chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Musculoskeletal chest pain, Nausea, Pain
Clinical narrative: redness in her chest area; Dry heaves; Felt weak; Nausea; Fatigue; Burning sensation; Sweats; Chills; 100 degree fever; Body aches /  stabbing pain in right rib area; Headache; pain around her eye; stabbing pain in right rib area that shot across her chest; stabbing pain in right rib area that shot across her chest; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021). Concurrent medical conditions included hashimoto's disease. Concomitant products included levothyroxine.   In December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than 2 weeks after receiving Shingrix, the patient experienced localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain. On an unknown date, the outcome of the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain were recovered/resolved.   It was unknown if the reporter considered the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The reporter stated that, she received her second dose of the Shingrix vaccine one day last week from the day of reporting and experienced pain around her eye, a headache, body aches, a 100 degree fever, chills, sweats, burning sensation, fatigue, nausea, felt weak, stabbing pain in right rib area that shot across her chest, dry heaves, and redness in her chest area. The patient had a history of Hashimoto's disease and was taking Levothyroxine 125 mcg to treat it. The reporter's adverse reactions subsided after 2 to 3 days.  The reporter was inquiring if what she experienced was an adverse reaction and was also inquiring about the recommendation to receive the Shingrix series again in 4 to 5 years.  The reporter inquired if she should report her adverse reactions to the pharmacy who administered her vaccine and spoke from the Shingrix frequently asked questions. Provided the medical advice disclaimer. The reporter was referred to the Healthcare professional. The reporter did not consent to follow up and also declined the permission to contact her Healthcare professional.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Periorbital pain, Pyrexia, Retching
Clinical narrative: redness in her chest area; Dry heaves; Felt weak; Nausea; Fatigue; Burning sensation; Sweats; Chills; 100 degree fever; Body aches /  stabbing pain in right rib area; Headache; pain around her eye; stabbing pain in right rib area that shot across her chest; stabbing pain in right rib area that shot across her chest; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021). Concurrent medical conditions included hashimoto's disease. Concomitant products included levothyroxine.   In December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than 2 weeks after receiving Shingrix, the patient experienced localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain. On an unknown date, the outcome of the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain were recovered/resolved.   It was unknown if the reporter considered the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The reporter stated that, she received her second dose of the Shingrix vaccine one day last week from the day of reporting and experienced pain around her eye, a headache, body aches, a 100 degree fever, chills, sweats, burning sensation, fatigue, nausea, felt weak, stabbing pain in right rib area that shot across her chest, dry heaves, and redness in her chest area. The patient had a history of Hashimoto's disease and was taking Levothyroxine 125 mcg to treat it. The reporter's adverse reactions subsided after 2 to 3 days.  The reporter was inquiring if what she experienced was an adverse reaction and was also inquiring about the recommendation to receive the Shingrix series again in 4 to 5 years.  The reporter inquired if she should report her adverse reactions to the pharmacy who administered her vaccine and spoke from the Shingrix frequently asked questions. Provided the medical advice disclaimer. The reporter was referred to the Healthcare professional. The reporter did not consent to follow up and also declined the permission to contact her Healthcare professional.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the Adjuvant only of the Shingrix vaccine; administered the Adjuvant only,then administered the complete vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular). In November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine in an unknown arm. The patient received only adjuvant of shingrix approximately 6 weeks ago from the date of reporting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter then administered the complete Shingrix vaccine the same day. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: given a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 3BD9E, expiry date 6th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020) and Shingrix (received 2nd dose on October 2020).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient inadvertently received 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consent to follow up.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose two of Engerix-B five and a half months after dose one; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 39-year-old male patient who received HBV (Engerix B adult) (batch number 4345R, expiry date 11th August 2023) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose five and a half months ago).   On 19th December 2021, the patient received the 2nd dose of Engerix B adult. On 19th December 2021, unknown after receiving Engerix B adult, 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 patient Pharmacist reports the patient received dose two of Engerix-B five and a half months after dose one, instead of one month after dose one, which led to lengthening of vaccination schedule.