chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-BarrE syndromE; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and COVID-19 VACCINE UNKNOWN. On an unknown date, immediately after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A physician informed me that one of her patients received her 1st dose of Shingrix along with a dose of COVID at a pharmacy.  This patient experienced Guillain-Barre syndrome shortly after the doses.  The doctor said she believes it could have been the COVID dose. The doctor told patient not to receive 2nd Shingrix dose.  The doctor said, she thought the patient already reported this incident and did not have the patients information available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Some fever; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th November 2021, the patient received Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had some fever and a headache after taking the Shingrix shot.  The patient asked if he/she could take Tylenol.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received HAVRIX 720ELU/0.5ML Prefilled syringe; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 45-year-old patient who received HAV (Havrix pediatric) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis A with an associated reaction of no adverse event (My initial dose was given by my previous employer).   On an unknown date, the patient received the 2nd dose of Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were reported as follows: Age at vaccination was not reported. The patient received first dose of Hepatitis A vaccine from employer. The patient received Pediatric dose of Havrix of 0.5 ml as second dose, which led to inappropriate age at vaccine administration. The patient confirmed the event from pharmacist. The patient was requested for consent to follow up.
Sex: U
Vaccine: UNK
Symptoms: Completed suicide, Death
Clinical narrative: This case was reported by a physician via (Tracking HCP SHINGRIX conversations on social media. Market research programs and described the occurrence of suicide in unspecified number of patients who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced suicide (serious criteria death and GSK medically significant). On an unknown date, the outcome of the suicide was fatal. The reported cause of death was suicide. It was unknown if the reporter considered the suicide to be related to Hz/su + AS01B. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it was so sad about the suicides post vaccination. The consent to follow up was denied. This case is linked with US2021AMR247029 and US2021AMR246983, reported by the same reporter. Note: The narrative seemed to be a generalized statement but as all the posts were related to SHINGRIX vaccination and its side effects, this case was conservatively processed.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR247029: same reporter US-GLAXOSMITHKLINE-US2021AMR246983: Same reporter - 1st dose US-GLAXOSMITHKLINE-US2021AMR246983: Same reporter - 1st dose US-GLAXOSMITHKLINE-US2021AMR247029:Same reporter.; Reported Cause(s) of Death: Suicide.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: I had a 3rd Shingrix shot.; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, 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 case was self reported by the patient. The age at vaccination was not reported. The reporter inadvertently had a 3rd dose of Shingrix, which led to extra dose administered. The reporter asked if that was dangerous. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Past due for second shot of Shingrix; This case was reported by a consumer via interactive digital media 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 on an unknown date).   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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was past due for second shot of Shingrix. The patient's doctor said to the patient that the patient should ask pharmacist but the pharmacist said to ask the doctor. Since neither would say what to do, the patient needed help with next step.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: FORGOT TO GET HER COME BACK TO GET THE 2ND; This case was reported by a other health professional via interactive digital media 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 (received 1st dose in September 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient forgot to came back to get 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: PATIENT FORGOT TO GET HER SECOND DOSE; This case was reported by a other health professional via interactive digital media 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 (received 1st dose in September 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the paient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient forgot to take 2nd dose of Shingrix.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received expired Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HBV (Engerix B adult) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received the 1st dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 22nd November 2021, unknown after receiving Engerix B adult and Engerix B 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 details were provided as follows: The patient received expired dose of Engerix B adult, which led to expired vaccine used. The reporter was transferred to Medical Information for further guidance. This case was linked with case US2021243048, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021243048:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: administrated less than the recommended dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2021, the patient received the 2nd dose of Shingrix. On 27th November 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administrated less than the recommended dose of Shingrix due to a leakage in the syringe. The needle was not appropriately attached to the syringe causing the vaccine liquid to leak. No further events were reported. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fatigue, headache and fever. On an unknown date, the outcome of the fatigue, headache and fever were recovered/resolved.   It was unknown if the reporter considered the fatigue, headache and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The age at vaccination was not reported. The patient had shingrix vaccine and experienced fatigue, headache, and fever. The patient questioned that, since he had a reaction to the first injection, does that mean that he would also have a worse reaction on the second injection. The reporter consented to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pyrexia, Therapeutic response unexpected
Clinical narrative: Flu like symptoms; slight fever; Arm pain; Unexpected therapeutic effect; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included attention deficit hyperactivity disorder.   On 12th November 2021, the patient received the 1st dose of Shingrix. On 12th November 2021, several hours after receiving Shingrix, the patient experienced influenza-like symptoms, fever and pain in arm. In November 2021, the patient experienced unexpected therapeutic effect. On 13th November 2021, the outcome of the influenza-like symptoms, fever and pain in arm were recovered/resolved. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient had shingrix vaccine and experienced flu-like symptoms, a slight fever, and arm pain a few hours after the dose. All symptoms began at the same time and all symptoms resolved at the end of the day on 13th November 2021. The patient had ADHD and experienced the unexpected benefit of mental clarity on 14th November 2021, which patient reported had not experienced in over 2 years. It resolved at the end of the day on 15th November  2021. The reporter did not consent for follow-up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was injected in a 19-month-old; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The age at vaccination was not reported. The 19-month-old patient received Kinrix, which led to inappropriate age at vaccine administration. The reporter stated that, dose of Kinrix was injected in a 19-month-old male, about 45 minutes ago and the representative learned of this adverse event 15 minutes ago from the date of reporting. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA66AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Bexsero and Bexsero 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 details were provided as follows: The age at vaccination was unknown but it could be 16 or 17 years. The reporter stated that, an expired dose of bexsero was administered to the patient, which led to expired vaccine used. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix) (batch number 4KJ79, expiry date 30th October 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th November 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th November 2021, unknown after receiving Havrix and Havrix 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 details were provided as follows: The patient received expired Havrix vaccine, which led to expired vaccine used. No additional details were provided by the caller. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Blistering; Itching; This case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received her first Shingrix vaccine and was now experiencing blistering and itching. This was not resolved.  The reporter did not consent to follow-up. No health care professional information provided. No demographics were obtained.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 49 year old received the 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   On 26th November 2021, the patient received the 1st dose of Shingrix. On 26th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The pharmacist reported that the 49 year old patient received the 1st dose of Shingrix, which led to inappropriate age at vaccine administration. The reporter was not sure if the patient was at an increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 4-DEC-2020, never came for second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that, till the time of reporting, the patient never came back for the second dose within recommended timeframe, which led to incomplete course of vaccination. The lot number or expiration date was not available. The reporter consented to follow up and provided email for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received second dose of Shingrix; This case was reported by a consumer 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 received approximately 1 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 to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster keratitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (had a history of herpes zoster (ocular keratitis)). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes zoster keratitis (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes zoster keratitis was not recovered/not resolved. It was unknown if the reporter considered the herpes zoster keratitis to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and there was a recurrence of herpes zoster (ocular keratitis) that most likely happened after the first dose. The patient was taking Valtrex at the time of reporting. The reporter declined to provide patient information (and follow-up from Safety). The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-392458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow up received added reporter's details and added dose number.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: ADMINISTRATION OF HALF A DOSE FOR BOOSTER SHOT; This spontaneous report received from a physician concerned a patient of unspecified age and sex of unspecified race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) 50 %, start therapy date was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. (Dose Number in Series: 2) No concomitant medications were reported.  On an unspecified date, the patient experienced administration of half a dose for booster shot. (Dose Number in Series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of administration of half a dose for booster shot was not reported.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; This spontaneous report received from a health care professional 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 was previously treated with covid-19 vaccine ad26. cov2. s  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. (Dose number in series 1)  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. (Dose number in series 2)  On 22-OCT-2021, the patient experienced inappropriate schedule of vaccine administration.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of inappropriate schedule of vaccine administration was not reported.  This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Expired product administered, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s  for prophylactic vaccination (Dose Number In Series 1: route of admin, frequency and batch number not reported) (unspecified manufacturer).   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination (Dose Number In Series 2). No concomitant medications were reported.   On 29-OCT-2021, the patient had expired lot number. (Dose Number In Series 2)  On 30-OCT-2021, the patient experienced headache and upset stomach.(Dose Number In Series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from headache, and upset stomach, and the outcome of expired lot number was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211061501.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; HEADACHE; FEVER; 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 experienced unspecified adverse event (dose number in series: 1) when received covid-19 vaccine ad26. cov2. s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported for prophylactic vaccination.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable  The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on OCT-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, the patient had body aches, headache, and fever. (Dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the headache, fever and body aches was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211165877.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: FELT NEEDLE GO IN; INSOMNIA DUE TO PAIN; SORENESS IN RIGHT ARM; FELT FEVERISH; MUSCLE ACHES; FATIGUE, TIREDNESS; SLEEPINESS; PAIN IN WRIST AND LOWER BACK; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: surgery and pains especially in his wrist and lower back. The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose Number in Series: 1) for prophylactic vaccination in MAR-2021 and had no adverse event.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, (Dose Number in Series: 2), 1 total administered on 28-OCT-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, 3 to 4 hours after getting the vaccine (booster dose), the patient experienced fatigue, tiredness, sleepiness, and muscle aches and pains especially in his wrist and lower back which he had problems with before the booster but that the pain was slowly getting better due to his use of medical marijuana for the pain. On an unspecified date, the patient experienced felt needle go in, insomnia due to pain, soreness in right arm, and felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.3 F.  Treatment medications (dates unspecified) included: oxycodone, and cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for events was recovering. However, it was also reported, patient was feeling better and that the symptoms were recovering. Tiredness, sleepiness, fatigue were better, wrist and back pain were a lot better and no longer feels feverish. The patient recovered from pain in wrist and lower back, and felt feverish, and was recovering from soreness in right arm, sleepiness, fatigue, tiredness, muscle aches, felt needle go in, and insomnia due to pain. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sensory disturbance, Sleep disorder due to general medical condition, insomnia type, Somnolence
Clinical narrative: FELT NEEDLE GO IN; INSOMNIA DUE TO PAIN; SORENESS IN RIGHT ARM; FELT FEVERISH; MUSCLE ACHES; FATIGUE, TIREDNESS; SLEEPINESS; PAIN IN WRIST AND LOWER BACK; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: surgery and pains especially in his wrist and lower back. The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose Number in Series: 1) for prophylactic vaccination in MAR-2021 and had no adverse event.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, (Dose Number in Series: 2), 1 total administered on 28-OCT-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, 3 to 4 hours after getting the vaccine (booster dose), the patient experienced fatigue, tiredness, sleepiness, and muscle aches and pains especially in his wrist and lower back which he had problems with before the booster but that the pain was slowly getting better due to his use of medical marijuana for the pain. On an unspecified date, the patient experienced felt needle go in, insomnia due to pain, soreness in right arm, and felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.3 F.  Treatment medications (dates unspecified) included: oxycodone, and cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for events was recovering. However, it was also reported, patient was feeling better and that the symptoms were recovering. Tiredness, sleepiness, fatigue were better, wrist and back pain were a lot better and no longer feels feverish. The patient recovered from pain in wrist and lower back, and felt feverish, and was recovering from soreness in right arm, sleepiness, fatigue, tiredness, muscle aches, felt needle go in, and insomnia due to pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED BENEFIT; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity.  The patient's height, and weight were not reported. The patient's concurrent condition included psoriasis. The patient was previously treated with Taltz (ixekizumab) for psoriasis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, dose number in series 01, administered on 02-APR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced unexpected benefit. He reported his psoriasis improved and flare ups were halted. He did not have to take his Taltz medication (dose number series 1).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of unexpected benefit was not reported.  On 26-OCT-2021, the patient received second dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry date: unknown) dose was not reported for prophylactic vaccination in left arm (dose number series 2).   The patient had no problems following second dose of covid-19 vaccine ad26.cov2.s (dose number series 2).  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Therapeutic response unexpected
Clinical narrative: LITTLE BIT DECREASED APPETITE; FELT YOUNGER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical condition included a drug allergy when treated with zolpidem tartrate. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series: 1) on MAR-2021. The patient subsequently received covid-19 vaccine ad26.cov2.s (dose number in series: 2)  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, frequency 1 total, administered on 19-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company was 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 little bit decreased appetite and felt younger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little bit decreased appetite and felt younger was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 68 year old male.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose Number In Series 1) (unspecified manufacturer).   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 23-AUG-2021) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination (Dose Number In Series 2). No concomitant medications were reported.   On 28-OCT-2021, the patient experienced expired vaccine administered (dose series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of expired vaccine administered was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211108214.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient concerned a 66 year old female of unspecified race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose Number in Series: 1) (suspension for injection, route of admin, and batch number were not reported expiry: Unknown) dose was not reported,1 total administered in12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications were not reported.  On 12-MAR-2021, the patient experienced tired. (Dose Number in Series: 1)   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 15-Mar-2021.  On 01-Nov-2021, the patient received non-company vaccine MRNA 1273 (form of admin, route of admin, and batch number were not reported expiry: Unknown) dose was not reported,1 total administered on vaccinated on right arm for prophylactic vaccination. (Dose Number in Series 2).  The patient had not reported any adverse events following vaccination with MRNA 1273. (Dose Number in Series 2).  The action taken with MRNA 1273, was not applicable.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MASSIVE FEVER; This spontaneous report received from a patient concerned a female of unspecified age.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported.(dose number in series 1) 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 first dose the patient experienced massive fever. (dose number in series 1)  On an unspecified date the patient received covid-19 vaccine ad26.cov2.s booster dose. (dose number in series 2) The patient had no side effects with covid-19 vaccine ad26.cov2.s booster dose and experienced nothing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of massive fever was not reported.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site pain
Clinical narrative: POTENTIAL DOSE ADMINISTRATION ERROR; PAIN AT SITE OF INJECTION DURING ADMINISTRATION; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnic origin.  The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported for prophylactic vaccination (dose number series 1).  The patient had no event following covid-19 vaccine ad26.cov2.s (manufacturer not specified)  (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2128218 expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination (dose number in series was 2).  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series was 2) booster dose, the patient experienced a potential dose administration error. The patient reported she thought that she got 6 cubic centimeter (cc) dose and that  "it hurt this time" (pain at site of injection during administration) ( dose series 2).   The action taken with covid-19 vaccine ad26.cov2.s (dose number in series 2) was not applicable.  The outcome of the pain at site of injection during administration and potential dose administration error was unknown.   This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache
Clinical narrative: FEELS KINDA FOGGY; JOINT PAINS; HEADACHE; 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 was knocked out for a whole day when treated with covid-19 vaccine ad26.cov2.s (Janssen series 1) for prophylactic vaccination.  The patient received booster dose with covid-19 vaccine ad26.cov2.s (series 2 from unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was 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 booster made her just feel kinda foggy with a headache and joint pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, joint pains and feels kinda foggy was not reported. This report was non-serious. This case, involving the same patient is linked to 20211164160.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vitreous floaters
Clinical narrative: DIZZY FOR 24 HOURS; TIRED FOR 24 HOURS; INK BLOB TYPE THINGS FLOATING IN VISION, ESPECIALLY RIGHT EYE; 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. On 07-MAR-2021, the patient received series 1 dose of Janssen covid-19 vaccine ad26. cov2.s (dose number in series 1) for prophylactic vaccination and had normal feeling like trash for 24 hours.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 03-NOV-2021, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-NOV-2021, the patient was dizzy and tired for 24 hours. In NOV-2021 (for 2-3 days following booster vaccination), the patient experienced ink blob type things floating in vision, especially right eye.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy for 24 hours, and tired for 24 hours on 04-NOV-2021, and had not recovered from ink blob type things floating in vision, especially right eye. This report was non-serious. This case, involving the same patient is linked to 20211164183.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER ON AND OFF ( EXTREMELY ANNOYING); 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 was previously treated with covid-19 vaccine ad26.cov2.s (dose series 1) for prophylactic vaccination (route of administration, batch number and therapy date not reported). No adverse events associated with dose series 1.    The patient received covid-19 vaccine ad26.cov2.s (dose series 2, manufacturer not specified) (suspension for injection, route of admin not reported, batch number: Unknown) 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 fever on and off (extremely annoying) for 5 days (dose series 2) .  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from fever on and off (extremely annoying).  This report was non-serious.