chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: received REMDESIVIR for COVID-19 treatment; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with remdesivir. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had received first dose of Shingrix and developed COVID-19. The patient received Remdesivir for COVID-19 infection on 27th March 2021 as a treatment. The patient had not received second dose of Shingrix yet. No other information was reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Hepatitis B vaccine in their first year of life /  80% were seronegative as teenagers; This case was reported by a physician via call center representative and described the occurrence of hepatitis b antibody negative in unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.  On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, more than 2 years after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter had 50 patients between 14 to 17 years of age who received Hepatitis B vaccine in their first year of life and 80 percent were seronegative as teenagers. It was unknown what hepatitis B vaccines were administered to the patients. The reporter consented to follow up. This case has been linked with case US2021090083, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090083:same reporter
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Product administered to patient of inappropriate age
Clinical narrative: red rash at the injection site; red rash at the injection site; Inappropriate age; This case was reported by a physician and described the occurrence of injection site rash in a 40-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site rash, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site rash and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient experienced a red rash at the injection site. It developed about 3 days after she received the injection and has resolved. The Shingrix vaccine was recommended for patients 50 years and above however patient received shingrix vaccine at age of 40 years old, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Shingrix vaccine on September 30, 2020 / second Shingrix vaccine accidently on November 3, 2020.; This case was reported by a consumer and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd November 2020, the patient received the 2nd dose of Shingrix. On 3rd November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The sister called for her brother. The age at vaccination was not reported. The patient had first dose of Shingrix on 30th September 2020 and accidently second dose was administered shorter than the recommended interval, which led to shortening of vaccination schedule. All information was not available. The sister was reluctant to report the adverse event. This case is linked to the case US2021090116, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090116:Possible same reporter and patient
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix was given subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2021, the patient received Shingrix (subcutaneous). On 21st April 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The shingrix was given subcutaneously to a patient instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow-up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given half of adult dose to substitute for pediatric dose; Given half of adult dose to substitute for pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a 1-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process and adult product administered to child. On an unknown date, the outcome of the wrong technique in product usage process and adult product administered to child 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 reporter stated that, the Havrix adult dose was halved and given to the pediatric patient, which led wrong technique in product usage process and adult product administered to child. The reporter asked if this dose was valid dose and how to proceed further. No other information was provided. The reporter consented to follow up. This case is linked with US2021090128, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090128:Same reporter. Patient 2 of 2.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Diarrhoea, Night sweats, Pyrexia
Clinical narrative: chills; fever / fever varied between 100.2 and 100.9; diarrhea; muscle aches are located in the patient's back; night sweats; This case was reported by a consumer and described the occurrence of chills in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th April 2021, 8 days after receiving Shingrix, the patient experienced chills, fever and diarrhea. In April 2021, the patient experienced night sweat and muscular back pain. In April 2021, the outcome of the chills, fever and diarrhea were recovered/resolved. On an unknown date, the outcome of the night sweat and muscular back pain were recovering/resolving.   It was unknown if the reporter considered the chills, fever, night sweat, diarrhea and muscular back pain to be related to Shingrix.  Additional details were provided as follows: The fever varied between 100.2 and 100.9 degree celsius. The patient experienced night sweats and muscle aches a couple of nights before the date of reporting. The muscle aches were located in the patient's back.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a Shingrix dose on the 4th of August 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2016).   On 4th August 2020, the patient received the 1st 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 age group was not reported but was captured as an adult as per vaccine indication.  The patient had received first dose of Shingles vaccine in 2016.  The reporter did not have any further details at the time of the call. On further follow-up, the health care professional who was not the same pharmacist stated that the patient received a Shingrix dose on the 4th of August, 2020. The health care professional would be receiving the patient on the reporting date in the afternoon, and would talk with the patient about the vaccination because the information they had was not clear.  The reporter consented to follow-up via email.  Note: As Shingrix came into market in 2017, dose given in 2020 was considered as 1st dose and hence incomplete course of vaccination event was coded conservatively until further clarification received on follow-up.
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Fatigue, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Overall soreness in the body; Fatigue; Some respiratory issues / shortness of breath and labored breathing; A shingles rash developed at the injection site; Rash / left some scarring; This case was reported by a consumer via call center representative and described the occurrence of rash zosteriform in a 63-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced rash zosteriform, scar, general body pain, shortness of breath and fatigue. On an unknown date, the outcome of the rash zosteriform, scar, general body pain and shortness of breath were recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the rash zosteriform, scar, general body pain, shortness of breath and fatigue to be related to Hepatitis B vaccine.  Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient received Hepatitis B vaccine in the 1990's, the manufacturer was unknown. The patient developed shingles rash at the injection site and travelled up to the armpit area following the administration. The rash lasted for 4 to 5 weeks and left some scarring. The patient also felt an overall soreness in the body and some respiratory issues described as shortness of breath and labored breathing that lasted approximately a month. The patient also experienced fatigue. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: mild case of shingles" on her back; experiencing a rash/ after receiving the 1st dose.; This case was reported by a consumer and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the dose of Shingrix about 6 week ago and experienced rash and for the past two weeks. Patient had experienced a "mild case of shingles" on her back. Consumer gave no further details, and ended the call precipitously. No further information available. The reporter was referred to the health care professional. The reporter did not consented to follow up
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix inadvertently administrated to 9 month old; Kinrix: inadvertently administrated instead of dtap and polio; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female 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 21st April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that medical assist inadvertently administered one shot of Kinrix to the patient instead of dtap and polio, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter asked what was recommended going forward. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient experienced a rash after the 1st dose of SHingrix; This case was reported by a physician via call center representative and described the occurrence of rash in a adult 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient had rash after vaccination. The reporter was unsure about the location of rash and if it had subsided. The reporter was in a hurry. No patient details provided. The reporter did not consent to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage/ given Boostrix to patients as young as 7; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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 applicable for this report. The medical assistant stated that the physician informed her that the physician had given Boostrix to patients as young as 7, which led to inappropriate age at vaccine administration. The reporter consented to follow up. No further details available to Medical Assistant at the time of this call, but she consented to follow up via email.
Sex: F
Vaccine: HEP, MNQ
Symptoms: Expired product administered
Clinical narrative: expired Engerix B vaccine was given to a patient / 29 days expired and expired Menveo vaccine was given to a patient / 22 days expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 22nd April 2021, the patient received Engerix B and Menveo. On 22nd April 2021, unknown after receiving Engerix B and 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. Nurse reported that  29 days expired Engerix B vaccine and 22 days expired Menveo vaccine was given to the patient. Both of these expired vaccines were given to the same patient on the same day, on 22nd April 2021, which led to Expired vaccine used. The reporter consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain in her hands and feet; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 30th September 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on August 2020). Concomitant products included celecoxib (Celebrex).   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than 6 months after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The patient developed joint pain in hands and feet. The patient was taking celebrex prior to getting the shingrix vaccine and her health care practitioner increased celebrex dose due to the joint pain in her hands and feet.  The joint pain had not yet resolved. The reporter consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix on 12Dec2019 / not received the second dose yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. HCP consented the follow up via email address, no other information provided
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was only injected with the adjuvant; Patient was only injected with the adjuvant; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 34SD3, expiry date unknown) for prophylaxis.   On 22nd April 2021, the patient received Shingrix. On 22nd April 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 was reported as follows: The patient received a dose of Shingrix and was administered only injected with the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No adverse event was reported. The reporter consented to follow up. The reported batch number was of Shingrix adjuvant.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu like symptoms; Sweats; CAN'T KEEP ANYTHING DOWN; Cold chills; Headache; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-MAR-2021 around 08:30 am for prophylactic vaccination. No concomitant medications were reported.  In the middle of the night, (captured as MAR-2021), the patient experienced flu like symptoms, sweats, cold chills, headache, can't keep anything down (PT of abdominal discomfort). The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The outcome of the flu like symptoms, sweats, cold chills, headache and can't keep anything down was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced body aches. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: PATIENT SAID SHE EXPERIENCED SIDE  EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced subject said she experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from patient said she experienced side effects. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast tenderness, Chills, Feeling abnormal, Feeling of body temperature change
Clinical narrative: FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROUBLE REGULATING BODY TEMPERATURE; HOT AND COLD FLASHES; SEVERE BREAST TENDERNESS; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 175 pounds, and height was 155 centimeters. The patient's concurrent conditions included drug allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. the patient was not breastfeeding at the time of vaccination. no history of drug abuse. the patient had no illness at the time of vaccination. no history of similar event in the past. the patient had no adverse events after any previous vaccination(s). the patient was allergic to amoxycillin. no pre-existing acute illness prior to vaccination. no history of hospitalization 30 days prior to vaccination. no family history of any disease relevant to vaccination or allergy. The patient was previously treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced incorrect route of drug administration. On 08-MAR-2021, the subject experienced severe body aches. On 08-MAR-2021, the subject experienced trouble regulating body temperature. On 08-MAR-2021, the subject experienced hot and cold flashes. On 08-MAR-2021, the subject experienced severe breast tenderness. On 08-MAR-2021, the subject experienced severe chills. On an unspecified date, the subject experienced feeling bad, sick, joint ache, headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, trouble regulating body temperature, hot and cold flashes, severe breast tenderness, and severe chills on 22-MAR-2021, was recovering from sick, had not recovered from joint ache, headache, injection site pain, and feeling bad, and the outcome of incorrect route of drug administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318992.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Incorrect route of product administration, Injection site pain, Pain
Clinical narrative: FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROUBLE REGULATING BODY TEMPERATURE; HOT AND COLD FLASHES; SEVERE BREAST TENDERNESS; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 175 pounds, and height was 155 centimeters. The patient's concurrent conditions included drug allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. the patient was not breastfeeding at the time of vaccination. no history of drug abuse. the patient had no illness at the time of vaccination. no history of similar event in the past. the patient had no adverse events after any previous vaccination(s). the patient was allergic to amoxycillin. no pre-existing acute illness prior to vaccination. no history of hospitalization 30 days prior to vaccination. no family history of any disease relevant to vaccination or allergy. The patient was previously treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced incorrect route of drug administration. On 08-MAR-2021, the subject experienced severe body aches. On 08-MAR-2021, the subject experienced trouble regulating body temperature. On 08-MAR-2021, the subject experienced hot and cold flashes. On 08-MAR-2021, the subject experienced severe breast tenderness. On 08-MAR-2021, the subject experienced severe chills. On an unspecified date, the subject experienced feeling bad, sick, joint ache, headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, trouble regulating body temperature, hot and cold flashes, severe breast tenderness, and severe chills on 22-MAR-2021, was recovering from sick, had not recovered from joint ache, headache, injection site pain, and feeling bad, and the outcome of incorrect route of drug administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318992.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature regulation disorder
Clinical narrative: FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROUBLE REGULATING BODY TEMPERATURE; HOT AND COLD FLASHES; SEVERE BREAST TENDERNESS; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 175 pounds, and height was 155 centimeters. The patient's concurrent conditions included drug allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. the patient was not breastfeeding at the time of vaccination. no history of drug abuse. the patient had no illness at the time of vaccination. no history of similar event in the past. the patient had no adverse events after any previous vaccination(s). the patient was allergic to amoxycillin. no pre-existing acute illness prior to vaccination. no history of hospitalization 30 days prior to vaccination. no family history of any disease relevant to vaccination or allergy. The patient was previously treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced incorrect route of drug administration. On 08-MAR-2021, the subject experienced severe body aches. On 08-MAR-2021, the subject experienced trouble regulating body temperature. On 08-MAR-2021, the subject experienced hot and cold flashes. On 08-MAR-2021, the subject experienced severe breast tenderness. On 08-MAR-2021, the subject experienced severe chills. On an unspecified date, the subject experienced feeling bad, sick, joint ache, headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, trouble regulating body temperature, hot and cold flashes, severe breast tenderness, and severe chills on 22-MAR-2021, was recovering from sick, had not recovered from joint ache, headache, injection site pain, and feeling bad, and the outcome of incorrect route of drug administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318992.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sensory disturbance
Clinical narrative: POPPING SOUND WHEN ADMINISTRATING THE VACCINE; LIGHT HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced light headache. On 08-MAR-2021, the subject experienced popping sound when administrating the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headache on MAR-2021, and the outcome of popping sound when administrating the vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; CHILLS; FEVER; SORENESS ON INJECTION SITE; BURNING ON INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced soreness on injection site. On 11-MAR-2021, the subject experienced burning on injection site. On 12-MAR-2021, the subject experienced flu like symptoms. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of chills, flu like symptoms, soreness on injection site and burning on injection site was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Blood glucose, Blood glucose decreased, Blood test, Fatigue
Clinical narrative: LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTION SITE; TIREDNESS; SLEEPINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes., hypertension, and non smoker, and other pre-existing medical conditions included patient do not smoke. patient has type 2 diabetes for approximately 17 years. patient also has hypertension. The patient received metformin non-company (prolonged-release tablet, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, glipizide, hydrochlorothiazide/triamterene, insulin glargine, losartan, and sitagliptin. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Results not specified. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sleepiness. On 10-MAR-2021, the subject experienced arm pain at injection site. On 11-MAR-2021, the subject experienced blood sugar lower than normal. On 11-MAR-2021, the subject experienced shoulder heaviness. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021 17:44, Laboratory data included: Blood glucose (NR: not provided) 97 (unit not specified). On 12-MAR-2021, the subject experienced legs feeling cold. On 12-MAR-2021 06:00, Laboratory data included: Blood glucose (NR: not provided) 166 (unit not specified). On 12-MAR-2021 16:00, Laboratory data included: Blood glucose (NR: not provided) 79 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metformin non-company was not reported. The patient recovered from legs feeling cold on 12-MAR-2021, was recovering from arm pain at injection site, shoulder heaviness, and back pain, and had not recovered from blood sugar lower than normal, tiredness, and sleepiness. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Limb discomfort, Peripheral coldness, Somnolence
Clinical narrative: LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTION SITE; TIREDNESS; SLEEPINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes., hypertension, and non smoker, and other pre-existing medical conditions included patient do not smoke. patient has type 2 diabetes for approximately 17 years. patient also has hypertension. The patient received metformin non-company (prolonged-release tablet, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, glipizide, hydrochlorothiazide/triamterene, insulin glargine, losartan, and sitagliptin. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Results not specified. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sleepiness. On 10-MAR-2021, the subject experienced arm pain at injection site. On 11-MAR-2021, the subject experienced blood sugar lower than normal. On 11-MAR-2021, the subject experienced shoulder heaviness. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021 17:44, Laboratory data included: Blood glucose (NR: not provided) 97 (unit not specified). On 12-MAR-2021, the subject experienced legs feeling cold. On 12-MAR-2021 06:00, Laboratory data included: Blood glucose (NR: not provided) 166 (unit not specified). On 12-MAR-2021 16:00, Laboratory data included: Blood glucose (NR: not provided) 79 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metformin non-company was not reported. The patient recovered from legs feeling cold on 12-MAR-2021, was recovering from arm pain at injection site, shoulder heaviness, and back pain, and had not recovered from blood sugar lower than normal, tiredness, and sleepiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; ACHES; This spontaneous report received from a vaccine facility via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 15-MAR-2021 09:45, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Skin plaque
Clinical narrative: REOCCURENCE OF SKIN PLAQUES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included skin plaques. The patient received combination product guselkumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Product constituent parts included one press (route of admin, lot, serial number, model number, UDI number, and expiration were not reported).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced recurrence of skin plaques. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The outcome of recurrence of skin plaques was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Insomnia
Clinical narrative: DID NOT SLEEP; CHILLS LIKE IN FLU; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer survivor, and concurrent conditions included heart disease, copd, back and nerve damage, and iodine dye allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose was not reported, once a total administered vaccinated on right deltoid on 17-MAR-2021 09:20 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021 21:00, the subject experienced did not sleep. On 17-MAR-2021 21:00, the subject experienced chills like in flu. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills like in flu on 19-MAR-2021, and was recovering from did not sleep. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ENTIRE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced pain in entire arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in entire arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chest pain, Fatigue, Headache
Clinical narrative: CHEST PAIN; STRUGGLED TO SLEEP; BEDRIDDEN; NECK PAIN; BODY PAIN; PAIN ALONG SPINE; SLIGHT ARM PAIN; WEAK; HYPERSENSITIVE ENERGY; HEADACHE; MALARIA LIKE FEVER/MILD FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date 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 subject experienced chest pain, struggled to sleep, bedridden, neck pain, body pain, pain along spine, slight arm pain, headache, malaria like fever/mild fever, hypersensitive energy, fatigue, and weak. Treatment medications (dates unspecified) included: cannabidiol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bedridden, and weak, and the outcome of headache, chest pain, slight arm pain, struggled to sleep, neck pain, body pain, pain along spine, hypersensitive energy, malaria like fever/mild fever and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Initial insomnia, Neck pain, Pain, Pain in extremity
Clinical narrative: CHEST PAIN; STRUGGLED TO SLEEP; BEDRIDDEN; NECK PAIN; BODY PAIN; PAIN ALONG SPINE; SLIGHT ARM PAIN; WEAK; HYPERSENSITIVE ENERGY; HEADACHE; MALARIA LIKE FEVER/MILD FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date 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 subject experienced chest pain, struggled to sleep, bedridden, neck pain, body pain, pain along spine, slight arm pain, headache, malaria like fever/mild fever, hypersensitive energy, fatigue, and weak. Treatment medications (dates unspecified) included: cannabidiol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bedridden, and weak, and the outcome of headache, chest pain, slight arm pain, struggled to sleep, neck pain, body pain, pain along spine, hypersensitive energy, malaria like fever/mild fever and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Spinal pain
Clinical narrative: CHEST PAIN; STRUGGLED TO SLEEP; BEDRIDDEN; NECK PAIN; BODY PAIN; PAIN ALONG SPINE; SLIGHT ARM PAIN; WEAK; HYPERSENSITIVE ENERGY; HEADACHE; MALARIA LIKE FEVER/MILD FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date 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 subject experienced chest pain, struggled to sleep, bedridden, neck pain, body pain, pain along spine, slight arm pain, headache, malaria like fever/mild fever, hypersensitive energy, fatigue, and weak. Treatment medications (dates unspecified) included: cannabidiol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bedridden, and weak, and the outcome of headache, chest pain, slight arm pain, struggled to sleep, neck pain, body pain, pain along spine, hypersensitive energy, malaria like fever/mild fever and fatigue was not reported. This report was non-serious.