chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Feeling fatigued; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021 14:30, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. In December 2021, 15 hrs 30 min after receiving Shingrix, the patient experienced headache, chills and fatigue. On an unknown date, the outcome of the headache, chills and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. Reporter could not provide the lot or expiration date of the vaccine administered. On the day of reporting (this morning around 6am), the patient woke up with a headache, chills, and felt fatigued. Reporter gave consent for safety to contact her but did not provide any information to contact her health care professional. The reporter consented to follow up.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination, Wrong product administered
Clinical narrative: first Twinrix on 11/17/21 later Engerix 12/17/21; first Twinrix, a month later Engerix, mix up; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 49-year-old male patient who received HBV (Engerix B adult) (batch number L5C49, expiry date 17th May 2022) for prophylaxis. Co-suspect products included HAB (Twinrix adult) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX ADULT). On 17th December 2021, the patient received Engerix B adult. On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Engerix B adult, not applicable after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device and an unknown time after receiving TWINRIX ADULT, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination 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 for Engerix B vaccine. The age at vaccination was not applicable for Twinrix adult. The patient received 1st dose of Twinrix adult on 17th November 2021, batch number 3Y7NL and expiry date 24th May 2022. The patient received Engerix B vaccine instead of Twinrix adult, which led to wrong vaccine administered. The patient did not receive 2nd dose of twinrix adult as per recommended vaccine schedule, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 10-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT 2021-2022 SEASON). On 17th December 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device and an unknown time after receiving FLUARIX QUADRIVALENT 2021-2022 SEASON, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 received 1st dose of Fluarix Quadrivalent 2021-2022 on 16th October 2021 and 2nd dose on the day of reporting, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only have one dose, Dec 30th 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th December 2020, batch number 52B24).   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 at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient received 2 doses of Shingrix but the Pharmacy records they only have one dose documented. So they were asking for information on a possible 3rd dose and late dose as well. The reporter consented to follow up.
Age: 8.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Shingrix rather than the COVID vaccine; 8 year old mistakenly received Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 8-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th December 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The patient mistakenly received Shingrix rather than the intended COVID vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Blister, Herpes zoster, Injected limb mobility decreased, Pain in extremity
Clinical narrative: contracted shingles on his leg; has high anxiety; rash; blisters; it was hard to lift anything; felt that he had got punched in his arm; This case was reported by a consumer and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 months ago (from the day of reporting)). Concurrent medical conditions included hiv infection.   On 17th December 2021, the patient received the 2nd dose of Shingrix. On 17th December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On 20th December 2021, the patient experienced shingles, anxiety, rash and blister. On an unknown date, the outcome of the shingles, anxiety, rash and blister were not recovered/not resolved and the outcome of the pain in arm and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the shingles, pain in arm, anxiety, injected limb mobility decreased, rash and blister to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The reporter stated that he had his second dose of Shingrix on the left deltoid, he felt that he had got punched in his arm and it was hard to lift anything. On the day of reporting, the patient contracted Shingles on his leg with rash and blisters. The reporter also stated that he had high anxiety. The reporter had limited information. The reporter consented to follow up with himself and with pharmacy
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: contracted shingles on his leg; has high anxiety; rash; blisters; it was hard to lift anything; felt that he had got punched in his arm; This case was reported by a consumer and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 months ago (from the day of reporting)). Concurrent medical conditions included hiv infection.   On 17th December 2021, the patient received the 2nd dose of Shingrix. On 17th December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On 20th December 2021, the patient experienced shingles, anxiety, rash and blister. On an unknown date, the outcome of the shingles, anxiety, rash and blister were not recovered/not resolved and the outcome of the pain in arm and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the shingles, pain in arm, anxiety, injected limb mobility decreased, rash and blister to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The reporter stated that he had his second dose of Shingrix on the left deltoid, he felt that he had got punched in his arm and it was hard to lift anything. On the day of reporting, the patient contracted Shingles on his leg with rash and blisters. The reporter also stated that he had high anxiety. The reporter had limited information. The reporter consented to follow up with himself and with pharmacy
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tricuspid valve repair (new heart also needed a pig valve repair on the tricuspid valve), mitral valve repair (on the old heart), cardiac resynchronization therapy / implantable cardioverter defibrillator insertion, surgery (Surgery for IV placements), hospitalization (was in the hospital for 45 days and 3 operations), shingles and meningitis. Previously administered products included Nucala with an associated reaction of heart transplant (was taking Nucala for several months in September 2019 for EGPA and experienced hospitalization, heart transplant, Tricuspid valve repair and surgery, refer case US2021AMR260553). Concurrent medical conditions included eosinophilic granulomatosis with polyangiitis and short-term memory loss.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient reported she was going into the health care professional's (HCP) office for three 100 mg injections but she did not recall the formulation used for Nucala.  She had to stop taking Nucala because she had to have a heart transplant and her heart transplant surgery was performed on 5th September 2019.  The patient was in the hospital for 45 days and 3 operations.  The patient reported that the new heart also needed a pig valve repair on the tricuspid valve.  She said her HCP decided to stop her on Nucala because of the surgery and that she would be on several new medications including anti-rejections drugs.  The patient said that her HCP was looking to restart her on Nucala for eosinophilic granulomatosis with polyangiitis (EGPA).  The patient also received the second shot of Shingles vaccine a couple of weeks before the date of reporting in anticipation of starting Nucala again.  She had arm pain from the Shingles shot, but no other symptoms. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260553:same patient
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 36 years old received an engerix-B pediatric dose; 36 years old received an engerix-B pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   On 15th December 2021, the patient received Engerix B pediatric. On 15th December 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 provided as follows: The age at vaccination was not reported. The medical assiatant reported that, 36 years old patient received an engerix-B pediatric dose, which led to underdose and adult use of a child product. The reported consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only powder component; received only powder component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the powder component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. It was unknown which patient received the incomplete dose out of 4 patients. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: joints ache / pain in her hips; pain at the injection site; fatigue; severe aches and pains / extremely sore / getting out of bed is very painful; debilitating; pain from her shoulder to her elbows; getting out of bed is very painful; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 76-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number B49F7, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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: Reporter was the husband of the patient. The patient received a FLUARIX vaccine and following day, she experienced severe aches and pains, pain at the injection site and fatigue. The reporter also said that she was extremely sore and her joints ache. reporter said these effects had been very debilitating. The patient included that getting out of bed was very painful for her as she had pain in her hips in the morning and pain from her shoulder to her elbows. The reporter was given medical advice disclaimer and was referred to HCP. The reporter consented to follow up. This case is linked to the case US2021259937, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259937:Same reporter, same product
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: joints ache / pain in her hips; pain at the injection site; fatigue; severe aches and pains / extremely sore / getting out of bed is very painful; debilitating; pain from her shoulder to her elbows; getting out of bed is very painful; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 76-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number B49F7, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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: Reporter was the husband of the patient. The patient received a FLUARIX vaccine and following day, she experienced severe aches and pains, pain at the injection site and fatigue. The reporter also said that she was extremely sore and her joints ache. reporter said these effects had been very debilitating. The patient included that getting out of bed was very painful for her as she had pain in her hips in the morning and pain from her shoulder to her elbows. The reporter was given medical advice disclaimer and was referred to HCP. The reporter consented to follow up. This case is linked to the case US2021259937, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259937:Same reporter, same product
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2021, the patient received the 3rd dose of Shingrix. On 15th December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter was not able to confirm which arm the vaccine was administered into or if it was given intramuscularly. The consent to contact was not obtained from the patient since the HCP was reporting.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number mb744, expiry date 1st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th December 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 19th December 2021, unknown after receiving Engerix B pediatric and Engerix B 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 age at vaccination was not reported. The patient received pediatrix dose of Engerix B instead of an adult dose, which led to underdose and adult use of a child product. The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered series only 3 weeks apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th June 2021, the patient received the 2nd dose of Shingrix. On 24th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 3rd June 2021. The reporter stated that, the patient received 2nd dose of Shingrix, 3 weeks apart, which led to shortening of vaccination schedule. The patient did not have any adverse effects, it was just discovered by chance when the patient went in for an office visit and the physician noted the dates of administration. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: 2nd dose was store incorrectlyand was administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th March 2021).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix that was store incorrectly (room temperature over 72 hours), which led to incorrect storage of drug. The reporter consented to follow up. This case was linked with case US2021259946, reported by same repoprter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259946:Same reporter
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose two of shingrix late; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number H54CA, expiry date 18th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On 18th December 2021, the patient received the 2nd dose of Shingrix. On 18th 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 medical assistant reported that, the patient received 2nd dose of Shingrix late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak of shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date 4th June 2022) for prophylaxis.   On 19th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th December 2021, 29 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in right deltoid and had an outbreak of shingles. The patient was currently being treated by his health care professional. The reporter consented to follow-up.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Arthralgia, Fatigue
