chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Monoplegia, Vomiting
Clinical narrative: severe pain of entire left arm; inability to move left arm; Severe Headache; Vomiting; Stomach cramps and pain; Dehydration; missed two days of work.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for pain in arm and injected limb mobility decreased.   Previously administered products included Shingrix (for tolerance to the 1st dose refer case US2019AMR124480).   On 4th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, the patient started Tylenol at an unknown dose and frequency. In July 2019, 3 hrs after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased, headache, vomiting, stomach cramps, dehydration and inability to work. The patient was treated with intravenous fluid (nos) (Intravenous Fluids), antiemetics and antinauseants (Nausea Medication (Nos)) and benadryl (nos) (Benadryl). The action taken with Tylenol was unknown (Dechallenge was unknown). Rechallenge with Tylenol was unknown. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, vomiting, stomach cramps, dehydration and inability to work were unknown and the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, headache, vomiting, stomach cramps, dehydration and inability to work to be related to Shingrix.  Additional information received were as follows: The age at the vaccination was not reported. Prior to the second injection, the patient told the person giving the injection what her reactions were to the first vaccine and was told they were normal reactions. The patient received Shingrix on left arm. After her second injection, her left arm was extremely painful and she could not move her arm. In July 2019, the patient received Tylenol for the pain as directed on the bottle. Immediately vomited after taking the Tylenol, 3 hours after receiving Shingrix, the patient experienced stomach cramps and pain, and became dehydrated from the vomiting. The patient's husband took her to the emergency room and she was there from 11am until around 7pm. The patient underwent a CAT scan of her head for her severe headache and to rule out a stroke and received IV fluids and anti-nausea medication and benadryl and slept for the next two days. The patient's headache was slowly resolving and on the reporting date which was the first day she actually felt like she was recovering. 3 hours after receiving Shingrix, the patient missed two days of work. The patient granted permission to contact her doctor for follow up.The caller reported her adverse reactions of both vaccines to the FDA.
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Abdominal pain upper, Computerised tomogram head, Dehydration, Headache, Impaired work ability
Clinical narrative: severe pain of entire left arm; inability to move left arm; Severe Headache; Vomiting; Stomach cramps and pain; Dehydration; missed two days of work.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for pain in arm and injected limb mobility decreased.   Previously administered products included Shingrix (for tolerance to the 1st dose refer case US2019AMR124480).   On 4th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, the patient started Tylenol at an unknown dose and frequency. In July 2019, 3 hrs after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased, headache, vomiting, stomach cramps, dehydration and inability to work. The patient was treated with intravenous fluid (nos) (Intravenous Fluids), antiemetics and antinauseants (Nausea Medication (Nos)) and benadryl (nos) (Benadryl). The action taken with Tylenol was unknown (Dechallenge was unknown). Rechallenge with Tylenol was unknown. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, vomiting, stomach cramps, dehydration and inability to work were unknown and the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, headache, vomiting, stomach cramps, dehydration and inability to work to be related to Shingrix.  Additional information received were as follows: The age at the vaccination was not reported. Prior to the second injection, the patient told the person giving the injection what her reactions were to the first vaccine and was told they were normal reactions. The patient received Shingrix on left arm. After her second injection, her left arm was extremely painful and she could not move her arm. In July 2019, the patient received Tylenol for the pain as directed on the bottle. Immediately vomited after taking the Tylenol, 3 hours after receiving Shingrix, the patient experienced stomach cramps and pain, and became dehydrated from the vomiting. The patient's husband took her to the emergency room and she was there from 11am until around 7pm. The patient underwent a CAT scan of her head for her severe headache and to rule out a stroke and received IV fluids and anti-nausea medication and benadryl and slept for the next two days. The patient's headache was slowly resolving and on the reporting date which was the first day she actually felt like she was recovering. 3 hours after receiving Shingrix, the patient missed two days of work. The patient granted permission to contact her doctor for follow up.The caller reported her adverse reactions of both vaccines to the FDA.