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received KINRIX instead of DTAP; 3YO patient (DOB: 4/23/2018) received KINRIX instead of DTAP; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th December 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Kinrix at the age of 3 years old instead of DTAP, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 months old patient receiving KINRIX instead of Pediarix; 4 months old patient receiving KINRIX; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th October 2020, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Kinrix at the age of 4 months instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021159292:Same reporter US-GLAXOSMITHKLINE-US2021159295:Same reporter US-GLAXOSMITHKLINE-US2021254893:Same reporter US-GLAXOSMITHKLINE-US2021254941:Same reporter US-GLAXOSMITHKLINE-US2021260746:Same reporter
Age: 44.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunodeficiency, Incomplete course of vaccination
Clinical narrative: patient is immunocompromised; 1st dose 5/23/2019, wants to get 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of immunocompromised in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immunocompromised (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the immunocompromised and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immunocompromised to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The registered pharmacist reported that the patient 45 years old had received her first dose of Shingrix and was immunocompromised. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The patient wanted to get 2nd dose of Shingrix. The patient enquired about how to proceed with the schedule. The reporter did not consent to follow up.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st October 2021) for prophylaxis.   On 22nd December 2021, the patient received Menveo. On 22nd December 2021, unknown after receiving Menveo, 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. The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Lyophilized powder reconstituted with 0.7 mL normal saline; Lyophilized powder reconstituted with 0.7 mL normal saline; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 58-year-old patient who received Herpes zoster (Shingrix) (batch number E344C, expiry date 1st April 2023) for prophylaxis.   On 26th November 2021, the patient received Shingrix. On 26th November 2021, unknown after receiving Shingrix, 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 director of nurse reported that, patient received Lyophilized powder reconstituted with 0.7 ml normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR262063:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: too painful; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician states a patient received the first dose of Shingrix in the deltoid, but it was too painful, so he was asking if the second dose could be given in his thigh. The physician declined to provide additional details on the call, stating she did not have the patient's permission to do so.  She consented to follow up from safety. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose of Shingrix over a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received over a year ago ).   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 provided as follows: The age at vaccination was not applicable for this report. The reporter stated that a patient received the 1st dose of Shingrix over a year before reporting and wanted to know if she should restart the series or get the 2nd dose at the time of reporting, which led to incomplete course of vaccination. The reporter did not provide initials of patient when asked and did not have the exact date of the first dose, stating that the patient did not get the 1st dose at their pharmacy.  The reporter requested to follow up via postal. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arms). At the time of the report, PAIN IN EXTREMITY (soreness in the arms) outcome was unknown.            No concomitant medications reported. No treatment reported   This case was linked to MOD-2021-423994 (Patient Link).   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: PAIN IN LEFT SHOULDER; NUMBNESS IN RIGHT LEG UPON SITTING OR FOLDING LEGS; TINGLING IN LEG ONCE STANDING OR UNFOLDED; HEADACHE ABOVE THE EYE ON THE RIGHT SIDE; TIGHTNESS IN CHEST; This spontaneous report received from a patient concerned a 41 year male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 06-MAR-2021 on left arm for prophylactic vaccination. When he had primary vaccination, about 1-3 hours after vaccination he felt dizzy, eyes shaken and then those symptoms disappeared. Face was numb then stopped, this occurred for 5 seconds. The patient took 2 Tylenol Ex-Strength Rapid release gels 500 mg before he went to bed. This did help the pain. He also took it the next day, the pain was not that bad. The day of the vaccination when he got out of the car he felt dizzy/fainting feeling that lasted about 5 seconds. The patient also experienced chest tightness, lots of cold sweats, very cold when was going to sleep, fever, shortness of breath, sex drive went down a lot and had been very low, forget, memory loss/mind not sharper like before, mind goes into a fog (between brain mind fog), get lost, headache on the left side of head, and brain freeze, and the vivid dreams at sleep (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, 1 total, administered on 13-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced pain in left shoulder. On an unspecified date in DEC-2021, the patient experienced tightness in chest, numbness in right leg upon sitting or folding legs, tingling in leg once standing or unfolded, and headache above the eye on the right side (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness in chest, and pain in left shoulder on DEC-2021, was recovering from headache above the eye on the right side, and had not recovered from numbness in right leg upon sitting or folding legs, and tingling in leg once standing or unfolded. This report was non-serious. This case, involving the same patient is linked to 20210313117 (case for dose number in series 1).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: RAPID HEARTBEAT; This spontaneous report received from a patient via a social media  via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: headache, rapid heartbeat, and heart palpitation, and concurrent conditions included: coffee drinker, and stress. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, 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 rapid heartbeat (dose number in series 1). She stated it is hard to tell if side effects are from vaccines or just the usual stuff we get anyway. She had headaches, rapid heartbeat, heart palpitations with no vaccine in body. She also stated that so many people's had anxiety after getting these covid-19 vaccines. That's part of the problem. No doubt there are those that will have side effects tho. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received non-company suspect vaccine included: bnt 162 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose not reported, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, the patient again experienced rapid heartbeat (dose number in series 2). The action taken with bnt 162 was not applicable. The patient recovered from rapid heartbeat. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain, Pain in extremity
Clinical narrative: PAIN HAS BEEN SO INTENSE; NOT GETTING ANY SLEEP; SHOULDERS WERE IN PAIN AGAIN; PAIN IS OCCURRING ALL THE WAY TO HER HAND/PAIN IN HAND IS NOT AS BAD AS SHOULDERS; This spontaneous report received from a patient concerned a 68 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, breast cancer, diabetic, alcohol user, non smoker, and drug allergy to penicillin (anaphylaxis). The patient had no history drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 20-JUN-2021) dose was not reported,1 total, administered on 07-APR-2021 on left arm for prophylactic vaccination.  On an unspecified date in APR-2021, the patient experienced pain in shoulders and worse (laid hand on top of shoulder and slide hand to deltoid area) and constant ache and soreness of muscles from both shoulders to both elbow (feels like been beat), pain in biceps (dose number in series 1). The patient was prescribed concomitant medications: diclofenac sodium arthritis pills and Advil for unknown indication. Nothing was helping the pain from massage and prescription medication. Primary care physician sent patient to see an orthopedic doctor in October. Orthopedic doctor injected both shoulders with concomitant medication prednisone for unknown indication. Within 3 days, left shoulder was better. She was pain free, until she received her next injection. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported,1 total, administered on 22-NOV-2021 on left arm for prophylactic vaccination.  On an unspecified date in  NOV-2021, within 48 hours after vaccination, the patient shoulders were in pain again, and pain was occurring all the way to her hand, pain in hand was not as bad as shoulders. Pain had been intense. She was not getting any sleep (dose number in series 2). She reached out to doctor for another prednisone shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shoulders were in pain again, pain is occurring all the way to her hand/pain in hand is not as bad as shoulders, pain has been so intense and not getting any sleep were unknown. This report was non-serious. This case, involving the same patient is linked to 20211240436 (dose number in series 1). This case, from the same reporter is linked to 20211240355, 20211240211 and 20211241144.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: RIGHT ARM/SHOULDER PAIN; CHILLS; 101F FEVER; FATIGUE; HEADACHE; NAUSEA; ANXIOUS; VERY FEARFUL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 127 pounds and height was 64 inches. The patient's past medical history included: percutaneous nephrostomy and concurrent conditions included: supraventricular tachycardia, fibromyalgia, thyroid disease, latex allergy, and sulfa allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 01-APR-2021 at 11:00 to left arm for prophylactic vaccination. The patient was previously treated with codeine phosphate for drug used for unknown indication. The patient experienced body aches, chills, drug allergy, fatigue, felt like hit by something/ in a fog, fever of 102F (Fahrenheit), frozen shoulder, headache, loss of appetite, poor injection technique, severe flu-like symptoms, slept a lot, sore arm and very sick following vaccination with first dose of covid-19 vaccine ad26. cov2. s  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 13-DEC-2021 at 16:45 to right arm for prophylactic vaccination. No concomitant medications were reported.  Following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), on 13-DEC-2021, the patient experienced right arm/shoulder pain, chills, 101 F (Fahrenheit) fever for 2 days, fatigue, headache and nausea. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date in DEC-2021, the patient contacted her HCP (health care professional) regarding these side effects as she became very fearful and anxious since being made aware of updated CDC (Centers for Disease Control and Prevention) recommendations via the media. Patient reached out to her HCP/vaccination provider and was reportedly informed that they were changing their distribution plan for the Janssen vaccine which further upset her.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 101 F fever on 15-DEC-2021, was recovering from fatigue, headache, right arm/shoulder pain, nausea, and chills, and the outcome of very fearful and anxious was not reported. This report was non-serious. This case, involving the same patient is linked to 20211240244 (dose number in series 1).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Headache, Nausea, Pyrexia
