chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vials were moved from freezer to refrigerated conditions on 28-DEC-2021; Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022) and PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-DEC-2021) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 prophylaxis.     Concomitant products included CHLORPROMAZINE, DOLUTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), PALIPERIDONE PALMITATE (INVEGA SUSTENNA) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for an unknown indication.    On 08-Feb-2022 at 2:45 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 08-Feb-2022 at 2:45 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-DEC-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022) and PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-DEC-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient had no known drug allergies and no known allergies. It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19.  Acute illness at the time of vaccination and up to one month before was reported as unknown.  Chronic or long standing health conditions were reported as unknown.  The vial did not undergo any temperature excursions.  The vials were moved from freezer to refrigerated conditions on 28-DEC-2021.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2022: Follow-up received contains Non significant information, Reporter information was added. On 20-Jun-2022: Follow up was received with significant information: Added reporter, patient details including their date of birth, age, gender, height and weight, concomitant medication and updated narrative.
Gave Fluarix injection. Gave Moderna Bivalent injection. Patient stated "I feel...." and slunk over front-wise as if fainting. I was there to hold her from falling out of her chair. Her arms then started to stiffen with her wrists bent backwards and had a seizure lasting about 10 to 15 seconds. When she came out of the seizure, she asked what had happened. She stated she was tired, and felt very warm. She wanted to lay on the floor as she thought she would feel better. Ambulance was called. Police officer arrived at the scene. Ambulance arrived later as the police officer accessed the situation. She was coherent and speaking with us, but very tired. She had texted a friend and the friend was able to drive her home after the ambulance crew evaluated her. She wanted to go home and stated that she would follow up with her primary doctor.
Mother reported fever of unknown value with wide spread raised red rash decreased appetite fussy shaking of arms & legs but not seizure activity.
Patient had fever, body aches, and chills on 9/5/19. Patient who is RN states that on 9/11/19 she had Varicella like rash to her left leg and arm. Rash has resolved at this time.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route, Lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
developed an inflammatory arthritis/PMR/RA post vaccination; developed an inflammatory arthritis/PMR/RA post vaccination; developed tendinitis/bursitis to left arm after booster; developed tendinitis/bursitis to left arm after booster; developed an inflammatory arthritis/PMR/RA post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID test positive", start date: 27Jul2022, stop date: 27Jul2022, notes: covid test type post vaccination: Nasal Swab; covid test name post vaccination: Abbott test. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: en6198, Location of injection: Arm Right), administration date: 10Apr2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "bursitis", "tendinitis", "covid-19"; BNT162b2 (Dose 2, single, Batch/Lot No: ew0170, Location of injection: Arm Right), administration date: 03May2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "covid-19", "tendinitis", "bursitis". The patient has no known drug allergies. The following information was reported: ARTHRITIS (disability), POLYMYALGIA RHEUMATICA (disability, medically significant), RHEUMATOID ARTHRITIS (disability, medically significant ) all with onset 2021, outcome "not recovered" and all described as "developed an inflammatory arthritis/PMR/RA post vaccination"; BURSITIS (disability), TENDONITIS (disability) all with onset 2021, outcome "not recovered" and all described as "developed tendinitis/bursitis to left arm after booster". The events "developed tendinitis/bursitis to left arm after booster" and "developed an inflammatory arthritis/pmr/ra post vaccination" required physician office visit. Therapeutic measures were taken as a result of bursitis, tendonitis, arthritis, polymyalgia rheumatica, rheumatoid arthritis and included cortisone shots and prednisone.
pt recv vax 19JAN96 area red,warm swollen;temp >101 unchanged w/APAP extremely irritable;
A large red hive appeared on 2nd day below  the vaccination site-  it is watm to toicj
Systemic: Headache-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: PATIENT REPORTED SEVERE LEFT EYE SIDE HEADACHE AND SWOLLEN LYMPH NODES
Presented with swelling, cough and SOB.  Diagnosed with Covid PNA and resp failure.  Requied intubation and vasopressors for shock.  Discharge Diagnosis: Cardiac Arrest, pt expired
Before the shot the doctor noted I was healthy with no significant health problems.  Within a few days of the shot I started to feel my engergy sinking.  I felt lethargic and could hardly get out of bed or walk to work. 39 days after the shot I was diagnosed with Hashimoto Thyroiditis.  My family had no previous history of Hashimotos or thyroid problems.
I received the Moderna booster shot on February 22nd. Since March 5th I have had rashes show up all over my body. These rashes show up throughout the day and are red and itchy. These rashes have still not subsided even after taking Claritan for over a week.
