chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA004277: US-009507513-2112USA003881: US-009507513-2112USA003882: US-009507513-2112USA003883: US-009507513-2112USA003885:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA004277: US-009507513-2112USA003881: US-009507513-2112USA003882: US-009507513-2112USA003883: US-009507513-2112USA003884:
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix (DTaP) dose given instead of TDaP; Infanrix (DTaP) given to 11 year old; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Infanrix .5 ml and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. Infanrix (DTaP), one .5ml dose given to this 11 year old patient instead of TDaP; which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 81.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had my first shot on 2/12/2019 and the second dose on 10/11/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th February 2021).   On 11th October 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was self reported by the patient. The patient received second dose later than the recommended interval, which led to lengthening of vaccine schedule. The patient reported that the doctor said good but site says second dose should be within 6 months. The patient enquired should he/she get a second dose now as my pharmacist suggested.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 17-JUL-2021, second dose has not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 17th July 2021).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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 the patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter stated that the patient was not immunocompromised. No further information reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed second dose; 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.   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 patient self-reported this case. The age at vaccination was not applicable for this report. The patient stated that if he/she missed 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: SHINGRIX dose 1= April 24, 2019 then dose 2 given 12/06/2021.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 24th April 2019).   On 6th December 2021, the patient received the 2nd dose of Shingrix. On 6th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this case. The patient received 2nd dose of shingrix  into his left arm later than the recommended interval, which led to drug dose administration interval too long. The reporter asked did he need to get another dose. No further information reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Keratitis, Vaccination failure
Clinical narrative: cornea keratitis, so unhappy; had two vaccinations, diagnosed with trigeminal herpes zoster; trigeminal herpes zoster; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 2nd June 2020, the patient received the 1st dose of Shingrix. On 26th November 2021, 403 days after receiving Shingrix and 542 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the patient experienced keratitis. On an unknown date, the outcome of the vaccination failure, herpes zoster and keratitis were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and keratitis to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccinations and diagnosed with trigeminal herpes zoster. A very severe case and the patient was devastating diagnosis.  The patient stated he/she also had cornea keratitis as a result. The patient was so unhappy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: My arm hurts; Side hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th December 2021, the patient received Shingles vaccine. On 8th December 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and pain localized. On an unknown date, the outcome of the pain in arm and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain localized to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccine today (on the day of reporting) and heard so many horrible stories about Shingles. The patient said that his/her arm and side hurts but it should only last another day.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 month old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number z9mz2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included diphtheria toxoid + hepatitis B vaccine + pertussis toxoid + poliomyelitis vaccine + tetanus toxoid (Pediarix).   On 30th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th 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 reported as follows: The patient received a dose of Kinrix at the age of 7 months, which led to inappropriate age of vaccination. The patient also received a dose of Pediarix on 14th September 2021, but no adverse events reported for that vaccine. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: pain at the injection site; sluggishness; sore arm; injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included guillain barre syndrome (had Guillain-Barre syndrome about 15 years ago).   On 22nd April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd April 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site swelling, sluggishness and pain in arm. On an unknown date, the outcome of the injection site pain, injection site swelling, sluggishness and pain in arm were recovered/resolved.   The reporter considered the injection site pain and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the sluggishness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that she had recovered from a diagnosed of Guillain-Barré Syndrome (GBS). The patient received dose of Shingrix vaccine in left arm and experienced injection site soreness immediately after the vaccination that lasted several days. The patient also experienced injection site swelling that lasted about a week, sluggishness and sore arm. The patient stated that these side effects felt exactly the same as the effects of GBS when she had previously been diagnosed. The patient asked if the Shingrix vaccine could reactive GBS. The reporter consented to follow-up. No further information reported. For 2nd dose tolerance, refer linked case US2021AMR251606, reported by the same reporter.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Inquire about 3rd dose, 4 years after 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 25-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received on 14th September 2017) and Engerix B adult (2nd dose received on 17th October 2017).   