chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Immediate post-injection reaction, Injection site urticaria, Malaise, Nausea
Clinical narrative: Have edema in his throat/Have swelling his throat; Have edema in his esophagus/Have swelling esophagus; he has not been able to eat or drink normally; Not been able to eat or drink normally has lost 40 pound; Developed a welt at the injection site the size of a baseball; Feeling very nauseous; Feeling sick; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   Concurrent medical conditions included tooth infection. Concomitant products included amoxicillin + clavulanic acid (Augmentin).   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2021, immediately after receiving Shingrix, the patient experienced injection site wheal, nausea and feeling unwell. In August 2021, the patient experienced throat edema, esophageal edema, swallowing difficult and weight loss. On an unknown date, the outcome of the injection site wheal, nausea and feeling unwell were recovered/resolved and the outcome of the throat edema and esophageal edema were not recovered/not resolved and the outcome of the swallowing difficult and weight loss were unknown.   It was unknown if the reporter considered the injection site wheal, nausea, feeling unwell, throat edema, esophageal edema, swallowing difficult and weight loss to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient received Shingrix in his left arm.  Soon after receiving the injection, he reported feeling very nauseous and sick, and he developed a welt at the injection site the size of a baseball. These symptoms last 3 days before resolving.  The reporter then stated that about one week after the vaccine, he began to had swelling and edema in his throat and esophagus and described his throat as a riverbed of rocks. He stated he had not been able to eat or drink normally since then and has lost 40 pounds.  The patient had an appointment for a GI (gastro-intestinal) exam later this week.  The reporter stated at the time of the Shingrix vaccine he was also suffering from a tooth infection and was being treated with the antibiotic Augmentin.  The patient reported the swelling of his throat and esophagus were the worst from the months of October through December and are still unresolved.  The patient stated that he would not be taking the second dose of Shingrix due to the adverse events experienced. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Oesophageal oedema, Pharyngeal oedema, Weight decreased
Clinical narrative: Have edema in his throat/Have swelling his throat; Have edema in his esophagus/Have swelling esophagus; he has not been able to eat or drink normally; Not been able to eat or drink normally has lost 40 pound; Developed a welt at the injection site the size of a baseball; Feeling very nauseous; Feeling sick; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   Concurrent medical conditions included tooth infection. Concomitant products included amoxicillin + clavulanic acid (Augmentin).   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2021, immediately after receiving Shingrix, the patient experienced injection site wheal, nausea and feeling unwell. In August 2021, the patient experienced throat edema, esophageal edema, swallowing difficult and weight loss. On an unknown date, the outcome of the injection site wheal, nausea and feeling unwell were recovered/resolved and the outcome of the throat edema and esophageal edema were not recovered/not resolved and the outcome of the swallowing difficult and weight loss were unknown.   It was unknown if the reporter considered the injection site wheal, nausea, feeling unwell, throat edema, esophageal edema, swallowing difficult and weight loss to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient received Shingrix in his left arm.  Soon after receiving the injection, he reported feeling very nauseous and sick, and he developed a welt at the injection site the size of a baseball. These symptoms last 3 days before resolving.  The reporter then stated that about one week after the vaccine, he began to had swelling and edema in his throat and esophagus and described his throat as a riverbed of rocks. He stated he had not been able to eat or drink normally since then and has lost 40 pounds.  The patient had an appointment for a GI (gastro-intestinal) exam later this week.  The reporter stated at the time of the Shingrix vaccine he was also suffering from a tooth infection and was being treated with the antibiotic Augmentin.  The patient reported the swelling of his throat and esophagus were the worst from the months of October through December and are still unresolved.  The patient stated that he would not be taking the second dose of Shingrix due to the adverse events experienced. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: 2 episodes of numbness in his legs from the thigh down; This case was reported by a consumer via call center representative and described the occurrence of numbness in leg in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2022, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In March 2022, less than 2 months after receiving Shingrix, the patient experienced numbness in leg. On an unknown date, the outcome of the numbness in leg was unknown.   It was unknown if the reporter considered the numbness in leg to be related to Shingrix.   Additional Information: GSK receipt date: 24-MAR-2022 Reporter's comment: The case was reported by the patient. The patient had received Shingrix vaccine in his left arm at his pharmacy.  Two weeks ago, he had 2 separate episodes of numbness in his legs from the thigh down while he was standing.  In order for the numbness to resolve, he had to lay down and move around his legs.  The reporter could not provide the lot or expiration date. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose oN August 11th 2021 2nd dose October 22nd 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult male patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 22nd October 2021, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 22nd October 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-March-2022 Additional Supportive Information: The age at vaccination was not reported. Registered pharmacist reported that a patient received 2nd dose of Havrix earlier than the recommended interval, which led to drug dose administration interval too short. HCP (health care professional) wanted to know how to proceed in this situation and if a 3rd dose was needed. The reporter only provided that this was an adult patient. No further information reported. The reporter consented to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the first dose on 18-jan-2022 and has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional information: GSK Receipt Date: 24-MAR-2022 Reporter's Comment: The pharmacist reported a patient received the first dose of Twinrix on 18th January 2022. The reporter consented to follow up. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Asthma
Clinical narrative: asthma attack/ prednisone-requiring exacerbation following administration of Shingrix; This case was reported by a physician via call center representative and described the occurrence of asthmatic attack in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and immunosuppression.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced asthmatic attack. The patient was treated with prednisone. On an unknown date, the outcome of the asthmatic attack was recovered/resolved.   It was unknown if the reporter considered the asthmatic attack to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-March-2022 and 24-March-2022 Additional Supportive Information: The age at vaccination was not reported. The patient was in his 60's. The patient's age and initials, date vaccine given, batch and expiration was unknown. The patient was a known asthmatic. The physician stated that a patient in received his dose of Shingrix several years ago and had an asthma attack (severe, prednisone-requiring exacerbation) and now a similar occurrence after third Covid vaccine dose.  Duration of effect was known. The patient was immunosuppressed and a fourth booster of Moderna was now recommended.  The patient was hesitant to receive because of reaction to last Covid dose. The physician had nothing else to report. The reporter had limited information at the time of reporting. The physician was trying to determine if there was a common ingredient between Shingrix and Moderna Covid vaccine. The components of the latter were listed on website, but physician unable to locate component list for Shingrix. The physician was asking for help and asking if we aware of any similar components between the two vaccines. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received expired dose yesterday.; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-Mar-2022 Reporter's Comment: The reporter consented to follow up. Additional supportive information: On the day before reporting, the patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only received first dose on 6-OCT-2020; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 6th October 2020 from batch number GM2Y4 with expiry date 10th May 2022).   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 Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The pharmacy technician reported that, the patient only received their first dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEP
Symptoms: Adult failure to thrive, Underdose
Clinical narrative: pediatric dose administered to adult; pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 38-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 20th September 2022) for prophylaxis.   On 24th March 2022, the patient received Engerix B pediatric. On 24th March 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date:24-Mar-2022 Reporter's Comments:  Reporter consented to follow up. Reporter declined to provide date of birth (DOB )for patient Additional Supportive Information: The pediatric dose of Engerix-B administered to an adult patient, which led to adult use of a child product and underdose.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered vaccine 5 days after expiration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The reporter stated that, the patient was administered a dose of Twinrix vaccine 5 days after the expiration date and asked that did we need to readminister. No consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019, has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2019).   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 Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The patient received the first dose of Shingrix and had not received dose two. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, 2nd dose of Shingrix was not received by the patient, which led to incomplete course of vaccination.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: ROTARIX via injection in the left thigh; This case was reported by a consumer via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 24th March 2022, the patient received Rotarix lyophilized formulation (injection) and Rotarix Oral Applicator Device. On 24th March 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022054975   Additional Information: GSK Receipt Date: 24-MAR-2022 Reporter's Comment:  The patient's mother reported on behalf of her child. The reporter reported that the nurse at the facility administered Rotarix via injection in the left thigh of her baby instead of giving the vaccine orally. The reporter would like to know if she needed to look out for any side effects , so information provided to her, telephone number for HCP (health care professional) to call.  The consent was obtained to contact reporter and HCP for follow-up but she declined to provide her contact information and her Childs name.  Additional supportive information: The Rotarix dose was given via injection instead of giving it orally, which led to Inappropriate route of vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Psoriasis, Stent placement
Clinical narrative: HAD A REACTION; PSORIASIS STARTED TO COME BACK AND THEN FLARED UP; STENT PLACED; This solicited report received from a consumer via Pharmacy concerned a 47 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. The patient received combination product golimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: LDS00MA expiry: 31-MAR-2024) 50 mg, 1 time every 1 months, therapy dates were not reported for psoriasis. Product constituent parts included Ultrasafe passive (route of administration, lot, serial number, model number, UDI number, and expiration were not reported); and Ultrasafe passive accessory (route of administration, lot, serial number, model number, UDI number, and expiration were not reported). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after patient had his covid vaccine, he had a reaction and a couple of weeks later, his psoriasis started to come back and then flared up. It was unknown if patient was taking Simponi at the time of vaccination. It was reported that, Simponi will be discontinued and he will be switching to Cosentyx. On unspecified date in NOV-2021, the patient had stent placement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of golimumab was not changed. The outcome of the psoriasis started to come back and then flared up, had a reaction and stent placed was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and stent placed, and had a reaction was related, and between covid-19 vaccine ad26.cov2.s, and psoriasis started to come back and then flared up was not related; and between golimumab, and stent placed, psoriasis started to come back and then flared up, and had a reaction was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220341028-COVID-19 VACCINE AD26.COV2.S -Stent placed. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Pain in extremity, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: TWO BREAKTHROUGH COVID-19 INFECTIONS; SUSPECTED CLINICAL VACCINATION FAILURE; PAIN RADIATED DOWN THE ARM; This spontaneous report received from a patient concerned a 42 year old female of unspecified race. The patient's height, and weight were not reported. Patient was not pregnant or breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 10-JUL-2022) dose was not reported, 1 total, administered on 16-DEC-2021 at left arm for prophylactic vaccination. Concomitant medications included cyanocobalamin (Vitamin B12) and salbutamol (blue inhaler). On an unspecified date, the patient experienced chest pains, pain radiated down her arm, heart palpitation, shortness of breath, rapid heart rate and had two breakthrough COVID-19 infections ever since she received the JNJ vaccine and had suspected clinical vaccination failure. Patient went to her PCP who advised her to go home and relax. Laboratory data included: Heart rate (NR: not provided) 117 beats/min even when she stood still. Patient stated that she monitored her heart rate and said that it went even higher when she moved around. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid-19 infections, had not recovered from pain radiated down the arm, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000222820.; Sender's Comments: V0: 20220342279-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . The event(s) has a unknown/unclear 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. Therefore, this event(s) is considered not related. 20220342279-Covid-19 vaccine ad26.cov2.s- Two breakthrough covid-19 infections. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: LITTLE TO NO NEGATIVE REACTION; SUSPECTED CLINICAL VACCINATION FAILURE; DIAGNOSED WITH COVID; This spontaneous report received from a patient via a company representative concerned a 74 year old of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported and batch number: unknown, expiry: unknown) dose was not reported, 01 total was administered on 15-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant therapy includes chemotherapy for breast cancer.  On 23-DEC-2021, two days before Christmas, the patient was diagnosed with Covid (suspected covid 19 infection) thus had suspected clinical vaccination failure. The patient had Covid-19 test resulted positive. The patient's physician sent the patient for monoclonal antibodies treatment. The treatment and vaccine worked. On an unspecified date, the patient had little to no negative reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diagnosed with covid, little to no negative reaction and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000222783.; Sender's Comments: V0: 20220344946-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related. 20220344946-COVID-19 VACCINE AD26.COV2.S- diagnosed with covid. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT SICK; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction to the vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: VERY WEAK, NO ENERGY AFTER THE PRIMARY VACCINATION, LACK ENERGY; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: handicapped. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced very weak, no energy after the primary vaccination, lack energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very weak, no energy after the primary vaccination, lack energy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: EXPERIENCED SOMETHINGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced experienced somethings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of experiencing somethings was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SUFFERING AFTER RECEIVING SHOT AND IT HAD BEEN A YEAR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suffering after receiving shot and it had been a year. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffering after receiving shot and it had been a year. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Helminthic infection, Injection site mass
Clinical narrative: worms in my body / injected me with horsehair worms; huge mass in my arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HELMINTHIC INFECTION (worms in my body / injected me with horsehair worms) and INJECTION SITE MASS (huge mass in my arm at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HELMINTHIC INFECTION (worms in my body / injected me with horsehair worms) and INJECTION SITE MASS (huge mass in my arm at injection site). At the time of the report, HELMINTHIC INFECTION (worms in my body / injected me with horsehair worms) and INJECTION SITE MASS (huge mass in my arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a  patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of Helminthic infection and Injection site mass. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The outcome of the events was reported as unknown. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a  patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of Helminthic infection and Injection site mass. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The outcome of the events was reported as unknown. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Eczema, Headache, Migraine
Clinical narrative: diagnosed with eczema/skin started getting bubbles; blood sugar started plummeting; severe headache; severe migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe migraine headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced MIGRAINE (severe migraine headache) (seriousness criterion medically significant). On an unknown date, the patient experienced ECZEMA (diagnosed with eczema/skin started getting bubbles), BLOOD GLUCOSE FLUCTUATION (blood sugar started plummeting) and HEADACHE (severe headache). At the time of the report, MIGRAINE (severe migraine headache), ECZEMA (diagnosed with eczema/skin started getting bubbles), BLOOD GLUCOSE FLUCTUATION (blood sugar started plummeting) and HEADACHE (severe headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  2nd dose was administered on 11Mar2021: 001B21A and Booster dose was administered on 21Dec2021: 032F21A. She also reports having gone to the emergency room on 24Feb2022 with a severe migraine headache.  Company comment: This spontaneous case concerns a 48-year-old female patient, with relevant medical history of Diabetes, who experienced the unexpected serious (medically significant) events Migraine, 378 days after the first dose of mRNA-1273. The patient had gone to the emergency room with a severe migraine headache. At the time of reporting, the outcome was unknown. Medical history of Diabetes could be a confounder for the event headache. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient, with relevant medical history of Diabetes, who experienced the unexpected serious (medically significant) events Migraine, 378 days after the first dose of mRNA-1273. The patient had gone to the emergency room with a severe migraine headache. At the time of reporting, the outcome was unknown. Medical history of Diabetes could be a confounder for the event headache. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Patient received a transplant and now qualifies as an immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (Patient received a transplant and now qualifies as an immunocompromised patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Patient received a transplant and now qualifies as an immunocompromised patient) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Patient received a transplant and now qualifies as an immunocompromised patient) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The patient received the two primary and the booster doses of the Moderna Covid 19 vaccine. However after receiving them, the patient received a transplant and now qualified as an immunocompromised patient.  Treatment information was not provided by the reporter. Company comment: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced serious (medically significant) unexpected event of immunodeficiency, which occurred on an unknown date after administration of the booster dose of mRNA-1273 vaccine. It was reported that after receiving the 3 doses of Moderna vaccine, the patient received a transplant and now qualifies as an immunocompromised patient. No further information regarding previous medical history of organ failure, other medical history or clinical course of the event were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced serious (medically significant) unexpected event of immunodeficiency, which occurred on an unknown date after administration of the booster dose of mRNA-1273 vaccine. It was reported that after receiving the 3 doses of Moderna vaccine, the patient received a transplant and now qualifies as an immunocompromised patient. No further information regarding previous medical history of organ failure, other medical history or clinical course of the event were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: flu like symptoms which lasted for 16 hours; sore right arm which lasted for 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms which lasted for 16 hours) and PAIN IN EXTREMITY (sore right arm which lasted for 16 hours) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms which lasted for 16 hours) and PAIN IN EXTREMITY (sore right arm which lasted for 16 hours). In February 2021, INFLUENZA LIKE ILLNESS (flu like symptoms which lasted for 16 hours) and PAIN IN EXTREMITY (sore right arm which lasted for 16 hours) had resolved.            No concomitant medications were reported.  The patient reports no adverse reactions or side effects to the first vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-521073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow up received contains no new information to add.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (an immunocompromised patient who received a half dose (0.25ml) for their third vaccine dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (an immunocompromised patient who received a half dose (0.25ml) for their third vaccine dose). At the time of the report, ACCIDENTAL UNDERDOSE (an immunocompromised patient who received a half dose (0.25ml) for their third vaccine dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022; Patient received vaccine after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 03-Jan-2022, its used by date was 02-Feb-2022 but was administered on 09-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported.  The vaccine was refrigerated on 03-Jan-2022 and used by date was 02-Feb-2022 but was administered on 09-Feb-2022. The vial did not undergo any temperature excursion.  No information on treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow document received includes no new information.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/hearing piercing whistling sound.; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (tinnitus/hearing piercing whistling sound.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus/hearing piercing whistling sound.). At the time of the report, TINNITUS (tinnitus/hearing piercing whistling sound.) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   A doctor suffers Tinnitus that almost made him crash his car while driving home from getting the covid jab that he believes it could be a new side effect.   No concomitant medication were reported.  No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Splenectomy. Previously administered products included for Product used for unknown indication: GSK's Shingrix vaccine. Past adverse reactions to the above products included Asthma with GSK's Shingrix vaccine. Concurrent medical conditions included Immunocompromised and Asthmatic. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   In October 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine). The patient was treated with PREDNISONE for Asthma, at a dose of 1 dosage form. At the time of the report, ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine) to be related.    Reporter stated that age of the patient was in the 60's. And also stated that the vaccine was not IgE mediated. Other treatment information includes: Required increase of asthma medications.