Pt. describe being given Tdap vaccine in (L) upper arm- slightly to rear of thickest area of deltoid. Had pain in shoulder (top & front) that aches while at rest and is sharp pain w/arm movement. Still c/o this pain.
Patient was given an expired dose, it was expired by 2 days. CDC was contacted as well as the manufacturer and parents.
pt recv vax;lab eval showed neg results of Hep B surface antibody,patient failed to seroconvert following all 3 doses;17jul95 test showed GGT (71 U/L) and alkaline phosphatase 121 U/L remained elev;f/u revealed that pt delivered baby;
Patient received flu vaccine on 10/13/15 at 0935 w/ no complications. On 10/14/15 awoke, with rash on torso and back that was "sore" the next day the rash continued to spread to arms and legs. On Saturday, 10/17/15, was seen by personal dermatologist and given oral steroid treatment. Reported to health center on 10/19/15 w/ rash improving but still present.
SEVER GASTROINTESTINAL UPSET, PAIN IN ENTIRE BODY, SWOLLEN THROAT, INABILITY TO FOCUS, PAIN AT INJECTION SITE AND PAIN DOWN ARM TO FINGERS. MUSCLE PAIN, BONE PAIN, JOINT PAIN, HEADACHE, DIFFICULTY SWALLOWING,
I have had a Severe period with extra heavy clots that has not stopped since the shot. As well I have all swollen lymph nodes in my arm pits and breasts and suspicious cancer is now appearing in several areas of my breasts.
This spontaneous report as received from the physician's assistant refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) (reported as lot # L041627 with expiry date: 20-APR-2017). No concomitant medication was reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Felt very dizzy, tingly, diarrhea, face and ears were bright red like a strawberry, dry heaves. Took Benadryl and called 911. Dispatcher stayed on the phone till I felt a little better. Did not send an ambulance. I went to bed and shivered with 6 blankets on me. Felt better the next morning when I woke.
5/22/15 left arm above elbow with raised area 4 inches length by 3 inch width. In center of raised area is redness 1 1/2 inch by 1 inch. Areas are WTT.
One week later I noticed redness, itching, and a hard swollen bump at the injection site.  I hadn't noticed it before. In all my post-injection reports I said there was nothing but one day of soreness around the site. I was either wrong, or this showed up a week later. But it's definitely red, blotchy, a little itchy, and swollen in a hard lump at the injection site.
Very strong Metallic taste in mouth appeared one week after receiving shot, and after receiving second dose, less than 3 hours later the metallic taste disappeared and has not returned. It had been constant from 1/27-2/12.
1x1 inch lump appeared 3 weeks post vaccine. Not painful, warm or fluctuent.
HIGH UNCONTROLLED PRESSURE, DROWNING (LACK OF BREATHING), SHAKY HANDS, HAND AND FEET NUMBING, LACK OF ENERGY, DIZZINESS, SWEATING, PALPITATION (TACHYCARDIA). TREATMENT; LEUTIROX 112, LOSARTAN 50 VITAMINS B12; VITAMIN C; VITAMIN D; ZINC REST FOR SIX WEEKS FORBIDDEN DRIVING. IN JULY TAKE OTHER CBC BLOOD CHEMISTRY GENERAL URINE EXAMS. TEST RESULT HIGH PROTEINS, ALBUMIN, MCH MCHC MPV AND CHOLESTEROL OUT OF RANGE (HIGH).
Initial report received on 21Apr06 from the pt's parent. A 13 year old female pt, with a medical history of mild asthma, received an administration of Decavac, lot number U1586CA; a dose of Tubersol 5 TU, lot number C2192AA; and a dose of Hep A vaccine, lot number HAHAVB077BA, on 11Jan06. The route and site of administration were not provided for any of the vaccines. Seven days later, the pt was weak and was experiencing headaches. She was subsequently treated for a sinus infection. 23 days later, the pt was seen in the emergency room and per the reporter, she has stopped walking and was unable to walk from the emergency room on 10Feb06. Diagnostic testing included a spinal tap, MRI of the brain, and a CAT scan of the sinuses. The dates and results of these tests were not reported. The pt has since been seen by an infectious disease physician, neurologist, rheumatologist and pediatrician, but no information was provided from these visits. At the time of this report, the pt had not recovered from these events.
17-year-old female received Moderna's COVID-19 vaccination; A spontaneous report was received from a nurse concerning a 17-years old, female patient who received Moderna's COVID-19 vaccine and experienced product administered to patient of inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) intramuscularly in the deltoid (unspecified) for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event, product administered to patient of inappropriate age, was resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Client tested positive 1/28/22 prior to scheduled procedure. Symptoms began 1/31/22. Symptoms include: confusion and weakness.  Treatment includes: Oxygen.
