chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: This spontaneous report was received from a consumer via an online article concerning her daughter, a female patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing details, lot and expiration date unknown) for prophylaxis. On an unknown date, the patient experienced paralysis. The outcome of paralysis was unknown. The reporter warned that GARDASIL vaccine was to blame for her daughter's paralysis (reporter causality: related). Upon internal review, the event of paralysis was considered to be serious as disability and medically significant. Additional information is not expected as reporter contact details are not available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M031574, expiration date on 11-NOV-2018 (Strength, dose number, route and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 48°F (Fahrenheit degrees) with a time frame of 10 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001769:
Sex: M
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 09Apr2017 as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient developed a reaction: welts and rash in Apr2017. The reaction started approximately 6 hours after getting the vaccine and had been ongoing for a couple of weeks. The consumer stated that the patient may have already received pneumococcal 13-val conj vac (dipht crm197 protein) when he got his flu shot 21 months ago. The consumer suspects that it may be a duplicate dose of Prevnar 13 but was not sure. Outcome of the events 'rash' and 'welts' was not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 00422751). A contactable female consumer reported for herself. The patient of an unspecified age and race received PREVNAR 13 at single dose on an unspecified date for immunization. 3 hours after receiving the injection the patient experienced a very severe reaction and was extremely sick. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18 years old male patient received the third dose of TRUMENBA (NDC number: 0005-0100-01, Lot#R45100, Exp date Jul2018) in the deltoid at 0.5 ml, single on 25Apr2017 for protect against MenB. Medical history and concomitant medications were none. No investigations were performed. The caller stated that the patient received the first dose of meningococcal group b rlp2086 about 6 months before and the second 2 months after the first one. After his second dose of meningococcal group b rlp2086, he experienced pain and fever with outcome of recovered. Approximately 6 to 8 hours after vaccination, that same evening on 25Apr2017, the patient began to experience numbness in his limbs and tingling in his spine. His mother was the prescribing pediatrician so she just kept an eye on him and no treatment was initiated. By the next morning the numbness and tingling were better and then they completely resolved on 26Apr2017.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood creatine phosphokinase normal, Blood electrolytes normal, Blood thyroid stimulating hormone normal, C-reactive protein, Injection site pain
Clinical narrative: Patient c/o brief episodes of myalgia on left deltoid that occurs daily and lasts about 15 min. Started about 1 week after HPV #3 administered and is still ongoing. (This was her second HPV vaccine received on left deltoid). Describes her left deltoid as intermittently "achy" and "feels like I need to move it." Occurs when she's at rest and is not using the arm/shoulder. Relates it to "when you write a lot and your hand starts to ache."
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Patient c/o brief episodes of myalgia on left deltoid that occurs daily and lasts about 15 min. Started about 1 week after HPV #3 administered and is still ongoing. (This was her second HPV vaccine received on left deltoid). Describes her left deltoid as intermittently "achy" and "feels like I need to move it." Occurs when she's at rest and is not using the arm/shoulder. Relates it to "when you write a lot and your hand starts to ache."