Clinical narrative: RIGHT ARM/SHOULDER PAIN; CHILLS; 101F FEVER; FATIGUE; HEADACHE; NAUSEA; ANXIOUS; VERY FEARFUL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 127 pounds and height was 64 inches. The patient's past medical history included: percutaneous nephrostomy and concurrent conditions included: supraventricular tachycardia, fibromyalgia, thyroid disease, latex allergy, and sulfa allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 01-APR-2021 at 11:00 to left arm for prophylactic vaccination. The patient was previously treated with codeine phosphate for drug used for unknown indication. The patient experienced body aches, chills, drug allergy, fatigue, felt like hit by something/ in a fog, fever of 102F (Fahrenheit), frozen shoulder, headache, loss of appetite, poor injection technique, severe flu-like symptoms, slept a lot, sore arm and very sick following vaccination with first dose of covid-19 vaccine ad26. cov2. s  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 13-DEC-2021 at 16:45 to right arm for prophylactic vaccination. No concomitant medications were reported.  Following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), on 13-DEC-2021, the patient experienced right arm/shoulder pain, chills, 101 F (Fahrenheit) fever for 2 days, fatigue, headache and nausea. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date in DEC-2021, the patient contacted her HCP (health care professional) regarding these side effects as she became very fearful and anxious since being made aware of updated CDC (Centers for Disease Control and Prevention) recommendations via the media. Patient reached out to her HCP/vaccination provider and was reportedly informed that they were changing their distribution plan for the Janssen vaccine which further upset her.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 101 F fever on 15-DEC-2021, was recovering from fatigue, headache, right arm/shoulder pain, nausea, and chills, and the outcome of very fearful and anxious was not reported. This report was non-serious. This case, involving the same patient is linked to 20211240244 (dose number in series 1).
Sex: M
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Paraesthesia, SARS-CoV-2 test, SARS-CoV-2 test positive, Weight decreased
Clinical narrative: CARPEL TUNNEL DIAGNOSIS; WEIGHT LOSS; TINGLING SENSATION IN RIGHT ARM/HAND; POSITIVE COVID TEST 3 WEEKS AFTER; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cardiac event, stents, vertigo, and stenosis back surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. Concomitant medications included naproxen for tingling pain. On JUL-2021, the patient experienced positive covid test 3 weeks after. Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the patient experienced carpel tunnel diagnosis, weight loss, and tingling sensation in right arm/hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling sensation in right arm/hand, carpel tunnel diagnosis, weight loss and positive covid test 3 weeks after was not reported. This report was non-serious. This report was associated with a product quality complaint 90000207743. This case, involving the same patient is linked to 20211240483(dose number in series was 2).; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyskinesia, Feeling abnormal, Skin discolouration, Visual acuity reduced
Clinical narrative: HEAD GOT ALL CLOUDY AND FELT LIKE WALKING AROUND IN A FOG; DETERIORATING EYE SIGHT; REDDISH BROWN SPOT ON FOREHEAD; WHEN USING RIGHT HAND THE LEFT HAND RAISES; DECREASED STRENGTH IN THE LEFT HAND AND LEFT UPPER BODY; This spontaneous report received from a patient concerned a 66-year-old elderly 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, and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested.  On 30-JUN-2021, the patient experienced head got all cloudy and felt like walking around in the fog, eye sight start started to deteriorate, left hand had significantly decreased strength, left upper body also had significantly decreased strength, a reddish, brown spot on forehead, and when using the right hand, the left hand raises (Dose number in series 1). The reporter stated that there was no change of lifestyle prior to receiving the vaccine. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered at right arm on 03-Dec-2021 for prophylactic vaccination (Dose number in series 2). It was unknown if the patient experienced adverse events with covid-19 vaccine ad26.cov2.s. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head got all cloudy and felt like walking around in a fog, deteriorating eye sight, decreased strength in the left hand and left upper body, reddish brown spot on forehead, and when using right hand the left hand raises. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PAIN IN BOTH KNEES; PAIN IN ARMS; This spontaneous report received from a consumer concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: Alzheimer's, non alcohol user, non smoker, and arthritis, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient had no known drug allergies. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number:1808980, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 on right arm for prophylactic vaccination. No adverse events reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number:1855194, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-NOV-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the reporter noticed that her husband was in pain after receiving the booster dose with his expressions of ooos and ahhs. The patient was specifically experiencing pain in both his knees and arms (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in both knees and pain in arms was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240355, 20211240436, 20211240486 and 20211240211.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SLIGHT SIDE EFFECTS; This spontaneous report received from a consumer via a company representative via a social media 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 previously received covid-19 vaccine  ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine  ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, 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, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient experienced slight side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211242345 and 20211242790.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SLIGHT SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 2). 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, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced slight side effects (dose number in series 2) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211242092 and 20211242790.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a male patient of unspecified age, race and ethnicity.  The patient's weight, height, and medical history 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, expiry: Unknown) 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 was tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20211246124.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a male 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 11-MAR-2021 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 chills, and fever (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious. This report was associated with product quality complaint:90000207912 The suspected product quality complaint has been confirmed to be voided (did not meet criteria as reported complaints were adverse events) based on the evaluation/investigation performed. This case, involving the same patient is linked to 20211139224 (dose number in series 2).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Dysgeusia, Fatigue
Clinical narrative: BRUISE IN RIGHT ARM; TIREDNESS; FELT LIKE TONGUE TASTED SALTY; This spontaneous report received from a patient concerned a 64 year old   female. The patient's height, and weight were not reported. The patient's concurrent conditions included: food allergy, pollen allergy, and sensitivity to medicines, and allergy to certain insects. The patient reported she had no drug allergies but  she did not want the Moderna or Pfizer vaccine due to the PEG content.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 30-JUL-2021,  around midnight, the patient felt like tongue tasted salty. On 31-JUL-2021, patient experienced tiredness. On 14-Aug-2021, she had a bruise on the right arm even though injection (dose number in series 1) was in left arm and she was told ( "by someone at J and J") to go to  the emergency room (ER). The hospital did a blood test and all was normal. She was tested for blood clots at hospital but does not remember exactly what was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like tongue tasted salty on 07-AUG-2021, bruise in right arm on 18-AUG-2021, and tiredness on 31-JUL-2021. This report was non-serious. This case, involving the same patient is linked to 20211245665 (dose number in series 2).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: LOW GRADE FEVER; This spontaneous report received from a patient concerned a 66-year-old female of unknown race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included: crawling sensation, drug allergy to latex, abstain alcohol, and nonsmoker. The patient previously received covid-19 vaccine ad26.cov2.S (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown ) dose was not reported, frequency one total administered on 10-APR-2021 for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, frequency one total, vaccinated at left arm, administered on 19-DEC-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. On 20-DEC-2021, the patient experienced a low-grade fever. (Event occurred in Dose number in series 2). Laboratory data included: Body temperature (NR: not provided) 99 F.  Treatment medications (dates unspecified) included: paracetamol (Tylenol) overnight for the fever. Patient reported that while reading through the paperwork that they gave her at the facility, then mentioned that She had a strange sensation in the back of her neck when she was sitting by her computer that goes away when she stands but did not know how to describe it to her doctor. When she read the paperwork, she saw the crawling sensation in the skin, so that reminded her of that feeling that she had had but did not know how to describe it. She stated that she wanted to clarify that she did not have this crawling sensation after the booster. She had this strange feeling (Crawling/tingling) for more than 2 years from the time of reporting. It comes and goes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on 21-DEC-2021. This report was non-serious.