chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: Kinrix vaccine in an unknown thigh; cellulitis; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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 pediatric patient received Kinrix in an unknown thigh which led to vaccine administered at inappropriate site.  Less than a week after receiving Kinrix, the patient developed cellulitis.  The reporter consented to follow up. The reporter and healthcare professional gave permission to contact them for further information. No other information was shared. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR154891:Same reporter US-GLAXOSMITHKLINE-US2021153977:Same reporter US-GLAXOSMITHKLINE-US2021AMR154892:same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Headache, Injection site pain, Peripheral swelling
Clinical narrative: redness on left arm; swelling of left arm; hives on left arm; my arm feels like it is on fire; headache; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she has had 12 to 18 outbreaks of shingles before receiving the Shingrix vaccine). Previously administered products included Zostavax (received Zostavax in 2012). Concurrent medical conditions included cyst (had a cyst on her back may be before the Shingles vaccine was unresolved) and pain (had cyst sore was unresolved). Concomitant products included paracetamol (Tylenol).   On 8th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 8th July 2021, 2 hrs after receiving Shingrix, the patient experienced injection site pain, erythema of extremities, swelling arm, headache, hives and burning sensation. On an unknown date, the outcome of the injection site pain, swelling arm and headache were recovered/resolved and the outcome of the erythema of extremities, hives and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, erythema of extremities, swelling arm, headache, hives and burning sensation to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient also had the Zostavax vaccine in 2012.  The patient has had 12  to 18 outbreaks of shingles before receiving the Shingrix vaccine on 8th July 2021.  The patient has a cyst on her back, she did not know when the cyst started, it may be before the Shingles vaccine on , the cyst was sore and unresolved. The patient was going to the doctor at the time of reporting for treatment for the cyst.  The took a Tylenol 2 hours before receiving her Shingles vaccine in her left deltoid. The patient received Shingrix vaccine and within 2 hours after the vaccine she experienced pain at the injection site (resolved after 5 days), redness on left arm (unresolved), swelling of left arm (unresolved),headache (resolved after 4 days), hives on left arm (unresolved), her arm felt like it was on fire (burning sensation left arm, unresolved). The patient consented to follow up with her doctor. The case had been linked with US2021151565, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151565:same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: redness on left arm; swelling of left arm; hives on left arm; my arm feels like it is on fire; headache; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she has had 12 to 18 outbreaks of shingles before receiving the Shingrix vaccine). Previously administered products included Zostavax (received Zostavax in 2012). Concurrent medical conditions included cyst (had a cyst on her back may be before the Shingles vaccine was unresolved) and pain (had cyst sore was unresolved). Concomitant products included paracetamol (Tylenol).   On 8th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 8th July 2021, 2 hrs after receiving Shingrix, the patient experienced injection site pain, erythema of extremities, swelling arm, headache, hives and burning sensation. On an unknown date, the outcome of the injection site pain, swelling arm and headache were recovered/resolved and the outcome of the erythema of extremities, hives and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, erythema of extremities, swelling arm, headache, hives and burning sensation to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient also had the Zostavax vaccine in 2012.  The patient has had 12  to 18 outbreaks of shingles before receiving the Shingrix vaccine on 8th July 2021.  The patient has a cyst on her back, she did not know when the cyst started, it may be before the Shingles vaccine on , the cyst was sore and unresolved. The patient was going to the doctor at the time of reporting for treatment for the cyst.  The took a Tylenol 2 hours before receiving her Shingles vaccine in her left deltoid. The patient received Shingrix vaccine and within 2 hours after the vaccine she experienced pain at the injection site (resolved after 5 days), redness on left arm (unresolved), swelling of left arm (unresolved),headache (resolved after 4 days), hives on left arm (unresolved), her arm felt like it was on fire (burning sensation left arm, unresolved). The patient consented to follow up with her doctor. The case had been linked with US2021151565, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151565:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st SHINGRIX  dose in early 2020/has not received 2nd dose due to COVID19 Pandemic.; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in early 2020, in pharmacy).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not applicable for this report. The reporter stated that, the patient had not received 2nd dose due to Covid 19 Pandemic, which led to social problem. The reporter was not able to provide exact details about month of 1st dose or shot administration details for the patient. The patient gave permission to follow up with his doctor.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Influenza like illness
