chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix in 2018/ Two months ago (April 2021) she received the second dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date in 2018).   In April 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient asked the pharmacist to restart the series and to schedule her for a third vaccine, but the pharmacist refused to administer a third vaccine.  The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: found an extra diluent / have mixed a /lyophilized component with sterile water; found an extra diluent / have mixed a /lyophilized component with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, 2 weeks ago, she found an extra diluent and healthcare professional must have mixed lyophilized component of Menveo which was reconstituted with sterile water, which led to wrong solution used for drug reconstitution and inappropriate dose of vaccine administered. The reporter also mentioned that, no additional details at the moment as they have not determined which patient received the dose. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: new born / administrated with an expired / Engerix-B on June 16 2021 /expired on April 6 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 3JD32, expiry date 6th April 2021) for prophylaxis.   On 16th June 2021, the patient received Engerix B. On 16th June 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 16th June 2021, the new born patient received Engerix B, which was expired on 6th April 2021. No adverse events were reported. No patient identifier was provided. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose of Shingrix / 03/10/2020/ did not receive 2nd shot yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were provided for 1st dose of Shingrix. The reporter consented to follow-up. No further information was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Injection site pain, Pain
Clinical narrative: FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches, blood pressure abnormal, iodine allergy, non-alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches, blood pressure abnormal, iodine allergy, non-alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: TROUBLE WITH HER VISION ON HER RIGHT SIDE; NUMBNESS IN RIGHT ARM AND LEG; TINGLING IN RIGHT ARM AND LEG; PRESSURE ON RIGHT SIDE OF HEAD; HEADACHE; PAINFUL ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and pain very rarely in her left leg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced painful arm. On 30-MAY-2021, the subject experienced tingling in right arm and leg. On 30-MAY-2021, the subject experienced pressure on right side of head. On 30-MAY-2021, the subject experienced headache. On 31-MAY-2021, the subject experienced numbness in right arm and leg. On an unspecified date, the subject experienced trouble with her vision on her right side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble with her vision on her right side, and painful arm on 29-MAY-2021, was recovering from headache, and pressure on right side of head, and had not recovered from numbness in right arm and leg, and tingling in right arm and leg. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: TROUBLE WITH HER VISION ON HER RIGHT SIDE; NUMBNESS IN RIGHT ARM AND LEG; TINGLING IN RIGHT ARM AND LEG; PRESSURE ON RIGHT SIDE OF HEAD; HEADACHE; PAINFUL ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and pain very rarely in her left leg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced painful arm. On 30-MAY-2021, the subject experienced tingling in right arm and leg. On 30-MAY-2021, the subject experienced pressure on right side of head. On 30-MAY-2021, the subject experienced headache. On 31-MAY-2021, the subject experienced numbness in right arm and leg. On an unspecified date, the subject experienced trouble with her vision on her right side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble with her vision on her right side, and painful arm on 29-MAY-2021, was recovering from headache, and pressure on right side of head, and had not recovered from numbness in right arm and leg, and tingling in right arm and leg. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Influenza like illness, Insomnia, Pain
Clinical narrative: LACK OF SLEEP; FEELING DRUGGY; FLU LIKE SYMPTOMS; SENSITIVITY; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unknown) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On 11-JUN-2021, the subject experienced lack of sleep. On 11-JUN-2021, the subject experienced feeling druggy. On 11-JUN-2021, the subject experienced flu like symptoms. On 11-JUN-2021, the subject experienced sensitivity. Laboratory data included: Body temperature (NR: not provided) 98.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lack of sleep, feeling druggy, flu like symptoms and sensitivity was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SITE HURTS; INJECTION SITE REDNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; NERVE PAIN EVERYWHERE; PAIN IN LUNGS WHEN TALKING OR MOVING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included fluticasone furoate for covid-19.  On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced nerve pain everywhere. On 10-JUN-2021, the subject experienced pain in lungs when talking or moving. On 10-JUN-2021, the subject experienced chills. On 10-JUN-2021, the subject experienced too tired. On 10-JUN-2021, the subject experienced injection site pain/ arm at injection site hurts. On 10-JUN-2021, the subject experienced injection site redness. On 10-JUN-2021, the subject experienced headache. On 10-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 14-JUN-2021, the subject experienced red spots under skin on chest and arms. Treatment medications (dates unspecified) included: salbutamol sulfate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-JUN-2021, was recovering from shortness of breath, and injection site redness, had not recovered from nerve pain everywhere, injection site pain/ arm at injection site hurts, red spots under skin on chest and arms, and headache, and the outcome of pain in lungs when talking or moving and too tired was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Neuralgia, Pulmonary pain, Pyrexia
