAIDS tried, then Gabapentin and Neurology referred. Suspected brachial neuritis.
Patients left arm is slightly swollen and red-warm to the touch. Patient received vaccine on 1/8/21. Symptoms started on 1/15/21. Reported to pharmacy on 1/19/21. States antibiotic cream has been helping.
Unable to speak properly, loss of balance, unable to move in quick pace gets dizzy if does, memory loss, blurred vision, severe headaches.
Extensive Limb Swelling (erythema, warmth, induration), no associated symptoms, 5cm x 7cm
Patient's Wife reported that patient did not experience any side effects from the vaccine. She reported they did their daily chores  after receiving the vaccine and patient did not complain about having any health issues on that day even before going to bed. She reported that patient did not wake up from his sleep the next morning.
Swollen armpit- lymph nodes- on left side  Swollen chest on left side Swollen left breast  Red marks on chest
she then inadvertently administered the PROQUAD to the patient instead of the MMR II; she confused the PROQUAD for the MMR II as they were stored in the same exact spot; 23-DEC-1985,  PROQUAD was inadvertently administered to a patient; confused the PROQUAD for the MMR II as they were stored in the same exact spot; No additional AE reported; This spontaneous report was received from a health care professional and referred to a currently 37-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On an unknown date, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (anatomical location, strength, dose, route, lot number, and expiration date were not reported; for prophylaxis) was scheduled to be administered, but the reporter confused the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as they were stored in the same exact spot (Product confusion, Product selection error). The caller said she then inadvertently administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA), 0.5 milliliter, lot #U024508, expiration date: 02-FEB-2023, administered for prophylaxis; strength, and route of administration were not provided) to the patient instead of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong product administered, Product administered to patient of inappropriate age). There was no adverse event.
Fever peaked next morning at 103. On 1/15, the fever was under 100. On 1/16 it was normal. I had lancinating left temple that lasted about 5-10 seconds or less. It was very frequent. It would occur every minute or so through the night for hours. The next day it occurred about 50 times. The day after, 1/16, I went down to a dozen times a day. By 1/18, it had resolved. I did not seek care at all, I just thought it was strange.
there was one man who just layed on a couch and said he did not feel good but he was ok he got up rather quickly if he needed something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1.), for Covid-19 Immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "there was one man who just layed on a couch and said he did not feel good but he was ok he got up rather quickly if he needed something".  Additional information: He didn't feel good but he was ok he got up rather quickly if he needed something. After two days he was good as normal his 75-year-old father showed no signs in comparison so.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.