Patient stated experienced nausea, vomiting and diarrhea about 4 hours after injection. Patient stated woke up this morning (2 days later) with tingling in her fingers on the same arm as the injection.
pt recvd vax 1DEC92 & almost immed following vax felt funny; felt faint, dizzy, nauseous; sx cont & progressed to sweating, weakness, burning up; Exam in ER show t100;
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: patient walked into pharmacy and presented with a swollen face, very swollen lips, body rash and itching. it was recomended she take benadryl asap and gor to er. she said she had benadryl at home and would take it there. she was counsled that this reaction could continue to get worse and her best course would be to go to ER. she seemed annoyed and unlikely to follow this recommendation.
Pt feeling light-headed, dizzy with mild headache. Pt states hx of similar symptoms 1.5 hours after first dose. Pt states marked improvement upon supination.  Vital Signs: BP 124/92 HR 104 Resp ~14 O2Sat 99  After ~4 min HR dropped to 68  Skin Signs: Warm and dry, Skin normal  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally, No increased or abnormal Res effort  Initial Treatment: Observation for 15 min. HR dropped to normal levels within a few min.  10:18 AM  Vital Signs: BP 162/98 HR 73-77 Resp 14 O2Sat 96  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Follow up Treatment: Had pt sit up slowly. Immediately reassessed vitals.  Vital Signs: BP 146/100 HR 73 O2Sat 97  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Notes:  No local reaction/swelling, no tenderness. Pt stood for 3 min to see if light-headedness spiked. Pt notes having caffeine before vaccination. Pt advised to follow up with PCP about blood pressure. Home by self.
About 24 hours later (9:20 PM), I developed severe chest pain on the right side of my chest with difficulty breathing.  This improved just slightly about an hour later.  The next morning my doctor ordered a D Dimer test which indicated a clot, and that afternoon a CT with contrast confirmed multiple pulmonary embolisms, primarily in my right lung.  I have also experience daily, intermittent pain in the lymph areas of my left arm since the vaccine.
she is 5'11" and shrinking; ulcers; Bad recurrence of genital herpes; Tingling sensation; This is a spontaneous report from a contactable consumer (patient reported herself).   A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration, administered in upper right arm on 27Feb2021 (Saturday) at 11:30 (at the age of 65-years-old) as single dose for covid-19 immunisation. Medical history included ongoing arthritis, fibromyalgia, insomnia, and irritable bowel syndrome. The patient concomitant medications included Ibuprofen 200mg, taking 400-600 mg daily for decades for arthritis from an unspecified start date (taking ibuprofen for decades), she stated it was as needed, but she takes daily; Gabapentin 300 mg capsules, 1 to 2 capsules by mouth daily at bed  time (can take up to 3 daily) for fibromyalgia from an unspecified date (since a few years ago),  started a few years ago for fibromyalgia; Dicyclomine 10 mg tablets by mouth taking about a year from an unspecified start date for irritable bowel syndrome and zolpidem tartrate (AMBIEN) 10 mg by mouth every night for over 10 years from an unspecified date for insomnia. All the concomitant medications are ongoing. The patient previously received an unspecified vaccine for shingles. On 27Feb2021, the patient experienced bad recurrence of genital herpes and tingling sensation at night after the vaccination. On 28Feb2021 (Sunday), the patient had ulcers started forming. She stated that it got progressively worse over the week and that it was still healing but it was slow to heal. It was reported that the tingling stopped once the ulcers began to form. She stated that it was now open ulcers that were beginning to resolve but not fully healed. She stated that she was 5.11 and was shrinking. She reported that one of the worst cases she has ever had after not having an outbreak for years. She had a prescription for valacyclovir and considered filling once the symptoms began coming on but was afraid to fill the prescription as she thought that it might negate the Covid vaccine. She was calling to inquire if there was any information regarding her ability to take valacyclovir after receiving the Covid-19 vaccine. The events did not require a visit to emergency room and physician office. No relevant tests were performed. All events were reported as non-serious. The outcome of the event tingling sensation was resolved on 28Feb2021, bad recurrence of genital herpes and ulcers was reported as resolving and the outcome of height shrinking was unknown.    No follow up attempts are possible. No further information is expected.
Called to complain experiencing increased heart rate sweating nausea and extreme headache at time of call I advised patient to go to ER or urgent care. She went to urgent care.
Began with onset of heaviness (R) arm with decreased R.O.M. Progressed to pain circling shoulder joint and radiating down to (R) elbow and up to (R) side of neck. Now has soreness, burning sensation from (R) shoulder to elbow. Denies numbness or weakness. Applying ice pack intermittently with relief.
I am recounting this as best as my wife can remember as I was not present: At about 3:15 pm my son was given two vaccines, the HPV (type unknown to us) and the MCV4P Meningococcal vaccines. Both were injected into his right arm. Within about 10 - 15 seconds my wife noticed his eyes looked sleepy, and he began to slouch forward toward the floor. My wife pushed him back onto the examining table and noticed he began to shake and his skin color was a pale yellow. He appeared to her to be unconscious but shaking with all his muscles tense. The nurse immediately left to get a doctor. My wife went after a several seconds to see if they were coming. Once they returned to the room was still shaking but coming to. He was very startled and wanted to know what was going on.  The medical staff put him on oxygen and monitored him for several minutes. After another examination pt said he was feeling better was comfortable to leave. This morning patient awoke tired, dizzy, and nauseous. He did not have much to eat; just some chicken soup. He was very lethargic and was running a mild fever or 100 degrees. We called the ask a nurse line provided by my healthcare provider and spoke with the nurse who had patient try to touch his chin to his chest. Patient's head tilted forward about 45 degrees and he jerked it back up in pain. Patient was also complaining of a headache. The nurse suggested patient drink plenty of fluids and we provided him some Tylenol. My wife intends on contacting the clinic again in the morning to follow up.
body ache; flu like symptoms; panic attack; felt sick; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), INFLUENZA LIKE ILLNESS (flu like symptoms), PANIC ATTACK (panic attack), ILLNESS (felt sick) and PYREXIA (fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2021, the patient experienced PAIN (body ache), INFLUENZA LIKE ILLNESS (flu like symptoms), PANIC ATTACK (panic attack), ILLNESS (felt sick) and PYREXIA (fever). In March 2021, PAIN (body ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever) had resolved. At the time of the report, PANIC ATTACK (panic attack) and ILLNESS (felt sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Arm swelled up, was red and warm to the touch.  Painful also.  It continued to get worse for a few days.  When she came in today to show me it was still red and swollen, warm to the touch and painful.  She did say that it was getting better, that yesterday it was worse.
Hyperglycemia (>200) beginning at onset of other side effects (low grade fever, chills, body aches) at around 8hrs after vaccine (1/16 @ 2000hrs). Hyperglycemia persisting past other effects (which lasted ~24hrs) and now at day 4 of persistent BGL >200, with periods of >300. BGL is typically well maintained (most recent A1C was 6.3%).
Reports sharp, frontal chest pain worse with deep breathe/movement.  began 25-30 minutes after recieving Pfizer's COVID-19 vaccination. 11:20am  Vts:  BP 109/54, P83, Sat 98%on RA.   Exam:  Alert, in NAD.  airway no swelling, wide open.  talking and sitting comfortably.  No dyspnea.  Hrrt RRR no murmur.  CTA c/l.  Left sternal border around rib 5 tender point reproduces her pain.  Laughing and talking.  Repeat bp at 11:30 109/63, P 79.  Respirations 12 and normal.
This spontaneous report as received from a 30 year old male patient concerning himself. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 04-JUL-2017, the patient was vaccinated with the first dose of GARDASIL, and on 06-SEP-2017, he was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date were not reported) for prophylaxis. It was unknown if the patient received the third dose. No adverse event.
Headache Narrative:  "Headache, lightheaded, sensitive to light" and exhaustion 08/25/2021 through 08/27/2021. Injection site pain and pruritus 08/24 through 08/25/2021. Resulted in unable to work 08/25/2021 and 08/26/2021. Did not seek medical attention.
Vaccine lot 048C21A expired on 11/9/21, but was administered on 11/10/21. As per Moderna, "The vaccine administered on November 10, 2021 from lot number 048C21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Initial healthcare professional report received on 17 Aug 2010: This patient received MENVEO (batch number 029011) 0.5 ml dose intramuscularly on 10 Aug 2010. After the vaccination with MENVEO, the patient experienced raised redness and swelling and pain at the injection site and got very irritable on 10 Aug 2010. However the patient did not experience fever. The outcome of the events was reported as unknown.
I had a sore arm at the injection site from the vaccine, I also had a breakthrough case of Covid I had fever, cough, headache, fatigue.
Unexplained abdominal rash 1 day after vaccination, fine , red pruritic, dry.