chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: any reports of vertigo after shingrix; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of vertigo in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked, if GSK (GlaxoSmithKline) have any reports of vertigo after 1st Shingrix dose. GSK Note- since follow up is not possible, there is not way to know if patient had vertigo or was just enquiring. Case considered valid by considering worst case approach.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Sleep disorder
Clinical narrative: my joints are aching so bad; I can't even sleep; This case was reported by a consumer via (Shingrix GSK Chatbot ) interactive digital media and described the occurrence of joint pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2021, the patient received the 2nd dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced joint pain and sleeplessness. On an unknown date, the outcome of the joint pain and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and sleeplessness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient got his/her second shingle shot on Thursday evening. The patient had a bunch of side effects and right now patient could not even sleep because joints were aching so bad. The patient was asked how long these side effects normally last. The patient consent to follow up was not asked.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Had received both / in 2018. Came in and got another / He forgot. I gave him a dose today; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had both doses in 2018).   On 30th May 2021, the patient received Shingrix. On 30th May 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 age at vaccination not reported. The patient had never received any dose . The patient forgot and so reporter gave him a dose on 30th May 2021, which led to extra dose administered.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed his second Bexsero shot of the primary series; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 17-year-old male patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was patient's parent. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Bexsero which led to incomplete course of vaccination. The reporter stated that the patient missed his 2nd Bexsero shot of the primary series and asked what they should do. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: What to use for skin rash after shingle shot?; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter asked what to use for skin rash after receiving shingles shot. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: My second dose after 6 / its been 7 months since my first shot; This case was reported by a consumer 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 (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this case. The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica, Synovitis
Clinical narrative: Polymyalgia Rheumatica; Synovitis; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 8th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2018, 22 days after receiving Shingrix, the patient experienced synovitis. On 30th October 2018, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the polymyalgia rheumatica and synovitis were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and synovitis to be related to Shingrix.  Initial information received via legal complaint on 27 May 2021.(This case is medically confirmed now).The patient received 1st dose of Shingrix on 8 August 2018 and he experienced polymyalgia rheumatica  and synovitis on 30 October 2018.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Mononeuropathy, Neck pain, Pain
Clinical narrative: Sudden onset of moderate sharp pain shooting into his right side of the neck; Sudden onset of moderate sharp pain shooting into his right side of the neck in to his ear; Mononeuropathy; This case was reported by a lawyer and described the occurrence of mononeuropathy in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th August 2020, 8 days after receiving Shingrix, the patient experienced mononeuropathy (serious criteria GSK medically significant). On an unknown date, the patient experienced neck pain and ear pain. The action taken with Shingrix was unknown. On an unknown date, the outcome of the mononeuropathy, neck pain and ear pain were unknown.   It was unknown if the reporter considered the mononeuropathy, neck pain and ear pain to be related to Shingrix.  Initial information received via legal complaint on 27 May 2021.The patient received 1st dose of Shingrix on 19 August 2020. The patient experienced sudden onset of moderate sharp pain shooting into his right side of the neck in to his ear as well as multiple places of moderate after taking shingrix vaccination. On 27 August 2020 the patient experienced mononeuropathy.
Sex: F
Vaccine: VARZOS
Symptoms: Ankle fracture, Balance disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Fall, Gait inability
Clinical narrative: CIDP; numbness in her legs; fracture her ankle; This case was reported by a consumer and described the occurrence of chronic inflammatory demyelinating polyradiculoneuropathy in a female 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 chronic inflammatory demyelinating polyradiculoneuropathy (serious criteria GSK medically significant), numbness in leg and ankle fracture. On an unknown date, the outcome of the chronic inflammatory demyelinating polyradiculoneuropathy, numbness in leg and ankle fracture were unknown.   It was unknown if the reporter considered the chronic inflammatory demyelinating polyradiculoneuropathy, numbness in leg and ankle fracture to be related to Shingrix.  The patient received her first shingrix vaccine on 6/8/2020. On 7/13/2020 she noticed something was wrong. On 7/14/2020 she woke up and was doing chores around the home and her legs went numb causing her to fall to the ground, she pulled herself up using her bed but fell again to her knees and was unable to get up again. She called 911 and was taken to the hospital where they treated her with an IV and was discharged home to be treated as an outpatient. Once home she fell once again however she was outside her home, she called 911 again and asked to be taken to a different hospital, they admitted her to the hospital.  She had to endure over 2 months of physical therapy to regain the ability to walk again. She underwent 5 treatments of plasma infusions however had to stop this treatment when she contracted MRSA in the hospital. She still suffers numbness in her legs which has affected her balance, which caused her to fall and fracture her ankle.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Infusion, Staphylococcal infection
Clinical narrative: CIDP; numbness in her legs; fracture her ankle; This case was reported by a consumer and described the occurrence of chronic inflammatory demyelinating polyradiculoneuropathy in a female 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 chronic inflammatory demyelinating polyradiculoneuropathy (serious criteria GSK medically significant), numbness in leg and ankle fracture. On an unknown date, the outcome of the chronic inflammatory demyelinating polyradiculoneuropathy, numbness in leg and ankle fracture were unknown.   It was unknown if the reporter considered the chronic inflammatory demyelinating polyradiculoneuropathy, numbness in leg and ankle fracture to be related to Shingrix.  The patient received her first shingrix vaccine on 6/8/2020. On 7/13/2020 she noticed something was wrong. On 7/14/2020 she woke up and was doing chores around the home and her legs went numb causing her to fall to the ground, she pulled herself up using her bed but fell again to her knees and was unable to get up again. She called 911 and was taken to the hospital where they treated her with an IV and was discharged home to be treated as an outpatient. Once home she fell once again however she was outside her home, she called 911 again and asked to be taken to a different hospital, they admitted her to the hospital.  She had to endure over 2 months of physical therapy to regain the ability to walk again. She underwent 5 treatments of plasma infusions however had to stop this treatment when she contracted MRSA in the hospital. She still suffers numbness in her legs which has affected her balance, which caused her to fall and fracture her ankle.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Nodule
Clinical narrative: On day eight I developed a hard knot at the injection site.  It has since started to feel warm and itch.  There's a small red area at the site as well.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Deep vein thrombosis, Fatigue, Headache, Malaise, Ultrasound scan
Clinical narrative: DEEP VEIN THROMBOSIS (BLOOD CLOT); FELT UNWELL; SLIGHT HEADACHE; FELT TIRED; This spontaneous report received from a patient concerned a 79-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient had not been tested positive for covid-19 and did not had covid-19. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine. On 02-Apr-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on left arm for prophylactic vaccination. Non-company suspect drugs included: rivaroxaban (form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, from APR-2021, and 15 mg, every 1 day, from 04-MAY-2021, frequency was not reported for deep vein thrombosis. The patient was not taking any concomitant medication while reporting.  On 03-Apr-2021, the patient experienced slight headache and felt tired. On the evening of 29-Apr-2021, the patient went to the hospital where the sonogram was performed. Laboratory data included: Sonogram (NR: not provided) Not reported. On Friday, 30-Apr-2021, the patient could hardly walk and had painful leg (pain in back of legs especially calf area and spreading) and on 30-Apr-2021, was admitted to the hospital. The hospital asked her to see family doctor. After discharge, the hospital told that patient had deep vein thrombosis (blood clot). The patient was prescribed Xarelto (rivaroxaban) in hospital and the patient went to family doctor next morning. The family doctor told her to start Xarelto. She was started on Xarelto 15 mg (30mg daily) twice a day from hospital discharge. The family doctor changed the dosage due to age and small size after 5 days to 15 mg daily because patient felt unwell on twice a day dose. The patient had been on Xarelto 15 mg daily since 04-May-2021. The patient would follow up with family doctor on 07-Jul-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 06-APR-2021, and was recovering from deep vein thrombosis (blood clot), and felt tired. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210556796-COVID-19 VACCINE AD26.COV2.S- Deep vein thrombosis. This event is considered unassessable. The event 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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD  TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard operating procedure ,as the case was assessed as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise, Nausea, Oxygen saturation, Pain
Clinical narrative: SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD  TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard operating procedure ,as the case was assessed as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD  TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard operating procedure ,as the case was assessed as non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: STIFFNESS IN BACK OF NECK; LITTLE NAUSEA; ACHE IN THE BACK OF NECK; SHIVERS; FEVER; HEAVY HEADACHES/ SLIGHT HEADACHE TO THE FRONT SIDE OF HEAD; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included a bit of anxiety problems, seasonal allergies, allergies to dog and cat, marijuana smoker, and non-alcohol user. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced ache in the back of neck. On 28-MAY-2021, the subject experienced shivers. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced heavy headaches/ slight headache to the front side of head. On 29-MAY-2021, the subject experienced stiffness in back of neck. On 29-MAY-2021, the subject experienced little nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from ache in the back of neck, shivers, fever, and little nausea on 29-MAY-2021, and had not recovered from heavy headaches/ slight headache to the front side of head, and stiffness in back of neck. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: STIFFNESS IN BACK OF NECK; LITTLE NAUSEA; ACHE IN THE BACK OF NECK; SHIVERS; FEVER; HEAVY HEADACHES/ SLIGHT HEADACHE TO THE FRONT SIDE OF HEAD; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included a bit of anxiety problems, seasonal allergies, allergies to dog and cat, marijuana smoker, and non-alcohol user. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced ache in the back of neck. On 28-MAY-2021, the subject experienced shivers. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced heavy headaches/ slight headache to the front side of head. On 29-MAY-2021, the subject experienced stiffness in back of neck. On 29-MAY-2021, the subject experienced little nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from ache in the back of neck, shivers, fever, and little nausea on 29-MAY-2021, and had not recovered from heavy headaches/ slight headache to the front side of head, and stiffness in back of neck. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Disorientation, Rash, Vision blurred
Clinical narrative: LEFT EYE BLURRY; FELT SLIGHT DISORIENTATED; SLIGHT DOUBLE VISION; SMALL RASH ON THIGH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced small rash on thigh. On 28-MAY-2021, the subject experienced left eye blurry. On 28-MAY-2021, the subject experienced felt slight disorientated. On 28-MAY-2021, the subject experienced slight double vision. The action taken with covid-19 vaccine was not applicable. The patient recovered from slight double vision on 28-MAY-2021, had not recovered from left eye blurry, and felt slight disorientated, and the outcome of small rash on thigh was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 02-JUN-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in MAY-2021, approximately one month after receiving the vaccine, the patient was tested positive for covid-19. The patient thought that the patient had a fairly mild case of the vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:  The suspected product quality complaint has been confirmed to be not voided (meets product quality complaint criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: COVID-19 VACCINE Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Pyrexia
Clinical narrative: ACHY BONES; SICK WITH FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 achy bones, and sick with fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy bones and sick with fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Low density lipoprotein increased
Clinical narrative: OXIDISED LOW DENSITY LIPOPROTEIN ABOVE 2500; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced oxidised low density lipoprotein above 2500. Laboratory data included: Blood test (NR: 10 - 170) Oxidized Low Density Lipoprotein Above 2500. The action taken with covid-19 vaccine was not applicable. The outcome of oxidised low density lipoprotein above 2500 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210601462 and 20210601430.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: GENERAL DISCOMFORT; ITCHING; PAIN FROM NECK TO ARM; FEVER; TIRED AND RETCHING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 general discomfort, itching, pain from neck to arm, fever, and tired and retching. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, general discomfort, pain from neck to arm, tired and retching and itching was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: BAD BODY PAINS; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 and lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced bad body pains, chills, fever, and fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fever, and the outcome of bad body pains and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; EXHAUSTION; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 aches, chills, exhaustion, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from aches, chills, exhaustion, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Eating disorder, Hypersomnia, Illness
Clinical narrative: SICK FOR 1ST DAY AFTER; MIGRAINE HEADACHE; COULDNT EAT OR DRINK; PUKE; SLEPT THE WHOLE DAY; BACK PAIN; STOMACH MUSCLES HURT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sick for 1st day after, migraine headache, couldnt eat or drink, puke, slept the whole day, back pain, and stomach muscles hurt. The action taken with covid-19 vaccine was not applicable. The patient recovered from sick for 1st day after, migraine headache, couldnt eat or drink, puke, and slept the whole day, and had not recovered from back pain, and stomach muscles hurt. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: SICK FOR 1ST DAY AFTER; MIGRAINE HEADACHE; COULDNT EAT OR DRINK; PUKE; SLEPT THE WHOLE DAY; BACK PAIN; STOMACH MUSCLES HURT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sick for 1st day after, migraine headache, couldnt eat or drink, puke, slept the whole day, back pain, and stomach muscles hurt. The action taken with covid-19 vaccine was not applicable. The patient recovered from sick for 1st day after, migraine headache, couldnt eat or drink, puke, and slept the whole day, and had not recovered from back pain, and stomach muscles hurt. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Illness, Injection site pain, Myalgia
Clinical narrative: HORRIBLE TASTE IN MOUTH, TONGUE AND LIPS; BREATHING ISSUE R/T ASTHMA; DIARRHEA; SICK; ARM HURTS AT INJECTION SITE; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced breathing issue r/t asthma. On 11-MAY-2021, the subject experienced diarrhea. On 11-MAY-2021, the subject experienced sick. On 11-MAY-2021, the subject experienced arm hurts at injection site. On 11-MAY-2021, the subject experienced muscle aches. On an unspecified date, the subject experienced horrible taste in mouth, tongue and lips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from horrible taste in mouth, tongue and lips, and the outcome of muscle aches, breathing issue r/t asthma, arm hurts at injection site, diarrhea and sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: HORRIBLE TASTE IN MOUTH, TONGUE AND LIPS; BREATHING ISSUE R/T ASTHMA; DIARRHEA; SICK; ARM HURTS AT INJECTION SITE; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced breathing issue r/t asthma. On 11-MAY-2021, the subject experienced diarrhea. On 11-MAY-2021, the subject experienced sick. On 11-MAY-2021, the subject experienced arm hurts at injection site. On 11-MAY-2021, the subject experienced muscle aches. On an unspecified date, the subject experienced horrible taste in mouth, tongue and lips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from horrible taste in mouth, tongue and lips, and the outcome of muscle aches, breathing issue r/t asthma, arm hurts at injection site, diarrhea and sick was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia
Clinical narrative: PAIN IN HANDS AND THUMB; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced pain in hands and thumb. Laboratory data (dates unspecified) included: Antinuclear antibody positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in hands and thumb was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Injection site swelling
Clinical narrative: ARMPIT SORENESS; SOME SWELLING AT INJECTION SITE; INJECTION SITE SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient 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 armpit soreness, some swelling at injection site, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some swelling at injection site, injection site soreness and armpit soreness was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional
Clinical narrative: DIFFICULTY BREATHING WHEN LAYING DOWN, SHORTNESS OF BREATH; DIFFICULTY BREATHING ON EXERTION; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On 30-MAY-2021, the subject experienced difficulty breathing when laying down, shortness of breath. On 30-MAY-2021, the subject experienced difficulty breathing on exertion. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from difficulty breathing when laying down, shortness of breath, and difficulty breathing on exertion. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, with frequency 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots. It was reported that the patient experienced blood clots after receiving the vaccination for which the prison has failed to provide the medical treatment. The action taken with covid-19 vaccine was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine Blood clots. 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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned 30 multiple patients (13 male, 15 female, 2 unaccounted). No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 25/MAY/2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, patients experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: BUG-BITE LIKE ABOUT 10-20 ITCHY SPOTS ON ARM,LEGS AND STOMACH THAT APPEARS LIKE MOSQUITO AND INSECT BITE; This spontaneous report received from a patient concerned a 38 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 (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: diphenhydramine hydrochloride. On 03-APR-2021, the subject experienced bug-bite like about 10-20 itchy spots on arm, legs and stomach that appears like mosquito and insect bite. On MAY-2021, treatment medications included: permethrin. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bug-bite like about 10-20 itchy spots on arm, legs and stomach that appears like mosquito and insect bite. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Gait disturbance, Peripheral swelling
Clinical narrative: GOT UP LIMPING A LITTLE BIT SORE TO THE TOUCH; RIGHT HIP BOTHERING/ SORENESS; LEFT LEG SWELLING,PARTICULARLY AROUND  AND ABOVE THE ANKLE BY 4 INCHES; 3-4 EPISODES OF DIARRHEA PER DAY/ LOOSE STOOL THAT HAS BEEN BOTH LIQUID AND SEMI FORMED/ STOOLS ARE NORMAL COLOR; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included leg injury, and darker skin discoloration, and concurrent conditions included asthma allergies, kiwi allergy, and reflux, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 2028A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included bismuth subsalicylate. On 27-MAY-2021, the subject experienced 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color. On 29-MAY-2021, the subject experienced left leg swelling, particularly around and above the ankle by 4 inches. On 30-MAY-2021, the subject experienced got up limping a little bit sore to the touch. On 30-MAY-2021, the subject experienced right hip bothering/ soreness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg swelling,particularly around and above the ankle by 4 inches, right hip bothering/ soreness, and 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color, and the outcome of got up limping a little bit sore to the touch was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: LOSS OF APPETITE; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced loss of appetite, fever, fatigue, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of appetite, fever, fatigue, and nausea. This report was non-serious.