Clinical narrative: flu like symptoms; chills / started 2-3 after the vaccine injection / it has not stopped but it has eased up. Chill symptoms are at a low level but had not stopped.; having diarrhea / started 2-3 after the vaccine injection / it has not stopped but it has eased up; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced influenza-like symptoms, chills, diarrhea and upset stomach. On an unknown date, the outcome of the influenza-like symptoms and upset stomach were unknown and the outcome of the chills and diarrhea were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, chills, diarrhea and upset stomach to be related to Shingrix.  Additional details were provided as follow: The case was reported by patient for herself. The patient had received 1st dose of Shingrix on an unknown date. The batch number and expiration date were not provided. Patient does not recall the date that she got the vaccine and does not know in which arm it was injected. The patient reported that she had Pneumonia vaccine on the same date. The patient stated that she continued having diarrhea, chills, flu like symptoms and upset stomach.  The  patient reported  that the diarrhea and chills started 2-3 after the vaccine injection.  The patient stated it had not stopped but it had eased up.  Chill symptoms are at a low level but had not stopped. Patient did not provide consent to follow up with healthcare professional until she had her appointment first. It was unknown if the reporter considered the influenza-like symptoms, chills, diarrhea and upset stomach to be related to PNEUMONIA VACCINE.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn´t received second dose of shingrix conisdering the schedule. First dose was given one year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 1 year ago from  the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. The reporter consented to follow up
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Dose / reconstituted with sterile water instead of the supplied adjuvant; Dose / reconstituted with sterile water instead of the supplied adjuvant; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 3rd April 2022) for prophylaxis.   On 8th July 2021, the patient received the 1st dose of Shingrix. On 8th July 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient was administered a first dose of shingrix that was reconstituted with sterile water instead of the supplied adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The nurse gave permission for follow-up. This case had been linked with US2021151600, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151600:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: 33 year old /presented / a written prescription from the healthcare provider for Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 33-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist reported that 33 years old patient presented to the pharmacy with a written prescription from the healthcare provider for Shingrix which led to intercepted drug prescribing error.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Product administered to patient of inappropriate age, Underdose
Clinical narrative: given one pediatric dose of Engerix-B / (0.5ML); given one pediatric dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 42-year-old female patient who received HBV (Engerix B pediatric) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 13th July 2021, the patient received Engerix B pediatric .5 ml. On 13th July 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The reporter drawn a titer, that an adult was given one pediatric dose of Engerix-B as a booster dose, which led to underdose and adult use of a child product. The reporter consented to follow up.
Age: 56.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administration of 1-adult dose of Havrix followed by 1-pediatric dose of Havrix; Adult use of child product; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 56-year-old patient who received HAV (Havrix 720) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult (1st dose received on 4th November 2020).   On 11th May 2021, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   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, the administration of 1 adult dose of Havrix followed by 1 pediatric dose of Havrix with patient, which led to underdose and adult use of a child product. The reporter did not consent to follow up. This case was linked with case US2021152082, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152082:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: first Shingrix vaccine in September of 2020/never got the second dose; itching on her arm for the next 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced itchy upper limbs and incomplete course of vaccination. On an unknown date, the outcome of the itchy upper limbs was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for 2nd dose. After receiving 1st dose of Shingrix, the patient experienced itching on her arm for the next 2 weeks. The symptom resolved after 2 weeks. No lot or expiration date was known for the first vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient declined to provide healthcare professional information. The reporter did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site pruritus, Injection site urticaria
Clinical narrative: hives/  on the right deltoid at the injection site; mild edema/ on the right deltoid at the injection site; mild erythema/  on the right deltoid at the injection site; itching/  on the right deltoid at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site hives in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number F3NL3, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 15th July 2021, 1 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site hives, injection site edema, injection site erythema and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site hives, injection site edema, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site hives, injection site edema, injection site erythema and injection site itching to be related to Boostrix and Boostrix Pre-Filled Syringe Device.  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 Boostrix on 14th July 2021, in the right deltoid. HCP (healthcare professional ) stated that, the next day on 15th July 2021, the patient began to experiencing itching, mild erythema, mild edema, and hives on the right deltoid at the injection site. The patient had received Benadryl for side effects. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema, Pruritus
Clinical narrative: hives/  on the right deltoid at the injection site; mild edema/ on the right deltoid at the injection site; mild erythema/  on the right deltoid at the injection site; itching/  on the right deltoid at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site hives in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number F3NL3, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 15th July 2021, 1 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site hives, injection site edema, injection site erythema and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site hives, injection site edema, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site hives, injection site edema, injection site erythema and injection site itching to be related to Boostrix and Boostrix Pre-Filled Syringe Device.  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 Boostrix on 14th July 2021, in the right deltoid. HCP (healthcare professional ) stated that, the next day on 15th July 2021, the patient began to experiencing itching, mild erythema, mild edema, and hives on the right deltoid at the injection site. The patient had received Benadryl for side effects. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose/Expiration date / May 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered Bexsero, which was expired on 31st May 2021. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient vaccinated on 08/24/19 / and the second dose is 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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th August 2019, batch number 2G2T7, expiry date 15th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up. This case has been linked with US2021152864 and US2021152856, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152864:Same reporter US-GLAXOSMITHKLINE-US2021152856:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / in 2018 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (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 for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional declined to provide patient demographics, lot number and expiration date. The reporter did not consent to follow up.
Age: 9.0
Sex: M
Vaccine: HEPA, HPVX
Symptoms: Overdose, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Havrix adult dose administered to a 9 y/o child; Havrix adult dose administered to a 9 y/o child; HPV vaccine administered at the same time; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old male patient who received HAV (Havrix adult) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On 16th July 2021, the patient received Havrix adult (intramuscular), hepatitis A vaccine pre-filled syringe device and HPV vaccine. On 16th July 2021, unknown after receiving Havrix adult and hepatitis A vaccine pre-filled syringe device and not applicable after receiving HPV vaccine, the patient experienced overdose, adult product administered to child and product use in unapproved population. On an unknown date, the outcome of the overdose, adult product administered to child and product use in unapproved population 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 healthcare professional reported administered Havrix adult dose to a child, which led to overdose and adult product administered to child and the HPV vaccine administered at the same time to male patient, which led to product use in unapproved population. The reporter consented to follow up. This case had been linked with US2021075972, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075972:Same reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Laboratory test, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: PERIPHERAL SWELLING; JOINT SWELLING; LABORATORY TEST; PAIN IN EXTREMITY; RASH; RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (reference number 1437585) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient experienced drug allergy when treated with levothyroxine, and lisinopril.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (aspirin low dose), atorvastatin, estradiol, gemfibrozil, insulin glargine (Lantus Solo star Pen), levothyroxine sodium(Synthroid), metformin, and omeprazole. On 18-MAY-2021, the patient experienced Left arm sore (pain in extremity) for about 9days and the patient's right finger had started to swell at the joint (joint swelling), On the same day the patient experienced rash, undergone laboratory test and was diagnosed with rheumatoid arthritis.  