chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Vomiting and dry heaves; Vomiting and dry heaves; Pounding headache; Joint pains; Eyes (saw crazy designs on walls) felt very shakey inside; Wanted to was sleep; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient).  A 79-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: POD 30) via an unspecified route of administration, administered in arm right on 26Mar2021 10:45 AM (age at vaccination: 79 years and non-pregnant at the time of vaccination) as dose 2, single and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, administered in arm right on 05Mar2021 10:00 AM (age at vaccination: 79 years non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis, osteoarthritis, renal disorder, emphysema, calcification metastatic, lung disorder, hypothyroidism, gastroesophageal reflux disease, hypersensitivity. Allergies to medications, food, or other products included Sulfur, Staydol nasal spray anesthetic. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other facility where the most recent COVID-19 vaccine was administered. Concomitant or list of other medications the patient received within 2 weeks of vaccination included hydroxychloroquine, famotidine, albendazole (Morezole), folic acid. On 26Mar2021 19:00 the patient experienced chills, nausea, vomiting & dry heaves, pounding headache, joint pains, fatigue, eyes (saw crazy designs on walls) felt very shakey inside. Eye doctor said what was happening with her eyes was a result of having gotten the COVID vaccine. Patient had the COVID-19 virus in late October. After quarantine, patient was tested and found to have antibodies in her system. Told to wait 90 days before patient got COVID vaccine - which patient did. Doctor said the antibodies were probably still in her body and that's why patient got such a bad reaction. Patient was never so sick. All patient wanted to was sleep. Adverse event results Doctor or other healthcare professional office/clinic visit. Patient was received treatment for the adverse event nausea. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, and allergy/drug reactions were reported. Approximately in 2017 (reported as between June 2017 and 21-AUG-2017), the patients were vaccinated with improperly stored VARIVAX lot # M027342 with expiry date: 01-JUN-2018, lot# M037643, expiry date: 01-SEP-2018 (dosing details, route, anatomical location were unknown) for prophylaxis. The vaccines were administered with sterile diluent that was properly stored (lot#, expiry unknown). It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 10 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010667: US-009507513-1708USA010668.
Allergies indoor/outdoor; 3 days after had low grade fever, runny nose, dry cough, and increased allergies and saw school nurse twice and has headache. Wheezy for the 1st time and kept her up all night. Lethargy, and extreme fatigue for 4 days. Before the vaccine she took a course of antibiotics; Cefdinir and Amoxicillin for strep from September to 30Oct2021.
Patient given Hep B, Flu and Hep A vaccines in that order. After the last inj pts head dropped and unresponsive. The nurse assisted pt to lying down position, pt regained consciousness after approx 7 seconds. Observed x 15 minutes no fall or injury.
This spontaneous report as received from a physician refers to a 2 month old patient of unknown gender. On 29-JAN-2015, the patient who was supposed to receive PREVENAR 13, was inadvertently vaccinated with a dose of PNEUMOVAX 23 (route intramuscular, dose, lot number and expiration date were not reported). There was no adverse effect reported. No product quality complaint was filled. Additional information has been requested.
Per internal reported event: COVID vaccine (Pfizer) given 12/29/20 1440. Hx reactions to vaccines. started c/o throat tightness 1450, given 50mg Benadryl PO. Pt reports sx resolved at 1515. Pt went home.
I woke up and had swelling in the left side of my neck, like a lymph node. I went back to employee health to report it, they told me to go to my PCP or urgent care. I left work to go to urgent care and was treated with Omnicef. The next day, 10/11/2009 the swelling had increased in size, it was more painful and difficult to swallow. The next day, 10/12/2009, the swelling had not improved so I went to the emergency room and was put on another antibiotic, Cleocin. Later on that evening the swelling started to improve and over the next few days it was resolved.