On an unknown date, the patient received the 3rd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, 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 3rd dose, which led to incomplete course of vaccination. Certified pharmacy technician called in to inquire about a third dose of Engerix. Since it had been years. The (Certified pharmacy technician) CPT did not to provide vaccine lot and expiration date. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   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 patient did not receive the 2nd dose till the time of reporting, which led to incomplete course of vaccination. No further information reported. The reporter consented to follow-up. This case has been linked with case US2021251176, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021251176:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2019, 2nd dose on 12/6/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2019).   On 6th December 2021, the patient received the 2nd dose of Shingrix. On 6th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. No demographics provided. The patient received the 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule. Permission denied for follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival discomfort, Gingival pain, Glossodynia, Oral pain, X-ray dental abnormal
Clinical narrative: pain in upper and lower gums; pain, right side of mouth/pain on roof of mouth; pain on tongue; gums were irritated; This case was reported by a consumer via call center representative and described the occurrence of gum pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th November 2021, 1 days after receiving Shingrix, the patient experienced gum pain, oral pain, tongue pain and irritation gum. The patient was treated with antibiotics nos and mouthwash, nos (Mouthwash). On an unknown date, the outcome of the gum pain, oral pain, tongue pain and irritation gum were recovered/resolved.   It was unknown if the reporter considered the gum pain, oral pain, tongue pain and irritation gum to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received 1st dose of Shingrix and the next day had pain in her upper and lower gums on the right side of her mouth, and on the roof of her mouth and tongue.  The patient reported that this lasted 2 weeks and had now resolved.  The patient reported that when this happened she visited her dentist, who did an x-ray and said that her gums were irritated.  The patient reported that her dentist prescribed her antibiotics and mouthwash.  The patient wanted more information about side effects and if she should take the 2nd dose. The patient wanted to know if this was a reported side effect. Consent obtained to contact health care professional and consumer. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, FLU4, HEP, HEPA, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Possible administration of vaccines after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd December 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Boostrix, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Boostrix, Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 medical assistant reported that, a below temperature excursion of negative 2.0 degree celcius for 6 minutes for Infanrix, Havrix, Engerix B, Pediarix, Flulaval QIV, Rotarix, Boostrix, which led to incorrect storage of drug. No priors excursions. The reporter was not completely sure if any of their patients might have been vaccinated with any of these vaccines. No details from patient or patients or any other details provided as reporter was not sure this happened or not. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 71 year old was administered  kinrix; was administered  kinrix instead of boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 71-year-old 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.   In November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. In November 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 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 patient received dose of Kinrix couple weeks ago from the date of reporting instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received a dose of expired Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number T2472, expiry date 26th November 2021) and (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 7th December 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 7th December 2021, unknown after receiving Shingrix, 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 pharma intern reported that, the patient received expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 3 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR252431:same reporter US-GLAXOSMITHKLINE-US2021AMR252432:same reporter
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number c5jl7, expiry date 28th November 2021) for prophylaxis.   On 8th December 2021, the patient received the 1st dose of Boostrix. On 8th December 2021, unknown after receiving Boostrix, 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 medical assistant reported that, an expired dose of boostrix was given to the patient, which led to expired vaccine used. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site mass, Limb discomfort, Pain, Pain in extremity, Paraesthesia
Clinical narrative: ARM HURTS; TINGLING FROM SHOT AREA DOWN ARM AND INTO FINGERS LIKE ARM WENT TO SLEEP; LITTLE LUMP WHERE VACCINE WAS GIVEN; TIGHTENING UP INSIDE ARM AND ROLLING AROUND; RIPPLING FEELING INSIDE ARM WHERE THE VACCINE WAS GIVEN; ARM GOT SORE; EXCRUITATING BURNING ON INJECTION; ACHINESS ALL OVER/ALWAYS SLIGHT ACHE; This spontaneous report received from a patient concerned a 71 year old female. 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: 1808982, and expiry: UNKNOWN) dose was not reported,1 total, administered on 08-APR-2021 into left arm for prophylactic vaccination (Dose Number In Series 1). Following vaccination, the minute she put it in it burned ("excruciating burning"). Her arm got sore, but the soreness had not gone away. On an unspecified date in APR-2021, the patient felt like a little lump where it was given and almost felt like tightening up inside arm and rolling around, also had achiness all over/always slight ache. On 01-SEP-2021, the patient experienced little lump where vaccine was given, tightening up inside arm and rolling around, rippling feeling inside arm where the vaccine was given and tingling from shot area down arm and into fingers like arm went to sleep (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness all over/always slight ache on 27-NOV-2021and excruciating burning on 08-APR-2021, had not recovered from arm got sore, little lump where vaccine was given, tingling from shot area down arm and into fingers like arm went to sleep, tightening up inside arm and rolling around, and rippling feeling inside arm where the vaccine was given. On an unspecified date in 26-NOV-2021, the patient received additional non-company suspect vaccine MRNA 1273 (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination (Dose Number In Series 2). On an 26-NOV-2021, following vaccination with MRNA 1273, her left arm hurt all day(dose series 2).  Treatment medications (dates unspecified) included: naproxen sodium, and acetylsalicylic acid. The action taken with mrna 1273, was not applicable.  The outcome of the arm hurts was not reported.  This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Skin tightness, Vaccination site pain