By 21-MAY-2021, the patient's finger pain went through hand and had painful bumps on elbows and fingers. On 28-MAY-2021, the patient both hands and left foot were swollen (peripheral swelling). It was reported that the patient had follow up appointment with doctor on 29-JUN-2021 and by then both the feet, hands and left knee were swollen. The patient's laboratory data included: Laboratory test (NR: not provided) Lupus, autoimmune negative and the patient was diagnosed with Rheumatoid arthritis based on symptoms. The patient visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis, pain in extremity, peripheral swelling, rash, joint swelling, and laboratory test. This report was serious (Other Medically Important Condition).  version created to amend previously reported information on 09-JUL-2021. Upon review, the following information was amended: onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021, narrative updated.; Sender's Comments: V1 - This version created to amend previously reported information on 09-JUL-2021 regarding : onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021. This does not change causality of previously reported events. 20210722011-covid-19 vaccine ad26.cov2.s-Rheumatoid Arthritis. 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).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: PERIPHERAL SWELLING; JOINT SWELLING; LABORATORY TEST; PAIN IN EXTREMITY; RASH; RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (reference number 1437585) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient experienced drug allergy when treated with levothyroxine, and lisinopril.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (aspirin low dose), atorvastatin, estradiol, gemfibrozil, insulin glargine (Lantus Solo star Pen), levothyroxine sodium(Synthroid), metformin, and omeprazole. On 18-MAY-2021, the patient experienced Left arm sore (pain in extremity) for about 9days and the patient's right finger had started to swell at the joint (joint swelling), On the same day the patient experienced rash, undergone laboratory test and was diagnosed with rheumatoid arthritis.  By 21-MAY-2021, the patient's finger pain went through hand and had painful bumps on elbows and fingers. On 28-MAY-2021, the patient both hands and left foot were swollen (peripheral swelling). It was reported that the patient had follow up appointment with doctor on 29-JUN-2021 and by then both the feet, hands and left knee were swollen. The patient's laboratory data included: Laboratory test (NR: not provided) Lupus, autoimmune negative and the patient was diagnosed with Rheumatoid arthritis based on symptoms. The patient visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis, pain in extremity, peripheral swelling, rash, joint swelling, and laboratory test. This report was serious (Other Medically Important Condition).  version created to amend previously reported information on 09-JUL-2021. Upon review, the following information was amended: onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021, narrative updated.; Sender's Comments: V1 - This version created to amend previously reported information on 09-JUL-2021 regarding : onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021. This does not change causality of previously reported events. 20210722011-covid-19 vaccine ad26.cov2.s-Rheumatoid Arthritis. 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: Illness
Clinical narrative: SICK; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 09-JUL-2021 was received on 12-JUL-2021 and concerned 8 patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; CHILLS; FEELING UNWELL; FEVER 100.8 FAHRENHEIT (F); FATIGUE; HEADACHE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a health care professional concerned a 34 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registryt number: C00060). The patient's weight was 52.15 kilograms, and height was not reported. The patient's past medical history included multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 14-MAR-2021 for prevention covid-19. 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 14-MAR-2021, the patient experienced maternal exposure during pregnancy. On 14-MAR-2021, the patient experienced sore arm. On 14-MAR-2021, the patient experienced chills. On 14-MAR-2021, the patient experienced feeling unwell. On 14-MAR-2021, the patient experienced fever 100.8 fahrenheit (f). On 14-MAR-2021, the patient experienced fatigue. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, fever 100.8 fahrenheit (f), headache, muscle pain, nausea, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, chills, feeling unwell, fever 100.8 fahrenheit (f), fatigue, headache, muscle pain, and nausea was related.  This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; CHILLS; FEELING UNWELL; FEVER 100.8 FAHRENHEIT (F); FATIGUE; HEADACHE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a health care professional concerned a 34 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registryt number: C00060). The patient's weight was 52.15 kilograms, and height was not reported. The patient's past medical history included multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 14-MAR-2021 for prevention covid-19. 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 14-MAR-2021, the patient experienced maternal exposure during pregnancy. On 14-MAR-2021, the patient experienced sore arm. On 14-MAR-2021, the patient experienced chills. On 14-MAR-2021, the patient experienced feeling unwell. On 14-MAR-2021, the patient experienced fever 100.8 fahrenheit (f). On 14-MAR-2021, the patient experienced fatigue. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, fever 100.8 fahrenheit (f), headache, muscle pain, nausea, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, chills, feeling unwell, fever 100.8 fahrenheit (f), fatigue, headache, muscle pain, and nausea was related.  This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hypersensitivity