No adverse effect; second dose on 12/21/2018, third dose ofGARDASIL 9, Lot #R025725/ exp. 5/25/2021, on 2/21/2019; This spontaneous report was received from a nurse regarding to patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse described that on 23-OCT-2018, the patient was vaccinated first dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #R002344 and expiry date 16-NOV-2020, the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #R002344 and expiry date 16-NOV-2020, on 21-DEC-2018, third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, lot # R025725 and expiry date 25-MAY-2021, on 21-FEB-2019,(dose, route, were not reported)for prophylaxis (inappropriate schedule of product administration). No adverse effects  and no product quality complaint reported.
Light Headed; A spontaneous report was received from a consumer, concerning a 23 year old female patient, who received Moderna's COVID-19 vaccine and experienced light headedness/ Dizziness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number- 043L20A) via intramuscular route for COVID-19 infection prophylaxis. The patient felt light headed 10 minutes after the vaccine administration.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, light headedness/ Dizziness was considered to be unknown at the time of this report.  Based on comment, light headedness/ Dizziness
High fever 103.2 degrees and vomiting.  Was taken to the E.R that night.
numbness around her mouth; tingling and burning in feet, tingling and burning in legs, tingling and burning in hands; tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness around her mouth), BURNING SENSATION (tingling and burning in feet, tingling and burning in legs, tingling and burning in hands) and PARAESTHESIA (tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HYPOAESTHESIA ORAL (numbness around her mouth), BURNING SENSATION (tingling and burning in feet, tingling and burning in legs, tingling and burning in hands) and PARAESTHESIA (tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands). At the time of the report, HYPOAESTHESIA ORAL (numbness around her mouth), BURNING SENSATION (tingling and burning in feet, tingling and burning in legs, tingling and burning in hands) and PARAESTHESIA (tingling and burning in feet, tinglling and burning in legs, tingling and burning in hands) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Admin'd 12/2 - achy on 12/3. Extensive warm red rash noticed on arm where given and under arm on 12/5. Suggested BENADRY/pain reliever. Called her MD.
Chest heaviness; Prolonged vertigo; Head was heavy; It hit her; Fatigue and good fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest heaviness), VERTIGO (Prolonged vertigo), HEAD DISCOMFORT (Head was heavy), VACCINATION COMPLICATION (It hit her) and FATIGUE (Fatigue and good fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04D21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperacusis (Susceptible to hearing distortion), Vertigo, Hypersensitivity (Hypersensitive to certain sounds) and Hearing disability (Hearing distortion.). Concomitant products included SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and VITAMINS NOS for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced CHEST DISCOMFORT (Chest heaviness), VERTIGO (Prolonged vertigo), HEAD DISCOMFORT (Head was heavy), VACCINATION COMPLICATION (It hit her) and FATIGUE (Fatigue and good fatigue). In July 2021, VERTIGO (Prolonged vertigo) had resolved. At the time of the report, CHEST DISCOMFORT (Chest heaviness), HEAD DISCOMFORT (Head was heavy), VACCINATION COMPLICATION (It hit her) and FATIGUE (Fatigue and good fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by reporter.   This case was linked to MOD-2021-285106 (Patient Link).
Patient's husband states that a few hours after receiving the flu vaccine, the patient was swimming and became very cold. She then tried to warm up in the hot tub.  After that, her arms began uncontrollably flailing around. She was taken to the emergency room.
Received influenza vaccine 11/1/04; 11/2/04 experienced weakness, numbness and tingling of both legs; also turned blue. Seen in ER that day; as vaccines given. Mom gave Motrin; symptoms resolved by 11/4/04. Examined 11/5/04 neurologic exam normal.
Intern failed to dilute vaccine prior to administration, resulting in the child receiving 0.2 mL of undiluted vaccine. After discovery of incident patient's guardian was contacted and told to look out for local and system side effects such as muscle soreness, swelling, and fever. Thus far, patient has not reported any adverse events to event.
