chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose on 06 Feb 2021 and second dose on 18 Mar 2021; Bones ache; Felt very sick for almost a week; Felt weak; Headache; Bodyache; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (High blood pressure), COPD, Cholesterol, Osteoporosis, Thyroid disorder NOS, Heart disease, unspecified, Acid reflux (esophageal) and Lung disorder NOS. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, EZETIMIBE for Cholesterol, ROSUVASTATIN for Heart disease, unspecified, LISINOPRIL for Hypertension, ALBUTEROL [SALBUTAMOL] for Lung disorder NOS, DENOSUMAB (PROLIA) for Osteoporosis, LEVOTHYROXINE for Thyroid disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06 Feb 2021 and second dose on 18 Mar 2021). On an unknown date, the patient experienced BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache). At the time of the report, BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06 Feb 2021 and second dose on 18 Mar 2021) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The AE did not cause patient to seek medical care.  Treatment information was not provided.   This case was linked to MOD-2022-582490, MOD-2022-582635 (Patient Link).
rash on both feet; Other vaccine same date vaccine date 05Oct2021; Other vaccine same date vaccine date 05Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 18:15 (Lot number: ff2589) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; METFORMIN; JARDIANCE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: er2613, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en6208, Location of injection: Arm Left), administration date: 18Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: RASH (non-serious) with onset 10Oct2021 07:00, outcome "not recovered", described as "rash on both feet"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 05Oct2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 05Oct2021". Therapeutic measures were not taken as a result of rash.  Additional Information: The patient was administered other vaccine (flu shot) on right arm. The patient reported that he had not received other vaccine in four weeks. The patient had no covid prior vaccination and had not tested post vaccination. The patient reported that he had no known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Ringing in the ears, tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8731) via an unspecified route of administration in the left arm on 21Apr2021 at 17:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 30Mar2021 at 16:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. On 23Apr2021, the patient experienced ringing in the ears, tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On 26Apr2021, the patient underwent nasal swab (SARS-CoV-2 test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event ringing in the ears, tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt notified nurse 4 days p/receiving 2nd Engerix-B that pt devel pain in lt arm, pain in chest, diaphoresis, weakness & light headedness approx 10" receiving vax says sx lasted approx 1/2hr;
Patient was seen and examined at the bedside. The patient is a 91 yr/o male with a history of CHF, NSVT, aortic stenosis, atrial fibrillation, HTN, hypothyroidism, DM2 who presents to the emergency room with complaints of chest pain and worsening shortness of breath.  He reports he got his second Covid vaccine yesterday and was feeling well until about 1 AM when he woke up acutely short of breath.  His wife checked his oxygen and reports he was 90% on his home 2 L.  He felt he could not breathe unless he was sitting straight up.  He changed over to his CPAP and was able to breathe and fall asleep comfortably.  Today throughout the day his shortness of breath has persisted and he was due to see his cardiologist so they went to his appointment.  While at the appointment he developed substernal chest pressure.  It did not radiate.  It resolved with 2 sublingual nitroglycerin.  Patient was transferred to the emergency room for further evaluation.  Patient denies any fever or chills.  He has a chronic cough with clear sputum unchanged.  He reports worsening lower extremity edema over the past few days.  He reports he has been taking all of his cardiac medications as prescribed.   Work-up in the emergency room concerning for acute on chronic CHF exacerbation.  Troponins mildly elevated but are plateaued.  No further chest pain while in the emergency room.  Patient to be admitted for further evaluation and treatment
Employee here with COVID vaccine reaction that started the day after her injection in left upper arm deltoid area. The initial reaction was a red area that did seem to go away then became itchy and redness spread. Area is red, swollen itching and warm to the touch. Measures 9 X 9.5cm and outlined in ink for monitoring. Explained conservative measures including cool compresses, and is allowed by PCP OTC IBU, and antihistamines. If the area worsens becomes taught or streaks develop advised to seek further care with PCP or walk in clinic. Employee verbalized understanding and agrees with plan.
This is an error report.  Patient received Moderna COVID-19 vaccine on 4/21/21 at.  Administration is not available in the state EMR for COVID-19 vaccine, Zotec.  Patient arrived at manufacturing company today and informed screeners that he was there to receive his first dose.  He was administered Pfizer COVID-19 vaccine.
My daughter was having a normal day and no history of fainting. She began slurring words, feeling sick, talking slow and vomiting. She became very pale and collapsing. We were in a store and this came on in an instant. The store staff called EMS and she was taken by ambulance to the ER. She fainted again during blood draw. She was given IV fluids and spent many hours in the hospital. She went back to the hospital again the next day for severe dizziness, weakness and was given more fluids. She was then sent to cardiology where she was diagnosed with POTS.
I have had tinnitus primarily in my right ear, starting two days after my second dose of Moderna.  MY initial dose was 2/11/21, second dose 3/11/21 & my booster dose was 11/8/21  The ringing in my ear gets louder and quieter at times, but is always there. It is especially noticeable late at night or when I wake up during the night.  I have discussed this with my doctor, she recommended I visit with audiology but I have not followed through with this yet
Vaccinated 7/16. On Sunday 7/20, noted a twitch in right eye. 7/21, had irritation and blurry vision right eye. 7/22 saw his PA because could not close right eye. Diagnosed with infection. Rx'ed opthalmic ointment. 7/23 numbness around right eye. 7/24 seen by PA again and diagnosed with Bell's Palsy. Prednisone/eyedrops. Now involves right side of face and back of head.  Follow-up information received on 7/28/2003 indicates this report as serious and OMIC.
Approx 10 mins after vaccines given pt stated her "feet feel funny" before pt left numbness almost totally resolved. When pt went home f/u call was made pt had a moment with a little blurred vision.
Shortly after her 1 year vaccinations, patient had hive like swelling and redness on her body as well as little red bumps and fever. It was dismissed as an allergic reaction. Now at age 13, she has been diagnosed with shingles. The only chicken pox exposure she has had is from the vaccinations. She had pain on her skin with no visible signs, followed a few days later with a painful blistering rash running along a nerve line.
2 cm area of erythema surrounded by flushed area, in total it is 4cm in diameter, warmth noted.
some reactions; a little tired; received a third full Moderna dose, instead of a booster half dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some reactions), FATIGUE (a little tired) and ACCIDENTAL OVERDOSE (received a third full Moderna dose, instead of a booster half dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION COMPLICATION (some reactions), FATIGUE (a little tired) and ACCIDENTAL OVERDOSE (received a third full Moderna dose, instead of a booster half dose). At the time of the report, VACCINATION COMPLICATION (some reactions), FATIGUE (a little tired) and ACCIDENTAL OVERDOSE (received a third full Moderna dose, instead of a booster half dose) outcome was unknown.            No concomitant medications were reported.   It was reported that the patient was not considered immunocompromised.  No treatment details were reported.   Reporter did not allow further contact
Much pain 8 out of 10; my arm pit area next to my breast felt sore and swollen/noticeable swelling below arm pit next to breast; my arm pit area next to my breast felt sore and swollen/noticeable swelling below arm pit next to breast; tenderness; my arm started to feel throbbing / my arm pit area next to my breast felt sore; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received the third dose of BNT162B2 via an unspecified route of administration on the right arm on 16Oct2021 at 17:15 (Lot Number: EW 0191) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included atrial fibrillation, asthmatic in winter and allergy to dust. The patient didn't received other vaccine in four weeks. The patient was not COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication was none. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 09Feb2021 at 04:30 AM (Batch/Lot Number: EL9264), the first dose on 19Jan2021 at 04:30 PM (Batch/Lot Number: EL 3247), both via an unspecified route of administration on the right arm at the age of 54-year-old as single dose for COVID-19 immunization. On 16Oct2021 at 18:00, about 45 min after the patient got shot, her arm started to feel throbbing. On 16Oct2021 at 18:15, the patient experienced tenderness. On 16Oct2021 at 21:15, about 4 hours after shot, her arm pit area next to breast felt sore and swollen. On 17Oct2021 at 18:15, 24 hours later noticeable swelling below arm pit next to breast, much pain 8 out of 10. Swelling and tenderness still as of 10:25 am. But he can't fill out bottom portion of this sheet as he was awaiting to hear back from her doctor. It was unknown whether the patient received treatment. The outcome of booster and off label use was unknown. The outcome of other events was not recovered.
Resident passed away on 10/19/21  he had received the Booster dose of Pfizer on 10/13/21  the primary doses were 1/28/21 and 2/22/21.     The Medical Director said to report it
Headache, Myalgia, Fever, NauseaVomiting, chills, weakness, chest tightness Narrative:
POSSIBLE ADMINISTRATION ERROR; INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-JUN-2021, the subject experienced possible administration error. On 19-JUN-2021, the subject experienced incorrect product storage. On 19-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible administration error, incorrect product storage and out of specification product use was not reported. This report was non-serious.
Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: slept for 2 days, dropped things, brain fog-Severe, Systemic: Weakness-Severe
facial Swelling; tongue Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autoimmune disorder. Concurrent medical conditions included food allergy.   On 16th August 2021, the patient received Shingrix (intramuscular). On 17th August 2021, 1 days after receiving Shingrix, the patient experienced facial swelling and swollen tongue. The patient was treated with benadryl (nos) (Benadryl) and antihistamine (Antihistamines). On an unknown date, the outcome of the facial swelling and swollen tongue were unknown.   It was unknown if the reporter considered the facial swelling and swollen tongue to be related to Shingrix.  Additional details were provided as follows: Pharmacist stated patient was approximately 52 years old. The pharmacist stated that patient was administered Shingrix vaccine in left deltoid muscle and one day after the vaccination the patient had facial and tongue swelling. On 18th August 2021,the patient called to pharmacist to report events but pharmacist believed event had been progressing since 17th August 2021. The patient was being treated with benadryl and antihistamines. The Pharmacist was calling from home and did not have vaccine lot number/expiration date. The reporter consented to follow up. The HCP (Health care professional) gave permission to follow-up.
Client is a 9 year old female who received her second dose Pfizer pediatric covid-19 vaccine today 12/1/21. Lead nurse was called over to the vaccination lane by support and found the child non-responsive to verbal stimuli, pale and diaphoretic . Within seconds the child started to revive. Client responded appropriately to her name and verbal commands. @1614 O2 sats 99%, HR 56,  BP 58/40.  Client instructed to lie down and elevate feet. @1618 O2 sat 96%, HR 77  snack given. @1621 Sprite soft drink given. @ 1423 O2 sat 100%, HR 84, BP 90/60. Color returned to client and client laughing.      Parents instructed to wait in recovery for 15 min and contact staff if there are further symptoms
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 06-MAY-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokw TIP) (lot # K019386, expiration date 09-JUN-2016) This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1392 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Loss language, toe walking, stimming, loss of upper body strength, loss of motor skills and loss of eye contact.
REACTION TO VACCINE; 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of reaction to vaccine was not reported. This report was non-serious.
pt exp hypotonic, hyporesponsive episode lasting 5 min on day of vax after mom pushed on spot where inject given
approx 2wk p/vax pt c/o sharp pains in area of vax;concerned about long term neuro effects;no prev hx of these type sx;
Severe pain at injection site about 6-7 hours post injection, lasting several days. Headache started on day two and has increased, worsening significantly at day 9. Dizziness began day 9, worsened day 10. Had to leave work early and call out the next day. No treatment sought as of yet, just self-administered ibuprofen. Minor improvement day 12.
This spontaneous case report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 11-DEC-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (lot number # K025759 and expiry date 08-JUN-2016) and VARIVAX (Merck) (lot number K007982 and expiry date: 06-MAR-2016) (overdose). Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The pharmacist stated that sterile diluent (manufacturer unknown) that was expired on 15-JAN-2016 (dose, route of administration and lot number were not reported) was used to reconstitute in-date ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported) and the dose was administered to the patient on 16-MAY-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
TOOK 2 UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 29-Aug-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201908-000701 (PVX2019-2217; wife) and PVX201908-000702 (PVX2019-2218; husband) were created and cross-linked in the database.  This case (PVX2019-2217) describes a female consumer who "took 2 unrefrigerated doses" (PT: Product storage error), while on therapy with Vivotif for an unknown indication.  Case report: The consumer took first two unrefrigerated doses of Vivotif on 27-Aug-2019 and 29-Aug-2019, respectively. The lot number was either 3003280 or 3003282.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took 2 unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201908-000702:
Initially had large local reaction at site of injection; developed purpuric rash 3 days later. DDx concerning for HSP. Diagnosed with hypersensitivity vasculitis.
For the first 24 hours had arm muscle ache and muscle pain from shoulder to elbow, difficult to lift my arm up above rib height. Within 12 hours from vaccination began to experience significant fatigue. At 26 hours from time of vaccination sudden onset of nausea, vomiting and stomach cramps, then within the next hour experienced diarrhea and chills. Stomach cramps felt like my stomach and intestines were being wrung out like a wet towel, after a few hours of diarrhea and chills went to sleep and symptoms  subsided.
headache, dizziness, nausea, vomiting  patient left the site at 15 minutes post-vaccination and returned shortly thereafter reporting symptoms as noted.
ON 08/15, ABOUT 6 HOURS AFTER VACCINE HE HAD A TEMPERATURE OF 102 WITHOUT HIS ARMS HURTING.  MOTRIN WAS GIVEN FOR HIS TEMPERATURE AND IT WENT DOWN.  HE ATE AND RAN AROUND AND PLAYED.  MOM REPORTS HE DIDN'T SLEEP UNTIL 2:00 ON 08/16 AND FELT HOT DIZZY, HIS NECK HURT AND COMPLAINED OF HIS CHEST HURTING WITH DEEP BREATHS AND WAS BREATHING FAST.  TEMP 104.  MOTRIN GIVEN AND HE FEELS BETTER.