chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Nerves would start to tingle; This case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included lysine (L-Lysine) for product used for unknown indication.   On an unknown date, the patient received Shingrix and L-Lysine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced tingling. The action taken with L-Lysine was unknown. On an unknown date, the outcome of the tingling was unknown.   It was unknown if the reporter considered the tingling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and stated even while taking the L-Lysine 1 to 2 times a day and the patient noticed that if he/she consumed nuts, bread and beer, the nerves would start to tingle. The patient finally agreed to the Shingrix proven effective vaccine. The reporter stated that L-Lysine was a supplement that was easily found at most drug Stores. It really helped. It was unknown if the reporter considered the tingling to be related to L-Lysine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The pateint stated that getting shingles shot was no big deal. The patient's arm was sore for one night. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR256465, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR256465:same reporter - 2nd dose
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure/have the two Shingles Shots, still got Shingles; they were spreading to my eye; Shingles on my face, spreading to my eye; itching on my face; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had Shingles on face).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pruritus facial. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pruritus facial were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pruritus facial to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient had shingles on face. They were spreading to eye. The patient still have itching on face at the time of reporting. The patient had a Shingles Shot, years before the date of reporting. The patient still got Shingles. The patient had two Shingles shots. The patient further stated that he or she never wanted shingles again. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Syringe issue, Underdose
Clinical narrative: leaky syringe from needle connection; leaky syringe from needle connection during administration; only a partial dose was received; squirted all over the patient; squirted all over the patient; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th December 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 7th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the patient experienced pharmaceutical product complaint and syringe connection issue. On an unknown date, the outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine, pharmaceutical product complaint and syringe connection issue were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Registered nurse stated this occurred at the time of administration and only a partial dose was received after the device started leaking, which led to accidental underdose. The patient received a dose of Kinrix, where the vaccine leaked and squirted all over the patient, which led to exposure via skin contact and inadvertent exposure to vaccine. Agent requested return of both the prefilled syringe and needle related to the product complaint and the original packaging without further manipulation/handling. Agent requested that a picture of defect be sent. The reporter assumed the leak to be at the tip. The syringe was assembled with needle at time of administration. The size of gauge needle was 23g. Also, safety glide came detached when the needle cap was removed. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Feeling cold, Malaise, Nasopharyngitis, Pain
Clinical narrative: Felt like a cold coming on, cold symptoms; Fever got up as high as 100.5; Cold symptoms; Runny nose; Body aches; Cough; Feels sick; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th December 2021, 2 days after receiving Shingrix, the patient experienced general body pain and cough. On 7th December 2021, the patient experienced runny nose and cold symptoms. On 8th December 2021, the patient experienced feeling cold and fever. In December 2021, the patient experienced feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the general body pain, cough, runny nose, feeling cold, fever, cold symptoms and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, cough, runny nose, feeling cold, fever, cold symptoms and feeling unwell to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix around 3pm in the afternoon and he felt fine on Saturday (4th December 2021) and on Sunday (5th December 2021).   2 days after receiving vaccine, the patient began to experienced body aches and cough. 3 days after receiving vaccine, the patient had runny nose and the patient also said that it felt like a cold coming on. 4 days after receiving vaccine, the patient had cold symptoms and fever and felt cold. On an unknown date, the patient stated that he still felt sick The patient said that his fever got up as high as 100.5 degree Fahrenheit. On 9th December 2021 (day of the call), the patient said that he still had a low grade temperature of 99, body aches which were not as bad as they initially were, and cold symptoms. .   The patient was taking Tylenol for his symptoms.  The patient also commented that he heard that the second dose was worse. The patient was given medical advice disclaimer. The patient was referred to health care professional. The case was linked with case US2021AMR253585, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252836:Same reporter US-GLAXOSMITHKLINE-US2021AMR253585:Same reporter. Hearsay case.