Redness at the injection site. The area is red and puffy w/ no pain.   injection done on 1/8
morning of 9/21/2023 "not feeling right."; turned into a knot on her left arm; fever; headache; body ache; chills; "felt like their bones were cracking"; the patient developed red mark; patient reported that they had bleeding at the site on left arm immediately after the injections; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; This spontaneous report was received from a pharmacist and refers to a 60-year-old female.  The patient's medical history included  pulmonary hypertension,  osteoporosis, and herniated disc. The patient's concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided); varicella zoster vaccine rge (cho) (SHINGRIX), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided); and  influenza vaccine rha 3v (baculovirus) (FLUBLOK), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided).  On 20-SEP-2023, the patient developed bleeding at site on the left arm immedistely after the injection. Then on morning on 21-SEP-2023, she woke up "not feeling right". On the same date at the afternoon, patient had developed a red mark that turned into a knot on her left arm and had a fever, headache, body ache, chills, and "felt like their bones were cracking." Caller stated the patient reported that the knot continued to get bigger for several days and cold and warm compresses only made it worse. Patient then reported that after several days she developed a blister on top of the knot on the left arm which has now "popped and is peeling." Caller stated that in her opinion the site appears to be improving and the patient stated "it is still a big knot but it is smaller than it was before." At the time of reporting, the patient was recovering from the all adverse events.    The causal relationship between all adverse events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient slumped on chair at observation area within 5 minutes of vaccination but quickly regained consciousness when rph attempted to assist patient. Patient did not hit the ground and was unconscious for less than 30 seconds. patient urinated on self. blood pressure reading was 107/75mmhg and temperature was 97. Patient was monitored for more than 30 minutes afterward and left with a family member.
Pemphigus Vulgaris diagnosed 3 months after Anthrax #3. Pre-vaccine serum negative for autoantibodies to pemphigus. Follow up: painful oral lesions, difficulty eating , infections, fatigue.
HIVES over entire body. Severe itching, unrelieved with steroids (prednisone 60mg) and antihistamine (Benadryl 50mg)
Arm had extreme pain; Fatigue got really bad/ extremely worn out; Little itchy; Not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 14May2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to penicillin. Concomitant medication included upadacitinib (RINVOQ) and Breo (MANUFACTURER UNKNOWN) for unknown indication taken on unknown date and unknown if ongoing. 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. The patient previously taken hydroxychloroquine (MANUFACTURER UNKNOWN) and had allergy. On 19May2021, the patient experienced extreme arm pain for almost 2 days, fatigue got really bad/ extremely worn out after about a week, little itchy and not feeling well. The patient reported that she missed a day of work so far. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme arm pain for almost 2 days, fatigue got really bad/ extremely worn out after about a week, little itchy and not feeling well was not resolved at the time of this report.
EE states that she started feeling dizzy and fatigued but it quickly resolved. Today, 12/24/2020 at 1:20pm EE states that she was driving and started having chest pains, sternum area, pain 3 out 10, the pain comes and goes, it happens when she is moving and resting, when asked about other symptoms, EE states that the chest pain is her only symptom at this time, tested negative for Covid, no travel history. I advised the EE to go to the ER immediately for further evaluation. The EE stated that she prefers to go the Urgent Care.
Patient is eligible for Flucelvax, not for Fluad, since patient is aged 63 and 11 months. Not eligible for FLUAD influenza vaccine but was administered to patient unintentionally.
Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose  for COVID-19 vaccination. Medical history and concomitant medication were not reported. On an unspecified date, the reporter stated that she heard 2 other people tested positive after receiving the vaccine. The clinical outcome of she heard 2 other people tested positive after receiving the vaccine was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082667 same reporter/drug/event, different patient
intensive itching rash/it travelled all over my body, every part; worst itching in torso and back; rash in ankles and bottom of the feet; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (intensive itching rash/it travelled all over my body, every part), PRURITUS (worst itching in torso and back) and RASH (rash in ankles and bottom of the feet) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (intensive itching rash/it travelled all over my body, every part), PRURITUS (worst itching in torso and back) and RASH (rash in ankles and bottom of the feet). At the time of the report, RASH PRURITIC (intensive itching rash/it travelled all over my body, every part), PRURITUS (worst itching in torso and back) and RASH (rash in ankles and bottom of the feet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information ascend cream (might have steroids) was provided.
2 days after receiving 5th INFANRIX, injection site, red swollen, warm, tender.  Seen at urgent care, treated for cellulitis with antibiotics (likely non-infectious)
Patient had tingling pain in left arm starting day after vaccine was administered. Pain was very painful for two weeks. Pain is less severe but continues to present time. Pain is relieved by Ibuprofen or TYLENOL.
- deltoid with edema and firm tissue to palpation; 1 week s/p vaccination - numbness/tingling at onset of symptoms 24 hours prior to presentation at the urgent care clinic
Loss if taste; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection), via intramuscular, administered in Arm Left on 28May2021 (Batch/Lot number was not reported) as, single dose for covid-19 immunisation. Medical history included hypothyroidism and shellfish. The patent historical vaccine for COVID-19 immunization was on 01May2021 at the age of 47-year-old (Dose: 1, Lot no: EW0182, Route: Intramuscular, Anatomical location: Left Arm). Concomitant medication included levothyroxine sodium (SYNTHROID); ibuprofen (EXCEDRIN IB). On 29May2021, the patient experienced loss if taste. The outcome of the event was recovered on May2021.
About three hours after receiving my two vaccinations, I started having throat congestion and coughing. I drank some tea and it resolved. However, I also began to experience the following symptoms with my eyes: they became very dry, red and painful with swollen eyelids and a lot of mucus build-up. The next morning, I developed a fever and chills. Within 36 hours, everything seems to be mostly resolved. So mainly I'm reporting this because of the unusual side effects related to my eyes for documentation purposes.
Patient stated that he did not feel well - that he felt dizzy & lightheaded. Patient became pale after - 15-20 minutes of being vaccinated. Emergency Medical Service contacted and transport patient to hospital.
Vaccine was administered into the abdominal subcutaneous tissue. Pt. was observed for the required amount of time with no adverse events. Pt. was informed of the site administration error and instructed to go to the ER if he experienced local or systemic adverse events.
Near syncope at time of injection. Then noted nausea and muscle twitches in (R) arm and chest the following day. 5 days later, still weak and tremulous. Also, c/o decreased concentration/attention in class. Exam WNL. CK 66. Lyme titer, negative. Negative CBC, Chem seven, normal, except low CO2; TSA, normal.  1/5/09 Reviewed PCP medical records. FINAL DX: none provided. Records reveal patient experienced with HPV#1 on 10/27/2008: pale, diaphoretic, BP 70/30, P56 post injection. Within 10 min, color improved, BP98/70, P64.  Malaise, feverish, muscle twitches & had sore arm next day.  By 11/3/08 felt uncoordinated, confused, staring, fatigue, weak legs, muscle tremors, pale, puffy eyes.
PATIENT'S HUSBAND CAME IN AND SAID SHE DEVELOPED A RASH A COUPLE OF DAYS AFTER VACCINATION. SHE STILL HAS THE RASH. THEY ALSO HAVE BEEN RENOVATING THEIR HOME DURING THIS TIME FRAME.
Ped Hep A given before minimum interval. due 12/11/19, accidently given early 12/3/19. Mom aware patient will require another dose.
The nurse inadvertently administered Pfizer Bivalent <5 vaccine instead of the Pfizer Monovalent <5 vaccine. Patient has not experienced any adverse events.
Case number PHEH2014US025065, is an initial spontaneous report received from nurse on 09 Dec 2014. This report refers to an 80 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
SWELLING OF LEGS; LEG PAINS; This spontaneous report received from a patient concerned a 51 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included varicose veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg pains. On an unspecified date, the subject experienced swelling of legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg pains and swelling of legs was not reported. This report was non-serious.
Myalgia, NauseaVomiting, fatigue, local pain, chills, Narrative: