chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 eye blood capyllaries had exploded; itchy in the site of injection; swelling and warm; Felt local pain in the other arm; swelling and warm; A spontaneous report was received from a consumer who was also a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced 3 eye blood capillaries had exploded, pain the in other arm, and itchy, swelling and warm in the site of injection.  The patient's medical history included hyperthyroidism. Products known to have been used by the patient, within two weeks prior to the event, included thiamazole, glucomannan and celecoxib.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 04 Jan 2021 in the left arm intramuscuarly in for prophylaxis of COVID-19 infection.   A consumer who is the patient called to report she received the Moderna COVID-19 vaccine on 04 Jan 2021. She reported the injection site itched, had swelling and was warm. The patient also reported she felt local pain on the opposite arm that was vaccinated.   On 05 Jan 2021, the patient stated her doctor told her that she had 2 or 3 eye blood capillaries that had exploded. The patient reported it was better, did not have any pain, and it was not itchy.    Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, pain the in other arm, and itchy, swelling and warm in the site of injection, was unknown. The outcome of the event, 3 eye blood capillaries had exploded, was recovering.; Reporter's Comments: This case concerns a 33-year-old, female, patient, who experienced a serious unexpected event of eye hemorrhage and non-serious unexpected events of injection site warmth, pain in extremity and non-serious expected event of injection site swelling and injection site pruritus. The event of injection site pruritus, injection site warmth, pain in extremity, and injection site swelling occurred 1 day (same day) after first dose of mRNA-1273, lot # 026L20A. The event of eye hemorrhage occurred 2 days after first dose of mRNA-1273, lot # 026L20A. Treatment included Panadol. The subject's concomitant medications included Tapazole, Propol, Celexa. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
According to mother, pt developed a fever of 101 at about 23:00 and was given Tylenol on the early AM for increased temperature. Left deltoid had a reddened area the size of a 25 cents to 50 cents piece. Alcohol was applied to area.
my left hand started to get numb, it has progressed to include left arm, left face and sometimes my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 28Nov2022, outcome "not recovered", described as "my left hand started to get numb, it has progressed to include left arm, left face and sometimes my left leg".  Additional information: Patient had 4th Pfizer COVID-19 vaccine shot on 28Nov2022. That evening patient's left hand started to get numb; it had progressed to include left arm, left face and sometimes left leg. Patient inquired if there was any advice that could be provided as had not subsided at all.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Hives all over body that come and go and appear in different areas, chest pain all the time that mimics heart attack symptoms, stomach pain
Rash (redness, swelling, itching) on left arm spreading to wrist, whole face swelling with swollen eyelids and neck, rash on thighs, taking Benadryl, no change
Directly after receiving the dose, began to sweat significantly. This subsided for a couple of hours. As the day went on, I began to experience a headache with sever fatigue. Later in the evening, began to have significant body aches, chills, nausea and what felt like a fever. Body hurt so much that it made it difficult to sleep. By next morning, all symptoms had subsided; however, felt weak and tired.
Headache night sweats, joint pain, fatigue Narrative:  Pt reported night sweats, headache, joiint paint, fatigue day after 2nd dose of covid vaccine. Pt treated with Tylenol & ibuprofen.
This spontaneous report was received from a physician via a company representative regarding a 58 year old female patient. Her medical history, concurrent conditions and concomitant medications were unknown. On 31-JUL-2017, the patient was vaccinated with ZOSTAVAX subcutaneous injection (0.65 ml, subcutaneous) (lot# and expiration date unknown) for prevention of shingles. On 04-AUG-2017, 5 days after onset of therapy, the patient experienced a 2 inch painful blister at the injection site (injection site vesicles and injection site pain) and contacted the office. On the same day, the patient was seen, the blister was lanced and culture was taken. The culture was reported to be negative for infection. The outcome of injection site vesicles and injection site pain was reported as recovered/resolved on an unknown date in August 2017. The causal relationship of injection site vesicles and injection site pain was unknown with ZOSTAVAX.
Blood clot; This is a spontaneous report from a contactable consumer (patient's friend) via Medical Information Team. A patient of an unspecified age and gender received an unknown dose number of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route, on an unknown date (Batch/Lot Number: unknown) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter reported that the patient actually had a blood clot after receiving a COVID Vaccine but did not verify manufacturer of friend's vaccine. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
Patient returned to the pharmacy on 7/20 with a red, swollen, warm spot on the back of her arm that appeared shortly after the immunization was given. The patient reports that on 7/19/16, it was the size of a quarter, and it was expanding in size. On 7/20/16 at 1:00 PM when she was seen at the pharmacy, the spot was about 4 inches in diameter, was very slightly raised, red, and the patient reported that it was still warm. Patient was referred to the doctor to determine if it was infected, or if it was an immune reaction, such as arthus.