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Vomiting
Clinical narrative: severe pain of entire left arm; inability to move left arm; Severe Headache; Vomiting; Stomach cramps and pain; Dehydration; missed two days of work.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for pain in arm and injected limb mobility decreased.   Previously administered products included Shingrix (for tolerance to the 1st dose refer case US2019AMR124480).   On 4th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, the patient started Tylenol at an unknown dose and frequency. In July 2019, 3 hrs after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased, headache, vomiting, stomach cramps, dehydration and inability to work. The patient was treated with intravenous fluid (nos) (Intravenous Fluids), antiemetics and antinauseants (Nausea Medication (Nos)) and benadryl (nos) (Benadryl). The action taken with Tylenol was unknown (Dechallenge was unknown). Rechallenge with Tylenol was unknown. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, vomiting, stomach cramps, dehydration and inability to work were unknown and the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, headache, vomiting, stomach cramps, dehydration and inability to work to be related to Shingrix.  Additional information received were as follows: The age at the vaccination was not reported. Prior to the second injection, the patient told the person giving the injection what her reactions were to the first vaccine and was told they were normal reactions. The patient received Shingrix on left arm. After her second injection, her left arm was extremely painful and she could not move her arm. In July 2019, the patient received Tylenol for the pain as directed on the bottle. Immediately vomited after taking the Tylenol, 3 hours after receiving Shingrix, the patient experienced stomach cramps and pain, and became dehydrated from the vomiting. The patient's husband took her to the emergency room and she was there from 11am until around 7pm. The patient underwent a CAT scan of her head for her severe headache and to rule out a stroke and received IV fluids and anti-nausea medication and benadryl and slept for the next two days. The patient's headache was slowly resolving and on the reporting date which was the first day she actually felt like she was recovering. 3 hours after receiving Shingrix, the patient missed two days of work. The patient granted permission to contact her doctor for follow up.The caller reported her adverse reactions of both vaccines to the FDA.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: pain left side; sensititvity left side; burning sensation left side; This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles a few years ago).   On 2nd July 2019, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced pain localized, sensitive skin and burning sensation. On an unknown date, the outcome of the pain localized, sensitive skin and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the pain localized, sensitive skin and burning sensation to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and approximately 4 days later she experienced pain, burning and sensitivity on her left side.  The patient stated that the outbreak was in that same spot on her left side.  The patient stated that there are no blisters, rash, or itching. The reporter consented to follow up. Emergency room visit required.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Sensitive skin
Clinical narrative: pain left side; sensititvity left side; burning sensation left side; This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles a few years ago).   On 2nd July 2019, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced pain localized, sensitive skin and burning sensation. On an unknown date, the outcome of the pain localized, sensitive skin and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the pain localized, sensitive skin and burning sensation to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and approximately 4 days later she experienced pain, burning and sensitivity on her left side.  The patient stated that the outbreak was in that same spot on her left side.  The patient stated that there are no blisters, rash, or itching. The reporter consented to follow up. Emergency room visit required.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: Rash on torso, arms and legs; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number T73K2, expiry date unknown) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix. On 22nd March 2019, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows The healthcare professional that was also the patient reported that he received Shingrix. Ever since he had been experiencing a rash on torso area, back, arms and legs at different time periods. It had not subsided. No additional information was reported.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash on torso, arms and legs; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number T73K2, expiry date unknown) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix. On 22nd March 2019, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows The healthcare professional that was also the patient reported that he received Shingrix. Ever since he had been experiencing a rash on torso area, back, arms and legs at different time periods. It had not subsided. No additional information was reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Headache, Lymphadenitis, Malaise, Pyrexia