Clinical narrative: RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SITE HURTS; INJECTION SITE REDNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; NERVE PAIN EVERYWHERE; PAIN IN LUNGS WHEN TALKING OR MOVING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included fluticasone furoate for covid-19.  On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced nerve pain everywhere. On 10-JUN-2021, the subject experienced pain in lungs when talking or moving. On 10-JUN-2021, the subject experienced chills. On 10-JUN-2021, the subject experienced too tired. On 10-JUN-2021, the subject experienced injection site pain/ arm at injection site hurts. On 10-JUN-2021, the subject experienced injection site redness. On 10-JUN-2021, the subject experienced headache. On 10-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 14-JUN-2021, the subject experienced red spots under skin on chest and arms. Treatment medications (dates unspecified) included: salbutamol sulfate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-JUN-2021, was recovering from shortness of breath, and injection site redness, had not recovered from nerve pain everywhere, injection site pain/ arm at injection site hurts, red spots under skin on chest and arms, and headache, and the outcome of pain in lungs when talking or moving and too tired was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SITE HURTS; INJECTION SITE REDNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; NERVE PAIN EVERYWHERE; PAIN IN LUNGS WHEN TALKING OR MOVING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included fluticasone furoate for covid-19.  On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced nerve pain everywhere. On 10-JUN-2021, the subject experienced pain in lungs when talking or moving. On 10-JUN-2021, the subject experienced chills. On 10-JUN-2021, the subject experienced too tired. On 10-JUN-2021, the subject experienced injection site pain/ arm at injection site hurts. On 10-JUN-2021, the subject experienced injection site redness. On 10-JUN-2021, the subject experienced headache. On 10-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 14-JUN-2021, the subject experienced red spots under skin on chest and arms. Treatment medications (dates unspecified) included: salbutamol sulfate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-JUN-2021, was recovering from shortness of breath, and injection site redness, had not recovered from nerve pain everywhere, injection site pain/ arm at injection site hurts, red spots under skin on chest and arms, and headache, and the outcome of pain in lungs when talking or moving and too tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Epistaxis
Clinical narrative: NOSE BLEED; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythemia vera.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered IN MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 5 mg, 2 times every 1 total, from JUL-2020 for polycythemia vera. No concomitant medications were reported.  In MAR-2021, the patient experienced nose bleed for 1 day and stopped. Then a week later, she had a nose bleed that lasted for 5 straight days. For the past 2 weeks before reporting, patient had only 1 nose bleed. Patient reported her nose bleed to physician, who suggested her to keep a watch on nose bleed. The patient had not experienced nose bleed until recently and wondered if receiving the vaccine and having nose bleed were related. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The outcome of nose bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210629648-covid-19 vaccine ad26.cov2.s -Nose bleeding. 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, UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative for Neutralizing Antibodies. Patient had confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000182890. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210629741-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS PUT IN SYRINGE AND LEFT AT ROOM TEMPERATURE; VACCINE ADMINISTERED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; .This spontaneous report received from a health care professional concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was new at clinic and no medical history on file. the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 202A21A expiry: 07/AUG/2021) dose was not reported, administered on 14-JUN-2021 13:36 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced vaccine was put in syringe and left at room temperature. On 14-JUN-2021, the subject experienced vaccine administered outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of the recommended storage conditions and vaccine was put in syringe and left at room temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629846.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Pain in extremity
Clinical narrative: PAIN IN GROIN; PAIN IN ARM/PAIN IN THIGH; PAIN IN SHOULDER; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in groin, pain in arm/pain in thigh, and pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm/pain in thigh, pain in groin, and pain in shoulder. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: ARMS ACHE; HIP ACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced arms ache. On 09-JUN-2021, the subject experienced hip ache. On 09-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, arms ache and hip ache was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE OF VACCINE GIVEN TO PATIENT FROM A VIAL THAT HAD BEEN PUNCTURED PREVIOUS MORNING; This spontaneous report received from a pharmacist concerned a 71 year old male. 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, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced dose of vaccine given to patient from a vial that had been punctured previous morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose of vaccine given to patient from a vial that had been punctured previous morning was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Malaise, Muscle contracture
Clinical narrative: FATIGUE; LEFT HAND CLENCHED INTO FIST FOR THE PAST TWO MONTHS AND A HALF; PREVIOUS RIGHT SIDED NUMBNESS WAS MORE INTENSE; DECREASED ENERGY; FEELING UNWELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, numbness of the right side, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced left hand clenched into fist for the past two months and a half. On 26-MAR-2021, the subject experienced previous right sided numbness was more intense. On 26-MAR-2021, the subject experienced decreased energy. On 26-MAR-2021, the subject experienced feeling unwell. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left hand clenched into fist for the past two months and a half on 15-MAY-2021, had not recovered from decreased energy, feeling unwell, and previous right sided numbness was more intense, and the outcome of fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PATIENT RECEIVED THE VACCINE 9.5 HOURS AFTER VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  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, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the patient experienced patient received the vaccine 9.5 hours after vial puncture. On 10-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the vaccine 9.5 hours after vial puncture and incorrect product storage was not reported. This report was non-serious.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine vial was diluted with bacterialstatic sodium chloride 0.9%. Customer is aware and is no wanting t be revaccined.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "vaccine arm" one week after first dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt. stated, "I felt dizzy 10 minutes after getting vaccinated."   Vital signs within normal range.  At 11:36am pt. stated, "I feel much better now."  At 10:43am pt. stated, "I'm ok now, I can go home."  Pt. went home at 10:44am.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Measles, Pruritus
Clinical narrative: Yesterday I finished the vaccination and now I have measles on my skin and itching. Is it an allergic reaction? Is this serious?
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Myalgia, Pain, Sleep disorder
Clinical narrative: 2:30am cst I woke up in a lot of pain. My whole body was being racked by wave after wave of muscle soreness. Anything that touched my bed hurt. I tried sitting up, turning over side to side, and the pain continued. This was accompanied by a severe chill that caused my teeth to rattle. The apartment was set to 68 which is slightly warm to me. I got up to go to the restroom and my legs grew tired almost immediately. I?ve tried laying back down and getting back up 2 more times. The chill and the pain have continued now for 3 hours and 17 minutes, although the chill has diminished to a mild child instead of severe. No notable fever has been measured thus far.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt that he was about to pass out and almost fell from the chair. He then lied down on the floor. He was awake and alert, was able to breathe normally. EMS arrived and checked on him saying his heart rate and blood pressure were normal. He wanted to be taken to the hospital to get checked up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypertension, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: After 3 hours patient said feeling better.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tachycardia, Tremor
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: After 3 hours patient said feeling better.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Eye swelling, Hypoaesthesia, Mouth swelling, Paraesthesia oral
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Upon awakening after the first moderna dose, patient discovered that her tongue felt swollen and raw.  Foods such as A1 steak sauce became intolerably spicy and all other foods lost their taste.  Patient had covid test prior a day prior to receiving the vaccine and had negative test results.  Patient's tongue has not improved over the 28 days from the first dose.  Has taken benadryll with no improvemet and is still mildly swollen.  Upon evaluation by pharmacist, tongue lacked bright red color.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Taste disorder, Tongue discolouration
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Upon awakening after the first moderna dose, patient discovered that her tongue felt swollen and raw.  Foods such as A1 steak sauce became intolerably spicy and all other foods lost their taste.  Patient had covid test prior a day prior to receiving the vaccine and had negative test results.  Patient's tongue has not improved over the 28 days from the first dose.  Has taken benadryll with no improvemet and is still mildly swollen.  Upon evaluation by pharmacist, tongue lacked bright red color.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Headache, Muscular weakness
Clinical narrative: severe headache dizziness fatigue arm soreness muscle weakness myalgia moderate chest pain heart palpitations  the dizziness appeared approximately 11 hours after the 2nd dose and the other symptoms appeared later in the day. the chest pain and heart palpitations also occurred with the first dose of the vaccine. symptoms resolved within 24 hours of onset.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Palpitations
Clinical narrative: severe headache dizziness fatigue arm soreness muscle weakness myalgia moderate chest pain heart palpitations  the dizziness appeared approximately 11 hours after the 2nd dose and the other symptoms appeared later in the day. the chest pain and heart palpitations also occurred with the first dose of the vaccine. symptoms resolved within 24 hours of onset.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufacture. initial and booster)
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood test, Computerised tomogram, Confusional state, Dysarthria
Clinical narrative: 24 hours after my second vaccine I started to get an ocular migraine which quickly progressed to speech slurring, numbness in right arm and left hand and confusion. I was unable to speak. I regained my vision the next afternoon after taking Butalbital every 4 hours. That next day I started my period despite being on birth control and taking my pill regularly. I had two other ocular migraines in the next 7 days.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Menstruation normal, Ophthalmic migraine, Urine analysis
Clinical narrative: 24 hours after my second vaccine I started to get an ocular migraine which quickly progressed to speech slurring, numbness in right arm and left hand and confusion. I was unable to speak. I regained my vision the next afternoon after taking Butalbital every 4 hours. That next day I started my period despite being on birth control and taking my pill regularly. I had two other ocular migraines in the next 7 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: EMS Called
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Paraesthesia, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on neck
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Mild, Additional Details: Patient complaint of being feeling hot after the vaccination, gave her cold water to drink and made her lie down on the floor, fanned her, soon she was feeling better, got up and sat back on the chair, she was feeling good after wards and left.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient experienced a mild rash after the first dose of Moderna on 5/13/2021, and she took Benadryl which helped but made her drowsy. So she didn't want to take Benadryl for the second dose. After 4 hours of receiving the second dose of Moderna on 6/17/2021, patient experienced the rash, and it was harsher than the first time. She still won't take the Benadryl since it makes her drowsy. Besides the rash, the patient states that she is fine when I asked her how she is feeling.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated, Epistaxis, Gait disturbance
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient experienced a mild rash after the first dose of Moderna on 5/13/2021, and she took Benadryl which helped but made her drowsy. So she didn't want to take Benadryl for the second dose. After 4 hours of receiving the second dose of Moderna on 6/17/2021, patient experienced the rash, and it was harsher than the first time. She still won't take the Benadryl since it makes her drowsy. Besides the rash, the patient states that she is fine when I asked her how she is feeling.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Peripheral swelling, Rash, Stomatitis, Swelling
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient experienced a mild rash after the first dose of Moderna on 5/13/2021, and she took Benadryl which helped but made her drowsy. So she didn't want to take Benadryl for the second dose. After 4 hours of receiving the second dose of Moderna on 6/17/2021, patient experienced the rash, and it was harsher than the first time. She still won't take the Benadryl since it makes her drowsy. Besides the rash, the patient states that she is fine when I asked her how she is feeling.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Severe
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Lymphadenopathy, Night sweats, Parosmia
Clinical narrative: When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3,  Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine.  Had a fever on Day 4 & 5 after the Covid Vaccine.  Would wake up in the night with her bed soaked with sweat and she would have to change her clothes.  She had a horrible smell in her nostrils.  Had diarrhea.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3,  Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine.  Had a fever on Day 4 & 5 after the Covid Vaccine.  Would wake up in the night with her bed soaked with sweat and she would have to change her clothes.  She had a horrible smell in her nostrils.  Had diarrhea.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Confusional state, Diarrhoea, Eye swelling, Headache
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Headache-Medium
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Mouth swelling, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Headache-Medium
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Swollen tongue
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Headache-Medium
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: She received Moderna lot 033B21A dose 1 on May 29.  On May 31st she started to develop significant intermittent dizzy spells.  By June 2 she had started having additionally diffuse joint pains and focal left heel pains that then started to spread up from the heel to the knees bilaterally, constant fatigue, and tingling sensations in the bilateral hands and bilateral lower legs.  Her joint pains have started to improve in general and her heel pain finally started to ease up as of June 16.  Her dizzy spells remain intermittent and impactful.  She has been on work from home status out of precaution.  She has not seen any improvement in the tingling sensations for the past 2 weeks.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: She received Moderna lot 033B21A dose 1 on May 29.  On May 31st she started to develop significant intermittent dizzy spells.  By June 2 she had started having additionally diffuse joint pains and focal left heel pains that then started to spread up from the heel to the knees bilaterally, constant fatigue, and tingling sensations in the bilateral hands and bilateral lower legs.  Her joint pains have started to improve in general and her heel pain finally started to ease up as of June 16.  Her dizzy spells remain intermittent and impactful.  She has been on work from home status out of precaution.  She has not seen any improvement in the tingling sensations for the past 2 weeks.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hallucination, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, Hallucinations, extremely sore arm
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Eructation, Headache, Heart rate irregular
Clinical narrative: Headache, fever, heavy chest, racing heart rate, muscle spasms throughout entire body, muscle cramping, random uncontrollable burping, chills
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Headache, fever, heavy chest, racing heart rate, muscle spasms throughout entire body, muscle cramping, random uncontrollable burping, chills
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio increased, Unevaluable event
Clinical narrative: 6/15/2021 INR was 1.9.  Second COVID vaccine received 6/16/201/21.  INR on 6/17/2021 was 3.6. No other changes with health, medication, lifestyle, etc. occurred.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, Pain, Pruritus, Rash
Clinical narrative: I started to have pain and skin sensitivity along sciatic nerve on my left side on 4/12, 10 days after receiving first COVID vaccine. 3 days later a rash started to develop in the same area. The rash continued to spread along back of left leg onto bottom of my left foot over the next week, accompanied by pain, sensitivity and itchiness. All symptoms subsided and resolved within about 6 weeks from onset.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: I started to have pain and skin sensitivity along sciatic nerve on my left side on 4/12, 10 days after receiving first COVID vaccine. 3 days later a rash started to develop in the same area. The rash continued to spread along back of left leg onto bottom of my left foot over the next week, accompanied by pain, sensitivity and itchiness. All symptoms subsided and resolved within about 6 weeks from onset.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Anxiety, Cognitive disorder, Confusional state, Gait disturbance
Clinical narrative: CONFUSION, MEMORY LOSS, ANXIETY, UNSTABLE GAIT.  EXAM SHOWS DECLINE IN SHORT TERM MEMORY AND COGNITIVE FUNCTION WHICH WAS RAPID FROM PRIOR VISITS WHERE NEUROCOGNITIVE FUNCTION WAS COMPLETLEY NORMAL.  GAIT  IS SLIGHTLY ATAXIC
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging head, Memory impairment, Neurological examination
Clinical narrative: CONFUSION, MEMORY LOSS, ANXIETY, UNSTABLE GAIT.  EXAM SHOWS DECLINE IN SHORT TERM MEMORY AND COGNITIVE FUNCTION WHICH WAS RAPID FROM PRIOR VISITS WHERE NEUROCOGNITIVE FUNCTION WAS COMPLETLEY NORMAL.  GAIT  IS SLIGHTLY ATAXIC
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac monitoring, Electrocardiogram, Heart rate increased, Heart rate irregular
Clinical narrative: After my vaccine on 03/17/21 I started experiencing a rapid heart beat and at time my heart would skip!  I reported this to the Covid 19 hotline immediately and also notified my doctor!  My doctor scheduled a visit and did an EKG and also ordered a heart monitor which I wore for two weeks.  The report from that went to Dr, a cardiologist at clinic where I was diagnosed as having Afib.  I was shocked since my heart has always been healthy and heart disease does not run in my family!  I was put on a beta blocker because of the concern of having a stroke!  A follow-up visit to discuss a procedure that will fix my Afib in scheduled for 06/22/21.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test
Clinical narrative: After my vaccine on 03/17/21 I started experiencing a rapid heart beat and at time my heart would skip!  I reported this to the Covid 19 hotline immediately and also notified my doctor!  My doctor scheduled a visit and did an EKG and also ordered a heart monitor which I wore for two weeks.  The report from that went to Dr, a cardiologist at clinic where I was diagnosed as having Afib.  I was shocked since my heart has always been healthy and heart disease does not run in my family!  I was put on a beta blocker because of the concern of having a stroke!  A follow-up visit to discuss a procedure that will fix my Afib in scheduled for 06/22/21.