chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Unknown cause of death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a specified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient's friend via (social media) interactive digital media. The reporter stated that your voice did not matter because three of his/her friends died after being jabbed.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: pain in the shot area; allergic reaction; arm swelled; arm swelled with heat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (first time had shingles was 20 years ago, started on right side of face and with huge knot on face spread down the side, cleared up no more problem. second shingles break out started with scalp, spread down the right side of face again and stopped by eye). Previously administered products included Covid-19 vaccine with an associated reaction of no adverse event (received two covid vaccines and then one booster shot on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: pain in the shot area), allergic reaction (Verbatim: allergic reaction), swelling arm (Verbatim: arm swelled) and heat edema (Verbatim: arm swelled with heat). The outcome of the injection site pain, allergic reaction, swelling arm and heat edema were not reported.   It was unknown if the reporter considered the injection site pain, allergic reaction, swelling arm and heat edema to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, allergic reaction, swelling arm and heat edema to be related to Shingles vaccine.   Additional Information: GSK received date: 07-Mar-2024 This case was reported by a patient via interactive digital media.  The patient took a shingles shot and arm swelled with heat and had lots of pain in the shot area.  Patient reported the allergic reaction to small town pharmacy. They were the ones that gave patient the shot.  Patient reported it to PRN nothing was done. Refused to take the second shot.  No more shots were taken.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy to vaccine (Verbatim: Allergic to the shot). The outcome of the allergy to vaccine was not reported.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.     It was unknown if the company considered the allergy to vaccine to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she was allergic to the shot and was bad for him/her. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: got shingles shots, and even though arm gets so sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it in 40s), pain (shingles was painful) and blister (blisters go away even after patient still have pain inside, that lasted about a year).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: got shingles shots, and even though arm gets so sore). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR038177   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that they got their Shingles shots and even though their arm gets so sore and that lasted about 3 days for each dose, it was nowhere as bad as the pain from shingles and patient suggested to get the shots. For tolerance of further dose refer case, US2024AMR038177. This case had been linked to the cases US2024AMR038200 and US2024AMR038204 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR038177:Same reporter, same patient for further unspecified dose US-GSK-US2024AMR038204:same reporter, different patient US-GSK-US2024AMR038200:same reporter, different patient
Sex: M
Vaccine: RSV
Symptoms: Metabolic function test, White blood cell count increased
Clinical narrative: did a CMP and my WBC was around 20K; This non-serious case was reported by a consumer via call center representative and described the occurrence of white blood cell increased in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced white blood cell increased (Verbatim: did a CMP and my WBC was around 20K). The outcome of the white blood cell increased was not reported.   The reporter considered the white blood cell increased to be possibly related to Arexvy.     The company considered the white blood cell increased to be possibly related to Arexvy.   Additional Information: GSK Receipt Date: 11-MAR-2024 The patient self reported this case who was a psychologist. The patient took an RSV vaccine injection and had a bad reaction about 3 days later and want to talk to a corporate social responsibility (CSR) to discuss and to see if it would be safe to take Shingles vaccine. The patient was not sure if my symptoms were a reaction to RSV or not. The patient's primary care physician (PCP), believes it was and since the RSV vaccine made by GSK, he was advising to not take the Shingrex vaccine. The patient advised to seek medical advice from his healthcare provider as his primary resource for patient care. The patient's doctor was recommending that he did not take the Shingrix vaccine concerned that it might had the same effect on him. The reporter asked, were the underlying ingredients similar and were they bowed on the same technology. When patient presented doctor did a CMP blood test (Comprehensive Metabolic Panel) and his WBC (White Blood Cell) was around 20 thousand. The reporter want to take the Shingrix vaccine but he was concerned because of the possible effect of Arexvy.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Arexvy may have been administered to pregnant women; This non-serious prospective pregnancy case was reported by a other health professional via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy may have been administered to pregnant women). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-MAR-2024 The reporter was director over multiple retail pharmacies.  It was indicated that due to shared clinical decision making (for example, physician order stating RSV vaccine there was/were occasions where Arexvy may have been administered to pregnant women, which led to vaccine exposure during pregnancy. No further information was provided as to AE (adverse events) reports being made to manufacturer or other reporting entities. The reporter did not consent to follow-up.
Age: 4.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was vaccinated with improper storage dose of LIQUID PEDVAXHIB; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old patient of unknown gender with no illness at the time of vaccination. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On 04-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was exposed to the temperature excursion of at total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes.  On the same date on 06-DEC-2023, the patient was vaccinated with an improperly storage dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, lot # X003664, expiration date 10-NOV-2025 (also reported as 12-NOV-2025),  for prophylaxis (quantity dose was not reported) (product storage error). The temperature excursion occurred because of a reading from Digital Data Logger in the vaccine storage in clinical practice. There was no adverse event.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2403USA004981: US-009507513-2403USA004979: US-009507513-2403USA004978: US-009507513-2403USA004977: US-009507513-2403USA004976: US-009507513-2403USA004975: US-009507513-2403USA004974: US-009507513-2403USA004980: US-009507513-2403USA004999: US-009507513-2403USA004998: US-009507513-2403USA004997: US-009507513-2403USA004996: US-009507513-2403USA004995: US-009507513-2403USA004994: US-009507513-2403USA004993: US-009507513-2403USA004986: US-009507513-2403USA004992: US-009507513-2403USA004991: US-009507513-2401USA016206: US-009507513-2403USA004989: US-009507513-2403USA004988: US-009507513-2403USA005000: US-009507513-2403USA004987: US-009507513-2403USA004990: US-009507513-2403USA005306: US-009507513-2403USA005307: US-009507513-2403USA005308: US-009507513-2403USA005305: US-009507513-2403USA005310: US-009507513-2403USA005311:
Age: 42.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Arthralgia, Hypoaesthesia, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: light numbness; pain in fingers and her wrists; pain in fingers and her wrists; joint discomfort; This spontaneous report was received from a nurse and refers to a 42-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included  low weight,  and muscle atrophy. Concomitant therapies were not reported.  On 08-JAN-2024, the patient was vaccinated with a dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis in the left deltoid (strength, lot #, expiry date, and route of administration were not provided); and hepatitis b vaccine rhbsag (yeast) (ENGERIX B), administered for prophylaxis in the left deltoid  (strength, formulation, lot #, expiry date, and route of administration were not provided).  On an unknown date in January 2024 (also reported as 1 or 2 days after vaccination), the patient experienced light numbness, pain in fingers and her wrists and joint discomfort. At the time of reporting, the outcome of the events was unknown.    The causal relationship between the events and the suspect vaccines were not provided.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site oedema
Clinical narrative: pain and soreness in her left upper arm; fever; generalized fatigue; headache; nausea; hot sensation in her left arm; edema and a hot sensation in her left arm; chills; Loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 03-MAR-2024, 2 days after receiving Shingrix, the patient experienced chills (Verbatim: chills) and appetite lost (Verbatim: Loss of appetite). In MAR-2024, the patient experienced injection site pain (Verbatim: pain and soreness in her left upper arm), fever (Verbatim: fever), fatigability generalized (Verbatim: generalized fatigue), headache (Verbatim: headache), nausea (Verbatim: nausea), extremities hot feeling of (Verbatim: hot sensation in her left arm) and edema arms (Verbatim: edema and a hot sensation in her left arm). In MAR-2024, the outcome of the injection site pain, fever, fatigability generalized, headache, nausea, extremities hot feeling of and edema arms were resolved. The outcome of the chills and appetite lost were resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, appetite lost, fatigability generalized, headache, nausea, extremities hot feeling of and edema arms to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, chills, appetite lost, fatigability generalized, headache, nausea, extremities hot feeling of and edema arms to be related to Shingrix.   Additional Information: GSK receipt date:11-MAR-2024 The patient received Shingrix vaccine and 24 hours after vaccination, experienced pain and soreness in her left upper arm, edema and a hot sensation in her left arm from her elbow to her shoulder. 28 hours after vaccination, experienced nausea, headache, generalized fatigue and fever. 2 days after vaccination, experienced loss of appetite and chills. All symptoms resolved within four days of receiving vaccine. The patient did not know the lot number of the vaccine given to her. The patient stated that she never had a reaction to any vaccine and she intends to get the second dose of the Shingrix series.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Nausea, Pyrexia
Clinical narrative: pain and soreness in her left upper arm; fever; generalized fatigue; headache; nausea; hot sensation in her left arm; edema and a hot sensation in her left arm; chills; Loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 03-MAR-2024, 2 days after receiving Shingrix, the patient experienced chills (Verbatim: chills) and appetite lost (Verbatim: Loss of appetite). In MAR-2024, the patient experienced injection site pain (Verbatim: pain and soreness in her left upper arm), fever (Verbatim: fever), fatigability generalized (Verbatim: generalized fatigue), headache (Verbatim: headache), nausea (Verbatim: nausea), extremities hot feeling of (Verbatim: hot sensation in her left arm) and edema arms (Verbatim: edema and a hot sensation in her left arm). In MAR-2024, the outcome of the injection site pain, fever, fatigability generalized, headache, nausea, extremities hot feeling of and edema arms were resolved. The outcome of the chills and appetite lost were resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, appetite lost, fatigability generalized, headache, nausea, extremities hot feeling of and edema arms to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, chills, appetite lost, fatigability generalized, headache, nausea, extremities hot feeling of and edema arms to be related to Shingrix.   Additional Information: GSK receipt date:11-MAR-2024 The patient received Shingrix vaccine and 24 hours after vaccination, experienced pain and soreness in her left upper arm, edema and a hot sensation in her left arm from her elbow to her shoulder. 28 hours after vaccination, experienced nausea, headache, generalized fatigue and fever. 2 days after vaccination, experienced loss of appetite and chills. All symptoms resolved within four days of receiving vaccine. The patient did not know the lot number of the vaccine given to her. The patient stated that she never had a reaction to any vaccine and she intends to get the second dose of the Shingrix series.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Product administered to patient of inappropriate age
Clinical narrative: a localized reaction in the upper half of her arm; Erythema; Patient under the prescribed Indicated age; Patient under the prescribed Indicated age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of local reaction in a 32-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, an unknown time after receiving Shingrix, the patient experienced local reaction (Verbatim: a localized reaction in the upper half of her arm), erythema of extremities (Verbatim: Erythema), inappropriate age at vaccine administration (Verbatim: Patient under the prescribed Indicated age) and drug prescribing error (Verbatim: Patient under the prescribed Indicated age). The outcome of the local reaction, erythema of extremities, inappropriate age at vaccine administration and drug prescribing error were unknown.   It was unknown if the reporter considered the local reaction and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the local reaction and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2024. The health care professional reported that patient experienced a localized reaction on upper half of arm where there was a lot of erythema.  There no clarifying question was asked if the patient was immunocompromised to determine if Shingrix was administered on or off label. The vaccine administration facility was the same as primary reporter. The health care professional mentioned that patient showed a photograph of the reaction and did not want to deep into the description. Age of patient was asked and confirmed that was under the prescribing indicated age and was administered, which led to drug prescribing error and inappropriate age at vaccine administration.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose too early; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old female patient who received HAV (Havrix) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 12-MAR-2024, the patient received the 2nd dose of Havrix. On 12-MAR-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose too early). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date:14-MAR-2024 The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.; Sender's Comments:  US-GSK-US2024033696:Diff. patient
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Adult dose was administered to a 10 year old; Adult dose was administered to a 10 year old; 1st dose og Hep B on 1st Sep 2013 and 2nd dosee of Hep on 2014; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 10-year-old female patient who received HBV (Engerix B adult) (batch number 9lk2g, expiry date 21-AUG-2026) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B (1st dose received on 1st September 2013).   On an unknown date, the patient received Engerix B adult and the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Engerix B adult and not applicable after receiving Hepatitis B vaccine, the patient experienced overdose (Verbatim: Adult dose was administered to a 10 year old), adult product administered to child (Verbatim: Adult dose was administered to a 10 year old) and drug dose administration interval too long (Verbatim: 1st dose og Hep B on 1st Sep 2013 and 2nd dosee of Hep on 2014). The outcome of the overdose, adult product administered to child and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 14-MAR-2024 and 15-MAR-2024 The reporter stated that Energix-B 20 mcg/mL adult dose was administered to a 10 year old (inappropriate age), which led to overdose and adult product administered to child. No further information was known. The second hepatitis B dose (unknown brand name) was on 2014. The reporter consented to follow up. The patient received 2nd dose of hepatitis B vaccine longer than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient inadvertently received a 2nd dose Tdap Boostrix one month apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number ET475, expiry date 08-MAY-2026) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix).   On 15-MAR-2024, the patient received the 2nd dose of Boostrix. On 15-MAR-2024, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: a patient inadvertently received a 2nd dose Tdap Boostrix one month apart). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAR-2024 The reporter reported that a patient inadvertently received a 2nd dose Tdap Boostrix one month apart.  The patient received 2nd dose of Boostrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Inappropriate reconstitution technique; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate reconstitution technique (Verbatim: Inappropriate reconstitution technique). The outcome of the inappropriate reconstitution technique was unknown.   Additional Information: GSK Receipt Date: 18-MAR-2024 The pharmacist reported that she took the needle out of the vial after mixing and before withdrawing liquid into the syringe, which led to inappropriate reconstitution technique. The reporter did not consent to follow-up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Facial paralysis, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: he experienced facial paralysis on that side of his face/ facial droop; tingling on side of face; numbness on side of face; face began to hurt/ touch that side of his face without pain; Cannot sleep well; This serious case was reported by a consumer via call center representative and described the occurrence of facial paralysis in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bell's palsy (Bell's Palsy on other side of face years ago).   On 09-MAR-2024, the patient received Shingrix (intramuscular). On 12-MAR-2024, 3 days after receiving Shingrix, the patient experienced facial paralysis (Verbatim: he experienced facial paralysis on that side of his face/ facial droop) (serious criteria hospitalization and GSK medically significant), tingling (Verbatim: tingling on side of face) (serious criteria hospitalization) and numbness facial (Verbatim: numbness on side of face) (serious criteria hospitalization). In MAR-2024, the patient experienced facial pain (Verbatim: face began to hurt/ touch that side of his face without pain) and poor sleep (Verbatim: Cannot sleep well). The patient was treated with prednisone. The outcome of the facial paralysis, tingling, numbness facial and facial pain were resolving and the outcome of the poor sleep was not reported.   It was unknown if the reporter considered the facial paralysis, tingling, numbness facial, facial pain and poor sleep to be related to Shingrix.     It was unknown if the company considered the facial paralysis, tingling, numbness facial, facial pain and poor sleep to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAR-2024. Reporter reached out on behalf of her son, who received a Shingrix Saturday, 9-MAR-2024.  The following Tuesday, patient was driving home when he felt something was wrong with the side of his face (side unconfirmed).  The patient began to tingle and droop and he went to hospital and stayed for three days where he experienced facial paralysis on that side of his face.  In MAR-2024 patient was hospitalized three days for tingling or numbness on side of face. Pain once dismissed. The patient released, and put on Prednisone.  After leaving hospital, side of face began to hurt patient could not sleep well or touch that side of his face without pain.  Hospital confirmed it was not a stroke. They had discussed Bell's Palsy or Ramsay Hunt, but officially unconfirmed.  The patient had a similar paralysis event occur to the other side of his face years ago, except without the pain. The cause of that was unknown. Emergency room visit required.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep
Clinical narrative: he experienced facial paralysis on that side of his face/ facial droop; tingling on side of face; numbness on side of face; face began to hurt/ touch that side of his face without pain; Cannot sleep well; This serious case was reported by a consumer via call center representative and described the occurrence of facial paralysis in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bell's palsy (Bell's Palsy on other side of face years ago).   On 09-MAR-2024, the patient received Shingrix (intramuscular). On 12-MAR-2024, 3 days after receiving Shingrix, the patient experienced facial paralysis (Verbatim: he experienced facial paralysis on that side of his face/ facial droop) (serious criteria hospitalization and GSK medically significant), tingling (Verbatim: tingling on side of face) (serious criteria hospitalization) and numbness facial (Verbatim: numbness on side of face) (serious criteria hospitalization). In MAR-2024, the patient experienced facial pain (Verbatim: face began to hurt/ touch that side of his face without pain) and poor sleep (Verbatim: Cannot sleep well). The patient was treated with prednisone. The outcome of the facial paralysis, tingling, numbness facial and facial pain were resolving and the outcome of the poor sleep was not reported.   It was unknown if the reporter considered the facial paralysis, tingling, numbness facial, facial pain and poor sleep to be related to Shingrix.     It was unknown if the company considered the facial paralysis, tingling, numbness facial, facial pain and poor sleep to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAR-2024. Reporter reached out on behalf of her son, who received a Shingrix Saturday, 9-MAR-2024.  The following Tuesday, patient was driving home when he felt something was wrong with the side of his face (side unconfirmed).  The patient began to tingle and droop and he went to hospital and stayed for three days where he experienced facial paralysis on that side of his face.  In MAR-2024 patient was hospitalized three days for tingling or numbness on side of face. Pain once dismissed. The patient released, and put on Prednisone.  After leaving hospital, side of face began to hurt patient could not sleep well or touch that side of his face without pain.  Hospital confirmed it was not a stroke. They had discussed Bell's Palsy or Ramsay Hunt, but officially unconfirmed.  The patient had a similar paralysis event occur to the other side of his face years ago, except without the pain. The cause of that was unknown. Emergency room visit required.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20-Oct-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-MAR-2024 The pharmacist reported a patient received 1st Shingrix dose and now (at the time of reporting) they were willing to get their 2nd dose after more than 6 months. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received a late second dose of Twinrix on month 3 instead of month 1; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Received 1st dose on 29th November 2023).   On 20-MAR-2024, the patient received the 2nd dose of Twinrix. On 20-MAR-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received a late second dose of Twinrix on month 3 instead of month 1). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAR-2024 The pharmacist reported that, a patient received a late second dose of Twinrix on month 3 instead of month 1 which led to drug dose administration interval too long. The reporter consented to follow up
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hospital gave another Hepatitis B to the baby 3 days; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 1-month-old male patient who received HBV (Engerix B pediatric) (batch number 47D3S, expiry date 21-FEB-2026) for prophylaxis.   Concomitant products included Hepatitis b vaccine (Hepatitis b).   On 19-MAR-2024, the patient received the 2nd dose of Engerix B pediatric. On 19-MAR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced drug dose administration interval too short (Verbatim: hospital gave another Hepatitis B to the baby 3 days). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAR-2024 The Medical Assistant reported that he/she vaccinated with Engerix B vaccine to patient yesterday (Before the day of reporting) but they did not notice that the hospital gave another Hepatitis B in March 2024 to the baby 3 days before. That means that the patient got pretty much 2 doses in the same week. The patient received two dose within week which led to shortening of vaccinations schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient who has 60 years old received Menveo 1-vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 60-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number L7373) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: A patient who has 60 years old received Menveo 1-vial). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 20-MAR-2024 The 60 year old patient received the 1 vial of Menveo which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Administered Shingrix, but the liquid form first without reconstituting; Administered Shingrix, but the liquid form first without reconstituting; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 542E3, expiry date 10-FEB-2026) for prophylaxis.   On 19-MAR-2024, the patient received Shingrix. On 19-MAR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered Shingrix, but the liquid form first without reconstituting) and inappropriate dose of vaccine administered (Verbatim: Administered Shingrix, but the liquid form first without reconstituting). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-Mar-2024 The reporter reported that on 19th March 2024 the colleague administered Shingrix, but the liquid form first without reconstituting and then she realized her mistake and got a reconstituted one.  According to reporter the adjuvant only and correctly reconstituted dose were given 30 minutes apart. The vaccine administration facility was the same as primary reporter. The reporter gave by error Shingrix adjuvant portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; This spontaneous report received from a J&J managed social media site concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (dose no series:1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 adverse event. Patient stated had several issues since having the earliest strain on the virus and then taking one dose of J&J vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis, Unevaluable event
Clinical narrative: BLOOD CLOTS; LOST MY  IMMUNITY TO ALL PENICILLINS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 15-MAR-2024 and 20-MAR-2024. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 blood clots, and lost my immunity to all penicillins (Dose number in series 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and lost my immunity to all penicillins was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be 90000317966-void-yes- this report indicates medical adverse events for the patient that they claim were a result of the covid vaccine. there is no product quality issue described in the information reported. based on the PQC evaluation/investigation performed.; Sender's Comments: V0- Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient via JNJ social media, concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose (dose series 1), dose was not reported, administered on 24-MAR-2021 for covid-19 prophylaxis. Batch number not reported. The company is unable to request the batch number.  No concomitant medications were reported.  On 21-DEC-2023, the patient experienced blood clots (dose series 1) as a result of taking covid vaccine. The patient was undergoing treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Thrombosis. The event shows an incompatible temporal relationship (2 years and 9 months after vaccination). Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness at the injection site and a little bit of swelling; Redness at the injection site and a little bit of swelling; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Redness at the injection site and a little bit of swelling) and INJECTION SITE ERYTHEMA (Redness at the injection site and a little bit of swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Frozen shoulder (Has a history of frozen shoulder from a sport injury on her right shoulder.).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Redness at the injection site and a little bit of swelling) and INJECTION SITE ERYTHEMA (Redness at the injection site and a little bit of swelling). At the time of the report, VACCINATION SITE SWELLING (Redness at the injection site and a little bit of swelling) and INJECTION SITE ERYTHEMA (Redness at the injection site and a little bit of swelling) had resolved.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2024-763479 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at the injection site; little bit of swelling injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (little bit of swelling injection site) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Frozen shoulder (from a sport injury on her right shoulder.).    On 14-Oct-2022, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (little bit of swelling injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (little bit of swelling injection site) had resolved.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2024-763479, MOD-2024-763495 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: became really sick after receiving it; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (became really sick after receiving it) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became really sick after receiving it). At the time of the report, ILLNESS (became really sick after receiving it) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient wants to know if Spikevax is the most recent Moderna full dose vaccine and if Spikevax has any preservatives. Patient was concerned that taking the full dose may make her unwell again. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: She coughs in public; This spontaneous case was reported by a patient and describes the occurrence of COUGH (She coughs in public) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy and Hard of hearing.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (She coughs in public). At the time of the report, COUGH (She coughs in public) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Lost her sight after receiving the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A female patient in her 40's received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "Lost her sight after receiving the vaccine".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400039506 same reporter/drug; different patient/AE;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Fresh hazlenuts" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURE UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURE UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURE UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 13Mar2024 to 18Mar2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.