Clinical narrative: "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; This spontaneous report was received from a physician referring to herself as a non-pregnant 43 years old female patient of unknown race. The patient's pertinent concurrent conditions included thalassaemia alpha, rhinitis, constipation, and glucose-6-phosphate dehydrogenase deficiency. Her allergies included Sulpha drugs. The patient's concomitant drugs included magnesium, biotin, lactase enzymes, fluticasone propionate (FLONASE), multivitamins and fexofenadine.   On 22-JUN-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) route of administration reported as injected, lot number 1602284 with expiration date on 26-SEP-2021 to protect against Human Papillomavirus (HPV) (dose and frequency were not reported).  On 28-JUN-2019 (reported as 6 days after the injection), the patient experienced every side effect, every day for the last two weeks, described as headaches, muscle weakness, fatigue, chills, fever, and swollen glands. The patient reported that she took acetaminophen (TYLENOL) and ibuprofen every day as treatment for the adverse event. On 12-JUL-2019, the patient sought her primary care physician, who advised her to keep taking acetaminophen (TYLENOL) and ibuprofen and to start a regimen with amoxicillin (+) clavulanate potassium (AUGMENTIN) which at the moment of this report the patient has not started. No laboratory diagnostics or studies were performed.   At the moment of this report the patient had not recovered from the adverse events.  The causal relationship between headaches, muscle weakness, fatigue, chills, fever, and swollen glands and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Muscular weakness
Clinical narrative: "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; This spontaneous report was received from a physician referring to herself as a non-pregnant 43 years old female patient of unknown race. The patient's pertinent concurrent conditions included thalassaemia alpha, rhinitis, constipation, and glucose-6-phosphate dehydrogenase deficiency. Her allergies included Sulpha drugs. The patient's concomitant drugs included magnesium, biotin, lactase enzymes, fluticasone propionate (FLONASE), multivitamins and fexofenadine.   On 22-JUN-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) route of administration reported as injected, lot number 1602284 with expiration date on 26-SEP-2021 to protect against Human Papillomavirus (HPV) (dose and frequency were not reported).  On 28-JUN-2019 (reported as 6 days after the injection), the patient experienced every side effect, every day for the last two weeks, described as headaches, muscle weakness, fatigue, chills, fever, and swollen glands. The patient reported that she took acetaminophen (TYLENOL) and ibuprofen every day as treatment for the adverse event. On 12-JUL-2019, the patient sought her primary care physician, who advised her to keep taking acetaminophen (TYLENOL) and ibuprofen and to start a regimen with amoxicillin (+) clavulanate potassium (AUGMENTIN) which at the moment of this report the patient has not started. No laboratory diagnostics or studies were performed.   At the moment of this report the patient had not recovered from the adverse events.  The causal relationship between headaches, muscle weakness, fatigue, chills, fever, and swollen glands and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pyrexia
Clinical narrative: "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; "I have headaches, muscle weakness, fatigue, chills, fever, and swollen glands."; This spontaneous report was received from a physician referring to herself as a non-pregnant 43 years old female patient of unknown race. The patient's pertinent concurrent conditions included thalassaemia alpha, rhinitis, constipation, and glucose-6-phosphate dehydrogenase deficiency. Her allergies included Sulpha drugs. The patient's concomitant drugs included magnesium, biotin, lactase enzymes, fluticasone propionate (FLONASE), multivitamins and fexofenadine.   On 22-JUN-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) route of administration reported as injected, lot number 1602284 with expiration date on 26-SEP-2021 to protect against Human Papillomavirus (HPV) (dose and frequency were not reported).  On 28-JUN-2019 (reported as 6 days after the injection), the patient experienced every side effect, every day for the last two weeks, described as headaches, muscle weakness, fatigue, chills, fever, and swollen glands. The patient reported that she took acetaminophen (TYLENOL) and ibuprofen every day as treatment for the adverse event. On 12-JUL-2019, the patient sought her primary care physician, who advised her to keep taking acetaminophen (TYLENOL) and ibuprofen and to start a regimen with amoxicillin (+) clavulanate potassium (AUGMENTIN) which at the moment of this report the patient has not started. No laboratory diagnostics or studies were performed.   At the moment of this report the patient had not recovered from the adverse events.  The causal relationship between headaches, muscle weakness, fatigue, chills, fever, and swollen glands and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Blisters; Shingles; Flu Like Symptoms; Fatigue; hot arm; achy arm and fingers; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix. On 5th July 2019, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue, skin warm, pain in extremity and shingles. On 7th July 2019, the patient experienced blister. On an unknown date, the outcome of the influenza-like symptoms, fatigue, skin warm, pain in extremity, blister and shingles were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, skin warm, pain in extremity, blister and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient experienced flu like symptoms, fatigue, hot arm, achy arm and fingers, sharp pain through entire arm and fingers. The patient broke out in blisters on the right hand palm and fingers. The patient visited her physician and was diagnosed with Shingles. Her doctor had put her on medication for Shingles. The reporter did not consent to follow up. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Fatigue, Herpes zoster, Influenza like illness, Pain in extremity
Clinical narrative: Blisters; Shingles; Flu Like Symptoms; Fatigue; hot arm; achy arm and fingers; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix. On 5th July 2019, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue, skin warm, pain in extremity and shingles. On 7th July 2019, the patient experienced blister. On an unknown date, the outcome of the influenza-like symptoms, fatigue, skin warm, pain in extremity, blister and shingles were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, skin warm, pain in extremity, blister and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient experienced flu like symptoms, fatigue, hot arm, achy arm and fingers, sharp pain through entire arm and fingers. The patient broke out in blisters on the right hand palm and fingers. The patient visited her physician and was diagnosed with Shingles. Her doctor had put her on medication for Shingles. The reporter did not consent to follow up. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Blisters; Shingles; Flu Like Symptoms; Fatigue; hot arm; achy arm and fingers; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix. On 5th July 2019, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue, skin warm, pain in extremity and shingles. On 7th July 2019, the patient experienced blister. On an unknown date, the outcome of the influenza-like symptoms, fatigue, skin warm, pain in extremity, blister and shingles were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, skin warm, pain in extremity, blister and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient experienced flu like symptoms, fatigue, hot arm, achy arm and fingers, sharp pain through entire arm and fingers. The patient broke out in blisters on the right hand palm and fingers. The patient visited her physician and was diagnosed with Shingles. Her doctor had put her on medication for Shingles. The reporter did not consent to follow up. No further details were provided.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle Pain; This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The pharmacy Intern called in to inquire if any information on this extended reaction to Shingrix. The healthcare professional stated that the patient received the Shingrix and experienced muscle pain that last over a month since receiving the dose.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Pt informed about having Left arm swollen, red and warm to touch entirely on deltoid inflammed
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Pt informed about having Left arm swollen, red and warm to touch entirely on deltoid inflammed
Age: 38.0
Sex: M
Vaccine: JEV1, MMR
Symptoms: Anxiety, Chest pain, Dizziness, Dysarthria, Dyspnoea
Clinical narrative: Within minutes of receiving vaccines, reported dizziness/light-headed feeling; not relieved by lying supine.  Sxms progressed over next 30 min to included CP, SOB, tingling/stiffness in jaw and arms, and slurred speech.  No specific globus, swelling, urticaria, or other skin changes.  Transported to ER and given only Benadryl; no epi.  Sxms resolved over approx 2 hrs of observation.  ER dxd "acute anxiety with hyperventilation."  Subsequent consultations were made to Allergy/Immunology, Psychiatry, and DHA Immunization Healthcare team.