Clinical narrative: ARTHRITIC PAINS; FATIGUE; This spontaneous report received from a patient via another manufacturer (Abbvie) concerned a 57-year-old male of unknown race and ethnic origin. The patient's height and weight were not reported. The patient had no known allergies and no relevant medical history. The patient was previously treated with an influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, Expiry: unknown ) frequency one total, dose and start therapy date were not reported for prophylactic vaccination. (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No known events were reported after vaccination. The Patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: unknown expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis The patient received Non-company suspect vaccine included: bnt 162 (intramuscular, batch number: unknown: expiry and form of admin was not reported) dose and start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue and rheumatoid arthritic pains (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s and bnt 162 was not applicable and not reported for adalimumab. The patient recovered from fatigue and the outcome of arthritic pains was not reported. This report was non-serious
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Contusion, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: ABDOMINAL PAIN; BRUISED ON ARM AND LEG; TINGLING ON LEFT SIDE; NUMBNESS ON LEFT SIDE; ARM HURTING/LEG PAIN/IRRITATING PAIN ON THE LEFT LEG THE SIDE WHERE SHE RECEIVED THE SHOT; This spontaneous report received from a patient concerned a 60 year old female. 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, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number not reported) dose was not reported,1 total, administered on 10-APR-2021 for prophylactic vaccination. No adverse events reported following initial dose of vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported,1 total, administered on 11-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-DEC-2021, the patient experienced  arm hurting, leg pain and irritating pain on the left leg the side where she received the shot. On 12-DEC-2021, the patient experienced tingling on left side and numbness on left side. On 13-DEC-2021, the patient experienced bruised on arm and leg. On an unspecified date, the patient experienced abdominal pain (all events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm hurting/leg pain/irritating pain on the left leg the side where she received the shot, tingling on left side, and numbness on left side, and had not recovered from bruised on arm and leg, and abdominal pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Formication, Varicose vein
Clinical narrative: VEINS IN LEGS; CRAWLING FEET; This spontaneous report received from a patient concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced veins in legs, and crawling feet (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the veins in legs and crawling feet was not reported. On an unspecified date, patient received additional non-company suspect vaccine BNT 162 (Pfizer) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination (Dose number in series 2). No known events were reported after vaccination (dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chronic sinusitis, Computerised tomogram, Cough, Magnetic resonance imaging
Clinical narrative: CHRONIC SINUSITIS; COUGH; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus issues, glaucoma/ocular hypertension, migraine headaches, and hypothyroidism. The patient experienced benign cyst on pituitary gland, flu like symptoms, headache, pain behind eyes and pressure in sinuses nose/eye area (events dose number in series 1) when received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 1 total, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination (Dose number in series 1). Treatment medications included diphenhydramine hydrochloride/paracetamol (Tylenol PM) for flu like symptoms. On 23-JUN-2021, It was reported that patient went to ENT (Otorhinolaryngology) who (years ago she had seen him for past sinus problems) sent her to have a CT (Computed tomography) scan cyst on pituitary gland. Found a cyst on pituitary gland (benign) but no issues with sinus on scan. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Everything came back normal. Saw neurosurgeon about that and that cyst was unrelated. MRI (Magnetic resonance imaging)) done after second ENT. The results of that was there are no sinus obstruction/disorder. She had chronic sinusitis (has been ongoing).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1555194, expiry: unknown) dose was not reported, 1 total, administered to left arm on 03-NOV-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On an unspecified date, the patient started up again was very bad, Constant drainage down the back of her throat causing cough. Clear mucous bad at night (when lying down) chronic sinusitis (events dose number in series 2). On 08-NOV-2021, the patient went to 3rd sinus doctor he said he looked at all the scans and history and he said chronic sinusitis. She got prescribed a nasal spray that seemed to make it worse. She uses saline nasal spray, oxymetazoline hydrochloride (Afrin), diphenhydramine hydrochloride (children's Benedryl cough syrup), pseudoephedrine and guaifenesin (Mucinex). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and chronic sinusitis. This report was non-serious. This case, involving the same patient is linked to 20211238505.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SERIOUS SIDE EFFECTS; This spontaneous report received from a consumer via social media concerned multiple patients 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 previously received covid-19 vaccine from unspecified manufacturer (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. (Dose number in series 1). It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Consumer reported that "And many of my coworkers have serious side effects present themselves, post-booster shot." (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240501.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Feeling abnormal
Clinical narrative: FELT SO AWFUL LIKE GOING TO DIE; SEVERE SIDE EFFECTS; This spontaneous report received from a consumer concerned a multiple patients of unspecified age and sex of unknown race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  The patients was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, frequency one total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patients had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were unknown ) dose, frequency one total, start therapy date were not reported for prophylactic vaccination. (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients felt so awful like going to die, and unspecified severe side effects (event occurred in dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt so awful like going to die and severe side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240244.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: FELT WEIRD; FEVER; CHILLS; This spontaneous report received from a patient concerned a male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, for prophylactic vaccination (dose number in series 1). No adverse events reported with dose number in series 1. The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total, administered on 14-DEC-2021 for prophylactic vaccination (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-DEC-2021 (Tuesday) the patient felt weird and patient experienced fever and chills, and it was most likely from booster (dose number in series 2). Patient informed that events duration was weird. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt weird, fever, and chills on 16-DEC-2021. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise
Clinical narrative: DISCOMFORT IN ARM; NOT FEELING WELL; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included: myocarditis and pericarditis in 1970. The patient was previously treated with covid-19 vaccine ad26. cov2. s(suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported,1 total administered on 26-MAR-2021 to right arm for prophylactic vaccination.(Dose number in series 1). On 26-MAR-2021, the patient had discomfort in arm, and was not feeling well  which lasted a few days (events occurred on dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported,1 total administered on 12-NOV-2021 for prophylactic vaccination (Dose number in series 2). No adverse events reported with booster dose. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort in arm, and not feeling well. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: PAIN IN SHOULDERS AND WORSE (LAID HAND ON TOP OF SHOULDER AND SLIDE HAND TO DELTOID AREA); CONSTANT ACHE AND SORENESS OF MUSCLES FROM BOTH SHOULDERS TO BOTH ELBOW (FEELS LIKE BEEN BEAT)/PAIN IN BICEPS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anaphylactic reaction, and concurrent conditions included: arthritis, breast cancer, diabetic, alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient past medication included prochlorperazine edisylate (compazine) whenever she experienced burning of mucus membrane, nausea, severe abdominal pain and vomiting. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 20-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced pain in shoulders and worse (laid hand on top of shoulder and slide hand to deltoid area). On APR-2021, the patient experienced constant ache and soreness of muscles from both shoulders to both elbow (feels like been beat) /pain in biceps (Dose number in series: 1). Treatment medications (dates unspecified) included: ibuprofen, diclofenac sodium, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in shoulders and worse (laid hand on top of shoulder and slide hand to deltoid area), and constant ache and soreness of muscles from both shoulders to both elbow (feels like been beat)/pain in biceps. This report was non-serious. This case, involving the same patient is linked to 20211240486 (Dose number in series: 2) This case, from the same reporter is linked to 20211240355, 20211241144 and 20211240211.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a male of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total administered on unspecified date for prophylactic vaccination. Following vaccination, no adverse events associated with covid-19 vaccine (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 and expiry date not reported) dose, 1 total, administered on unspecified date in NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in NOV-2021, the patient had fever (for an hour). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on an unspecified date NOV-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age and race, ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1), (suspension for injection, route of admin not reported, batch number: and expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination and it was unknown whether patient had any adverse events (dose number in series: 1 - manufacturer unspecified). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin not reported, batch number: and expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient tested positive for coronavirus disease (covid-19), (test was unspecified), (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was unknown. This report was non-serious. This report was associated with product quality complaint: 90000207648.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Cerebrovascular accident, Computerised tomogram, Influenza like illness, Pain in extremity
Clinical narrative: STROKE; MEMORY LOSS; CAN NOT SEE; COLD/FLU LIKE SYMPTOMS; SORE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergy, alcohol user (On Occasion), smoker (Half a pack a day or less), and blind (glaucoma). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 21-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the patient experienced stroke, memory loss and can not see. On same day, the patient was hospitalized for 15 days. On 15-AUG-2021, the patient discharged from hospital. On same day, patient visited emergency room and physician office for stroke, memory loss and can not see. The reporter stated, they went to the hospital, and they were told the patient was outside the window for administering anything for the stroke. The patient, couldn't tell what year it was (he said it was 1987) and also he doesn't remember his neighbors. One day, he didn't remember his girlfriend (reporter), and also he didn't remember his grown (38 year old) daughter. On an unspecified date, the patient experienced cold/flu like symptoms, sore arm and laboratory data included: Computed tomography (CAT) scan result was confirmed stroke. Treatment medications (dates unspecified) included: Plavix (clopidogrel bisulfate) for stroke and heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold/flu like symptoms on 26-JUN-2021, and sore arm, was recovering from stroke, had not recovered from memory loss and the outcome of could not see was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211240605-covid-19 vaccine ad26.cov2.s -Stroke, memory loss, cannot see. 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).