chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, HEP
Symptoms: Cardiac flutter, Chest discomfort, Palpitations
Clinical narrative: For about 2 weeks afterward (on and off, not constantly) I was feeling a tightness in my chest, and maybe I could describe the sensation as heart palpitations.  The second week it was more like chest tightening and heart fluttering which usually happened in the mornings when I woke up, still in bed.  The occurrences never lasted 10 minutes.  This past week I don't recall having any tightness nor unusual heart behavior.
Age: 97.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was scheduled to receive dose #2 of the primary series and was instead given the bivalent booster vaccine dose. Patient was given a second bivalent booster dose per director of nurse consulting to equal primary dose.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Drooling, Dyskinesia, Eye movement disorder, Facial paralysis
Clinical narrative: 13 days after vaccine booster started having sharp pain running up left side of neck and behind left ear.  I felt like my neck was filling up with fluid and could even hear gushing sound of liquid in neck.  Pain continued and second night family witnessed left eye open while sleeping.  Third day awoke and left side of face felt numb and still had pain in neck and behind left ear.  Fourth day had all previous symptoms plus complete paralysis of left side of face.  Left eye could not close, left eye continual tearing, left side of mouth not movable, drooling, eye brow not movable and loss of taste.  Whole left side of face drooping.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Hypoaesthesia, Laboratory test, Lacrimation increased, Lagophthalmos
Clinical narrative: 13 days after vaccine booster started having sharp pain running up left side of neck and behind left ear.  I felt like my neck was filling up with fluid and could even hear gushing sound of liquid in neck.  Pain continued and second night family witnessed left eye open while sleeping.  Third day awoke and left side of face felt numb and still had pain in neck and behind left ear.  Fourth day had all previous symptoms plus complete paralysis of left side of face.  Left eye could not close, left eye continual tearing, left side of mouth not movable, drooling, eye brow not movable and loss of taste.  Whole left side of face drooping.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neck pain
Clinical narrative: 13 days after vaccine booster started having sharp pain running up left side of neck and behind left ear.  I felt like my neck was filling up with fluid and could even hear gushing sound of liquid in neck.  Pain continued and second night family witnessed left eye open while sleeping.  Third day awoke and left side of face felt numb and still had pain in neck and behind left ear.  Fourth day had all previous symptoms plus complete paralysis of left side of face.  Left eye could not close, left eye continual tearing, left side of mouth not movable, drooling, eye brow not movable and loss of taste.  Whole left side of face drooping.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given regular adult dose of Pfizer Bivalent Booster
Age: 5.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU4, MMRV
Symptoms: Discomfort, Injection site induration, Injection site swelling
Clinical narrative: Mom contacted PCP office on 12/7/22 to say patient's left upper arm is swollen and hard to the touch (indurated). Onset of swelling was 12/6/22, and on 12/7/22 the affected area is more swollen and spreading to the left shoulder. Patient's left arm and shoulder with normal range of motion, per mom. Occasional c/o discomfort. Advised topical cold pack and administration of ibuprofen.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Dyspnoea, Lung infiltration
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/19/21 Lot# 046A21A;  MOderna 4/16/21 Lot# 017B21A
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal disorder, SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/19/21 Lot# 046A21A;  MOderna 4/16/21 Lot# 017B21A
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/19/21 Lot# 046A21A;  MOderna 4/16/21 Lot# 017B21A
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Headache, Laboratory test, Magnetic resonance imaging, Mobility decreased
Clinical narrative: shingles on her buttock; pain from shingles/left sided pain/; neuropathy in her legs and feet; loss of sensation in legs; loss of mobility; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles (serious criteria hospitalization), generalized aching (serious criteria hospitalization), peripheral neuropathy (serious criteria hospitalization and GSK medically significant), loss of sensation (serious criteria hospitalization) and immobile (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the shingles, loss of sensation and immobile were recovered/resolved and the outcome of the generalized aching and peripheral neuropathy were not recovered/not resolved.   It was unknown if the reporter considered the shingles, generalized aching, peripheral neuropathy, loss of sensation and immobile to be related to Shingrix.     Linked case(s) involving the same patient:  US2022181009   Additional Information: GSK Receipt Date: 02-Dec-2022 Reporter's Comments:  This case was self reported by the patient. The patient received first Shingrix vaccine on left arm.  The patient experienced left sided pain shortly after vaccine.  The patient developed Shingles on right buttock. Currently, the patient still had neuropathy in legs and feet. The pain from the shingles sent her back to the emergency room and was hospitalized again for about a week and was discharged. The shingles had cleared up.   The reporter consented to follow up. The emergency room visit required. Immediately after vaccine, the patient experienced generalized aching, loss of sensation and immobile . This case had been linked with US2022181009 same patient.; Sender's Comments:  US-GSK-US2022181009:same reporter - 1st admission
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Pain of skin, Paraesthesia, Pyrexia, Rash
Clinical narrative: shingles on her buttock; pain from shingles/left sided pain/; neuropathy in her legs and feet; loss of sensation in legs; loss of mobility; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles (serious criteria hospitalization), generalized aching (serious criteria hospitalization), peripheral neuropathy (serious criteria hospitalization and GSK medically significant), loss of sensation (serious criteria hospitalization) and immobile (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the shingles, loss of sensation and immobile were recovered/resolved and the outcome of the generalized aching and peripheral neuropathy were not recovered/not resolved.   It was unknown if the reporter considered the shingles, generalized aching, peripheral neuropathy, loss of sensation and immobile to be related to Shingrix.     Linked case(s) involving the same patient:  US2022181009   Additional Information: GSK Receipt Date: 02-Dec-2022 Reporter's Comments:  This case was self reported by the patient. The patient received first Shingrix vaccine on left arm.  The patient experienced left sided pain shortly after vaccine.  The patient developed Shingles on right buttock. Currently, the patient still had neuropathy in legs and feet. The pain from the shingles sent her back to the emergency room and was hospitalized again for about a week and was discharged. The shingles had cleared up.   The reporter consented to follow up. The emergency room visit required. Immediately after vaccine, the patient experienced generalized aching, loss of sensation and immobile . This case had been linked with US2022181009 same patient.; Sender's Comments:  US-GSK-US2022181009:same reporter - 1st admission
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Sensory loss
Clinical narrative: shingles on her buttock; pain from shingles/left sided pain/; neuropathy in her legs and feet; loss of sensation in legs; loss of mobility; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles (serious criteria hospitalization), generalized aching (serious criteria hospitalization), peripheral neuropathy (serious criteria hospitalization and GSK medically significant), loss of sensation (serious criteria hospitalization) and immobile (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the shingles, loss of sensation and immobile were recovered/resolved and the outcome of the generalized aching and peripheral neuropathy were not recovered/not resolved.   It was unknown if the reporter considered the shingles, generalized aching, peripheral neuropathy, loss of sensation and immobile to be related to Shingrix.     Linked case(s) involving the same patient:  US2022181009   Additional Information: GSK Receipt Date: 02-Dec-2022 Reporter's Comments:  This case was self reported by the patient. The patient received first Shingrix vaccine on left arm.  The patient experienced left sided pain shortly after vaccine.  The patient developed Shingles on right buttock. Currently, the patient still had neuropathy in legs and feet. The pain from the shingles sent her back to the emergency room and was hospitalized again for about a week and was discharged. The shingles had cleared up.   The reporter consented to follow up. The emergency room visit required. Immediately after vaccine, the patient experienced generalized aching, loss of sensation and immobile . This case had been linked with US2022181009 same patient.; Sender's Comments:  US-GSK-US2022181009:same reporter - 1st admission
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immobile, Neuropathy peripheral, Pain, Sensory loss
Clinical narrative: shingles on her buttock; pain from shingles/left sided pain/; neuropathy in her legs and feet; loss of sensation in legs; loss of mobility; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles (serious criteria hospitalization), generalized aching (serious criteria hospitalization), peripheral neuropathy (serious criteria hospitalization and GSK medically significant), loss of sensation (serious criteria hospitalization) and immobile (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the shingles, loss of sensation and immobile were recovered/resolved and the outcome of the generalized aching and peripheral neuropathy were not recovered/not resolved.   It was unknown if the reporter considered the shingles, generalized aching, peripheral neuropathy, loss of sensation and immobile to be related to Shingrix.     Linked case(s) involving the same patient:  US2022181009   Additional Information: GSK Receipt Date: 02-Dec-2022 Reporter's Comments:  This case was self reported by the patient. The patient received first Shingrix vaccine on left arm.  The patient experienced left sided pain shortly after vaccine.  The patient developed Shingles on right buttock. Currently, the patient still had neuropathy in legs and feet. The pain from the shingles sent her back to the emergency room and was hospitalized again for about a week and was discharged. The shingles had cleared up.   The reporter consented to follow up. The emergency room visit required. Immediately after vaccine, the patient experienced generalized aching, loss of sensation and immobile . This case had been linked with US2022181009 same patient.; Sender's Comments:  US-GSK-US2022181009:same reporter - 1st admission
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Feeling abnormal, Insomnia, Malaise, Pain in extremity
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary dose completed , Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Clinical course: Caller stated that she called Pfizer a few weeks ago she informed the agent that she had received "the newest booster. She stated she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, "I always get a sore arm where I get the shot. I did share information about friends that came down with Covid a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose."   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary dose completed , Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Clinical course: Caller stated that she called Pfizer a few weeks ago she informed the agent that she had received "the newest booster. She stated she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, "I always get a sore arm where I get the shot. I did share information about friends that came down with Covid a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose."   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Aptyalism, Dry mouth, Mouth ulceration
Clinical narrative: cold; Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.; . Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), DRY MOUTH (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) and MOUTH ULCERATION (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D21A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller has allergies to dust, but aside from that nothing. Caller has no past medical conditions and not on any medications.  The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (first dose) on 07-Apr-2021, COVID-19 VACCINE JANSSEN (first booster) on 25-Oct-2021 and COVID-19 VACCINE JANSSEN (second booster) on 21-Apr-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN, COVID-19 VACCINE JANSSEN and COVID-19 VACCINE JANSSEN. Concurrent medical conditions included Dust allergy.    On 26-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Nov-2022, the patient experienced NASOPHARYNGITIS (cold), DRY MOUTH (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) and MOUTH ULCERATION (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.). At the time of the report, NASOPHARYNGITIS (cold), DRY MOUTH (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) and MOUTH ULCERATION (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 07-Sep-2022, SARS-CoV-2 test: (Negative) Negative. On 09-Sep-2022, SARS-CoV-2 test: (Negative) Negative. On 11-Sep-2022, SARS-CoV-2 test: (Negative) Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Dry mouth, Mouth ulceration, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold; Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.; . Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), DRY MOUTH (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) and MOUTH ULCERATION (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D21A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller has allergies to dust, but aside from that nothing. Caller has no past medical conditions and not on any medications.  The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (first dose) on 07-Apr-2021, COVID-19 VACCINE JANSSEN (first booster) on 25-Oct-2021 and COVID-19 VACCINE JANSSEN (second booster) on 21-Apr-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN, COVID-19 VACCINE JANSSEN and COVID-19 VACCINE JANSSEN. Concurrent medical conditions included Dust allergy.    On 26-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Nov-2022, the patient experienced NASOPHARYNGITIS (cold), DRY MOUTH (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) and MOUTH ULCERATION (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.). At the time of the report, NASOPHARYNGITIS (cold), DRY MOUTH (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) and MOUTH ULCERATION (Caller got the shot and later that day the started developing an extremely dry mouth and mouth ulcers.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 07-Sep-2022, SARS-CoV-2 test: (Negative) Negative. On 09-Sep-2022, SARS-CoV-2 test: (Negative) Negative. On 11-Sep-2022, SARS-CoV-2 test: (Negative) Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022178648   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix into unknown arm and her arm was sore for 5 days. The patient reported that the first dose only made her arm felt sore. The patient did not indicate in which arm the first dose was administered, did not provide the date when the first dose was administered. The patient reported that she had a very negative reaction with Shingrix vaccine. The patient did not provide additional information for the first dose of Shingrix vaccine. Lot and expiration where not provided for vaccine dose one or two, also site of injection were not provided for the first dose of Shingrix.  The patient did provide name of the pharmacist that administered the vaccine and did not provide pharmacy information for follow up. The patient provided consent to follow up with HCP that did not administer the vaccine. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022178648.; Sender's Comments:  US-GSK-US2022178648:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022178648   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix into unknown arm and her arm was sore for 5 days. The patient reported that the first dose only made her arm felt sore. The patient did not indicate in which arm the first dose was administered, did not provide the date when the first dose was administered. The patient reported that she had a very negative reaction with Shingrix vaccine. The patient did not provide additional information for the first dose of Shingrix vaccine. Lot and expiration where not provided for vaccine dose one or two, also site of injection were not provided for the first dose of Shingrix.  The patient did provide name of the pharmacist that administered the vaccine and did not provide pharmacy information for follow up. The patient provided consent to follow up with HCP that did not administer the vaccine. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022178648.; Sender's Comments:  US-GSK-US2022178648:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: painful arm when moving, Sore arm when not moving; still in pain, terrible pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm, refer case US2022AMR179123).   On 23rd September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and pain upon movement. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain upon movement to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR179123   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix into left arm at a pharmacy and it had been over 2 months she was still in pain. The patient reported that it was administered with a one inch needle. The patient reported that she had a very negative reaction with Shingrix vaccine. The patient reported that the arm was sore when she was not moving it. The patient reported that she had a terrible pain when she was moving left arm. Lot and expiration where not provided for vaccine dose one or two, also site of injection were not provided for the first dose of Shingrix.  The patient did provide name of the pharmacist that administered the vaccine and did not provide pharmacy information for follow up. The patient provided consent to follow up with HCP that did not administer the vaccine. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022AMR179123:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: painful arm when moving, Sore arm when not moving; still in pain, terrible pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm, refer case US2022AMR179123).   On 23rd September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and pain upon movement. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain upon movement to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR179123   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix into left arm at a pharmacy and it had been over 2 months she was still in pain. The patient reported that it was administered with a one inch needle. The patient reported that she had a very negative reaction with Shingrix vaccine. The patient reported that the arm was sore when she was not moving it. The patient reported that she had a terrible pain when she was moving left arm. Lot and expiration where not provided for vaccine dose one or two, also site of injection were not provided for the first dose of Shingrix.  The patient did provide name of the pharmacist that administered the vaccine and did not provide pharmacy information for follow up. The patient provided consent to follow up with HCP that did not administer the vaccine. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022AMR179123:Same reporter
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Neck pain, Pain in extremity, Somnolence
Clinical narrative: experience soreness as described all over his neck, arms, thighs; experience soreness as described all over his neck, arms, thighs; having issues with walking; Wants to go to bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Walks like a 100 year old man", "Sore all over neck, arms, thighs", "Sore all over neck, arms, thighs", "Wants to go to bed". The following information was reported: SOMNOLENCE (non-serious) with onset Dec2022, outcome "unknown", described as "Wants to go to bed"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Dec2022, outcome "unknown" and all described as "experience soreness as described all over his neck, arms, thighs"; GAIT DISTURBANCE (non-serious) with onset Dec2022, outcome "unknown", described as "having issues with walking".  Additional information: The patient was asking if it was a normal response to experience soreness as described all over neck, arms, thighs and having issues with walking after receiving the booster. The patient felt like he was run over by a truck or beat up with a baseball bat. He was walking like a 100-year-old man and wanted to go to bed. The patient had same symptoms last time, he had a COVID vaccine, unspecified. He would never get a COVID vaccine again, after the last time. The caller stated that he was going to take ibuprofen. This report is not serious.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201349877 same patient, event and reporter, different dose;
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: 1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022; No adverse event; 1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021), EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Patient did not have any diseases, allergies or medical conditions.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 12-Feb-2021, Moderna COVID-19 Vaccine on 29-Aug-2021, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 05-Sep-2022; for Product used for unknown indication: influenza vaccine. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and influenza vaccine.    On 03-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Additional Booster. On 03-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event). On 03-Dec-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) and EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022).    Patient did not experienced any adverse events after any of the vaccines. Concomitant medication not reported. Treatment medication not reported.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022; No adverse event; 1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021), EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Patient did not have any diseases, allergies or medical conditions.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 12-Feb-2021, Moderna COVID-19 Vaccine on 29-Aug-2021, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 05-Sep-2022; for Product used for unknown indication: influenza vaccine. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and influenza vaccine.    On 03-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Additional Booster. On 03-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event). On 03-Dec-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) and EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022).    Patient did not experienced any adverse events after any of the vaccines. Concomitant medication not reported. Treatment medication not reported.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient did not have any diseases, allergies or medical conditions.  Previously administered products included for Product used for unknown indication: influenza vaccine. Past adverse reactions to the above products included No adverse event with influenza vaccine.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided          Concomitant medications were not reported.  Patient received first regular booster on 09Feb2022 and first bivalent booster on 5Sep2022. Patient did not experienced any adverse event after any of the vaccines. Treatment medications were not reported.   This case was linked to MOD-2022-684495 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient did not have any diseases, allergies or medical conditions.  Previously administered products included for Product used for unknown indication: influenza vaccine. Past adverse reactions to the above products included No adverse event with influenza vaccine.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided          Concomitant medications were not reported.  Patient received first regular booster on 09Feb2022 and first bivalent booster on 5Sep2022. Patient did not experienced any adverse event after any of the vaccines. Treatment medications were not reported.   This case was linked to MOD-2022-684495 (Patient Link).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE's; The caller states that a pediatric patient was administered an expired dose of VAQTA; This spontaneous report has been received from a nurse, regarding to a child patient (also reported as pediatric person) of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.   On 21-NOV-2022, the patient was vaccinated with an expired dose of with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, (lot number: U031911, which was determined to be valid, with an expiration date on 11-NOV-2022) (strength, dose, route of administration, and anatomical site of injection were not reported) (expired product administered).   No additional adverse events were reported in the patient.
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month old infant was administered GARDASIL 9; No adverse event reported; This spontaneous report was received from a pharmacist referring to a 4-month-old patient of unspecified gender. Information regarding medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided  On 29-NOV-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (product administered to patient of inappropriate age).  No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Herpes zoster reactivation, Ill-defined disorder
Clinical narrative: Shingles; Ill-defined disorder; Death; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 05-DEC-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about 20-NOV-2022, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for long-term prevention of shingles and zoster-related conditions in the local pharmacy. Subsequently the pt was treated for shingles and other zoster-related conditions.  On 02-MAY-2018, the pt passed away, the cause of death as well as if an autopsy was performed were not reported. At the reporting time, the outcome of herpes zoster reactivation and other related conditions was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE; PNEUMOVAX 23 was administered after the expiry date. Caller did not provide the date administered, the lot or date of expiration; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 31-OCT-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) syringe piston, lot number U010533 has been verified to be a valid lot number with expiration date on 29-OCT-2022, administered as prophylaxis (strength, dose, frequency, route of administration and anatomical location was not provided). There was no previous temperature excursion. No additional adverse events were reported.
Age: 69.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Fever; Feel off in general; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab solution for injection in pre-filled pen for asthma.   On 21st October 2022, the patient received Shingrix. In February 2022, the patient started dupilumab (subcutaneous) 300 mg at an unknown frequency. In October 2022, less than a month after receiving Shingrix, the patient experienced fever and feeling abnormal. The action taken with dupilumab was unknown. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Nov-2022 Reporter's Comments:  The patient developed pyrexia and feel of in general. The patient stated that this was not inaudible and feels better.    The additional information was received from patient via specialty pharmacy.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain
Clinical narrative: pain more than before the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain.   In November 2022, the patient received Shingles vaccine. In November 2022, 3 weeks after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-NOV-2022. Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had got the vaccine 3 weeks ago and at the time of reporting, he/she had experienced pain more than before the vaccine itself. Additional supportive information: Follow-up would not possible as no contact details were available.