chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use
Clinical narrative: Booster dose 19Aug2021; Booster dose 19Aug2021; This is a spontaneous report received from contactable reporter(s) (Physician) for a Pfizer sponsored program (004756). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 08:00 (Lot number: EW0196) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 02, Lot: EK4176 Expiry: Unknown), administration date: 04Jan2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose 01), administration date: Dec2020, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 19Aug2021 08:00, outcome "unknown" and all described as "Booster dose 19Aug2021".  Follow-up attempts are completed. No further information is expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored; no additioanl AE; This spontaneous report was received from a healthcare business professional referring to a 4 year old female patient.  The patient's pertinent medical history and drug reactions/ allergies were unknown. Patient was not being administered any concomitant medications at event time.  On 08-OCT-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status of rHA (recombinant human albumin)) (PROQUAD) (lot # U010745, expiration date 03-OCT-2022; strength, dose and route were unknown) for prophylaxis (product storage error).         Previous temperature excursion was minus 10 degree Celsius to 8 degree Celsius (0.91 degree Celsius) for 6 hours on 04-OCT-2021 and minus 10 degree Celsius to 8 degree Celsius (1.45 degree Celsius) for 6 hours. Temperature excursion of this vaccine on 08-OCT-2021 was minus 14.6 degree Celsius for 6 hours. No additional adverse event was reported.  Additional Excursions had occurred after patient was administered the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD): 13-OCT-2021 from minus 10 degrees Celsius to 8 degree Celsius (0.54 degree Celsius) for 13 hours.   This is one of several reports received from same reporter. ; Sender's Comments:  US-009507513-2111USA004036: US-009507513-2111USA003910: US-009507513-2111USA003731: US-009507513-2111USA004109:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored; NO ADDTIOANL AE; This spontaneous report was received from a healthcare business professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.    On 05-OCT-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were unknown) for prophylaxis (product storage error). Caller was unable to clarify the varicella virus vaccine live (oka/merck) (VARIVAX) the Lot# and expiration date was U020244, 28-JUN-2023 or U010395, 01-APR-2023.      Temperature excursion of this vaccine was 1.45 degrees Celsius for 6 hours. Previous temperature excursion was reported as from minus 10 degrees Celsius to 8 degrees Celsius (0.91 degrees Celsius) for 6 hours on 04-OCT-2021. No additional adverse event was reported.  Additional Excursions had occurred after patient was administered the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX): 08-OCT-2021: minus 50 degrees Celsius to minus 15 degrees Celsius (minus 14.6 degrees Celsius) for 15 Hours. On 13-10-2021: minus 10 degrees Celsius to 8 degrees Celsius (0.54 degrees Celsius) for 13 Hours.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2111USA004036: US-009507513-2111USA003726: US-009507513-2111USA003910: US-009507513-2111USA004109:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse experiences; Was administered an expired dose of Recombivax HB; This spontaneous report was received from an office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date in 2021, the patient was vaccinated with an expired dose of hepatitis b vaccine thimerosal-free (recombinant)(RECOMBIVAX HB), lot number S022584 with expiration date  31-OCT-2021, single dose, for prophylaxis (dose, strength, frequency and route of administration were not provided).  At the reporting time, the patient's outcome was unknown.  This is one of several reports from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a consumer referting to themselves, a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient experienced shingles (herpes zoster). The outcome of herpes zoster was unknown.        The causal relationship between zoster vaccine live (ZOSTAVAX) and herpes zoster was unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  2112USA003883: 2112USA003885: 2112USA003882: 2112USA003881: 2112USA003884:
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AEs reported; PNEUMOV AX 23 was administered to a 12 month old patient instead of the intended PCV13 vaccine; This spontaneous report has been received from a licensed practical nurse referring to a 12 month old patient. The patient's pertinent medical history, drug reactions/allergies,concurrent condition and concomitant medication were not provided.     On 19-OCT-2021, pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)( dose, route, anatomical location, lot # and expiration date were not reported) was administered to the patient for prophylaxis instead of the intended pneumococcal vaccine 13v(PCV13) vaccine. The reporter denied further adverse event(AE). No additional AEs were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; expired dose of PNEUMOVAX 23 administered; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-NOV-2021 the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, lot # T007383, expiration date 23-AUG-2021, anatomical location not reported) for prophylaxis (Expired product administered). No additional adverse events(AEs) or product quality complaints (PQC) were reported.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; The interval between the first and second dose was outside the recommended time range; This spontaneous report was received from a physician concerning a 16-year-old patient of unknown gender. Informaiton on concurrent conditions, medical history or concomitant medications was not reported.   On 20-OCT-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 mL for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). The patient received the second dose outside the recommended time range on 20-FEB-2017 (Inappropriate schedule of product administration). The interval between the second and third dose was under the recommended time range, as it was administered on 20-APR-2017. No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; MMR-II that underwent temperature excursions was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.      On 13-OCT-2021 the patient was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-RVAXPRO) however reporter was unsure about which lot number administered to patient (Lot T000890 with expiration date reported 08-JAN-2022 and Lot T010650 with expiration date reported 26-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not provided) for prophylaxis, which was improperly stored (product storage error).  The temperature of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RVAXPRO) was stored had been above was 46F (49.6F) for 2 hours 21 minutes for lot T000890 and was 46F (56.1F) for 3 hours 33 minutes for Lot T010650. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000049: US-009507513-2112USA000050: US-009507513-2112USA000033:
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Inadverently administered M-M-R- II vaccine instead of an M-M-R-II vaccine titre test; His daughter is not experienced any additional side effects; This spontaneous report was received from a veterinarian referring to a 29 year old female patient. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 29-NOV-2021, the patient was going to do an measles, mumps, and rubella (MMR) titer test, but was inadvertently administered with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin (rHA) or human serum albumin (HAS), only leave one after receiving validation result of therapy type) (M-M-R II) for prophylaxis (accidental exposure to product) (strength, dose, vaccination scheme, route of administration, anatomical location were not reported; lot number U006487 has been verified to be a valid lot number, expiration date was 26-FEB-2023). The patient was not experiencing any additional side effects at the time (no adverse event). The reporter stated that he did not believe the patient was pregnant, but the patient was worried about since her and her husband were trying to become pregnant.
Sex: F
Vaccine: MMR, MMR
Symptoms: No adverse event, Vaccination error
Clinical narrative: Inadverently administered M-M-R- II vaccine instead of an M-M-R-II vaccine titre test; His daughter is not experienced any additional side effects; This spontaneous report was received from a veterinarian referring to a 29 year old female patient. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 29-NOV-2021, the patient was going to do an measles, mumps, and rubella (MMR) titer test, but was inadvertently administered with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin (rHA) or human serum albumin (HAS), only leave one after receiving validation result of therapy type) (M-M-R II) for prophylaxis (accidental exposure to product) (strength, dose, vaccination scheme, route of administration, anatomical location were not reported; lot number U006487 has been verified to be a valid lot number, expiration date was 26-FEB-2023). The patient was not experiencing any additional side effects at the time (no adverse event). The reporter stated that he did not believe the patient was pregnant, but the patient was worried about since her and her husband were trying to become pregnant.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Gait disturbance, Myalgia, Pyrexia
Clinical narrative: Extreme dizziness before going to bed, and especially when getting up from bed at night or getting up the next morning. Dizziness was such that I could barely walk and crashed into walls.  Also, extremely intense headache behind the eyes;  Headache was slightly better after taking 1 or 2 full-sized aspirin.  Fever and muscle soreness was probably typical.  Symptoms came on the night of the vaccination and seemed to subside the next day. Dizziness was notable upon getting up in the morning but went away slowly, as I attempted to "walk it out".
