chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Sore arm; Feeling of heaviness in body; Severe hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 03Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to adhesive. Concomitant medications were not reported. 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. On 03Apr2021 at 12:00, the patient experienced headache, sore arm, feeling of heaviness in body and severe hot flashes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, sore arm, feeling of heaviness in body and severe hot flashes was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pharmacy administered a Moderna Vaccination after the vial was punctured and at room temperature for longer than 12 hours. The vial was punctured on 4/21/2022 @ 08:37 AM, which means the vial expired on 04/21/2022 @ 08:37 PM. The vial was left out overnight and was used for patients' vaccination on 04/22/2022 @ 10:22 AM. Patient has been called multiple times but has yet to be reached by the pharmacy.
Muscle Cramps radiating from shoulder, arm , leg  and feet for over 30 days
Breakthrough case admission after 5 vaccines Moderna 1/29/21 Lot# 026L20A;  Moderna 2/26/21 Lot# 001A21A;  Moderna 11/3/21 Lot# 071F;  Moderna 5/18/22 Lot# 057M21A;  Moderna 10/6/22 Lot# 053D22A
It's the longevity of the side effects at a level preventing work and daily activities that is the biggest problem; fatigue; headaches; fevers; chills; dizziness; generalized pain; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL324, expiry date: not reported), via unspecified route of administration on 22Jan2021 05:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccine in four weeks prior vaccination. Medical history included epilepsy and asthma. Concomitant medications included lamotrigine (LAMICTAL), escitalopram oxalate (LEXAPRO), riboflavin (VITAMIN b2), magnesium (MAGNESIUM), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via unspecified route of administration on 02Jan2021 07:00 PM at a single dose on the left arm for COVID-19 immunization (age at vaccination: 47-year-old). Past drug history included known allergies to Parafon forte and Macrobid. The patient stated that it's the longevity of the side effects at a level preventing work and daily activities that is the biggest problem. She stated that she's 5 days post injection at the time of report (26Jan2021), and the fatigue, headaches, fevers/chills, dizziness and generalized pain are not going away (started on an unspecified date in Jan2021). Her doctor told me to report this to the manufacturer and get advice. No treatment was received. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  Outcome of the events was recovering.
Following 2 mos vaccines (Rotavirus, Pediarix, HiB, + Prevnar) - pt developed hoarseness 2 days after. Persisted x2 weeks within no other sx. At 4 mos - received Rotavirus + Pediarix - 2 day after developed hoarse voice. No fever, cough or nasal sx.
Narrative: Patient reported having fatigue, body aches and diarrhea beginning about 12 hours after receiving the vaccines. Reported to UC and was cleared of other issues. Instructed to rest and that the symptoms should resolved over time, no interventions were done.
very bad, uncontrollable chills. body aches. fever. then sweats. then it broke. 24 hours after first side effect.
no adverse effects; expired dose of VARIVAX was inadvertenly administered; This spontaneous report was received from a medical assistant referring to a 12-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 18-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously, Lot # N014630 expiration date reported as 11-MAY-2019, but upon internal validation established as 11-AUG-2019 (dosage schedule and anatomical location were not reported), for prophylaxis (expired product administered). No adverse effects were reported.  The outcome was reported as supported.
Information has been received from a physician concerning a 61 year old male with no known allergies, hypercholesterolemia, gastroesophageal reflux disease and cardiac disorder and a history of coronary stent placement (2006) who on 25-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (651404/0352F), 0.5 mL, IM.  Concomitant included LIPITOR, PLAVIX, PRILOSEC and TOPROL XL.  On 25-OCT-2006, the patient experienced swelling, fever, pain and rash (also reported as large swollen area/lump of deltoid).  The patient was seen in the physician's office on 26-OCT-2006 when he received the vaccination but was not seen again until 27-OCT-2006 as he was out of town.  In the meantime, the patient experienced rash and itch.  On 15-JAN-2007, "90 persistent rash on upper extremity".  The patient was taking BENADRYL as needed.  It was reported that "throughout period had been asked to see dermatologist."  The patient was treated with MEDROL, CLARITIN, ALLEGRA, tablet, 60 mg, daily from 03-NOV-2006 to 21-NOV-2006 and KEFLEX.  The patient's swelling, fever, pain, upper extremity mass, pruritis and rash persisted.  At the time of the report, the patient still had the rash.  Follow-up information has been received regarding the lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Injection site pain - 3 days so far Tiredness - 2 days Headache, body pains, fever, chills, sweats, nausea - 1 day
CHILLS LATE NIGHT; SWEATING ALL NIGHT; LEGS GOT WET / BED GOT WET; OXYGEN LEVEL DROPPED; SICK ALL DAY; sick overnight; FEVER 101.7; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick overnight), PYREXIA (FEVER 101.7), CHILLS (CHILLS LATE NIGHT), ILLNESS (SICK ALL DAY) and HYPERHIDROSIS (SWEATING ALL NIGHT) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0308217) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included FUROSEMIDE, ESCITALOPRAM, LEVOTHYROXINE, FINASTERIDE, preserdision, DABIGATRAN ETEXILATE MESILATE (PRADAXA), MEMANTINE HYDROCHLORIDE (MEMANTINA ACCORD), POTASSIUM, LEVODOPA, ENALAPRIL, TERAZOSIN and ALLOPURINOL 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 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (sick overnight), PYREXIA (FEVER 101.7) and ILLNESS (SICK ALL DAY). On 07-Mar-2021, the patient experienced CHILLS (CHILLS LATE NIGHT), HYPERHIDROSIS (SWEATING ALL NIGHT), NIGHT SWEATS (LEGS GOT WET / BED GOT WET) and OXYGEN SATURATION DECREASED (OXYGEN LEVEL DROPPED). At the time of the report, ILLNESS (sick overnight), PYREXIA (FEVER 101.7), CHILLS (CHILLS LATE NIGHT), ILLNESS (SICK ALL DAY), HYPERHIDROSIS (SWEATING ALL NIGHT), NIGHT SWEATS (LEGS GOT WET / BED GOT WET) and OXYGEN SATURATION DECREASED (OXYGEN LEVEL DROPPED) outcome was unknown.            No treatment information provided
Lightheaded for 12 hours  Tired for 15 hours Hot flashes for 6 hours Extremely sore arm for 24 hours Hot and hard at injection site for 1 week so far
Patient informed  she had develop a rash two days after her flu shot.  Her pictures shows a rash from elbow down to wrist from outside of arm, and from inside of arm a rash from wrist to armpit. No redness or swollen at site of injection.  No fever or pain.  She said day after injection she got a few mosquitos bite at injection arm.  The next day rash develop and it was very itchy at rash areas. She called her doctor who advice her to go emergency room. She said doctor prescribed prenidone.
fever of 100.6; chills; fatigue that lasted 36 hours.; This is a spontaneous report from a contactable consumer. This 34-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), second dose, via an unspecified route of administration on 19Jan2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. The patient did not have any known allergies. 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 vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK9231), dose #1, via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 vaccination. On 20Jan2021, the patient received her second dose and experienced fever of 100.6 degrees Fahrenheit, chills and fatigue that lasted 36 hours. No therapeutic measures were taken as a result of the events. The clinical outcomes of the fever of 100.6 degrees Fahrenheit, chills and fatigue were resolved on unspecified dates in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
started with headache, chills hours later, fever after 6-8 hrs, aching in shoulder joints, nausea, tiredness this went on for 28 hrs. Did take one ibuprofen for fever which did help.
ill for 4 days after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single 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. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill for 4 days after the booster dose". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It was a most unpleasant experience, also frightening. It may be relevant that any weight is 94 pounds. I was given the same dose as my partner who weighs 185. He was ill for 4days after the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
extreme spinal inflammatory reaction. To the point where I could not get up on from the couch on my own. I am 6'5" and 220lbs, and very physically well. I do have a hx of a herniated disc from a lifting injury and within three days after receiving the shot, began having intense pain in by back.  Osteopathic Manipulative treatment, which was unsuccessful in decreasing pain.  Was treated with steroid dose pack to get the pain controlled enough to walk again.  Consultation with Spine Surgeon.  After the second dose I was given a steroidal injection under fluoroscopy into my lumbar spine.   After the steriod injection the pain is minimized to the point of no longer needing steroidal shots. However, I continue to have mild pain when standing after sleeping, or after sitting for extended periods of time. I do not have the positive medical symptoms I had when first given these shots however my body has not returned to baseline free of pain that I had prior to taking these vaccinations.
Severe joint pain, severe headache, difficulty breathing, heart beating fast, swelling and severe pain at injection site. Overall sensitivity to touch over entire body. Frequent trips to the bathroom during the night to urinate (over 10). Twenty four hours after initial injection site of injection is very sore and swollen.
Shortness of breath lasting over 7 days; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 14:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, depression, anxiety, restless legs, allergies, COVID-19 and ADHD (attention deficit hyperactivity disorder). The patient had known allergy to wheat, milk, peanuts, pollens, dust, cat and dog dander. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 08:00, the patient experienced shortness of breath lasting over 7 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shortness of breath was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ oral liquid, lot # L013193, expiration date 20-JAN-2017, orally (strength and dose were not reported), which were exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours (cumulative time to the date of reporting). No adverse effect was reported. There were no previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax in 1980's & the next day exp heaviness of chest, SOB, tightness, & was unable to walk because of SOB; sx resolved p/1 wk; no further details were provided;
MUSCLE WEAKNESS; FEVER; BODY ACHE; CONGESTION; OXYGEN WENT DOWN TO 86; TROUBLE BREATHING; TROUBLE SLEEPING; VOMITING; HEADACHE; This spontaneous report received from a parent concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease, asthma, high blood pressure, non alcohol user, and cigarette smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine, and prednisolone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left deltoid on 12-MAR-2021 around 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced headache 40 minutes after her vaccine and resolved the day after. The patient had trouble breathing during the day of vaccine lasted for one day and the patient had vomiting all day after she got her vaccine and resolved the next day. The patient also had trouble sleeping the day of her vaccination but resolved the day after. On 28-MAR-2021,16 days after the vaccination, she experienced trouble breathing, fever, body ache and congestion. Her oxygen went down to 86. These symptoms lasted for a week and a half and resolved. On an unspecified date, the patient experienced muscle weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Oxygen saturation (NR: not provided) 86 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen saturation decreased to 86, and trouble breathing on APR-2021, trouble sleeping, vomiting, and headache on 13-MAR-2021, and body ache, congestion, and fever on 07-APR-2021, and the outcome of muscle weakness was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210739940.; Sender's Comments: V0: V0: 20210739000-COVID-19 VACCINE AD26.COV2.S-Oxygen went down to 86. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Client fainted for 5-10 seconds right as she rec'd the HPV vaccine. Had already had 2 injections and was vey anxious at that time. grandmother with her at that time was holing her hand and client face was covered. client came back to and c\o feeling dizzy with nausea.BP-80/50,P-52. 30 minutes later BP-110/74,P-70.called on 10/22/07 spoke with client and no other adverse reacion noted since injection
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 19-year-old female patient who received BEXSERO for prophylaxis. On 10th August 2018, the patient received BEXSERO. On 10th August 2018, less than a day after receiving BEXSERO, the patient experienced pain in arm, fever, general body pain and vaccine administered at inappropriate site. The patient was treated with ALEVE and Muscle Relaxant. On an unknown date, the outcome of the pain in arm, fever and general body pain were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the pain in arm, fever and general body pain to be related to BEXSERO. Additional details were provided as follows: The patient reported that she might have received the BEXSERO injection outside of the deltoid region on the upper arm, which led to vaccine administered at inappropriate site. The patient reported arm soreness, body aches, and fever. The patient was seen by the physician and prescribed ALEVE and a muscle relaxant. Symptoms still remains. The mother of the patient was the reporter, the mother said the medical staff might have injected the bone or a nerve in the arm.
Vaccine was stored after expiration date in the refrigerator; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator was 29Oct2021. Patient did not experience temp excursion and any adverse event
hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.; red, raised hive; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) and ERYTHEMA (red, raised hive) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 046A21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, 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 experienced URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) and ERYTHEMA (red, raised hive). The patient was treated with FEXOFENADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and ALPRAZOLAM (ATARAX [ALPRAZOLAM]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) had not resolved and ERYTHEMA (red, raised hive) outcome was unknown.            No Concomitant medication was reported.  Treatment medication don't stop the hives; they just stop the itching.The patient stated she is currently on Treatment medication.  Patient gave examples of getting hives where she wears her watch, touching her face, and wearing high-collared shirt or where the jeans hit the waist, anywhere that is tight on her skin.   This case was linked to MOD-2022-462294, MOD-2022-462295 (Patient Link).
Patient experienced dizziness, light-headedness during post-vaccination observation. Client has a history of anxiety. Client was evaluated by onsite EMS. EMS reported that vital signs were within normal limits. Client was reassured and symptoms improved gradually. Client was cleared to exit and left under own power without further exacerbation.
Pt states she had a cough a couple of days ago, but no known exposure.  Pt was admitted to labor and delivery and tested there.
24 hours after the injection, my arm hurt and there was a swollen bump.  That went away within 2 days.  The following Thursday, my arm began to itch.  The injection site became swollen and red again.  The red bump grew to a diameter of about 6 inches over the next day.  5 days later, it is still itchy and I still have a large bump.  It is not as red as it was before.
23AUg94 1030AM began having chills & fever plus h/a & puffy eyes;