chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a 18 year old male patient. On 20-AUG-2013, after the patient was vaccinated with dose 1 of GARDASIL 0.5 ml, intramuscular and he had an anaphylactic reaction in the office. On 20-AUG-2013, ten minutes after receiving GARDASIL concomitantly with NEVEO, the patient's through closed up and he could not breathe. His oxygen levels were examined and he was give 50 mg of BENADRYL. There was no other anaphylactic reaction other than difficulty breathing. The patient had decided not to continue the GARDASIL dosing. The outcome of difficulty breathing was reported as recovered approximately in August 2013. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated orally with doses of, oral, ROTATEQ (dose, frequency, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Report fr parents brief twitching movements of mouth & face, lethargy afteward seen 5JUN had nl exam;
cannot move the arm; left arm still inflamed; left arm is itchy; left arm is warm to touch; noticed a lump (caller unsure if its called lump) on her left underarm; could be a possible infection; left arm was red; left arm was tender; left arm was swollen; left arm was painful with pain scale of; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm was painful with pain scale of) and LIMB DISCOMFORT (cannot move the arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Shrimp). Concomitant products included BIOTIN, B-COMPLEX 2000 and ZINC for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen) and PAIN IN EXTREMITY (left arm was painful with pain scale of). On 05-Apr-2021, the patient experienced LIMB DISCOMFORT (cannot move the arm), BURNING SENSATION (left arm still inflamed), PRURITUS (left arm is itchy), VACCINATION SITE WARMTH (left arm is warm to touch), SWELLING (noticed a lump (caller unsure if its called lump) on her left underarm) and INFECTION (could be a possible infection). The patient was treated with SULFAMETHOXAZOLE at a dose of 875mg/125mg and RIFAMPIN at a dose of 300 mg once a day. On 03-Apr-2021, ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen) and PAIN IN EXTREMITY (left arm was painful with pain scale of) had resolved. At the time of the report, LIMB DISCOMFORT (cannot move the arm), BURNING SENSATION (left arm still inflamed), PRURITUS (left arm is itchy), VACCINATION SITE WARMTH (left arm is warm to touch), SWELLING (noticed a lump (caller unsure if its called lump) on her left underarm) and INFECTION (could be a possible infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received on 28-MAY-2021, no new information
Upon arrival for second dose, patient stated that she has been experiencing left should joint pain since the time of the first injection. Patient stated that upon the first dose injection,  her vaccinator reported to her resistance in injecting the vaccine. Patient stated concern that the vaccine had ended up in her rotator cuff.   Patient stated continuous pain, tenderness, weakness, and limited range of motion in her left arm since the injection.   Patient rated pain as a 1-2/10 while at rest and 4-5/10 with movement . Patient described pain as pinching , continuous, and increasing with movement.   Patient requested to still receive 2nd dose in her left arm. The site was assessed. A second dose of Moderna Covid-19 vaccine was administered into left deltoid of patient with no resistance felt by author.   Patient was encouraged by Author to follow up with her Primary Care Physician (PCP). Patient stated that she had a plan and date set to meet with her PCP and would discuss her shoulder at that time as well.   Patient stated no further concerns or requests at this time.
Patient reported light headedness. We instructed him to sit. Shortly after patient passed out for roughly 30 seconds before becoming responsive again. Patient was given water once alert and monitored an additional 30 minutes. Patient left without further medical attention and was reporting feeling normal.
My mother has late onset Alzheimers, but has been doing markedly better since starting donepezil in September 2021.  Several days after she received her Pfizer booster shot she became much more confused and her memory got worse.  I'm well aware that Alzheimer's is a progressive disease, but her decline has been rapid and alarming since getting the booster, so much so that the caregivers mentioned her memory care of it to me.
Started with shoulder ache and malaise on afternoon on second day after vaccination. Then severe headache that lasted 2 1/2 days, extreme fatigue, loss of appetite, shooting pains in head and ears, sore eye sockets, difficulty walking. Felt better on 4/19 and went for a Covid test that was negative. Then started to feel bad again, and on 4/23 tried to get a doctor appointment for the pain in my ears. Told to go to urgent care where they did remove ear wax but were unable to diagnose the issue and kept asking why I was walking (more like shuffling) that way. They sent me to the ER. Got an EKG, CT scan of head, removal of ear wax missed by urgent care, and bloodwork. Was told that some people who previously had Covid have very robust responses after the second Covid shot. Re: previously having Covid, I was on a business trip on Feb 13-15, 2020. On the Tuesday after getting home, I got very sick. Loss of smell, taste, and appetite. Extreme fatigue. Felt like a severe head cold. Weight loss of 10 pounds that I've not gained back. This happened before there were Covid tests. I asked my PCP about getting an antibody test but was told they weren't available. So while I was never officially diagnosed with Covid, I'm 99% sure that's what I had in February 2020. It took me weeks to recover from the side effect episode in April.
It is possible that the patient received a third dose of this two dose series. I have spoken with him and he denied experiencing any problems thus far.
Erythema multiforme at day 10 on back; resolved within a few days.  No vesicle, only classic iris lesions and macules.
Initial report received from a non-healthcare professional on 19 December 2014. A 7-years-old male patient, whose had no medical history and concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date, route and site of vaccination were not reported), in November 2014 on an unspecified date. On an unspecified date, in November 2014 stated at first had redness and soreness at injection site which lasted for over one and half weeks. Then patient developed severe headache, spine ache, and abdominal pain. Stated patient has seen his pediatrician and has had consult with infectious diseases MD. At the time of this report the patient continues to have headaches, spinal ache, and abdominal pain. The patient had an elevated IGG for antibodies for Epstein Barr but did not have an active infection. The patient had "mild cold" at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The patient required ER visit. At the time of this report, the outcome of the adverse events was not recovered. The case was considered as serious due to important medical event elevated IgG antibodies for Epstein Barr, spine ache, abdominal pain and severe headache. List of documents held by sender: none.
pt states later the evening after getting the 1st dose Shingrix vax that he developed 101 fever, body aches and pains along with chills. He was unable to sleep.  These symptoms lasted one day.
Patient with 3 Moderna COVID vaccinations who admitted to hospital with positive COVID test found incidentally during admission testing.  No hypoxia or fever during stay.  Patient admitted with behavioral health needs.
Started on 1/25/2021. Patient developed palpable purpura and petichia to bilateral lower legs. Platelet count transient drop to 126k, then back up to 150k.
This is a spontaneous report from a contactable consumer. This female consumer reported a female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown, expiry date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation.  The patient's medical history not reported. There were no concomitant medications. The patient experienced dizziness, extremely weak, sore arm and chills on an unspecified date. Caller stated that the second Pfizer COVID-19 shot was due on Tuesday. With the first shot within some minutes of getting it, caller felt a little dizzy. It passed quickly. Then, 4-5 hours later experienced extreme dizziness, caller family walked her to the bed. Caller got to the bed in time was extremely weak and dizzy. The dizziness was still there the next morning, and  was mildly dizzy a couple of days later. Caller also had the common side effects like pain in her arm and chills, but consumer expected that. The dizziness was listed as more of a less common side effect. It was not one of the common ones or an allergic issue. It was not a common side effect. Caller was not sure if she would  get the second shot. The initial dizziness was immediately within minutes following the injection. So this worried her for the second. The outcome of events: unknown. No follow-up attempts possible. Information on lot/batch cannot be obtained.
This 33-year old female subject was enrolled in the prophylactic observer blind study 108933 (HPV-010) which compares GSK's Human Papillomavirus type 16 and 18 vaccine to Merck's GARDASIL. She received three doses of blinded vaccine on 21 February 2007, 28 March 2007 and 30 April 2007. The subject has a medical history of tension headaches, anxiety-depression bipolar disorder, reflux esophagitis and gastrooesophageal reflux disease. In 2005, she was diagnosed with chronic lower back pain associated with a disc disease. In November 2006, the subject developed migrainous headache for which a CAT scan of the head without contrast was unremarkable on 01 March 2007. Since 2000, the subject was taking bupropion hydrochloride (for depression), was taking Omeprazole since 01 April 2007 (for gastrooesophageal reflux disease), and used baclofen and vicodin for chronic pain control. On 30 April 2007, 33 days after the second of vaccine and on the same day as the third dose of vaccine, the subject went to the emergency room because of blurred vision. A MRI of the brain performed the same day was suspicious for an early demyelinating process. The cervical spine MRI was within normal limits, as were the visual evoked potentials and brainstem evoked potentials. She was treated with sodium chloride, prednisone and methylpredisolone sodium succinate for treatment of multiple sclerosis. Following this treatment, the double vision resolved. On 01 May 2007, the MRI of the cervical spine with and without contrast was negative. She was discharged from the hospital on 02 May 2007. At the time of reporting, the event was unresolved. The subject is being followed by a neurologist. The investigator considered there was no reasonable possibility that the multiple sclerosis may have been caused by the administration of the investigational product. Expert review: A blinded review of the case by an independent expert did not support the diagnosis of multiple sclerosis as this diagnosis required a dissemination of lesions in space and time. This subject most likely presents with a "clinically isolated syndrome" (CIS) suggestive of a first demyelinating event. The expert comments that hypointense MRI lesions could indicate a latent disease present before vaccination.
Severe muscle aches and joint pain/stiffness not alleviated by extra strength acetaminophen, stretching, warm compress, or rest.  Feverish symptoms: chills, dehydration
Janssen 3/4/21, 11/5/21. Positive on 11/22/22
Tremors - Mild Petit mal seizures Oxygen administered by members of the clinic Oxygen sat - 100% Mother & patient to follow-up with PCP
sore; Tongue began to swell/area below tongue began to swell; dizziness; felt her brain would explode; swelling in throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), SWOLLEN TONGUE (Tongue began to swell/area below tongue began to swell), DIZZINESS (dizziness), FEELING ABNORMAL (felt her brain would explode) and PHARYNGEAL SWELLING (swelling in throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B12A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Iodine allergy.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (sore), SWOLLEN TONGUE (Tongue began to swell/area below tongue began to swell), DIZZINESS (dizziness), FEELING ABNORMAL (felt her brain would explode) and PHARYNGEAL SWELLING (swelling in throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (sore), SWOLLEN TONGUE (Tongue began to swell/area below tongue began to swell), DIZZINESS (dizziness), FEELING ABNORMAL (felt her brain would explode) and PHARYNGEAL SWELLING (swelling in throat) outcome was unknown.        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.   No concomitant  medications provided. Treatment included Benadryl liquigels taken one tablet every six hours Tylenol
hack up from lungs to spit out and it was blood/spitting a blood about seven or eight times; This is a spontaneous report from a contactable consumer. An 89-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the arm on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified blood thinners. The consumer is a veteran and had the Pfizer COVID 19 vaccine first dose yesterday on 14Jan2021. He had it in his arm and got a print-out that he took out and it says something about if you have a bleeding disorder and are on blood thinners. His provider did not ask him. He wanted to know if this vaccine is a blood thinner. He felt good after getting it and went to sleep last night. He got up and sort of hack up from lungs to spit out and it was blood and was like that from 6am-7am on 15Jan2021. It was also reported that he was spitting a blood about seven or eight times but then it stopped. He is okay now. Nothing is happening. He wanted to know if he should take a blood thinner when he gets the second one. He would feel like he should not take the blood thinner when he gets the second one. The outcome of the event was recovered on 15Jan2021.  Information about lot/batch number has been requested.
Patient did not feel well at all within 1 hr of receiving the flu and PREVNAR 13 vaccines. On Feb 18 he started complaining of feeling like he had fluid on his lungs, went to emergency room. They did EKG was ok, chest x-ray showed small amount of fluid in left lung. Was given LASIX seemed to clear up. This was a Thurs doctor not in on Fri, was going to go to Dr on Tues, but early Tues 2/23/16 morning around 1:30 am was having trouble getting air into lungs went to hospital by ambulance around 6 AM. Heart stopped on way to hospital lungs so full of fluid his heart could not beat. Was resuscitated but due to already depleted oxygen level irreparable brain damage occurred, was in coma 2 weeks and passed. I know him being given the flu vaccine and the PREVNAR 13 vaccines at the same time killed my husband. This practice has to stop! He was transferred from one hospital to another. While in hospital we were advised of bacterial pneumonia, fungal pneumonia and B3 staph were present. Previously thought CHF or COPD but was never diagnosed with this. X-rays of 2/3/16 show all clear no signs of problems. Testosterone usage was not understood by doctor, at all. He used 1 mL every 10 days NOT 200 mg a week. Doctors in hospital said his usage had no relation to his condition. Once pneumonia found CHF and COPD dismissed.
Swollen lymph nodes (left side of neck, under arm, left chest); Dry mouth; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL 3247, expiry: unknown), via an unspecified route of administration in the left arm on 27Jan2021 12:45 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included endometriosis, vertigo, pure hypercholesterolemia and allergies to sulfa, orange citrus and almonds. The patient has no covid prior to vaccination. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), rosuvastatin calcium (CRESTOR), magnesium, ethinylestradiol, norgestimate (SPRINTEC) and multivitamin. The patient had no other vaccine in four weeks. The patient had PCR test via nasal swab on 04Feb2021 which was negative. The patient experienced dry mouth on 27Jan2021at 13:00 and swollen lymph nodes in the left side of neck, under arm, and left chest on 31Jan2021 at 13:00. The events were not treated. The event dry mouth recovered with sequelae on 31Jan2021 while swollen lymph nodes recovered with sequelae on 07Feb2021.
Pt experienced inconsolable crying for 4 hours. No treatment was given; self resolved.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 2-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 03-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
This spontaneous report as received from a pharmacist refers to a 70 year old male patient with high blood pressure,high cholesterol and diabetes. The pharmacist reported that the patient received a dose of PNEUMOVAX 23 (dose was not reported, unknown lot#/exp. date) on 27-SEP-2016 against pneumonia and patient over 65 years old. Concomitant therapies included lisinopril (manufacturer unknown), metformin, amlodipine and glimepiride. The patient received a second dose of PNEUMOVAX 23 (unknown lot#/exp.date) on 21-SEP-2017 concomitantly with an unspecified flu vaccine. The pharmacist stated that the patient woke up on 22-SEP-2017 and had trouble getting up and felt dizzy. On the same day, the patient called into the pharmacy. None lab diagnostic studies were performed and no treatment was given for adverse events. The outcome of adverse event and dizziness was not recovered. Causality assessment was not reported. Additional information has been requested.
Received the J&J Covid Vaccine shoot on Sunday, April 11th at the  Clinic. The night of receiving my shot, I had a migraine and neck pain which resulted in trouble sleeping.  When I got up in the morning, I started having severe muscle pain in my thighs and in my calf, mild cramps in the abdomen.  The leg pain lasted the entire day with exhaustion, which interfered with my ability to work a full day.  When I went to bed later that night, I still had pain behind my left knee and I was worried about if there was a blood clot.  I got up the next morning and my legs were still cramping but improved from the prior day.  When I saw the news discussing the blood clot issue associated with the J&J vaccine, I felt it was important to contact my Dr. to discuss the leg pain.  They did an ultrasound (vascular scan) on my left leg and follow up with my doctor's office walk-in clinic after the scan.  My legs were examined and no clots were identified.  We discussed things to watch for.
Tiredness, injection site pain. Progressed to pain, redness, swelling at injection site, and tiredness, muscle pain, severe headache, shivering, possibly fever.
ERYTHEMA, SWELLING AND HEAT. WAS SEEN BY URGENT CARE OVER WEEKEND.
Leg pain; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose (Lot Number: EW0176; Expiration Date: 31Aug2021) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient queried if there had been any side effect reported of leg pain. The patient stated had the shot and had the side effects associated with COVID-19 on an unspecified date. The outcome of event was unknown.
Approximately 14 days after first injection I went to ER with Atrial Fibrilation symptoms. Had been feeling weak and tired for about a week before but ignored symptoms. Awoken early March 21st with NEW Apple watch alerting to high heart rate while sleeping over 150 bpm. Ran ECG and stated Atrial Fibrilation was occuring.
Patient received expired vaccine. Vaccine expired on 4/4 in the freezer but wasn't noticed and sent to clinic who administered expired vaccine to patient on 4/6.