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Painful respiration
Clinical narrative: PT experience chest pain, dizziness, and pain upon breathing after vaccination.  These symptoms started about a minute after vaccination. EMTs were called and pt was transported to the hospital for evaluation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Incorrect route of product administration, Joint range of motion decreased, Malaise
Clinical narrative: The vaccine was injected on 11/29/21 and higher than it should have been, into my shoulder area. The following day 11/30/21 I had slight numbness in my entire left arm.  Loss of range of motion and significant pain in my shoulder and pain down my arm to above my elbow area, at rest and with any type of movement. Per ER physician, X-ray was unremarkable. The pain started to subside on 12/5/21, however on 12/7/21 the pain returned significantly along with a low grade fever. On 12/10/21 the significant pain in shoulder and down my arm continues, along with low grade fever, and a general feeling of illness in my head. I self tested for Covid, results are negative.  An ultrasound was performed on 12/10/21, per physician, also unremarkable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Ultrasound scan normal, X-ray normal
Clinical narrative: The vaccine was injected on 11/29/21 and higher than it should have been, into my shoulder area. The following day 11/30/21 I had slight numbness in my entire left arm.  Loss of range of motion and significant pain in my shoulder and pain down my arm to above my elbow area, at rest and with any type of movement. Per ER physician, X-ray was unremarkable. The pain started to subside on 12/5/21, however on 12/7/21 the pain returned significantly along with a low grade fever. On 12/10/21 the significant pain in shoulder and down my arm continues, along with low grade fever, and a general feeling of illness in my head. I self tested for Covid, results are negative.  An ultrasound was performed on 12/10/21, per physician, also unremarkable.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Fever of 100 +, chills, body aches, fatigue, headache, congestion, breathing more difficult, numbness in fingers
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever of 100 +, chills, body aches, fatigue, headache, congestion, breathing more difficult, numbness in fingers
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue
Clinical narrative: Nurse noticed that COVID vaccine syringe was empty while she was injecting . She alerted the patient that he must get another vaccine since the previous syringe might have been empty. The nurse asserted that everytime she uses a syringe she retracts the needle before putting it in the sharps container and she demonstrated the procedure to the patient.  Patient was worried that he was injected with a used syringe.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Headache, Pyrexia
Clinical narrative: head ache, slight fever, disorientation
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: There were vaccines drawn from an expired Moderna vial. The vial expired 12/09/21 at  11:05 pm  and the dose was given 12/10.  Patient has not exhibited adverse events post vaccination.  Moderna was called to inquire about further steps and whether or not the patient needs to be contacted to be revaccinated. The case was escalated and the turn around time for a response is 3 days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: There were vaccines drawn from an expired Moderna vial. The vial expired 12/09/21  and the dose was given 12/10.  Patient has not exhibited adverse events post vaccination.  Moderna was called to inquire about further steps and whether or not the patient needs to be contacted to be revaccinated. The case was escalated and the turn around time for a response is 3 days.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Three weeks following the vaccine I continue to have shoulder pain, limited range of motion, and my level of physical activity has been hindered by the pain.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Shoulder injury related to vaccine administration
Clinical narrative: Three weeks following the vaccine I continue to have shoulder pain, limited range of motion, and my level of physical activity has been hindered by the pain.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: There were vaccines drawn from an expired Moderna vial. The vial expired 12/09/21  and the dose was given 12/10.  Patient has not exhibited adverse events post vaccination.  Moderna was called to inquire about further steps and whether or not the patient needs to be contacted to be revaccinated. The case was escalated and the turn around time for a response is 3 days.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Product was administered to patient after an excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.       On 29-NOV-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine Live recombinant human albumin (rHA)(PROQUAD) (lot # U015479 expiration date reported 13-NOV-2022) after an excursion for prophylaxis (product storage error).   The temperature of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored had been between 14F to 46F (31.8F) for 5 hours 30 minutes for lot U015479. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001166:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt received the pediatric dose vs the 12 + adult dose.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong vaccine. I gave a booster 0.25mL dose of Moderna vaccine rather than the intended 0.2mL dose of Pfizer for 5-11 age group.  Patient tolerated the vaccine well during the observation period.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Hives that started out as itchy bumps and spread across entire body within 24 hours. Required oral steroid and Benadryl course to treat.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: There were vaccines drawn from an expired Moderna vial. The vial expired 12/09/21  and the dose was given 12/10.  Patient has not exhibited adverse events post vaccination.  Moderna was called to inquire about further steps and whether or not the patient needs to be contacted to be revaccinated. The case was escalated and the turn around time for a response is 3 days.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling hot, Gait disturbance, Headache
Clinical narrative: Within one hour of my booster shot my left foot, namely the heal, began to hurt. It was so bad I could barely walk. I am still in a lot of pain  3 weeks later. I also felt so ill that I thought I may need to go to the hospital. I was shivering, feeling hot, headache, muscle aches, joint pain,  I felt horrible all over my body. I called a nurse practitioner friend of mine for advice, and decided to stay home. I was sick for several days. My foot on some days is very gradually getting better, on other days it still hurts to the point that I limp and am in great pain.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: Within one hour of my booster shot my left foot, namely the heal, began to hurt. It was so bad I could barely walk. I am still in a lot of pain  3 weeks later. I also felt so ill that I thought I may need to go to the hospital. I was shivering, feeling hot, headache, muscle aches, joint pain,  I felt horrible all over my body. I called a nurse practitioner friend of mine for advice, and decided to stay home. I was sick for several days. My foot on some days is very gradually getting better, on other days it still hurts to the point that I limp and am in great pain.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were vaccines drawn from an expired Moderna vial. The vial expired 12/09/21 and the dose was given 12/10.  Patient has not exhibited adverse events post vaccination.  Moderna was called to inquire about further steps and whether or not the patient needs to be contacted to be revaccinated. The case was escalated and the turn around time for a response is 3 days.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: Reported chills around 7:30 pm on December 10, 2021.  Fever of 102.7 degrees fahrenheit  taken with the  Braun No Touch + Forehead Thermometer on the same day around 10:00 pm.  Gave two ibuprofen 200 mg gel caps at 10:30 pm. reported he still had cold chills
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Migraine, Nausea, Pyrexia
Clinical narrative: 12 hrs later woke up with fever, nausea, migraine lasted 24 hrs, took ibprofen every 6 hrs for 24 hr period once symptoms began. Did not fully recover until 72 hrs later full appetite back, headache gone
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Menstrual bleeding post menopause after Modena booster shot. Last period was March 2020.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Erythema, Peripheral swelling
Clinical narrative: Left arm has giant hive, red , hot and swollen. Did not have this reaction to the first two shots.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Breast swelling, Condition aggravated, Decreased appetite
Clinical narrative: - got sick immediately after for a few days, the same as the first 2 doses (nausea, vomiting, fatigue, heavy limbs)  - the side effect I am most concerned about began Friday December 10th.  - I have started my period almost a week early. Usually my periods are painful, but it is especially painful with cramping, nausea that is affecting my appetite (can't eat much at all), swollen and sore breasts, and it is extremely heavy.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Illness, Immediate post-injection reaction, Limb discomfort
Clinical narrative: - got sick immediately after for a few days, the same as the first 2 doses (nausea, vomiting, fatigue, heavy limbs)  - the side effect I am most concerned about began Friday December 10th.  - I have started my period almost a week early. Usually my periods are painful, but it is especially painful with cramping, nausea that is affecting my appetite (can't eat much at all), swollen and sore breasts, and it is extremely heavy.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Nausea, Vomiting
Clinical narrative: - got sick immediately after for a few days, the same as the first 2 doses (nausea, vomiting, fatigue, heavy limbs)  - the side effect I am most concerned about began Friday December 10th.  - I have started my period almost a week early. Usually my periods are painful, but it is especially painful with cramping, nausea that is affecting my appetite (can't eat much at all), swollen and sore breasts, and it is extremely heavy.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Blood glucose normal, Blood uric acid normal, C-reactive protein increased, Cellulitis
Clinical narrative: Since around October 14, 2020, I have had recurring, alternating painful ankles and feet with edema.  Signs and symptoms match sprained ankles, cellulitis, gout.  Swelling, pain, limping, shinny skin, edema subcutaneous, dry skin, skin peeling, redness, slight  warmth.   When the left ankle is swollen, the right foot will be formal.  When the right foot is swollen, the left foot is normal.  They take turns being swollen.   NO FEVER NO PUS  NO INFECTION      Rocephin 2 rounds of 3 day injections - no change Keflex - No change Ice packs - no change Legs elevated at night  - swelling gets better, but comes back within 5 minutes   This is all speculation.  Medical staff says that they are not sure what is causing this.  I have seen about 8 physicians.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Dry skin, Echocardiogram normal, Electrocardiogram normal, Erythema, Gait disturbance
Clinical narrative: Since around October 14, 2020, I have had recurring, alternating painful ankles and feet with edema.  Signs and symptoms match sprained ankles, cellulitis, gout.  Swelling, pain, limping, shinny skin, edema subcutaneous, dry skin, skin peeling, redness, slight  warmth.   When the left ankle is swollen, the right foot will be formal.  When the right foot is swollen, the left foot is normal.  They take turns being swollen.   NO FEVER NO PUS  NO INFECTION      Rocephin 2 rounds of 3 day injections - no change Keflex - No change Ice packs - no change Legs elevated at night  - swelling gets better, but comes back within 5 minutes   This is all speculation.  Medical staff says that they are not sure what is causing this.  I have seen about 8 physicians.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Glycosylated haemoglobin normal, Gout, Laboratory test, Ligament sprain, Magnetic resonance imaging normal
Clinical narrative: Since around October 14, 2020, I have had recurring, alternating painful ankles and feet with edema.  Signs and symptoms match sprained ankles, cellulitis, gout.  Swelling, pain, limping, shinny skin, edema subcutaneous, dry skin, skin peeling, redness, slight  warmth.   When the left ankle is swollen, the right foot will be formal.  When the right foot is swollen, the left foot is normal.  They take turns being swollen.   NO FEVER NO PUS  NO INFECTION      Rocephin 2 rounds of 3 day injections - no change Keflex - No change Ice packs - no change Legs elevated at night  - swelling gets better, but comes back within 5 minutes   This is all speculation.  Medical staff says that they are not sure what is causing this.  I have seen about 8 physicians.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pain in extremity, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Since around October 14, 2020, I have had recurring, alternating painful ankles and feet with edema.  Signs and symptoms match sprained ankles, cellulitis, gout.  Swelling, pain, limping, shinny skin, edema subcutaneous, dry skin, skin peeling, redness, slight  warmth.   When the left ankle is swollen, the right foot will be formal.  When the right foot is swollen, the left foot is normal.  They take turns being swollen.   NO FEVER NO PUS  NO INFECTION      Rocephin 2 rounds of 3 day injections - no change Keflex - No change Ice packs - no change Legs elevated at night  - swelling gets better, but comes back within 5 minutes   This is all speculation.  Medical staff says that they are not sure what is causing this.  I have seen about 8 physicians.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Skin disorder, Skin exfoliation, Skin oedema, Skin warm, Swelling
Clinical narrative: Since around October 14, 2020, I have had recurring, alternating painful ankles and feet with edema.  Signs and symptoms match sprained ankles, cellulitis, gout.  Swelling, pain, limping, shinny skin, edema subcutaneous, dry skin, skin peeling, redness, slight  warmth.   When the left ankle is swollen, the right foot will be formal.  When the right foot is swollen, the left foot is normal.  They take turns being swollen.   NO FEVER NO PUS  NO INFECTION      Rocephin 2 rounds of 3 day injections - no change Keflex - No change Ice packs - no change Legs elevated at night  - swelling gets better, but comes back within 5 minutes   This is all speculation.  Medical staff says that they are not sure what is causing this.  I have seen about 8 physicians.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Ultrasound Doppler normal, Urine analysis normal, White blood cell count normal, X-ray normal
Clinical narrative: Since around October 14, 2020, I have had recurring, alternating painful ankles and feet with edema.  Signs and symptoms match sprained ankles, cellulitis, gout.  Swelling, pain, limping, shinny skin, edema subcutaneous, dry skin, skin peeling, redness, slight  warmth.   When the left ankle is swollen, the right foot will be formal.  When the right foot is swollen, the left foot is normal.  They take turns being swollen.   NO FEVER NO PUS  NO INFECTION      Rocephin 2 rounds of 3 day injections - no change Keflex - No change Ice packs - no change Legs elevated at night  - swelling gets better, but comes back within 5 minutes   This is all speculation.  Medical staff says that they are not sure what is causing this.  I have seen about 8 physicians.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Decubitus ulcer, Dysstasia, Gait inability, Guillain-Barre syndrome
Clinical narrative: Within less than 12 hours there was complete paralysis from the waist down. He was hospitalized, diagnosed with GBS. He had GBS in his legs with complete paralysis and minor weakness in his hands and lower arms. He developed a Stage 4 pressure ulcer on his butt, never walked or stood again, and spent 3 1/2 months going back and forth between the hospital and a SNF. He never returned home and passed away on September 20, 2021.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Paralysis
Clinical narrative: Within less than 12 hours there was complete paralysis from the waist down. He was hospitalized, diagnosed with GBS. He had GBS in his legs with complete paralysis and minor weakness in his hands and lower arms. He developed a Stage 4 pressure ulcer on his butt, never walked or stood again, and spent 3 1/2 months going back and forth between the hospital and a SNF. He never returned home and passed away on September 20, 2021.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Bled more than we?ve ever saw from a shot. And left a raised bruise. Almost immediately husband felt tingly in his skin and face. Within an hour he was feeling dizzy and tired. He got chills and a fever. He started to feel aches all over. He slept five hours in the middle of the day. And had a bad headache. This lasted Monday, Tuesday, Wednesday and most of Thursday. By Friday he had just the headache, aches, and tiredness.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Pain, Paraesthesia, Pyrexia
Clinical narrative: Bled more than we?ve ever saw from a shot. And left a raised bruise. Almost immediately husband felt tingly in his skin and face. Within an hour he was feeling dizzy and tired. He got chills and a fever. He started to feel aches all over. He slept five hours in the middle of the day. And had a bad headache. This lasted Monday, Tuesday, Wednesday and most of Thursday. By Friday he had just the headache, aches, and tiredness.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product use issue, Wrong product administered
Clinical narrative: No additional AE reported; A 17-Year-Old patient received Proquad; Patinet was inadverently administered Proquad instead of the inteded MMR II; This spontaneous report was received from nurse referring to a 17 years old male patient. The information about patient's concurrent conditions, medical history, concomitant medications was not reported.  On 09-NOV-2021, the 17-year-old patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) subcutaneously for prophylaxis (strength, dose, vaccination scheme, and anatomical location were not reported; lot number T034825 has been verified to be a valid lot number, expiration date was 11-APR-2022) instead of the intended measles, mumps, and rubella virus vaccine live (M-M-R II) (product use issue and wrong product administered). The lab diagnostics/studies performed were unknown by reporter. At the time of the report, the patient had not been administered with measles, mumps, and rubella virus vaccine live (M-M-R II). No additional adverse event, product quality complaints (PQC) or further information was reported.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Hyperhidrosis, Skin discolouration
Clinical narrative: Patient felt the following symptoms post vaccination: 1) sweating 2) elevated temperature 3) slight face discoloration 4) dizziness. Patient monitored closely by staff until Mother claimed he had recovered. After assessment, staff also confirmed that the patient recovered from his symptoms before he left the pharmacy.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Hyperhidrosis, Pain in extremity, Peripheral swelling, Spider vein
Clinical narrative: Impression: 1. Occlusive deep vein thrombosis extending from mid femoral vein to the distal femoral vein. 2. Nonocclusive deep vein thrombosis within the proximal femoral vein and popliteal vein. 3. Calf veins were not visualized. POSITIVE ALERT The results of this study have been annotated as abnormal in EPIC, the patient's electronic medical record. Received report and assumed care of patient. In to introduce self to patient at this time. Patient A&O x4, resting quietly on stretcher in room. On observation left leg swollen to greater size than right, some spider-type veins observed to inner calcaneous patient reports are new. Pedal pulse palpated easily however slightly diminished in comparison to right pedal pulse. Call light placed in reach, patient denies other needs at this time.  Triage Note:  Patient is a 54 year old male who presents with left calf pain onset two days.   Swelling noted by patient. Hurst when he walks around. Reports some sweating today.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: Impression: 1. Occlusive deep vein thrombosis extending from mid femoral vein to the distal femoral vein. 2. Nonocclusive deep vein thrombosis within the proximal femoral vein and popliteal vein. 3. Calf veins were not visualized. POSITIVE ALERT The results of this study have been annotated as abnormal in EPIC, the patient's electronic medical record. Received report and assumed care of patient. In to introduce self to patient at this time. Patient A&O x4, resting quietly on stretcher in room. On observation left leg swollen to greater size than right, some spider-type veins observed to inner calcaneous patient reports are new. Pedal pulse palpated easily however slightly diminished in comparison to right pedal pulse. Call light placed in reach, patient denies other needs at this time.  Triage Note:  Patient is a 54 year old male who presents with left calf pain onset two days.   Swelling noted by patient. Hurst when he walks around. Reports some sweating today.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Deep vein thrombosis, Echocardiogram, Laboratory test, Pulmonary embolism
Clinical narrative: acute vein thrombosis (saphein vein) and pulmonary embolism
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: acute vein thrombosis (saphein vein) and pulmonary embolism
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient (pt) of unknown age . There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. In or around 2016,the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving the zoster vaccine live (ZOSTAVAX) the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries. Further, as a tragic consequence of vaccination with zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of shingles was considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Encephalitis, Herpes zoster, Post herpetic neuralgia
Clinical narrative: encephalitis; post-herpetic neuralgia; shingles; Information has been 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 and concomitant medications. In or about 2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) by a nurse in a medical group practice for the long-term prevention of shingles and zoster-related conditions. Subsequently to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers for shingles, post-herpetic neuralgia and encephalitis. The outcome of shingles, post-herpetic neuralgia and encephalitis was not reported. The reporter considered shingles, post-herpetic neuralgia and encephalitis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of encephalitis was determined to be medically significant.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Patient had been given a dose of ROTATEQ six days early on 28-OCT-2021 after receiving the first dose of ROTATEQ on 06-OCT-2021; This spontaneous report was received from a nurse and refers to a 4 months old patient of unknown gender. The information about patient's concurrent condition, medical and drug history and concomitant medications were not provided.  On 06-OCT-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml, orally ( lot number and expiration date were not reported) for prophylaxis. On 28-OCT-2021, the patient received second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at the dose of 2 ml (lot number and expiration date not reported); six days early after receiving the first dose (Inappropriate schedule of product administration). No additional adverse event (AE) reported.
Sex: F
Vaccine: FLUX, PPV, UNK, UNK
Symptoms: Adverse event, Pain in extremity, Pneumonia, Vaccination failure
Clinical narrative: Pneumonia; Left arm was sore; vaccination failure; This spontaneous report was received as other company letter from (manufacturer control number: 21K-163-4165505-00) reported by a female consumer of 63-year-old referring to herself.   The patient's medical history included chicken pox (all over the body including the mouth). Information regarding concomitant therapies was not provided.   On an unspecified date, the patient had pneumonia and was hospitalized on 23-SEP-2021, until 06-OCT-2021. It was reported that, unspecified injections of medications were given on 18-OCT-2021, and 23-OCT-2021. On 10-NOV-2021, she started adalimumab (HUMIRA) solution for injection in prefilled pen, strength 40 mg/ 0.8 mL, at a dose of 40 mg (1 in 2-2), subcutaneously, for moderate to severe rheumatoid arthritis, and arthropathic psoriasis (unspecified).  On 15-NOV-2021, she was vaccinated with pneumococcal vaccine (manufacturer unknown), and with an unspecified influenza vaccine; both as prophylaxis.  On an unknown date in 2021, the patient experienced pneumonia (vaccination failure) and was hospitalized due to this event. On an unspecified date in November 2021, she experienced left arm sore (pain in extremity) which was considered as non-serious adverse event by the reporter. On 24-NOV-2021, the last reported dose of adalimumab (HUMIRA) was given to the patient. Later, this medication was discontinued. At the time of the report, the outcomes of the events and the action taken with the suspect therapies were unknown.   The causality assessment between pneumococcal vaccine (manufacturer unknown) and unspecified influenza vaccine with the events pneumonia and pain in extremity was reported as unknown. The reporter considered adalimumab (HUMIRA) to be probable related (reported as reasonable possibility) to pneumonia, but to be not related to pain in extremity (conflicting information also reported as unknown).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003883: US-009507513-2112USA003884: US-009507513-2112USA003885: US-009507513-2111USA004277: US-009507513-2112USA003882:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA004277: US-009507513-2112USA003883: US-009507513-2112USA003884: US-009507513-2112USA003885: US-009507513-2112USA003881:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA004277: US-009507513-2112USA003881: US-009507513-2112USA003882: US-009507513-2112USA003884: US-009507513-2112USA003885: