chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate to severe muscle aches; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EK9231, expiry date: not reported), via an unspecified route of administration on 07Jan2021 05:30 PM at a single dose on the right arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included arthritis, hypersomnia, depression, anxiety, IBS (irritable bowel syndrome) and allergy to sulfa. Concomitant medications included desvenlafaxine succinate (PRISTIQ), modafinil (MODAFINIL), fluticasone propionate (FLONASE), ibuprofen (IBUPROFEN). The patient  previously received the first dose of bnt162b2 (BNT162B2, lot number: EK5730) on 16Dec2020 05:30 PM at a single dose on the right arm for COVID-19 immunization (age at vaccination: 37-year-old). On 08Jan2021 07:00 AM, the patient experienced moderate to severe muscle aches, joint pain, and fatigue. No treatment was received for the events. Outcome of the events was recovered/resolved with sequel. The reporter assessed the events as non-serious. Since the vaccination, the patient not been tested for COVID-19.
Shooting-sharp pains  above the L elbow lateral/posterior ; lasts a few minutes then subsides. Not aggregated with movement nor relief with repostioning. Occurs randomly several times through the day.
Aches, tiredness, joint pain, nausea, vomiting, injection site swelling and redness
Injection site on left detoid was slightly sore for 2 days. Then 9 days post injection, dry skin with itchy rash began on upper left back and shoulder area. 19 days post injection, red itchy spots  noted on upper left shoulder and down bicep of left arm, initially to elbow joint. Pulsing muscle pain, level 4 on pain scale at site of vaccination in deltoid muscle that extended down through bicep to elbow area. No problems on tricep muscle. Slight headache with achy body and malaise. Body temperature normal. Difficulty sleeping due to pain. Painful left shoulder joint. Limited motion due to pain. Pulsing muscle pain up left side of neck to ear. Diagnosed as shingles on 11/06/2018.
Legs Rubbery; Weak; Feels like Flu; Swollen Lymph Gland the size of a baseball; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache). At the time of the report, MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
throat started feeling tight; Throat was swollen; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (throat started feeling tight) and PHARYNGEAL SWELLING (Throat was swollen) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Allergy to animal and Allergy to chemicals (possible polyethylene glycol allergy).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced THROAT TIGHTNESS (throat started feeling tight) (seriousness criterion life threatening) and PHARYNGEAL SWELLING (Throat was swollen) (seriousness criterion life threatening). At the time of the report, THROAT TIGHTNESS (throat started feeling tight) and PHARYNGEAL SWELLING (Throat was swollen) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medication was not provided. Based on the current available information which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.
Severe varicelliform eruption, primarily on right leg, occurring approximately ten days after vaccinations given as below; Varivax was given in the right leg.
Arm would hurt for a day or 2; Initial information was received on 05-Nov-2021 regarding an unsolicited valid social media non-serious case received from Regulatory Authority.  This case involves a patient (unknown age and unknown gender) who experienced arm would hurt for a day or 2 (pain in extremity) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient experienced arm would hurt for a day or 2 (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got the senior shot in early Oct and had a 4 day reaction to it. Usually with the regular shot my arm would hurt for a day or 2".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.    At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
CDC recommended pneumovax-20 but pharmacy only had prevnar-13 in stock at the time.  We thought it would be best that prevnar-13 be given to the patient rather than no pneumonia vaccine.  Patient was notified to come after 12 months to receive the pneumovax-23 vaccine to complete the series
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of RECOMBIVAX HB (lot # L001456 with expiry date 22-OCT-2016, lot # reported as L020216 with expiry date 17-SEP-2016 and lot # L025738 with expiry date 14-AUG-2017; route was not reported), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Cough; Runny nose; Malaise; Chest pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose), MALAISE (Malaise), CHEST PAIN (Chest pain) and PYREXIA (Fever) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose), MALAISE (Malaise), CHEST PAIN (Chest pain) and PYREXIA (Fever). At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose), MALAISE (Malaise), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
About 40 minutes after the injection, I experienced numbness in the left side of my face from lower eyelid to upper lip. The skin was numb to the touch and I had the sensation that my face was drooping, although visually it did not appear to be. The sensation dissipated within about 20 minutes and has not returned.  I am 9.5 weeks pregnant. Estimated due date 7/13/2021. As far as I know at this point, there are no pregnancy complications.
Patient was administered his 2nd dose of Moderna vaccine. Patient was instructed to wait in the store for 15 minutes after the shot. Patient was sitting in a chair in the designated waiting area and decided to look at the vitamins. Next thing I knew, patient fainted and hit the floor. Patient was taken back to the chair where he was sitting and instructed to wait another 20 minutes. I watched the patient very closely. Patient was given water and OJ. Pt told me that he put nicotine gum in his mouth a minute before I injected him.
Approx 30 min to 45 min after immunization child was brought back to clinic with flushed face, red eyes and coughing and started to show signs of hives on back and chest. B/p was 100/80 0.3 ml of Benadryl was given IM. He immediately started to look better.
Fatigue onset was around 12:30am about 10 hours after receiving the vaccine. Woke the next morning around 8am very achy, fatigued, and with a headache that lasted about 3 hours. Became more achy over the next several hours until about 1pm when I started to feel a little better. Headache and aches returned and became worse around 10pm that night. Still a little achy in the legs and shoulders the next day but fine otherwise.
Flu vaccine given to 3 month infant at flu clinic -> MD notified after administered and mom called offc. No adverse reactions at this time.
Breakthrough case admission after 3 vaccines Pfizer 3/5/21 Lot# En6200;  Pfizer 3/26/21 Lot# EN6202;  Pfizer 12/17/21 Lot# 330130BA
Swelling of tongue; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150), via an unspecified route of administration in left arm on 06Apr2021 at 09:30 (at the age of 63 years) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in right arm on 16Mar2021 at 09:30 as single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021 at 19:00, patient experienced swelling of tongue. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event swelling of tongue was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Chest discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary vasospasm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included vitamin b12 (MANUFACTURER UNKNOWN), clopidogrel bisulfate (MANUFACTURER UNKNOWN), diltiazem (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 04:30, the patient experienced chest discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event chest discomfort was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt was given the tdap and menveo in the right deltoid, pt was given the flu and HPV in the left deltoid. Pt mom brought him back in the next day with the right arm red and hot to the touch. pt was seen by the provider and she prescribed antibiotic cephalexin 500 mg three times daily for one week and loratadine 10 mg daily she advised him to ice it and marked redness with pen
Pain under arm of injection site (left) noticed upon waking up. Ibuprofen taken orally
Pt reported slept all day Tues 11-09-10. Ran fever that pm (11 09 10) on 11-10-10 both arms very red (large area) around site - no heat noted to area. Reports arms sore. BENADRYL started per mom & cold compresses.
Fully body rash on chest, arms, face urticaria, maculopapular rash pruritic: Also on legs
Pt was admitted on 2/19/12 with ITP and treated. Vaccine was given on 1-26-12. Pt has been in remission for 1 yr now.
felt bad; fever; pain in his shoulder; This is a spontaneous report from a non-contactable consumer (patient parent) via medical information team. A 17-Year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Unknown) as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Unknown) as a single dose for COVID-19 immunization. On an unspecified date, the patient felt bad and had a fever. The patient had 800mg Tylenol which helped. That night, the patient had fever again and had 500 mg of Tylenol, which helped once again. The patient experienced pain in shoulder. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash and itching on left upper arm 1 inch below shot entrance. About 5 inches long and 4 inches wide
Flu like symptoms since vaccination adminstration. Body aches, chest and sinus congestion. No noted temperature. Left arm and shoulder pain.
1) small orange-sized mass in left breast with redness, warmth, pain 2) Tingling pain radiating across back from waist to shoulders
administered an expired Daptacel vaccine, NO AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.   This case involves an 18 months old female patient who received an expired Daptacel vaccine (expired product administered), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included VARICELLA ZOSTER VACCINE (varicella vaccine).   On 05-Feb-2020, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5367AA and expiry date: 30-Jan-2020 via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022; dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     BMI was reported as 40.0-44.9 Patient had no known drug allergies. Patient had morbid (severe). Patient not tested positive for COVID within last month.  The patient's past medical history included Tubal ligation. Concurrent medical conditions included Obesity, Hyperlipidemia, Acute atopic conjunctivitis, Visual disturbances, Acute nasopharyngitis, Tooth development disorder, Pain in knee, Cervical pain, Snoring, Pelvic pain, Perineal pain, Glucose abnormal, Vitamin D deficiency and Gastritis haemorrhagic. Concomitant products included FAMOTIDINE, SALBUTAMOL (VENTOLINE [SALBUTAMOL]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN D3 for an unknown indication.    On 30-Mar-2022 at 10:40 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022 at 10:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The product expiration date was 25-Mar-2022. It was reported that HCP confirmed the patients did not experience any side effects yet. On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022 and expired. The vial did not undergo any temperature excursions. Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a multiple unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with VARIVAX (lot # M033907 with expiration date: 20-JUL-2017, lot # M033214 with expiration date: 13-JUL-2018), for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) lot # reported as N015632 with expiration date: 18-FEB-2019. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA000187:
Chills, fever of 101.7F (tympanic), body aches, and mild headache starting at 1:00AM.  Chills subsided and transitioning to sweats between 4:00-6:00 AM. Ibuprofen 600mg taken at 4:15AM. Body aches improved until about 2:00PM. Sweats fluctuated between 6:00am and 5:00pm on 1/21/2021. Full resolution of symptoms by 5:00PM on 1/21/2021.
After imms administered, the client c/o itching inside his throat, frequent spitting and foals from eyes noted. Very later wheezing and soft tone grunting present. 911 was called. Client evaluated by EMS staff. Symptoms ceased within minutes without treatment.
pt recvd vax & devel elevated temp w/in 24 hrs p/vax; temp not measured-cont x 1 wk; had high pitched scream, unconsolable, for periods < 3 hrs; occurred periodically 3-4 days; sleeplessness 7-10 days; seen by MD 5OCT93;
A lot of pain in my legs; walking very hard; pain wakes me up at night; headaches;
Second Varivax administered SQ to left upper arm.  Pt with questionable neomycin allergy.  Pt with erythematous area about 5cm by 5cm and with a 3cm raised wheal at injection site.  Pt waited in office after injection 20 minutes and then CPNP observed reaction.  Benadryl 2 tsp given.  Slight decrease in redness and size of redness about 10 minutes after Benadryl administered.  Followup the next day revealed no increase in reaction and redness continuing to decrease.  Mom called 2 days after vaccine given, and still with pink raised area and warm to touch - mom advised to come in if area increased in size or symptoms persisted.
Patient presented after syncopal episode and abdominal pain, was found to have profound thrombocytopenia. CT abdomen was done which was concerning for ruptured ovarian cyst. Hgb dropped to 5.8, plts at time of report were 13. Patient transferred to the ICU for further management
The administer said the injection felt "weird" after injecting patient. She then gave my daughter her injection and said that felt normal.  She said it felt like there was no pressure pushing the plunger as though it was empty.  She thinks that was an empty syringe.
losing weight; loss my sense of taste; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient of unknown age and gender who experienced losing weight (Weight decreased) and loss my sense of taste (Ageusia), while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for vaccination.  On an unknown  date (unknown latency), the patient developed a non-serious losing weight (weight decreased) and loss my sense of taste (ageusia)following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Final diagnosis was loss my sense of taste and losing weight.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for losing weight and for loss my sense of taste.