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Felt like a cold coming on, cold symptoms; Fever got up as high as 100.5; Cold symptoms; Runny nose; Body aches; Cough; Feels sick; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th December 2021, 2 days after receiving Shingrix, the patient experienced general body pain and cough. On 7th December 2021, the patient experienced runny nose and cold symptoms. On 8th December 2021, the patient experienced feeling cold and fever. In December 2021, the patient experienced feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the general body pain, cough, runny nose, feeling cold, fever, cold symptoms and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, cough, runny nose, feeling cold, fever, cold symptoms and feeling unwell to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix around 3pm in the afternoon and he felt fine on Saturday (4th December 2021) and on Sunday (5th December 2021).   2 days after receiving vaccine, the patient began to experienced body aches and cough. 3 days after receiving vaccine, the patient had runny nose and the patient also said that it felt like a cold coming on. 4 days after receiving vaccine, the patient had cold symptoms and fever and felt cold. On an unknown date, the patient stated that he still felt sick The patient said that his fever got up as high as 100.5 degree Fahrenheit. On 9th December 2021 (day of the call), the patient said that he still had a low grade temperature of 99, body aches which were not as bad as they initially were, and cold symptoms. .   The patient was taking Tylenol for his symptoms.  The patient also commented that he heard that the second dose was worse. The patient was given medical advice disclaimer. The patient was referred to health care professional. The case was linked with case US2021AMR253585, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252836:Same reporter US-GLAXOSMITHKLINE-US2021AMR253585:Same reporter. Hearsay case.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: injected with shingrix reconstituted with sterile water; injected with shingrix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 72p98, expiry date 9th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: Age at vaccination was not applicable as this scenario was related to several patients (approximately 5). The patients received a dose of Shingrix where it was reconstituted with sterile water, which led to Inappropriate dose of vaccine administered and Inappropriate reconstitution technique. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252847:same reporter, duplicate,deleted case
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Accidental underdose, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 2nd dose of the Engerix-B (adult dose) vaccine today (9-December 2021; was administered pediatric dose; female patient was administered the pediatric dose of the first dose of Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 29-year-old female patient who received HBV (Engerix B adult) (batch number P4DJ5, expiry date 15th December 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On 9th December 2021, the patient received the 2nd dose of Engerix B adult. On 21st October 2021, the patient received the 1st dose of Engerix B pediatric. On 21st October 2021, not applicable after receiving Engerix B adult and unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On 9th December 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the accidental underdose, adult use of a child product and drug dose administration interval too long were unknown.  Additional details provided were as follows: Pharmacist called to report that a patient was administered the pediatric dose of the first dose of Engerix-B vaccine inadvertently which led to accidental underdose and adult use of a child product. The patient received the 2nd dose of the Engerix-B (adult dose) vaccine on the day of reporting which led to drug dose administration interval too long. No further details provided. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Joint swelling, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ankle swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th December 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, 1 week after receiving Shingrix, the patient experienced ankle swelling, joint pain and tingling of extremity. On 15th December 2020, the patient experienced malaise, tiredness, pain, tremor and shivering. On an unknown date, the outcome of the ankle swelling and joint pain were not recovered/not resolved and the outcome of the malaise, tiredness, pain, tremor, shivering and tingling of extremity were recovered/resolved. It was unknown if the reporter considered the ankle swelling, joint pain, malaise, tiredness, pain, tremor, shivering and tingling of extremity to be related to Shingrix. Additional details were provided as follows: The case was reported by patient herself. The patient received her first dose of Shingrix and 12 hours after experienced tingling in her hands and toes. Next day after vaccination, the patient experienced shivering, shaking, achiness, tiredness and malaise. The patient stated that one week after the first dose she experienced joint pain, and swelling in her ankles, and this remained unresolved. On 13th February 2021, patient had received her second dose of Shingrix vaccine. The reporter was provided with medical disclaimer, medical information phone number for health care professional reference and was referred to the health care professional. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ankle swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th December 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, 1 week after receiving Shingrix, the patient experienced ankle swelling, joint pain and tingling of extremity. On 15th December 2020, the patient experienced malaise, tiredness, pain, tremor and shivering. On an unknown date, the outcome of the ankle swelling and joint pain were not recovered/not resolved and the outcome of the malaise, tiredness, pain, tremor, shivering and tingling of extremity were recovered/resolved. It was unknown if the reporter considered the ankle swelling, joint pain, malaise, tiredness, pain, tremor, shivering and tingling of extremity to be related to Shingrix. Additional details were provided as follows: The case was reported by patient herself. The patient received her first dose of Shingrix and 12 hours after experienced tingling in her hands and toes. Next day after vaccination, the patient experienced shivering, shaking, achiness, tiredness and malaise. The patient stated that one week after the first dose she experienced joint pain, and swelling in her ankles, and this remained unresolved. On 13th February 2021, patient had received her second dose of Shingrix vaccine. The reporter was provided with medical disclaimer, medical information phone number for health care professional reference and was referred to the health care professional. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infection, Rash, Skin lesion, Vaccination failure
Clinical narrative: got her two doses / gotten shingles 3 times since/Suspected vaccination failure; Shingles; lesions; rash / spread to her skull, hairline, right arm and both legs; infection; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin lesion, generalized rash and infection. On an unknown date, the outcome of the vaccination failure, shingles, skin lesion and generalized rash were unknown and the outcome of the infection was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, generalized rash and infection to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient called in to get additional information about getting an additional booster dose of Shingrix because she got her two doses, but she thought it was wearing off because she said she had gotten shingles 3 times since getting the vaccine.  The patient stated in 2018, she had shingles the first time the exact dates was unknown to the patient.  After the lesions cleared up, she stated about a month later they came back up and it came back a second time.  The rash was disseminated.  Her most recent infection started on 3rd December 2021 which started at her neck.  Now she said the rash had spread to her skull, hairline, right arm and both legs.  The infection had not gone away, referred to health care professional (HCP).  The patient verbalized understanding would place a call to her HCP. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injected limb mobility decreased, Injection site swelling, Pain
Clinical narrative: swelling at the injection site; fever of 101 degrees; tired; achy joints; painful to move anything; she was able to move better/painful to move anything; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 9th December 2021 04:00, the patient received the 2nd dose of Shingrix (intramuscular). On 9th December 2021 08:00, 4 hrs after receiving Shingrix, the patient experienced tiredness and joint pain. On 10th December 2021, the patient experienced injection site swelling and fever. In December 2021, the patient experienced injected limb mobility decreased and pain. On 12th December 2021, the outcome of the injection site swelling and fever were recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased and pain were unknown and the outcome of the tiredness and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site swelling, tiredness, joint pain, fever and pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received her second Shingrix vaccine in the right arm at about 4 pm.  She reported that at about 8 pm that night, she began to feel tired and achy joints. On 10th September 2021, 1 day after receiving Shingrix, the patient experienced injection site swelling and fever. In December 2021, less than a week after receiving Shingrix, the patient experienced injected limb mobility decreased and pain. The patient reported that she was taking Tylenol about every 4 hours (unknown dosage).  The patient reported that by Friday, she was also had fever of 101 degree F and swelling on the right arm at the injection site. The patient reported that she wanted to just remain still because it was painful to move anything.  The patient reported that by Sunday, she was feeling a little better. The fever was resolved, and the swelling on her right arm at the injection site was also resolved and she was able to move better. The patient reported that she was still feeling tired and had achy joints in morning (13th December 2021). The reporter did not consent to follow-up and did not gave permission to contact HCP.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: swelling at the injection site; fever of 101 degrees; tired; achy joints; painful to move anything; she was able to move better/painful to move anything; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 9th December 2021 04:00, the patient received the 2nd dose of Shingrix (intramuscular). On 9th December 2021 08:00, 4 hrs after receiving Shingrix, the patient experienced tiredness and joint pain. On 10th December 2021, the patient experienced injection site swelling and fever. In December 2021, the patient experienced injected limb mobility decreased and pain. On 12th December 2021, the outcome of the injection site swelling and fever were recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased and pain were unknown and the outcome of the tiredness and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site swelling, tiredness, joint pain, fever and pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received her second Shingrix vaccine in the right arm at about 4 pm.  She reported that at about 8 pm that night, she began to feel tired and achy joints. On 10th September 2021, 1 day after receiving Shingrix, the patient experienced injection site swelling and fever. In December 2021, less than a week after receiving Shingrix, the patient experienced injected limb mobility decreased and pain. The patient reported that she was taking Tylenol about every 4 hours (unknown dosage).  The patient reported that by Friday, she was also had fever of 101 degree F and swelling on the right arm at the injection site. The patient reported that she wanted to just remain still because it was painful to move anything.  The patient reported that by Sunday, she was feeling a little better. The fever was resolved, and the swelling on her right arm at the injection site was also resolved and she was able to move better. The patient reported that she was still feeling tired and had achy joints in morning (13th December 2021). The reporter did not consent to follow-up and did not gave permission to contact HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 2018, 2nd dose in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number DJ3FL, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 age at vaccination was not reported. The patient received 2nd dose of Shingrix in 2021, later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: unsure if received 2nd dose, 1st dose on 05/12/2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th May 2021, batch number YM74C, expiry date 18th March 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was unsure if patient received second dose and wanted to possibly gave third dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 07Nov2019 and is late for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer via social media via a company representative concerned a 92 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: surgery (At the time of vaccination patient was recovering from an unspecified surgery). The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer)(suspension for injection, route of administration and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unspecified whether patient had any adverse reaction on covid-19 vaccine ad26.cov2.s.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration batch number and expiration date were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2).  Patient  received the vaccine in the hospital where she was recovering from surgery. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date patient had covid-19 infection and suspected clinical vaccination failure. Patient tested positive but had very few symptoms  (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection and outcome for the suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated the product quality compliant:90000206366. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed.; Sender's Comments: V0 : 20211215353- covid-19 vaccine ad26.cov2.s -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
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient via another manufacturer (Abbvie) concerned a 52 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient was previously treated with covid-19 vaccine ad26. cov2. s for covid-19 vaccination (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 01-APR-2021 for  prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date were unknown) dose was not reported, 1 total administered on 01-NOV-2021 for prophylactic vaccination (dose number in series was 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient received additional non-company suspect Humira (Solution for injection in pre-filled pen, subcutaneous, batch number and expiration date were not reported) dose was not reported, for moderate to severe rheumatoid arthritis.  No concomitant medications were reported.  On unspecified date in NOV-2021, the patient experienced rheumatoid arthritis flare up (dose number in series was 2). Laboratory data (dates unspecified) included: Blood test (NR: not provided) not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Humira was unknown. The patient had not recovered from rheumatoid arthritis flare up. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211217128-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare up. 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: MEDICAL HISTORY.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Thrombosis
Clinical narrative: BLOOD CLOT SYMPTOMS; VERY BAD SIDE EFFECTS; This spontaneous report received from a patient via monitoring through company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, and batch number: unknown, Expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, Expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported 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.  On an unspecified date, the patient experienced very bad side effects (captured as: adverse drug reaction NOS), and ended up in Emergency room (ER) with blood clot symptoms (events subsumed under blood clot symptoms) (Dose number in series 2). As per the report "I got my second dose of the #johnsonandjohnson vaccine got very bad side effects, ended up in the ER with blood clot symptoms and these are my bills! Who's paying for this horrible side effects? Us? No way! Outrageous!" No additional information was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot symptoms and very bad side effects (adverse drug reaction NOS) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211218623-covid-19 vaccine ad26.cov2.s-Blood clot symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Groin pain
Clinical narrative: GROIN PAIN; This spontaneous report received from a patient concerned a 6 decade old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-infectious intermediate, posterior and panuveitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 in total, administered on 21-APR-2021 for prophylactic vaccination (dose number series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient's age at the time of vaccination was 50 years. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported (therapy ongoing) for non-infectious intermediate, posterior and panuveitis.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date, the patient experienced groin pain. (dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from groin pain. This report was non-serious. This case, involving the same patient is linked to 20211231043.
Sex: U
Vaccine: COVID19
Symptoms: Injection site nodule, Vascular injury
Clinical narrative: KNOT FORMED AROUND THE AREA OF INJECTION, FILLED WITH BLOOD; NICKED A SMALL BLOOD VESSEL; This spontaneous report received from a pharmacist 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Janssen dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on 09-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-DEC-2021, after being vaccinated, patient had a knot formed around the area of injection and appeared to be filled with blood. She thinks she nicked a small blood vessel (dose number in series 2 adverse events). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knot formed around the area of injection, filled with blood and nicked a small blood vessel was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia, Suspected COVID-19, Vaccination failure
Clinical narrative: PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; GOT COVID AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex and unspecified race and 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 previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), dose was not reported (dose number in series 1), for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 2). The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced pneumonia, suspected clinical vaccination failure, and got covid after vaccination (captured as: suspected Covid-19 infection) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from got covid after vaccination (captured: suspected Covid- 19 infection) and the outcome for suspected clinical vaccination failure and pneumonia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter was linked to 20211212673 and 20211212261. This report was associated with regulatory authority: 90000206895.; Sender's Comments: V0: 20211223580-covid-19 vaccine ad26.cov2.s-pneumonia, got covid after vaccination. 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).  20211223580-covid-19 vaccine ad26.cov2.s-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: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID-19 AFTER VACCINATION BUT ASYMPTOTIC; This spontaneous report received from a consumer concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced tested positive for covid-19 after vaccination but asymptotic. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 after vaccination but asymptotic was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, Nasal congestion, Pain in extremity, Pruritus, SARS-CoV-2 antibody test
Clinical narrative: LOW ANTIBODY TEST; ARM HURT FOR A COUPLE DAYS; ITCHY EAR(ONLY ONE); A LITTLE NASAL CONGESTION; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to soybean oil, and autoimmune, and other pre-existing medical conditions included: The patient did not have thyroid. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced itchy ear (only one). On 06-MAR-2021, the patient experienced a little nasal congestion. On 06-MAR-2021, the patient experienced arm hurt for a couple days. Treatment medications included: guaifenesin/pseudoephedrine hydrochloride. On AUG-2021, the patient experienced low antibody test. Laboratory data included: COVID-19 antibody test (NR: not provided) Protein negative, proteins quantitative 151. The action taken with covid-19 vaccine  was not applicable. The patient recovered from itchy ear (only one), and a little nasal congestion on 06-MAR-2021, and arm hurt for a couple days on 08-MAR-2021, and the outcome of low antibody test was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000206625.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. Initial information was processed along with additional information received on 10-DEC-2021 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2. s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose and start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patient experienced runny nose, headache, congestion (previous event subsumed within suspected COVID-19 infection), and tested positive for covid-19 which indicates patient had suspected Covid-19 infection and suspected clinical vaccination failure (dose number in series 1). Laboratory test type for COVID-19 was not specified. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch/lot number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for prophylactic vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000206508.; Sender's Comments: V0: 20211225687-covid-19 vaccine ad26.cov2.s-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: Death
Clinical narrative: DEATH; This spontaneous report received from consumer via company representative through social media concerned 2 patients of an unspecified age, 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 (dose number series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose and, therapy dates were not reported, 01 total, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  Reporter stated that, "My daughter knew two people who had the shots and got it and died. I guess if it is time for us to go nothing can stop it. But I did get the booster." On an unspecified date, the patient died from unknown cause. It was unspecified whether autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was reported as fatal. This report was serious (Death).; Sender's Comments: V0: 20211227721-Covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH