chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Helicobacter infection, Insomnia, Ocular hyperaemia, Oral herpes
Clinical narrative: Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tonsillitis
Clinical narrative: Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Dyspepsia, Dysphagia, Eczema
Clinical narrative: Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.      Antihistamine 2 times a day for eczema and Omeprazole 40mg once a day for 8 weeks for stomach heartburn/reflux.  I started my therapy  4 weeks ago and I'm slowly improving. The most difficult to deal with pain, is my stomach!  Useful to know that for my eczema I'm following a histamine free diet where I try to limit the consumption of food which contains or produce too much histamine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Full blood count normal, Helicobacter test negative, Insomnia, Ocular hyperaemia
Clinical narrative: Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.      Antihistamine 2 times a day for eczema and Omeprazole 40mg once a day for 8 weeks for stomach heartburn/reflux.  I started my therapy  4 weeks ago and I'm slowly improving. The most difficult to deal with pain, is my stomach!  Useful to know that for my eczema I'm following a histamine free diet where I try to limit the consumption of food which contains or produce too much histamine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pruritus, Stool analysis normal, Tonsillitis
Clinical narrative: Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.      Antihistamine 2 times a day for eczema and Omeprazole 40mg once a day for 8 weeks for stomach heartburn/reflux.  I started my therapy  4 weeks ago and I'm slowly improving. The most difficult to deal with pain, is my stomach!  Useful to know that for my eczema I'm following a histamine free diet where I try to limit the consumption of food which contains or produce too much histamine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Computerised tomogram, Cranial nerve disorder
Clinical narrative: I had the Moderna booster on 10/28/2021 with no major side effects. I woke up 12/31/2021 with 6th cranial nerve palsy in my right eye.  I had bumped my head 12/24/2021 and assumed it was from the bump, but maybe it was the vaccine. I have been very symptomatic with inflammation during the time period also. Face swollen, ankles swollen, knee painful, low back pain in SI joint. Hand arthritis.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Joint swelling, Magnetic resonance imaging, Swelling face
Clinical narrative: I had the Moderna booster on 10/28/2021 with no major side effects. I woke up 12/31/2021 with 6th cranial nerve palsy in my right eye.  I had bumped my head 12/24/2021 and assumed it was from the bump, but maybe it was the vaccine. I have been very symptomatic with inflammation during the time period also. Face swollen, ankles swollen, knee painful, low back pain in SI joint. Hand arthritis.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain in extremity
Clinical narrative: sore arm; she got a little sick; a little nauseous; nausea lasted for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (she got a little sick) and NAUSEA (a little nauseous; nausea lasted for a day) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Blood pressure high, Diabetes and Obesity.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), ILLNESS (she got a little sick) and NAUSEA (a little nauseous; nausea lasted for a day). At the time of the report, PAIN IN EXTREMITY (sore arm) and ILLNESS (she got a little sick) outcome was unknown and NAUSEA (a little nauseous; nausea lasted for a day) had resolved.            Concomitant product use was not provided by the reporter. After the 2nd dose she got a little sick, a little nauseous, and sore arm. The nausea lasted for 2 days. No treatment information was provided.   This case was linked to MOD-2022-494417, MOD-2022-494503 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (MAST cells disorder and Tryptase disorder) and Allergy (She states she has a lot of allergies).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) because her disorders can cause leukemia.         Patient height was 5 feet 3 inches.  Patient with immune disorders received booster dose instead of third dose. First, second and booster where received in the recommended time frame. Patient wants to know if she can receive another booster shot for immunocompromised people, she heard there was another booster shot coming in march, and wants to know if she qualifies.   She has not yet spoke to her physician about this enquiry.   No concomitant medication were reported.   She states she has a lot of allergies. She can provide more information if contacted by safety team.  Patient was not tested positive.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-496387, MOD-2022-496388 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Malaise, Pyrexia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (MAST cells disorder and Tryptase disorder) and Allergy (She states she has a lot of allergies).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) because her disorders can cause leukemia.         Patient height was 5 feet 3 inches.  Patient with immune disorders received booster dose instead of third dose. First, second and booster where received in the recommended time frame. Patient wants to know if she can receive another booster shot for immunocompromised people, she heard there was another booster shot coming in march, and wants to know if she qualifies.   She has not yet spoke to her physician about this enquiry.   No concomitant medication were reported.   She states she has a lot of allergies. She can provide more information if contacted by safety team.  Patient was not tested positive.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-496387, MOD-2022-496388 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: Did not feel good at all (2nd dose); Fever (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel good at all (2nd dose)) and PYREXIA (Fever (2nd dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (The patient had two autoimmune disorders MAST cells disorder and Tryptase disorder.) and Multiple allergies (She stated she had a lot of allergies.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (Did not feel good at all (2nd dose)) and PYREXIA (Fever (2nd dose)). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel good at all (2nd dose)) and PYREXIA (Fever (2nd dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: not reported not reported.         She was not taking any medication (concomitant/regular medication). Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as no.  The patient was not yet spoke to her physician about her enquiry. They only test her blood because her disorders can cause leukemia. The patient was not diagnose/tested positive to COVID-19.  Treatment was given for symptoms with Aleve.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Malaise, Pyrexia
Clinical narrative: Did not feel good at all (2nd dose); Fever (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel good at all (2nd dose)) and PYREXIA (Fever (2nd dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (The patient had two autoimmune disorders MAST cells disorder and Tryptase disorder.) and Multiple allergies (She stated she had a lot of allergies.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (Did not feel good at all (2nd dose)) and PYREXIA (Fever (2nd dose)). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel good at all (2nd dose)) and PYREXIA (Fever (2nd dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: not reported not reported.         She was not taking any medication (concomitant/regular medication). Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as no.  The patient was not yet spoke to her physician about her enquiry. They only test her blood because her disorders can cause leukemia. The patient was not diagnose/tested positive to COVID-19.  Treatment was given for symptoms with Aleve.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.  The Moderna vaccine BUD was 16-Jan-2022.  Reporter confirmed that 23 patients received shots after the 30-day use by date. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Number of doses/vials: 23 doses. On 17-Dec-2021, the vial was initially stored in the refrigerator. The vial didn't undergo any temperature excursions.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during breast feeding
Clinical narrative: Pharmacist called, they administered 2 expired vaccines/administration of an expired vaccine; Maternal Exposure during breastfeeding; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist called, they administered 2 expired vaccines/administration of an expired vaccine) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal Exposure during breastfeeding) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called, they administered 2 expired vaccines/administration of an expired vaccine) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal Exposure during breastfeeding). On 17-Feb-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal Exposure during breastfeeding) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist called, they administered 2 expired vaccines/administration of an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. Vaccines placed in refrigerator on 13-Jan-2022    This case was linked to MOD-2022-491348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received on 24-FEB-2022, contains patient details. On 25-Feb-2022: Follow-up document received on 25-FEB-2022, contains no new information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual period cycle is now reduced from approximately 30 days to approximately 18 days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Anti factor V antibody, Antinuclear antibody, Antiphospholipid antibodies, Antithrombin III
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood culture, Blood ethanol
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Cardiac monitoring, Cardiolipin antibody, Chest X-ray
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Computerised tomogram head, Computerised tomogram neck, Differential white blood cell count, Dysgraphia
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Fibrin D dimer, Full blood count, Gene mutation identification test, Immunology test
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Implantable cardiac monitor insertion, Lipids, Magnetic resonance imaging head, Metabolic function test, Polymerase chain reaction
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test urine, Protein total, Prothrombin level, Transient ischaemic attack, Treponema test
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine free, Troponin, Ultrasound Doppler, Urine analysis
Clinical narrative: On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored doses of ROT ATEQ and PED VAX; No adverse event reported; This spontaneous report was received from Other Health Professional referring to an unknown age and gender patient.  The patient's medical history, concurrent and concomitant therapies were not reported.  On 15-FEB-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1742464, expiration date: 20-SEP-2022 (strength, route of administration, and indication were not provided); and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U024089, expiration date: 27-OCT-2023 (strength, route of administration, and indication were not provided).  It was reported that the vaccines were expose to a temperature above 47 Fahrenheit degrees (F), 47.5 F for 20 minutes, 46.7 F for 10 minutes and 47.1 for 20 minutes. No previous temperature excursions or adverse events were reported. At the time of reporting, the outcome of the event improperly stored doses of ROT ATEQ and PED VAX (Product Storage Error) was unknown.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Patient who is over 15 weeks old received the first dose of ROTATEQ; This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 04-FEB-2022, the patient who was over 15 weeks old was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other issues or concerns noted; improperly stored Varivax had been administered; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot #U020238, expiration date: 28-JUN-2023 (formulation, strength, dose, frequency, site and route of administration were not provided) for prophylaxis (product storage error). The vaccine experienced a temperature excursion of 41 degrees Fahrenheit for 45 minutes. No previous temperature excursions were reported. No other issues or concerns noted.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; AN EXPIRED DOSE OF M-M-R WAS ADMINISTERED TO A PATIENT; This spontaneous report was received from a registered nurse and refers to a patient with unknow age and gender.  The patient's pertinent medical history and concurrent conditions were not reported.  On 07-FEB-2022, an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (0.5 milliliter, lot #T001214, expiration date: 12-JAN-2022, administered for prophylaxis) and also sterile diluent (STERILE DILUENT) solution for injection/infusion was administered to the patient.  The reporter confirmed that the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) did not experienced a temperature excursion. No additional AE reported (no adverse event)
Sex: F
Vaccine: HIBV, RV5
Symptoms: Expired product administered
Clinical narrative: No additional AEs reported; Caller states her daughter received ROTATEQ and PEDVAX HIB Vaccines in 12/2021 that expired in 11/2021; This spontaneous report was received from the patient's concerning to her daughter a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in December 2021, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquidunk, expiration date: 15-NOV-2021 (strength, lot #, route of administration, and indication were not provided); and  hib vaccine conj (ompc) (PEDVAXHIB), (strength, formulation, lot #, route of administration, and indication were not provided).   In February 2021 the reporter states her daughter was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus B conjugate (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis. However, it was reported that, both vaccines were expired (on an unspecified date in November 2021) (expired product administered).
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE's reported; improperly stored doses of ROTATEQ and PEDVAX HB; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 15-FEB-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 mL one time, lot #1742464, expiration date: 20-SEP-2022, administered orally for prophylaxis (strength was not provided); and  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 mL one time, lot #U024089, expiration date: 27-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided).   The administered doses of the vaccines experienced temperature excursions in the range above 47°F (47.5°F) for 20 minutes; above 47°F (46.7°F) for 10 minutes; and above 4 7°F (47.1°F) for 20 minutes. Total time frame: 50 minutes. The vaccines had not had any previous temperature excursions. It was not reported if it was recorded by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 12-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, and lot # not provided) for long-term prevention of shingles and zoster-related conditions.         Subsequently, as a direct result of zoster vaccine live (ZOSTAVAX) use, the patient was treated for herpes zoster and post herpetic neuralgia. At the time of the report, the patient's outcome was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received an expired dose of VARIVAX; This spontaneous report was received from a nurse prescriber concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not provided.  On 17-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter, once, lot # T000343, with an expiration of 05-JAN-2022, for prophylaxis (strength, anatomical site of vaccination, schedule of vaccination, and route of administration were not reported) (expired product administered). No additional information was obtained regarding the patient and no additional adverse event.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: patient was administered a dose ofMMR II and V ARlV AX that was reconstituted with 0.9%; A 9-month-old pediatric patient was administered a dose of MMR II and VARlVAX; No adverse event reported; This spontaneous report was received from Registered nurse referring to a 9-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliter (lot #u006488, expiration date: 26-FEB-2023)(Product administered to patient of inappropriate age), and (varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter (lot #u025202, expiration date: 13-AUG-2023), both vaccines administered for prophylaxis (strength, and route of administration for both vaccines were not provided). The reporter stated that the vaccines were reconstituted with sodium chloride 0.9% (formulation, dose description, lot #, expiry date, route of administration, and indication were not provided) instead of the company supplied diluent (Product preparation issue). No additional adverse event was reported.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: underwent a temperature excursion and was then administered to a patient; This spontaneous report has been received from a clinic administrator was received from physician and refers to a 3-year-old patient.  The patient's medical history, the patient's concurrent conditions, concomitant therapies, and drugs reactions or allergies were not reported.  On 21-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, lot #U022732, expiration date: 20-JUL-2023, administered as prophylaxis (formulation, strength, and route of administration were not provided).  There was no adverse effect. The stored temperature was 12 degrees Fahrenheit (F) the time frame was 9 hours and 38 minutes. There was previous temperature excursion (9.7 degree Fahrenheit for 2 hours and 41 minutes; 10.8 degree Fahrenheit for 2 hours and 45 minutes; 10.6 degree Fahrenheit for 4 hours and 16 minutes; 11.1 degree Fahrenheit for 3 hours and 14 minutes; 10.9 degree Fahrenheit for 4 hours and 43 minutes; 10.8 degree Fahrenheit for 2 hours and 17 minutes; 18.3 degree Fahrenheit for 2 hours and 36 minutes; 18.7 degree Fahrenheit for 3 hours and 4 minutes; 12.4 degree Fahrenheit for 9 hours and 43 minutes; 17.4 degree Fahrenheit for 24 hours and 00 minutes; 19.9 degree Fahrenheit for 10 hours and 57 minutes. (product storage error).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA006001:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; A dose of VARIVAX expired on 12/23/2021 and was administered on 2/16/2022; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 16-FEB-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, anatomical location, and route of administration were not reported) (lot # R024144 has been verified to be a valid lot number, expiration date reported as 23-DEC-2021 but upon internal validation established as 23-AUG-2020) for prophylaxis (expired product administered).         No temperature excursions were reported. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen; Arm painful; Arm red; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced swelling arm, pain in arm and erythema of extremities. On an unknown date, the outcome of the swelling arm, pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm, pain in arm and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient asked that was it normal for his/her arm to be swollen, painful and red 2 days after the second shot. The follow up would not possible, as no contact details were available.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Polyneuropathy
Clinical narrative: polyneuropathy in hands and lips; This case was reported by a consumer via call center representative and described the occurrence of polyneuropathy in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles (had a prior history of Shingles with a case reported in 2020).   In March 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On an unknown date, the patient received COVID-19 VACCINE. On an unknown date, several weeks after receiving Shingrix, the patient experienced polyneuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the polyneuropathy was not recovered/not resolved.   It was unknown if the reporter considered the polyneuropathy to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. Around March 2021, the patient completed her 2 dose Shingrix series.  She reported that a few weeks after her second dose of the Shingrix vaccine received on unknown arm, that she began to develop polyneuropathy in her hands and her lips that was currently still unresolved.  She stated that she was unsure if the Shingrix had caused this reaction but that her physician told her that it could be possible.  The patient stated that she had also received a Covid vaccine within a few months of the Shingrix but did not get it concurrently with the Shingrix.  It was unknown if the reporter considered the polyneuropathy to be related to Covid vaccine. The patient could not provide lot number, expiration date, exact date of vaccines, or route or site of administration. The reporter gave consent to contact health care professional. The reporter consented to follow up. Note: Clarification was raised but as no start date for Covid vaccine was mentioned and reported that received within few months of Shingrix (unclear after 1st or 2nd dose) Covid vaccine received so both vaccines coded as suspect.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Inappropriate schedule of product administration, Polyneuropathy
Clinical narrative: polyneuropathy in hands and lips; This case was reported by a consumer via call center representative and described the occurrence of polyneuropathy in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles (had a prior history of Shingles with a case reported in 2020).   In March 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On an unknown date, the patient received COVID-19 VACCINE. On an unknown date, several weeks after receiving Shingrix, the patient experienced polyneuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the polyneuropathy was not recovered/not resolved.   It was unknown if the reporter considered the polyneuropathy to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. Around March 2021, the patient completed her 2 dose Shingrix series.  She reported that a few weeks after her second dose of the Shingrix vaccine received on unknown arm, that she began to develop polyneuropathy in her hands and her lips that was currently still unresolved.  She stated that she was unsure if the Shingrix had caused this reaction but that her physician told her that it could be possible.  The patient stated that she had also received a Covid vaccine within a few months of the Shingrix but did not get it concurrently with the Shingrix.  It was unknown if the reporter considered the polyneuropathy to be related to Covid vaccine. The patient could not provide lot number, expiration date, exact date of vaccines, or route or site of administration. The reporter gave consent to contact health care professional. The reporter consented to follow up. Note: Clarification was raised but as no start date for Covid vaccine was mentioned and reported that received within few months of Shingrix (unclear after 1st or 2nd dose) Covid vaccine received so both vaccines coded as suspect.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling cold, Feeling hot, Induration
Clinical narrative: She said every thing hurt( she had muscle pain); Swelling; Rash is itchy/ Rash of her right arm/Itchiness; Arm Hardness; hotness in arm/ rash is hot; hotness in arm; spent the next couple of days in bed; she experienced shivering; Feeling cold; Redness just below the injection site; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   The patient's past medical history included shingles (had 2 episodes of Shingles when she was in her 30's). Previously administered products included Zostavax (1st dose received in 8th December 2014).   On 18th February 2022, the patient received the 1st dose of Shingrix .5 ml. On 18th February 2022, less than a day after receiving Shingrix, the patient experienced shivering, feeling cold, erythema and pain in arm. On 19th February 2022, the patient experienced muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased. On an unknown date, the outcome of the shivering, erythema, swelling, itchy rash, induration, heat rash and extremities hot feeling of were not recovered/not resolved and the outcome of the feeling cold, pain in arm, muscle pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling cold, erythema, pain in arm, muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in right deltoid and that night she experienced shivering, feeling cold, a sore arm, and redness just below the injection site.  The following day she said every thing hurt( she had muscle pain), and that she spent the next couple of days in bed.  The patient also noticed a rash, itchiness, swelling, hotness, and hardness of her right arm. The patient had measured the size of her rash and stated it was 3 inches in diameter, but it had increased yesterday on 21st February 2022) to 4 inches across and 5 inches in length. On the day of reporting she stated that she no longer had pain, and she felt better, but the the rash continues and it was hot and itchy around the edges. She had not yet measured the size of the rash but stated that it was almost wrapping around her arm Gave medical advice disclaimer. Spoke per content. Spoke per PI (package insert). Referred to health care professional.  The reporter consented to follow-up with HCP (health care Professional). The reporter consented to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Miliaria, Mobility decreased, Myalgia, Pain in extremity, Rash pruritic
Clinical narrative: She said every thing hurt( she had muscle pain); Swelling; Rash is itchy/ Rash of her right arm/Itchiness; Arm Hardness; hotness in arm/ rash is hot; hotness in arm; spent the next couple of days in bed; she experienced shivering; Feeling cold; Redness just below the injection site; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   The patient's past medical history included shingles (had 2 episodes of Shingles when she was in her 30's). Previously administered products included Zostavax (1st dose received in 8th December 2014).   On 18th February 2022, the patient received the 1st dose of Shingrix .5 ml. On 18th February 2022, less than a day after receiving Shingrix, the patient experienced shivering, feeling cold, erythema and pain in arm. On 19th February 2022, the patient experienced muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased. On an unknown date, the outcome of the shivering, erythema, swelling, itchy rash, induration, heat rash and extremities hot feeling of were not recovered/not resolved and the outcome of the feeling cold, pain in arm, muscle pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling cold, erythema, pain in arm, muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in right deltoid and that night she experienced shivering, feeling cold, a sore arm, and redness just below the injection site.  The following day she said every thing hurt( she had muscle pain), and that she spent the next couple of days in bed.  The patient also noticed a rash, itchiness, swelling, hotness, and hardness of her right arm. The patient had measured the size of her rash and stated it was 3 inches in diameter, but it had increased yesterday on 21st February 2022) to 4 inches across and 5 inches in length. On the day of reporting she stated that she no longer had pain, and she felt better, but the the rash continues and it was hot and itchy around the edges. She had not yet measured the size of the rash but stated that it was almost wrapping around her arm Gave medical advice disclaimer. Spoke per content. Spoke per PI (package insert). Referred to health care professional.  The reporter consented to follow-up with HCP (health care Professional). The reporter consented to follow-up.