I felt sick with a headache and low grade fever and body ache from 24 hours post injection till 4 days post injection.  On the evening of the fifth day, I felt somewhat better until I experienced extreme upper left side abdominal pain and left side chest pain.  The pain persisted for approximately 2 hours and was not immediately relieved by otc pain reliever.  It was accompanied by a fever and chills.   I did not seek medical assistance.
This spontaneous report as received from a pharmacist regarding a 3 year and 5 months old Child patient of unknown gender. There was no information regarding concurrent condition, concomitant and historical medication. At the age of 12 months approximately in 2015 patient was vaccinated with first dose of VAQTA 25/0.5 (units unknown) for prophylaxis. Now at the age of 3 year and 5 months approximately in 2018, the patient was vaccinated with second dose of VAQTA for prophylaxis. Patient was also vaccinated with the flu vaccine influenza virus vaccine (unspecified) in 2018.  On 05-DEC-2018, the patient inadvertently received the third dose of VAQTA instead of flu booster (extra dose administered and wrong product administered). No adverse event was reported.
administered with both pentacel and vaxelis at the same time with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and gender patient who was administered with both diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid [Vaxelis] at the same time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine and vaxelis not produced by Sanofi Pasteur (batch number, expiry date, route, administration site) for immunization at the same time with no reported adverse event (Inappropriate schedule of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered with both pentacel and vaxelis at the same time with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA223170:01697765
Severe pain in left arm daily, range of motion lost, SIRVA, still experiencing pain 6 months after injection.  have had x-ray and cortisone shot in shoulder, but it did not help with the pain at all.
On 12/17/2021, the Covid Nurse for Community Clinic notified the Director Health Clinics, that the PA at the other Clinic has been keeping open vaccines vials for 5 days after the initial puncuture date. Accodring the CDC and Moderna guidance the vial is only to be keep for 12 hours after the puncture time. The PA was keeping them for 5 days. After initial interviews  and findings we have a possible 48 patients that might have been affected by this stanard of practice.
Weakness and chest pain with shortness of breath. Right shoulder was very painful for 3 days. Tire easily and just want to sleep. Feel cold at times. Sore throat.
Patient reports experiencing right upper arm pain for 48 hours following injection and slight headache. 8 days later she woke up with a 5 x 4 cm area of redness at site of injection, warm to touch, painful and radiating into shoulder. Seen in clinic  the same day and placed on cephalexin for suspected cellulitis.
Initially nausea, followed by headache, low grade fever, body aches, back ache, chills
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8727), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: EW0196), in left arm and on 08Jun2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) positive; (24Sep2023) negative; (25Sep2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 18Sep2023 to 22Sep2023.
Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter mentioned that the patients have not experienced any symptoms after receiving the vaccine and have not received any treatments.  No concomitant medications were reported.
Within a few days my toes on my right foot felt numb. Then pins and needles progressed to  my right foot, both hands, right cheek and my ear lobes were going numb. This was all intermittent and progressed over 2 months time. Muscles were being ?pulled? easily and hands became very hard to use like I would think arthritis feels like. Orthopedic doc could find nothing of significance. It has gradually gotten better, but still mildly present.
The pt experienced a generalized rash over entire body that began 2 days post vax. Mom states that same rash occurred 2 days after 1st dose.
Received BEXSERO yesterday afternoon about 1500 without issues --- some immediate soreness but seemed fine. Went to volleyball practice in A/C'ed gym after with no issues. Finished practice and went to friends game in a non-air-conditioned gym but was not doing anything but watching. About 2100 began to get a worsening HA (but had some HA on the two days PRIOR to the vaccine as well) and it hurt to "open her eyes". She began shaking a lot, some muscle twitching and "wringing of her neck". She described muscle spasms as the cause of these movements. Mom felt temp. 100.9 in the ER on arrival. Taken to the ER for evaluation. Labs WNL except low Na of 133, rest normal including CT of the head. Once she got a bolus of NS in the ER she significantly improved. No prior episodes of similar symptoms. No family HX of neuromuscular disorders.
This spontaneous report as received from a consumer via Clinic refers to a currently 8 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date : 01-OCT-2017), subsequently on 28-AUG-2017 and 27-OCT-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733 and M031650, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Swelling and pain in left axilla. Tyenol and warm compresses applied without relief. Unable to take Ibuprophen. Pain & swelling persist at this time, 10/11/2009, 5:00 PM. Attempted to visit an urgent care since private MD not available on weekend but it was too late on Sunday to do so. If pain & swelling persist tomorrow will visit a doctor.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 10-DEC-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot #, expiration date, dose, route and site of administration were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Starting 12 hours after second Moderna does: fever, sweats, high resting heart rate, terrible headache and terrible body Aches.  Tylenol helped, but not much.  This peaked at about 24 hours after the vaccine, and slowly faded over the next 24 hours.  Still having bad headaches and minor body aches four days after the vaccine.  Most people I know under 40 have reported nearly the same side effects, so it's a bit frustrating that people aren't warned to expect this, and are told side-effects are rare.  That does not seem to be true.
From telephone correspondence received at manufacturer on 5/3/02, it was reported that a 15 month old male received TRIPEDIA and ACTHIB on 5/2/02 in the left thigh. Patient developed localized redness, swelling and hardness approximately 2 inches in diameter.
Pt recvd 3 doses of Engerix-B; 5JUN91 tested Hep B surface antibody (HBSAB) was neg; 19JUN91 recvd 4th dose of Engerix-B; 19SEP91 HBSAB was neg;
Fever, abd cramping, N/V beginning 2/27/05 diagnosed campylobacter, treated with Zithromax 3/3/05 to 3/4/05.
Gradual swelling of tissue in left deltoid with emergence of circular type hematoma at injection site mid deltoid muscle with induration of the muscle with tenderness no heat, no erythema to mid upper arm to elbow.
stroke; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program. A female patient (reporter's girlfriend) of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had a stroke on an unspecified date and it was reported that reporter knew several others that died from the COVID vaccine. Reporter wanted to know the side effects of the COVID vaccine. Reporter also wanter to know how it got approved and was advised to check out government website. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called on 12-9-16 morning stating following symptoms. Chills, headache, fever, body ache, muscle ache.
Patient went to bed around 11pm on Saturday PM and sometime between then and 1:30am on Sunday morning got up and went into the living room without waking up her husband (which is normal).  At 1:30am, the husband got up to use the restroom and she was out of bed then, but the husband did not know if she was having any problems at this time.  When he got up at 7:45am, she was in the recliner and did not move or anything, which is normal for her.  At 8:45am, the husband went back into the living room and tried to wake his wife and that is when he noticed there was no pulse and he called 9-1-1 at this time.  EMS got on scene and did CPR for 30 mins and she was pronounced dead at 9:21am.
Information has been received from a physician, via a company representative, concerning a female patient (age not specified), who on an unspecified date was vaccinated with the second dose of PedvaxHIB (lot # not reported). Subsequently the patient developed an abscess on both of her thighs. The patient sought medical attention, though treatment details were not provided. After an unknown duration of time, the patient recovered from the events. Additional information has been requested. Initial and follow up information has been received from a physician, concerning a 27 week old female infant with no known medical conditions or allergies, who on 23-AUG-2007 was vaccinated with the second dose of PEDVAXHIB (lot # unknown). There was no illness at the timeof vaccination. On 27-AUG-2007, the infant presented to the physician as a new patient after she had developed 'nodular swellings, firm in consistency; cellulitis and abscess of both thinghs.' Treatment details were not provided. After an unknown duration of time, the patient recovered from the events. Additional information is not expected.
C/O "itching" ,  observed a fine rash on upper rt chest above collar bone. Denied throat irritation or a need to cough- Benadryl 12.5 mg given PO. Observed for further reactions,  none apparent - laughing, smiling, joking with dad and staff after aprox 20 minutes rash resolved. Instructed father on s/s to monitor and to contact primary physician or call 911 if problems reoccur , verbalized understanding  of instructions.
NONE COVID 19 VACCINE EXPIRED 11/22/22 GIVEN 11/28/2022
This spontaneous report as received from a other health professional refers to an approximately 18 year old patient. On 10-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Neck pain, severe lethargy and the worst headache I have ever had in my life, nausea, confusion, SOB, entire severe body pain x 3 days.  My husband had to carry me to bed. I could not walk up the stairs. Took 3600 mg ibuprofen x 3 days with no relief. Starting about a month later, I have had neuropathy in both feet and am seeing podiatrist. I have a right foot drop now with difficulty walking. Also, my neck still hurts and I have had pain in different joints - both hips, shoulders, right ankle, neck and lower back, some fingers.  I still have the joint pain, neuropathy, SOB with just walking, and right foot drop to this day. Seeing podiatrist, neurologist, and PCP to request blood tests. I should have gone to the E.D.
Redness on arm, warm when she lays on it. Pt refused to answer report questions. Pt was advised to seek medical attention.
Fever 104.8 for 24 hours  Bone pain for 24 hours Dizziness  Injection site pain continues
Information has been received from a nurse, for the Merck pregnancy registry, concerning a 15 year old female with no previous medical history or no known drug allergies who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml first dose of GARDASIL (Lot # 654535/0960F).  On 21-MAY-2007, the patient developed a headache and took over the counter ibuprofen.  On 16-JAN-2008, the patient was vaccinated intramuscularly in the right deltoid with a 0.5 ml second dose of GARDASIL (Lot# 658558/1061U).  On 26-MAR-2008, the patient was vaccinated intramuscularly in the right deltoid with a 0.5 ml third dose of GARDASIL (Lot# 659657/1487U).  On 13-MAR-2008, the patient had a pre natal check up and lab work, blood test, and a pregnancy test.  It was reported that the patient is now pregnant with a LMP of 15-Dec-2007.  Unspecified medical attention was sought in the office.  The patient's outcome was unknown.  Additional information has been requested.