chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain; Not able to sleep; chills; headache; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and BACK PAIN (Back pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020 and Hysterectomy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 15-Jan-2021, the patient experienced BACK PAIN (Back pain) and INSOMNIA (Not able to sleep). At the time of the report, CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved, BACK PAIN (Back pain) had not resolved and INSOMNIA (Not able to sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient attended a health fair for students and stated she wanted to receive the Hep B series that was offered.  Patient had completed the Hep B series in 1999.  Patient received an unecessary dose of Hep B vaccine.
Patient became nervous about vaccine just prior to administration and began to sweat. Shortly after administration, she became lightheaded and felt she was going to faint. Her friend went to buy her a cold drink and I sat with her to keep her from falling out of her chair. When her friend returned and gave her a drink, she quickly recovered and felt fine prior to leaving. We observed her for an additional 15 minutes following her near-fainting spell. Heart rate and breathing rate returned to normal shortly after the spell. She was able to get up and walk without assistance. She was asked by me to sign up for V-safe and to report any other symptoms that she felt might be reactions to the vaccine.
UrticariaPruritus, HYPERtension, hot flash/coldness Narrative:  stated she was given a steroid shot afterwards.  Other Relevant History:
No additional AE reported; the patient received the doses outside of the recommended administration schedule in the prescribing information; the patient was vaccinated with the third dose on 21-JUN-2022; the patient received the doses outside of the recommended administration schedule in the prescribing information; On 17-AUG-2021, the patient was vaccinated with the second dose; This spontaneous report has been received from a registered nurse (reported as a health care professional (HCP)) and referred to a 14-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 12-NOV-2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot#, and expiration date were not reported) for prophylaxis. On 17-AUG-2021, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot#, and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). On 21-JUN-2022, because the HCP was originally unaware that the patient had received doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) previously, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml once (1 dose) at the right upper arm, syringe formulation (valid lot# U008897 with expiration date 16-MAY-2023; strength, and route were not reported) for prophylaxis (inappropriate schedule of product administration). The patient received the doses outside of the recommended administration schedule in the prescribing information (for the patient who started the vaccine before age 15, only 2 doses were needed, however, the patient received 3 doses, and for age 9-14 years old, the 3 doses should be indicated as 2, 4 months intervals). No additional adverse effects were reported (no adverse event). There was no prescription drug treatment for the experience required.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-DEC-2014, the patient was vaccinated with a dose of ROTATEQ, (strength, dose, route and anatomical location were not reported), (lot# J011336, expiration date: 14-MAY-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
A dose of (COVID-19 Pfizer 5 through 11 years) expired vaccine was given on Oct 3rd 2022 at 4:55pm.  Vaccine Lot # FL2757 exp. date 9/30/2022.   No adverse event has been reported.
PERIPHERAL NEUROPATHY 2/10/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Lymph node near left clavicle significantly swelled after 30 min of receiving injection
Information has been received from a Licensed Practical Nurse concerning a 63 year old female with penicillin allergy, cholesterol high and hyperthyroidism who on 21-OCT-2008 was vaccinated with PNEUMOVAX 23 0.5 mL, intramuscularly (lot number was unspecified by reporter). Concomitant therapy included SYNTHROID, simvastatin (MSD) and LOVAZA. It was reported that the patient who received the PNEUMOVAX 23 was seen on 24-OCT-2008 for fever of 103F. The nurse stated that the patient went to the ER and was hospitalized, and was diagnosed with pneumonia at the hospital. Patient recovered on an unspecified date. This is one of three cases reported by the same source. Additional information has been requested.
2 days post vax pt devel redness & soreness @ site;by 72hr post vax, upper arm & axillary area was swollen, reddened, painful;pt was seen @ ER & told to use ASA, cold packs;by 5th day post vax, site is less swollen & tender but still sl red
Swelling lump under skin and both legs; Stomach cramping; Swelling lump under skin and both legs; Severe pain in her joint and knee; Severe pain in her joint and knee; This spontaneous case was reported by an other health care professional and describes the occurrence of MASS (Swelling lump under skin and both legs), ABDOMINAL PAIN UPPER (Stomach cramping), PERIPHERAL SWELLING (Swelling lump under skin and both legs), the first episode of ARTHRALGIA (Severe pain in her joint and knee) and the second episode of ARTHRALGIA (Severe pain in her joint and knee) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and SIMVASTATIN for an unknown indication.   On 25-Jan-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MASS (Swelling lump under skin and both legs), ABDOMINAL PAIN UPPER (Stomach cramping), PERIPHERAL SWELLING (Swelling lump under skin and both legs), the first episode of ARTHRALGIA (Severe pain in her joint and knee) and the second episode of ARTHRALGIA (Severe pain in her joint and knee). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MASS (Swelling lump under skin and both legs), ABDOMINAL PAIN UPPER (Stomach cramping), PERIPHERAL SWELLING (Swelling lump under skin and both legs) and the last episode of ARTHRALGIA (Severe pain in her joint and knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Action taken with mRNA-1273 in response to the drug was not applicable. Treatment information included some topical cream NOS.
Information has been received from the Merck Pregnancy registry concerning a 17 year old white female who on 24-APR-2007 was vaccinated with her first dose of Gardasil and on 27-JUN-2007 was vaccinated with her second dose. Concomitant medication included Keflex and prenatal vitamins. Subsequently the patient became pregnant after being vaccinated. The patients LMP was 05-JUL-2007, estimated date of conception was 19-JUL-2007, and estimated date of delivery was 12-APR-2007. On 26-OCT-2007 an MSAFP test showed positive results for Down Syndrome - Risk 1:9, and on 14-NOV-2007 an ultrasound also showed positive results for Down Syndrome. It was also reported that the patient had a toe nail infection on 21-NOV-2007 and was treated with 500mg QUID with Keflex. Additional information has been requested.
8/24/17 had one spot that she thought was a bug bite (itchy, red) at time of reporting she had a diffuse rash ankles to neck. Itchy and red no pain.
begining about 12noon pt began to have a sl fever; 230PM t104.5 & pt had a blotchy pink rash over entire body; pt also had a very loud hoarse cry; fever did subside w/APAP;
2 hours after receiving the vaccine my heart started racing, my blood pressure was 177/77, pulse was 110, & I had a massive headache. I've had a headache every day since then, my blood pressure & pulse have been going up & down everyday.
ACUTE RESPIRATORY FAILURE 1/2/2023,  2/22/2023,  1/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a physician concerning a male patient with post herpetic neuralgia, no allergies and a history of shingles who was vaccinated with 0.65 ml dose of Zostavax. The patient's post herpetic neuralgia pain got worse after vaccination. At the time of report the patient did not recover. Unspecified medical attention was sought. A product quality complaint was not involved.
HEART ATTACK; BLOOD CLOT; This spontaneous report received from a consumer via social media  through a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated "My cousin died from a heart attack because the johnson and johnson vaccine caused a blood clot. Because she trusted people like you". On an unspecified date, the patient died from heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0.20220118705-covid-19 vaccine ad26.cov2.s -Heart attack, Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Swelling and pain in abdominal area-Medium, Additional Details: Patient received her second dose of Pfizer COVID-19 vaccine and informed pharmacist that she had endometriosis. Due to case reports of  patients with endometriosis having flare-ups after receiving the vaccine, pharmacist advised her to remain for 30 minutes after vaccination for monitoring. Approximately 20 minutes into monitoring , patient approached pharmacist and advised of flares in abdominal region and pain. Pharmacist called 911, and patient was transported by EMTs for further care.
After first shots baby developed Mucus stool.  His skin started to dry up.  I took him in and they told me this was normal, and baby would start to have ezcema.  After his 4 month Vaccination, baby had massive mucus diarrhea stool and developed red splotchy blotches under his skin.  He stopped gaining weight even with extra feedings and adding in formula.  The mucus stool kept going on for almost 4 months straight.  We took him in several times and they claimed it was ezcema.  We unknowingly switched pediatricians that were interconnected to the first pediatrician.  They claimed it was my milk. They tested his stool in office and there was blood in his stool and it was my mother's milk causing this. Switched his milk, lotion, soaps as directed and his body  got worse. His face and eyes kept swelling up, he kept scratching his skin raw until he bled.  Would glove and he would cry.  Baby has never slept 8 hrs since he was born.   I finally added probiotics and the diarrhea slowed down, But he still would not gain weight. Then 6 months vaccination happened, and his skin got worse, started to peel.  Baby went from 40% down to 5%.  Took him to urgent care at facility, they claimed same eczema.  We took him to see another pediatrician at Hospital.  His blood results showed elevated Eosinophils, elevated liver enzymes, and allergic basically to everything now.  I went on strict diet, cut out, soy, dairy, eggs, gluten, and he still was the same.  Finally found a functional doctor.  She ran bloodwork, stool test, and genetic testing.  The panels showed, his liver elevated, his stool showed he had parasites (possibly from Rotavirus Vacc) , and also allergic to certain antibiotics.  She also referred us to skin doctor as baby would get large bumps on his back out of of nowwhere. Blood work showed he has inflammatory cykotines .  His genetic panel also showed he has genetic mutations that does not allow him to properly detox heavy metals from vaccinations easily.  He does not methylated well.  The Functional Dr. prescribed supplements, herbal ones along with some antibiotic skin creams.  It has been roughly 8 months and he has much improved.  He still suffers from skin rashes, and food allergies but not as bad as his when his reactions happened starting at 2 month vaccs-6 months.
Three severe episodes of Meniere's  on 1/30/2021; 2/9/2021 and 2/10/2021. All three lasted about 2-3 hours with severe vertigo and nystagmus.
Suffered from what seemed like a stomach virus with vomiting and diarrhea. Symptoms would stop and then high fever started (102.8). Fever subsided. Vomiting and diarrhea came back. Next day a raised red rash appeared over face and arms. Went away during the day, came back at night. Next night it was itchy. He's lethargic and dehydrated. No one will deal with the rash or discuss the possibility that it is connected to the vaccine. Given at the same time as a Hep A vaccine. As of today, six days later he still has the rash reappearing at night.
Small rash on left arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 02:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, allergies and peritoneal mesothelioma. The patient was allergic to BACTRIM (Sulfa). Concomitant medications included pentosan polysulfate sodium (ELMIRON), montelukast sodium (SINGULAIR) and antihistamine (MANUFACTURER UNKNOWN) all for unknown indications, started from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 19:00, the patient experienced small rash on left arm about 4 hours after injection. Therapeutic measures were not taken as a result of this event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event small rash on left arm was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
210/112 blood pressure. Went to ER. MRI and CT scans showed no reason. Pressure came down after several hours to 160/90 range. Ringing in ears. Subsided somewhat.
Patient received a 1st dose with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 13-JUN-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a patient received Engerix-B with an expired dose. The reporter consented to follow up. Additional Supportive Information: A patient received a expired dose of Engerix-B, which led to expired vaccine used.
within 2 minutes having the J and J covid vaccine, patient became pale, clammy and almost fainted.  She was non verbally communicative to her spouse and I, she was "zoned out and incoherent" .  Paramedics were called, but after 10 minutes she became sick, vomited and then color came back and then she was fine.  Patients says she doesn't remember even getting the shot.
had a fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had reported that her husband had got the vaccine and had a fever, Additional supportive information: Follow-up would not possible as no contact details were available.
Headache that started about 31/2 hours later. 2 Tylenol capsules were taken. The headache pain was reduced to only slightly in about an hour.
Onset of hives, itching, swollen lips and eyes 45 minutes after immunes given.  Child taken immediately to hospital ER.
NAUSEA, VOMITING, HEADACHE, MYALGIAS, DRY COUGH, SOB, FATIGUE, WEAKNESS
first dose was on 14-AUG-20220 and second on 17-AUG-2021; Crohn's disease (stomach cramps, anemia, weight loss); arrythmias; sepsis; Information has been received via company representative from a Physician regarding her 11-year-old daughter with drug allergy (to adalimumab). No other information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 14-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1, intramuscularly for prophylaxis (dose, site of administration, lot number and expiration date were not reported).   On an unspecified date, reported as "shortly after", side effects began.     On 17-AUG-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration) intramuscularly for prophylaxis (dose, site of administration, lot number and expiration date were not reported).   On an unspecified date, reported as "shortly after",  the patient went to the emergency room for stomach cramps, arrhythmias, "noclasum," anemia, weight loss, sepsis, and later diagnosed with Crohn's disease. Side effects continued for 6 months after dose. The caller stated the patient was "in recovery" (conflicting information, also reported as "outcome: not recovered").  The patient sought medical attention and was prescribed holistic treatments including "like 30 different vitamins". It was unknown if any laboratory test was performed.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events.  Upon internal review, Crohn's disease, sepsis and arrhythmia were determined medically significant.
Swelling at site of injection with urticaria over arm and abdomen and neck & face.
PATIENT FELT FAINT AND WAS HAVING A REACTION 2 MINUTES AFTER GIVEN VACCINE
Possible TIA; He woke up with black clouds in both eyes surrounded by red; This is a spontaneous report from a contactable consumer (patient's son/daughter). A 75-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EN6202, expiration date unknown) via unspecified route of administration at arm left on 04Mar2021 at 11:30 AM at age of 74-year-old at single dose for COVID-19 immunisation. Medical history included traumatic brain injury (TBI) 1.5 years ago due to a horse accident. There was no known allergies. Concomitant medication was reported as none. There was no other vaccine in four weeks and no other medications in two weeks. Patient woke up with black clouds in both eyes surrounded by red. He went to an eye doctor the next day that told him not to get the next dose and to go see a doctor immediately. He did, he has still not received any real answers. The eye doctor was afraid it was a possible transient ischaemic attack (TIA). Onset date of events was 24Mar2021 at 03:30 AM. Outcome of events was not recovered. No treatment received for the events. Events resulted in doctor or other healthcare professional office/clinic visit. There was no Covid prior vaccination. Covid was not tested post vaccination.
Same day he received the 2nd dose he felt very weak and had stiffness and arm pain, sleeping a lot. Occasional cold sweats; PT states hes not eating normally due to feeling sick feeling when eating. On 9/6/2021 PT became short of breath and had cold sweats and collapsed. Went to ER on 9/7/2021, PT states he has no memory from 9/7/2021 to 9/9/2021, PT left hospital on 9/13/2021 and went to a different ER until October. ER said PT had a viral infection and was being treated with antibiotics; Pt developed abcess in nerves  and is paralyzed in left arm. PT says his heart has become swollen and heart beat is faster now.