Clinical narrative: SHORTNESS OF BREATH; FELT LIKE I WAS GOING TO DIE; ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no pertinent medical history. the patient was a healthy person and had not been to an emergency room in years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A 21A, and expiry: 05-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced felt like i was going to die. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, felt like i was going to die and allergic reaction was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza like illness
Clinical narrative: SHINGLES; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 87 pounds, and height was 60 inches. The patient's past medical history included hives, and concurrent conditions included lymphedema in left leg, bronchiectasis, abstain from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid, clarithromycin, and doxycycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced flu like symptoms. On 09-JUN-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 12-MAR-2021, and had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Asthenia, Blood pressure measurement, Chills, Decreased appetite
Clinical narrative: FEELING NUMBNESS IN THE PALM  OF HER RIGHT HAND AND IN RIGHT LEG AND FOOT; DIFFICULT TO MOVE FOR ABOUT 4 DAYS; FELT SEVERE PAIN IN BOTH THE HANDS, LEGS, AND ARMS; ABNORMAL HEART BEAT; HIGH BLOOD PRESSURE; FELT WEAK; SLIGHT HEADACHE; PAIN ON INJECTION SITE; LOSS OF APPETITE; SLIGHT CHILLS; This spontaneous report received from a patient concerned a 26 year old ,  female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, non alcohol use, and blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the patient experienced loss of appetite, slight chills, weakness, slight headache and pain on injection site. After 2-3 weeks after receiving vaccine, on 01-MAY-2021, the patient experienced sever pain in hands, legs and arms and it was very difficult to move for about 4 days. Patient went to the clinic in May to seek help for her pain and new heart side effects. Patient noticed that her heart was beating abnormally, It would beat hard 10 minutes and then stop. On MAY-2021, Laboratory data included: Scan (NR: not provided) No abnormalities with heart. In clinic they also checked blood pressure and Laboratory data included: Blood pressure (NR: not provided) Abnormally high, Heart rate (NR: not provided) normal, Patient did an Magnetic resonance imaging (MRI) 3 days after the clinic appointment and had No abnormalities, results came normal. On 11-JUL-2021, the patient experienced feeling numbness in the palm of right hand and in right leg and foot and Patient said it's not serious but had been dealing with the symptoms continuously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficult to move for about 4 days, and loss of appetite, slight chills, weakness, slight headache, and pain on injection site on 11-APR-2021, had not recovered from felt severe pain in both the hands, legs, and arms, abnormal heart beat, and feeling numbness in the palm of right hand and in right leg and foot, and the outcome of high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210730598-covid-19 vaccine ad26.cov2.s -Abnormal heart beat. 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).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Hypertension, Hypoaesthesia, Injection site pain
Clinical narrative: FEELING NUMBNESS IN THE PALM  OF HER RIGHT HAND AND IN RIGHT LEG AND FOOT; DIFFICULT TO MOVE FOR ABOUT 4 DAYS; FELT SEVERE PAIN IN BOTH THE HANDS, LEGS, AND ARMS; ABNORMAL HEART BEAT; HIGH BLOOD PRESSURE; FELT WEAK; SLIGHT HEADACHE; PAIN ON INJECTION SITE; LOSS OF APPETITE; SLIGHT CHILLS; This spontaneous report received from a patient concerned a 26 year old ,  female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, non alcohol use, and blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the patient experienced loss of appetite, slight chills, weakness, slight headache and pain on injection site. After 2-3 weeks after receiving vaccine, on 01-MAY-2021, the patient experienced sever pain in hands, legs and arms and it was very difficult to move for about 4 days. Patient went to the clinic in May to seek help for her pain and new heart side effects. Patient noticed that her heart was beating abnormally, It would beat hard 10 minutes and then stop. On MAY-2021, Laboratory data included: Scan (NR: not provided) No abnormalities with heart. In clinic they also checked blood pressure and Laboratory data included: Blood pressure (NR: not provided) Abnormally high, Heart rate (NR: not provided) normal, Patient did an Magnetic resonance imaging (MRI) 3 days after the clinic appointment and had No abnormalities, results came normal. On 11-JUL-2021, the patient experienced feeling numbness in the palm of right hand and in right leg and foot and Patient said it's not serious but had been dealing with the symptoms continuously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficult to move for about 4 days, and loss of appetite, slight chills, weakness, slight headache, and pain on injection site on 11-APR-2021, had not recovered from felt severe pain in both the hands, legs, and arms, abnormal heart beat, and feeling numbness in the palm of right hand and in right leg and foot, and the outcome of high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210730598-covid-19 vaccine ad26.cov2.s -Abnormal heart beat. 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).