Age: 38.0
Sex: M
Vaccine: JEV1, MMR
Symptoms: Hyperventilation, Joint stiffness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Within minutes of receiving vaccines, reported dizziness/light-headed feeling; not relieved by lying supine.  Sxms progressed over next 30 min to included CP, SOB, tingling/stiffness in jaw and arms, and slurred speech.  No specific globus, swelling, urticaria, or other skin changes.  Transported to ER and given only Benadryl; no epi.  Sxms resolved over approx 2 hrs of observation.  ER dxd "acute anxiety with hyperventilation."  Subsequent consultations were made to Allergy/Immunology, Psychiatry, and DHA Immunization Healthcare team.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Gait disturbance, Metabolic function test, Muscular weakness, Urine analysis
Clinical narrative: Severe weakness -- especially in legs -- had difficulty walking in to the emergency room
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pain when injected.    Sore, swollen, red arm approximately 3 1/2 inches by 3 inches.     This was second of the series.   I had sore arm with first but not swelling or redness.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: she developed cellulitis on the left arm after the vaccine was applied; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-APR-2019, the patient was vaccinated with shot of zoster vaccine live (ZOSTAVAX) lot # was reported as 27KS5610 with expiration date reported as 10-JUN-2021, , left deltoid at pharmacy (dose, dose number and route of administration were not reported). Lot number 27KS5610 is an invalid lot number for zoster vaccine live.  On 08-APR-2019 reported as 3 days later, the patient returned to store and advised she developed cellulitis on the left arm after the vaccine was applied. On an unknown date in 2019, the patient required medical attention and treatment. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review the event of cellulitis on the left arm was considered to be medically significant.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diet refusal, Dizziness, Gait disturbance, Infantile spitting up, Malaise
Clinical narrative: she now has a fever of 104; When she forces her to take the Motrin she just spits it out and she won't take it.; does not want to walk, she is wobbling; her daughter is still sick; she threw up; she had a fever of 101 .1; She refused all food; she has lost 3 pounds; She refuse milk; This spontaneous report was received from a consumer concerning her daughter, a 12 months old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. It was reported she was a healthy baby and she has never been sick. On 01-JUL-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (HSA), lot # S001329, expiration date 14-JAN-2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX), lot # R035225, expiration date 04-DEC-2020 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The vaccines were reconstituted with diluent MRK (lot # and expiration date were not reported).  On the same date in the evening, the patient refused to drink milk (diet refusal). She had lost 3 pounds (weight decreased). On 02-JUL-2019 also reported as (the following day), she refused all food (food refusal). On 07-JUL-2019 also reported as (last night), she had a fever of 101.1 (units not provided) (pyrexia). Subsequently she threw up (vomiting). On 08-JUL-2019 also reported as (now), the patient had a fever of 104 (units not provided). On the same date in the morning, she went to the doctor. They instructed the mother to keep her hydrated and to give ibuprofen (MOTRIN) but she was refusing to take anything by mouth so her fever was still high. When the mother forced her to take the ibuprofen (MOTRIN) she just spat it out and she won't take it (infantile spitting up). It was also reported that, the baby did not want to walk she was wobbling (dizziness) and was not eating or drinking. The mother was upset because her daughter was still sick (malaise) and they were traveling abroad that day. The outcome of all the aforementioned events was not recovered. The causality assessment was not reported.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Vomiting, Weight decreased
Clinical narrative: she now has a fever of 104; When she forces her to take the Motrin she just spits it out and she won't take it.; does not want to walk, she is wobbling; her daughter is still sick; she threw up; she had a fever of 101 .1; She refused all food; she has lost 3 pounds; She refuse milk; This spontaneous report was received from a consumer concerning her daughter, a 12 months old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. It was reported she was a healthy baby and she has never been sick. On 01-JUL-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (HSA), lot # S001329, expiration date 14-JAN-2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX), lot # R035225, expiration date 04-DEC-2020 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The vaccines were reconstituted with diluent MRK (lot # and expiration date were not reported).  On the same date in the evening, the patient refused to drink milk (diet refusal). She had lost 3 pounds (weight decreased). On 02-JUL-2019 also reported as (the following day), she refused all food (food refusal). On 07-JUL-2019 also reported as (last night), she had a fever of 101.1 (units not provided) (pyrexia). Subsequently she threw up (vomiting). On 08-JUL-2019 also reported as (now), the patient had a fever of 104 (units not provided). On the same date in the morning, she went to the doctor. They instructed the mother to keep her hydrated and to give ibuprofen (MOTRIN) but she was refusing to take anything by mouth so her fever was still high. When the mother forced her to take the ibuprofen (MOTRIN) she just spat it out and she won't take it (infantile spitting up). It was also reported that, the baby did not want to walk she was wobbling (dizziness) and was not eating or drinking. The mother was upset because her daughter was still sick (malaise) and they were traveling abroad that day. The outcome of all the aforementioned events was not recovered. The causality assessment was not reported.
Sex: F
Vaccine: PPV
Symptoms: Death, Pneumococcal infection
Clinical narrative: The unspecified patient received a dose of PNEUMOVAX 23 on an unspecified date. The patient died, on an unspecified date a few years later.; Pneumococcal infection; This spontaneous report was received from a physician via a company representative concerning to a female patient in her 70's. The patient's concurrent conditions included diabetes mellitus. The patient's medical history, allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an unspecified dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided).  The reporter indicated that on an unknown date (reported as "a few years later" after the vaccination), the patient was hospitalized, and she had may been experienced a pneumococcal infection. On an unknown date, she died from an unknown cause of death, at an unspecified hospital. It was also unknown if treatment was given fir the adverse events, if laboratory diagnostics or studies were performed or if the patient sought medical attention.  The causality assessment between the events pneumococcal infection and the patient's death and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, the pneumococcal infection was considered to be a medically significant event.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: HPV9
Symptoms: Biopsy lymph gland, Burning sensation, Headache, Hot flush, Insomnia
Clinical narrative: Patient experienced swelling of lymph nodes, severe headaches, a reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that bum and itch very badly, hot flashes, and insomnia.; Patient experienced swelling of lymph nodes, severe headaches, a reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that bum and itch very badly, hot flashes, and insomnia.; Skin rash; breakouts of hives from head to toe that bum and itch very badly; bum and itch very badly, hot flashes, and insomnia.; bum and itch very badly, hot flashes, and insomnia.; This spontaneous report was received from a consumer, referring herself, a female patient of unknown age. The patient's historical conditions, medical history, concurrent conditions, drug reactions or allergies were not reported. It was reported that the patient used a concomitant medication mentioned as: "birth control".   On 23-DEC-2019, 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) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.   On 24-FEB-2019, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.  On 03-JUL-2019, the patient was vaccinated with the final and third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.  It was reported that "some time shortly after 03-JUL-2019, the patient experienced swelling of lymph nodes, severe headaches and reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that burn and itch very badly, hot flashes and insomnia. It was reported that a biopsy of lymph nodes was performed, and the result was not provided. At the time of this report, the patient was still not recovered from the events. The patient visited "multiple physicians".   At the time of this report, the causality assessment between of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events, was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Pruritus, Rash, Urticaria
Clinical narrative: Patient experienced swelling of lymph nodes, severe headaches, a reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that bum and itch very badly, hot flashes, and insomnia.; Patient experienced swelling of lymph nodes, severe headaches, a reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that bum and itch very badly, hot flashes, and insomnia.; Skin rash; breakouts of hives from head to toe that bum and itch very badly; bum and itch very badly, hot flashes, and insomnia.; bum and itch very badly, hot flashes, and insomnia.; This spontaneous report was received from a consumer, referring herself, a female patient of unknown age. The patient's historical conditions, medical history, concurrent conditions, drug reactions or allergies were not reported. It was reported that the patient used a concomitant medication mentioned as: "birth control".   On 23-DEC-2019, 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) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.   On 24-FEB-2019, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.  On 03-JUL-2019, the patient was vaccinated with the final and third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.  It was reported that "some time shortly after 03-JUL-2019, the patient experienced swelling of lymph nodes, severe headaches and reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that burn and itch very badly, hot flashes and insomnia. It was reported that a biopsy of lymph nodes was performed, and the result was not provided. At the time of this report, the patient was still not recovered from the events. The patient visited "multiple physicians".   At the time of this report, the causality assessment between of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events, was not reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Not known adverse effects; an administered dose of M-M-R II underwent a temperature excursion prior to being administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications were not provided.  It was reported that an administered dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) by subcutaneous route, for prophylaxis, lot number R014689 and expiration date 23-MAY-2020, underwent a temperature excursion prior to be administered (product storage error). The temperature excursion started on the evening of 09-JUL-2019 and finished on the morning of 10-JUL-2019, it was reported as 12.4 Celsius degrees during a time frame of 19 hours. Data logger was involved.  On 10-JUL-2019, the patient was vaccinated with the improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II), after the temperature excursion had concluded. No adverse effects were reported. ; Sender's Comments:  US-009507513-1907USA008694:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Idiopathic intracranial hypertension, Nuclear magnetic resonance imaging brain abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: the patient "had an abnormal PAP test on an unspecified date in 2018, that was positive for HPV" / the patient "has had unspecified frequent retesting, and is still positive for HPV".; pseudo brain tumor diagnosed by MRI in 2017; This spontaneous report was received from patient's mother referring to her 22-year-old daughter.  The patient's concurrent conditions and medical history were not reported. The patient did not have concomitant therapies, drug reactions or allergies.  On an unspecified date in approximately 2010 (reported as when patient was 13-year-old), she was vaccinated with 3 dose series of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, lot # and expiration dates were not reported) for prevention of Human Papilloma Virus (HPV).         On an unspecified date in 2017, the patient was diagnosed through magnetic resonance imaging (MRI) with pseudo brain tumor (idiopathic intracranial hypertension) which was treated with high dose steroids (unspecified). On an unspecified date in 2018, the patient had an abnormal Papanicolaou Smear (PAP) test, that was positive for HPV (papilloma viral infection). The patient had unspecified frequent retesting, that was still positive for HPV. It was reported that the patient received treatment for the event, and that she sougth medical attention. At the reporting time, the outcome for idiopathic intracranial hypertension was unknown while for papilloma viral infection was reported as not recovered.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Upon internal review idiopathic intracranial hypertension was considered to be a medically significant event.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; A patient was administered 2 doses of MMR II or 2 doses of VARIVAX; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 11-JUL-2019, the patient was vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) or varicella virus vaccine live (oka/merck)(VARIVAX) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects were reported in the patient; A patient received a dose of MMR II after its expiration date; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, drug reactions or allergies were not reported.   On 02-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) lot # R002930 expiration date 31-JAN-2019, for prophylaxis (strength, frequency, route of administration and anatomical site of injection were not provided) (expired product administered). No adverse effects were reported in the patient.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: One patient received one dose of MMRII and VARIVAX that were reconstituded with expired DILUENT; One patient received one dose of MMRII and VARIVAX that were reconstituded with expired DILUENT; No adverse effects reported; This spontaneous report was received from  an office manager, concerning to a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.  On 28-JUN-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (M-M-R II) (Lot. No. R030810 has been verified to be a valid lot number for measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live rHA, expiration date on 24-OCT-2020) and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot. No. N021582 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 28-AUG-2019, but upon internal validation establish as 09-AUG-2019) (inappropriate schedule of product administration) that were reconstituted with expired sterile diluent (Lot. No N026990 has been validated to be a valid lot number for sterile diluent, expiration date on 26-SEP-2018) (expired product administered), it was reported that all products were stored properly with no temperature excursions. No adverse effects reported, nor product quality complain involved.; Sender's Comments:  US-009507513-1907USA011428:
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; one patient received on dose of MMR II (R036582 12/17/2020) reconstituted with expired DILUENT (N026990 9/26/2018). All products stored properly with no temperature excursions.; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 01-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II) lot # R036582, expiration date reported as 17-DEC-2020, for prophylaxis (strength, dose, route and frequency were not reported) that was reconstituted with an expired sterile diluent(MERCK STERILE DILUENT) lot # N026990, expiration date reported as 26-SEP-2018 (strength, dose, route, frequency and indication were not reported). No adverse effect reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA011374:01273448