Clinical narrative: ARM HURTS; TINGLING FROM SHOT AREA DOWN ARM AND INTO FINGERS LIKE ARM WENT TO SLEEP; LITTLE LUMP WHERE VACCINE WAS GIVEN; TIGHTENING UP INSIDE ARM AND ROLLING AROUND; RIPPLING FEELING INSIDE ARM WHERE THE VACCINE WAS GIVEN; ARM GOT SORE; EXCRUITATING BURNING ON INJECTION; ACHINESS ALL OVER/ALWAYS SLIGHT ACHE; This spontaneous report received from a patient concerned a 71 year old female. 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: 1808982, and expiry: UNKNOWN) dose was not reported,1 total, administered on 08-APR-2021 into left arm for prophylactic vaccination (Dose Number In Series 1). Following vaccination, the minute she put it in it burned ("excruciating burning"). Her arm got sore, but the soreness had not gone away. On an unspecified date in APR-2021, the patient felt like a little lump where it was given and almost felt like tightening up inside arm and rolling around, also had achiness all over/always slight ache. On 01-SEP-2021, the patient experienced little lump where vaccine was given, tightening up inside arm and rolling around, rippling feeling inside arm where the vaccine was given and tingling from shot area down arm and into fingers like arm went to sleep (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness all over/always slight ache on 27-NOV-2021and excruciating burning on 08-APR-2021, had not recovered from arm got sore, little lump where vaccine was given, tingling from shot area down arm and into fingers like arm went to sleep, tightening up inside arm and rolling around, and rippling feeling inside arm where the vaccine was given. On an unspecified date in 26-NOV-2021, the patient received additional non-company suspect vaccine MRNA 1273 (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination (Dose Number In Series 2). On an 26-NOV-2021, following vaccination with MRNA 1273, her left arm hurt all day(dose series 2).  Treatment medications (dates unspecified) included: naproxen sodium, and acetylsalicylic acid. The action taken with mrna 1273, was not applicable.  The outcome of the arm hurts was not reported.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient via a company representative via social media 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 (unspecified manufacturer) for prophylactic vaccination on an unspecified date.  The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose not reported, start therapy date were not reported for prophylactic vaccination as a booster dose. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid (coronavirus disease). The patient reported "I am one of the person's that got COVID after getting a second dose" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with a product quality complaint:90000204395. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM STILL HURTS OFF AND ON; This spontaneous report received from a patient via social media concerned a patient of unspecified age, sex, race and ethic 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) dose was not reported, (dose number in series was 2), 1 total administered on OCT-2021 for prophylactic vaccination as a booster. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced arm still hurts off and on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurts off and on. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 47 year old male male of unspecified race and ethnic origin.   The patient's weight, height, and medical history were not reported.  On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 2), administered on 27-NOV-2021 for prophylactic vaccination   The patient received half dose for booster (Off label use)  (dose number in series: 2). No concomitant medications were reported.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the received half dose for booster and off label use was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211202250, 20211201046, 20211201228, 20211201168, 20211202193, 20211200717, 20211200723, 20211200769, 20211200994, 20211201179, 20211201286, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202371 and 20211202379. .
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 30 year old female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 or 211A21A expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 2), administered on 27-NOV-2021 for prophylactic vaccination (RRT: Received half dose for booster, LLT: vaccine underdose, and Off label use). No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for booster and off label use was not reported. This report was non-serious.  This case, from the same reporter is linked to 20211202250, 20211200717, 20211200723, 20211200752, 20211200769, 20211200994, 20211201082, 20211201168, 20211201179, 20211201228, 20211201286, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202371, 20211202379 and 20211202193.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 36 year old female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 or 211A21A expiry: UNKNOWN) dose of 0.25 milliliters, 1 in total, (dose number in series: 2), administered on 27-NOV-2021 for prophylactic vaccination (RRT: Received half dose for booster, LLT: vaccine underdose, and Off label use). No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for booster and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211200717, 20211200723, 20211200752, 20211200769, 20211200994, 20211201179, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202371, 20211202379, 20211202469, 20211204104, 20211220152, 20211220146, 20211220262, 20211220145, 20211220619 and 20211220155.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Paraesthesia, Skin swelling
Clinical narrative: SWELLING SKIN; PAIN IN BACK; PAIN IN ARMS AND LEGS; TINGLING; 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 (dose number in series 1)(suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced swelling skin, pain in back, pain in arms and legs, and tingling (all events series 1). Patient stated she has visited some doctors and had some failed treatments. On 29-OCT-2021, she received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) as booster dose for prophylactic vaccinations. No events reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling, swelling skin, pain in arms and legs, and pain in back. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Fatigue, Pancreatitis acute, Pyrexia
Clinical narrative: ACUTE PANCREATITIS; CHILLS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 54 year old male.  The patient's weight was 240 pounds and height was 69 inches. The patient's concurrent conditions included: abstains from alcohol and non-smoker. The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. Patient never had pancreatitis previously.  On unspecified dates in APR-2021, the patient previously received the series bnt 162 (dose number in series 1, manufacturer: Pfizer) (form of admin, route of admin and batch number: unknown expiry: unknown) dose was not reported, for prophylactic vaccination.   On 18-NOV-2021, 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 expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. 12 to 24 hours after vaccination, the patient experienced fever, chills and fatigue (dose number in series 2).   On 28-NOV-2021, the patient began experiencing severe epigastric pain around 12pm. That same evening at 7pm, patient went to local hospital emergency room (ER) since the pain was not resolving. The patient was seen and treated for acute pancreatitis (dose number in series 2) with treatment medications which included: pain medications (unable to capture) and an antiemetic (unable to capture). Laboratory data included: CAT (computed tomography) scan abdominal which confirmed acute pancreatitis diagnosis.  On 29-NOV-2021 (Monday), the patient was discharged from the ER.   On 30-NOV-2021 (Tuesday), the patient followed-up with gastroenterologist who confirmed the diagnosis of acute pancreatitis but unsure of the cause. It was reported, by the patient that he recovered and was on a low fat diet. The patient has a scheduled for an abdominal MRI (Magnetic resonance imaging) for 20-DEC-2021 for further evaluation of the cause.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from acute pancreatitis and the outcome of fever, chills, and fatigue was not reported.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211201960-covid-19 vaccine ad26.cov2.s-Acute pancreatitis . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abdominal rigidity, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: SORE THROAT; STOMACH PAIN; FEEL MISERABLE; FACIAL SWELLING; SWELLING OF EYE LIDS; ITCHING; A LOT OF PAIN UNDER RIB CAGE; EXACERBATING FIBROMYALGIA; EXACERBATING INFLAMMATORY REACTION THROUGH BODY; PAIN; STOMACH SPASM; FEELING SO SICK; CHILLS; DIARRHEA; VOMITING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: concussion, and concurrent conditions included: autoimmune issues, genetic issues lump into fibromyalgia, and fibromyalgia in upper chest. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number series 1) (batch number:1805020) on 15-MAR-2021 for prophylactic vaccination; and experienced itching inside chest when treated with diphenhydramine hydrochloride for itching in chest ( dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin not reported, batch number: 1071855194, and expiry: UNKNOWN) dose was not reported,1 total, administered on 26-NOV-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced pain, stomach spasm, feeling so sick, chills, diarrhea and vomiting. On an unspecified date, the patient experienced exacerbating fibromyalgia, exacerbating inflammatory reaction through body, sore throat, stomach pain, feel miserable, facial swelling, swelling of eye lids, itching, and a lot of pain under rib cage  ( all events in dose number series 2). She denies having a temperature. She reports her symptoms are not in the medical books and she reacts differently than majority of the people. Treatment medications (dates unspecified) included: dicycloverine hydrochloride for stomach issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exacerbating fibromyalgia, chills, diarrhea, vomiting, pain, stomach spasm, feeling so sick, exacerbating inflammatory reaction through body, stomach pain, sore throat, feel miserable, facial swelling, itching, a lot of pain under rib cage and swelling of eye lids was not reported. This report was non-serious. This case, involving the same patient is linked to 20211206613.
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Inflammation, Malaise, Musculoskeletal chest pain, Oropharyngeal pain
Clinical narrative: SORE THROAT; STOMACH PAIN; FEEL MISERABLE; FACIAL SWELLING; SWELLING OF EYE LIDS; ITCHING; A LOT OF PAIN UNDER RIB CAGE; EXACERBATING FIBROMYALGIA; EXACERBATING INFLAMMATORY REACTION THROUGH BODY; PAIN; STOMACH SPASM; FEELING SO SICK; CHILLS; DIARRHEA; VOMITING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: concussion, and concurrent conditions included: autoimmune issues, genetic issues lump into fibromyalgia, and fibromyalgia in upper chest. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number series 1) (batch number:1805020) on 15-MAR-2021 for prophylactic vaccination; and experienced itching inside chest when treated with diphenhydramine hydrochloride for itching in chest ( dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin not reported, batch number: 1071855194, and expiry: UNKNOWN) dose was not reported,1 total, administered on 26-NOV-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced pain, stomach spasm, feeling so sick, chills, diarrhea and vomiting. On an unspecified date, the patient experienced exacerbating fibromyalgia, exacerbating inflammatory reaction through body, sore throat, stomach pain, feel miserable, facial swelling, swelling of eye lids, itching, and a lot of pain under rib cage  ( all events in dose number series 2). She denies having a temperature. She reports her symptoms are not in the medical books and she reacts differently than majority of the people. Treatment medications (dates unspecified) included: dicycloverine hydrochloride for stomach issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exacerbating fibromyalgia, chills, diarrhea, vomiting, pain, stomach spasm, feeling so sick, exacerbating inflammatory reaction through body, stomach pain, sore throat, feel miserable, facial swelling, itching, a lot of pain under rib cage and swelling of eye lids was not reported. This report was non-serious. This case, involving the same patient is linked to 20211206613.