chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient's son). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER5730, Expiry Date: Mar2021), via an unspecified route of administration on 22Dec2020 at a single dose on Left Deltoid for COVID-19 immunization. Medical history included asthma and sickle cell disease. There were no concomitant medications. She has had issues with vaccines in the past but not to this extent. Prior she experienced swelling in the arm from a pneumonia vaccination for immunization, back in 2012, she has no Lot or Expiry of this previous vaccine. She adds that she did feel dizzy after the first vaccine dose but that subsided. She has had no positive tests for COVID, and no antibody tests. The outcome of the event was recovered on an unspecified date.
Information has been received from a pharmacy tech concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665903/1427Y) from a multi dose vial. After vaccination the patient had red swollen feverish injection site reactions with temperatures to 103 degrees F and feeling achy. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665903/1427Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patient and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of VAQTA lots # L041676 and M011116 with expiration date 15-APR-2017 and 17-JUN-2017 respectively, (concentration, dosage and therapy route were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS# 1608USA009575, 1608USA010369, 1608USA010370, 1608USA010371). Additional information has been requested.
Acute GI hemorrhage. She was restarted on her anticoagulation without further bleeding. ED visit and hospitalization. This visit was within 6 weeks of receiving the COVID vaccine.
About two weeks after getting the second dose of the vaccine I experienced extreme fatigue. I was exhausted and I could barely get out of bed. I recovered and after that I had a rapid heart rate for no reason. I got Nitroglycerine and my heart rate was 169. I was hospitalized. I had heart testing and there was no blockage. All tests were negative and they could not find anything wrong. It has not happened again.
Information has been received from a Nurse concerning a female patient who was vaccinated with the first dose of GARDASIL (Lot # not reported). Patient broke out in hives all over her body after receiving the first dose of vaccine. The patient sought medical attention with the physician. Additional information has been requested.
None at time of injections. In July, I broke out with an itching, burning rash mainly on arms, legs, & neck. This was the first time I have had these problems. Until I spoke with a representative of yours, I did not think this was a side effect. I had it for 3 to 4 weeks.
Patient has no family history or underlying health care conditions until symptoms began mid-february 2022  of increased thirst and weight loss. No other symptoms. On February 18th, took him to the pediatrician, and was immediately diagnosed with Type 1 diabetes.
Hospitalized from 4/1/2021 to 4/3/2021 - insidious onset of speech irregularities and facila droop- family staates speech wesa slurred and had a droop - family brought her to ER  discharge diagnosis  - TIA
Swollen and reddness of left arm for three days post DTaP  vaccination. Advised can try Benadryl topical cream to site 2/10/03
Pain at the L shoulder injection site never improved and became continuously more severe, despite use of Ibuprofen. On 4/6/2022 after no longer being able to being able to bear the pain. I left work and went to urgent care, where I saw Dr. A 3 view X-ray was taken and I was diagnosed with L shoulder Calcific Tendonosis. I've now been placed on Steroids and have to complete physical therapy.
2 DAYS OF ALMOST CRAWLING TO THE BATHROOM AFTER THAT SHOT; HURT ALL OVER; COULD NOT SLEEP; SLEPT WAY MORE THAN NORMAL; DID NOT EAT VERY MUCH; FEVER; PUKED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced 2 days of almost crawling to the bathroom after that shot, hurt all over, could not sleep, slept way more than normal, did not eat very much, fever, puked, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 2 days of almost crawling to the bathroom after that shot, and could not sleep, and the outcome of puked, fever, hurt all over, headache, slept way more than normal and did not eat very much was not reported. This report was non-serious.
This spontaneous report was received from a register nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) injection, (lot number, expiration date, dosage, dosage and route were not reported). Concomitant therapy was not reported. The reporter informed that on an unknown date the VARIVAX (Merck) reached temperatures outside of the prescribing information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 21 month old male who on 28-MAR-2007 was vaccinated intramuscularly into the left thigh with a second dose of PEDVAXHIB (OMPC) (Lot # 655076/1272F).  Concomitant therapy included PREVNAR.  Beginning at night on 28-MAR-2007 the patient developed a "little fever".  By the next morning, the child would not walk and was irritable.  When the patient was seen at the office on 29-MAR-2007, he had bilateral limping and would not readily walk.  The patient was given ibuprofen (MOTRIN).  The patient was scheduled for x-rays.  It was noted that this was the patient's second dose of PEDVAXHIB (OMPC) and that he had no symptoms after the first dose.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  No further information is available.
3 days p/vax lt upper arm swollen, inc warm & mild erythema;
Information has been received from a health professional concerning a 30 year old female with asthma who on 5/12/2006 was vaccinated IM with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). On about 5/15/2006, the patient was seen in the office with an infected arm. She was admitted to the hospital that day for a possible staph infection. Laboratory diagnostic studies included blood and other test done in the hospital. At the time of this report, she was still in the hospital receiving intravenous antibiotics and had not recovered. It was noted that the patient received a dose of Pneumococcal 23v polysaccharide vaccine 5 years ago. No product quality complaint was involved. Infected arm was considered to be an other important medical event (OMIC). Additional information has been requested.
had a shooting pain in arm; felt like getting temperature; severe headache; chills, hot and cold chills; shivering; Nauseous; joint pain; wiped out totally tired; Perspiring; dizziness; Arm was shaky; hot flashes; need to be careful when walk; shook her body; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021. The most recent information was received on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Perspiring), DIZZINESS (dizziness), NERVOUSNESS (Arm was shaky), HOT FLUSH (hot flashes) and GAIT DISTURBANCE (need to be careful when walk) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced HYPERHIDROSIS (Perspiring). 08-Mar-2021, the patient experienced DIZZINESS (dizziness), NERVOUSNESS (Arm was shaky), GAIT DISTURBANCE (need to be careful when walk), TREMOR (shook her body), HEADACHE (severe headache), CHILLS (chills, hot and cold chills), CHILLS (shivering), NAUSEA (Nauseous) and ARTHRALGIA (joint pain). 08-Mar-2021, the patient experienced HOT FLUSH (hot flashes), PYREXIA (felt like getting temperature) and FATIGUE (wiped out totally tired). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (had a shooting pain in arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 250 mg and FEXOFENADINE on 10-Mar-2021 at a dose of 1 dosage form, 1 dose. On 10-Mar-2021, PAIN IN EXTREMITY (had a shooting pain in arm) had resolved. On 11-Mar-2021, HEADACHE (severe headache) had resolved. At the time of the report, HYPERHIDROSIS (Perspiring), DIZZINESS (dizziness), NERVOUSNESS (Arm was shaky), HOT FLUSH (hot flashes), GAIT DISTURBANCE (need to be careful when walk), TREMOR (shook her body), PYREXIA (felt like getting temperature), CHILLS (chills, hot and cold chills), NAUSEA (Nauseous), ARTHRALGIA (joint pain) and FATIGUE (wiped out totally tired) outcome was unknown and CHILLS (shivering) had resolved.      No treatment information or concomitant medications were provided by reporter.  Action taken with the drug in response to the events was not provided by the Reporter.  Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: significant follow up accepted on 08-06-2021
This spontaneous report as received from a medical assistant via a field employee refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the third dose of GARDASIL, injection (lot#, expiry and dose not reported) at a hospital and had difficulty walking afterward. The patient was diagnosed with Guillain Barre Syndrome. The patient sought an unspecified medical attention. Unspecified treatment was given for adverse events. The outcome of the events was unknown. Upon internal review, Guillain Barre Syndrome was considered as medically significant. Additional information has been requested.
Throat tightness leading to deliberate swallowing starting approx 10 min after shot and lasting 3-4 hours,  by 8 hours later 85% better and by next morning, totally recovered.  Note - I was drinking water throughout and ate lunch approx 90 min after shot.  I did not seek medical treatment because the condition did not worsen, stated the same and then progressively got better.
About 3-4 weeks following second vaccine, developed headaches to base of skull and neck tension. Progressed into nerve pain, facial numbness to left side, and severe vertigo. Diagnosed with trigeminal neuralgia and occipital neuralgia. It was also discovered I had left hearing loss with the vertigo.  From March 2-July: I had 3 emergency visits, 6 days  hospitalization, 14 weeks of vestibular rehabilitation, and continue to struggle.   My doctors stated to me though I cannot find recorded in my medical record, "may" have been autoimmune response to vaccination. Or said "cannot rule out cause from vaccine because don't know enough".
16NOV Am c/o chills, fever, coughing up phelm, achyness; worsened during day; 17NOV cont as above; spent day in bed; 18NOV feeling better; back @ work;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On approximately 17-OCT-2014 (reported as "about one week or two weeks ago") the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously (lot # J011211) that had expired on 31-JUL-2014. No adverse effect reported. Additional information has been requested.
Sore arm, fever of 100 degrees Fahrenheit, body aches, swollen lymph node under left arm
Within 24 hrs developed nausea, vomiting, diarrhea, fever, swollen arm, with diffuse arthralgias and myalgias. This was severe for 24-48 hrs then was left with severe weakness, fatigue, arthralgias and myalgias diffusely. These latter symptoms have continued.
No Adverse Event; Supposed to be their 5th dose (1st bivalent booster but they received the original Monovalent vaccine); This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Supposed to be their 5th dose (1st bivalent booster but they received the original Monovalent vaccine)) and NO ADVERSE EVENT (No Adverse Event) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: MODERNA COVID-19 VACCINE (Dose 3, booster), MODERNA COVID-19 VACCINE (Dose 4, booster), MODERNA COVID-19 VACCINE (Dose 1) and MODERNA COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.   On 19-Dec-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Supposed to be their 5th dose (1st bivalent booster but they received the original Monovalent vaccine)). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Supposed to be their 5th dose (1st bivalent booster but they received the original Monovalent vaccine)) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Supposed to be their 5th dose (1st bivalent booster but they received the original Monovalent vaccine)).    No Medical history was reported. No concomitant medications were reported. No treatment medications were reported.
Shopping in local store when I experienced severe back and leg pain. I could no longer walk so returned home. Went to bed at 8:00 PM. The following day I still had mild pain but it finally subsided later in the day (11-10-16). I did report incident to doctor's office.
pt recvd flu vax & devel erythema @ the site of inject which persisted for 24 to 48 hrs;
Patient was given Moderna as a 13 year old, was told by manager that 2nd dose was to be given per CDC recommendations since patient was over the age of 12.
Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 48-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EL3249; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma, pain and allergies to sulfa drugs. Concomitant medication included montelukast sodium (SINGULAIR), estradiol, meloxicam and fexofenadine (FEXOFENADINE). The patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EJ1685) via an unspecified route of administration left arm on 19Dec2020 04:45 PM at a single dose for covid-19 immunization. The patient has not received other vaccines in four weeks. The received her vaccine in a hospital. On 08Jan2021 5:30 PM, the patient experienced severe headache chills, body pain, intermittent nausea, extreme fatigue, brain fog and arm pain at injection site. No treatment was received from the adverse events. The patient was not diagnosed with Covid prior to vaccination and has not been tested for Covid post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 27-AUG-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose detail and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. The patient was treated by a physician for herpes zoster on an unknown date. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
The night after receiving the covid vaccine booster, I had body aches.   I experienced numbness and tingling in my left leg and pain and aching on the left side from the neck down, including my arms elbow, and hand.  (note:My left arm had remained stiff and a little sore (when used) after a shingles vaccine.)  I took ibuprofen and Tylenol for two weeks.   This did not work very well on the pain in my arm.  After a few weeks of movement and exercise  the pain in my knee receded, however the pain in my arm was so bad that I could not sleep.  I have continued to take Tylenol, Aleve and ibuprofen with very little relief.  The pain is so bad at night that I cannot sleep.  I  experience pain when dressing, trying to reach and when I am just sit-in.  I have seen a doctor recently.
patient received QUADRACEL at 4 and 6 month instead of PENTACEL/ NO AE; male patient received QUADRACEL at 2-month and 6-month of age/ NO AE; while administering vaccine nurse added the ActHIB in QUADRACEL/ NO AE; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a nurse via call-center.  This case involves a patient (current age 12 month) who received 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiry date not reported via intramuscular route at an unknown administration site) at the age of 2-months and then 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number and expiry date not reported via intramuscular route at an unknown administration site) (in error) instead of PENTACEL (wrong product administered) at 4 months and 6 months of age (product administered to patient of inappropriate age) while administrating nurse added ActHIB to the QUADRACEL vaccine (wrong technique in product usage process) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to Wrong product administered, Product administered to patient of inappropriate age and Wrong technique in product usage process (latency: 1-day).  Caller wants to know if QUADRACEL valid for there age of 4 and 6 month.   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.  There will be no information available on the batch number for this case.
First Time for FLU vaccine. Pt tolerated procedure well. Observed for 20 minutes. Pt said she felt good, no complaints. She left room. Seating area outside vaccination room. Complained she did not feel right and sat down. Two nurses were fiving vaccine. RN saw to patient's needs. 10:05 BP 140/100, HR 80. C/O nausea, feeling lightheaded. Gave OJ and English Muffin. Pt had nothing to eat up until now. 10:25 BP 188/102, HR 76. Still C/o nausea, lightheaded. 10:37 BP 180/100. 10:43 BP 180/98. No H/O HTN. Pt agreed to go via ambulance to ER. Pt was discharged later.
Immediately after administering FLULAVAL in RIGHT Deltoid, patient's arm developed swelling soft non-erthyrometis egg sized at injection site. Patient was evaluated by MD and remained in clinic for 15 minutes and was explained what to look out for and that his arm would be sore.
PT WOKE UP AT 3 AM WITH HEADACHE SEVERE, VOMITING AND FEVER 101.
The place where the injection took place is now red, swollen, itchy.  So perhaps hives only around the injection site.  It's about 3-4 inches in diameter.
Initial report received from a healthcare professional on 10 December 2013: A 34 year-old female patient who had no illness at the time of vaccination, had iodine allergy and concomitant medication were not reported, had received a subcutaneous dose of YF-VAX (lot number, dose number, and anatomical site of administration were not reported) on 03 December 2013. On 03 December 2013 at evening, the patient had a severe headache and malaise. Next day, the physician saw the patient and still the patient had severe frontal headache, dizziness, and not able to function normally. The patient went to Emergency Room. Lumbar puncture performed and results showed Aseptic Meningitis. The patient was admitted and discharged after 3 days. The patient had received TYLENOL, IMITREX, REGLAN, TORADOL, Magnesium and DECADRON as corrective treatments. At the time of this report, the patient had not recovered from events.
Pt developed vomiting and diarrhea the day after receiving vaccines. She felt warm and had decreased activity. GI symptoms stopped. She broke out in a macular rash on trunk and head. Eyes looked red and puffy. Suboccipital nodes were swollen.