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPV, HIBV, MMRV, PNC13
Symptoms: Erythema multiforme, Urticaria, Viral rash
Clinical narrative: Erythema multiforme and urticarial rash from the torso, spreading to the face and legs. Was seen by physician office on 5/3/17. Sent home on BENADRYL. Went to the ED because mother was worried about rash spreading, sent home and diagnosed with viral exanthem. Sent home on BENADRYL. Seen again on 5/5/17. Despite rash now spreading to face, pt was well-appearing with nonpruritic multiforme rash.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphagia, Rash
Clinical narrative: Rash and difficulty swallowing.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Feeling hot, Injection site pain
Clinical narrative: Extreme pain in upper left arm. An hour later, sudden paleness, weakness, felt very hot and faint, followed by extreme chills and weakness. Fever spiked to 101.7; vomited off and on through the night. Most symptoms went away within 6 hours. Still had extreme pain in shoulder with limited mobility and fever. Went to Clinic 04/25/17. Confirmed symptoms still from receiving the PPSV vaccine and to continue with the Ibuprofen for a few more days. Now all symptoms except for some minor shoulder discomfort have ceased.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal discomfort, Musculoskeletal pain, Pallor, Pyrexia
Clinical narrative: Extreme pain in upper left arm. An hour later, sudden paleness, weakness, felt very hot and faint, followed by extreme chills and weakness. Fever spiked to 101.7; vomited off and on through the night. Most symptoms went away within 6 hours. Still had extreme pain in shoulder with limited mobility and fever. Went to Clinic 04/25/17. Confirmed symptoms still from receiving the PPSV vaccine and to continue with the Ibuprofen for a few more days. Now all symptoms except for some minor shoulder discomfort have ceased.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Extreme pain in upper left arm. An hour later, sudden paleness, weakness, felt very hot and faint, followed by extreme chills and weakness. Fever spiked to 101.7; vomited off and on through the night. Most symptoms went away within 6 hours. Still had extreme pain in shoulder with limited mobility and fever. Went to Clinic 04/25/17. Confirmed symptoms still from receiving the PPSV vaccine and to continue with the Ibuprofen for a few more days. Now all symptoms except for some minor shoulder discomfort have ceased.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chest pain, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient complaints of difficulty breathing, SOB, chest pain, numbness in extremities and back pain 5 mins after Tdap vaccine given.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient started therapy with unspecified flu vaccine (manufacturer unknown) (dose, strength, route, formulation, lot number and expiry date were not reported) for prophylaxis. Nurse stated that the patient developed acute rheumatological events following the administration of an unspecified flu vaccine (manufacturer unknown). The patient also had osteoarthritis and degenerative joint disease and had "extensive cervical reconstruction" (spinal cord operation). The nurse did not state whether the patient's osteoarthritis, degenerative joint disease and cervical reconstruction occurred before or after the patient received the flu vaccine. The outcome of the events were not reported. Causality between the therapy and the events was not reported. Upon internal review, the event of extensive cervical reconstruction was considered to be medically significant. No further information provided. Follow up information was received on 28-APR-2017, from the reporting nurse regarding the female patient of unknown age with concurrent conditions of acute rheumatological events, degenerative joint disease, osteoarthritis, unspecified neck problems and a history of extensive cervical reconstruction. The nurse stated that the patient was a retired physician and had never been given any Merck vaccine before. The nurse was calling Merck when the patient was considering being vaccinated with ZOSTAVAX in her thigh instead of her arm due to the neck issues. The patient did not receive the vaccine as she wanted to talk to her doctor before being given a live vaccine. There was no issue or event reported. This case has been downgraded. The patient did not experience any adverse reaction and did not receive Merck product (only considered this action). Additional information is not expected.
Age: 23.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning a 23-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse symptoms or further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies  was reported. Concomitant therapies included the sterile diluent (STERILE DILUENT). On 10-APR-2017, the patient was inadvertently vaccinated with an expired VARIVAX single dose, subcutaneously for prophylaxis (lot # L008273 and expiration date was 11-MAR-2017). It was also reported that the vaccine had been improperly stored prior to the administration at a temperature of 40 °F for 6 hours. The vaccine did not have a previous temperature excursion and no data logger was involved. The sterile diluent, had been properly stored prior to the reconstitution of VARIVAX. No adverse effects were reported. Additional information is not expected because there was no consent to contact a physician.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-APR-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # L037790 with expiration date 30-DEC-2016 (route of administration and anatomical location were not reported) for prophylaxis. It was reported that sterile diluent (company product) (dose, lot# and expiration date were not reported) used for vaccination was not expired. No adverse effects were reported. The product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation, Needle issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2017 the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (lot # M037015, expiry date: 22-NOV-2017) for prophylaxis. Other suspect therapies included sterile diluent. The reporter stated that during administration of a dose of ZOSTAVAX, the needle 'retracted too early' causing some of the ZOSTAVAX to leak out of the injection site onto the patient's skin, resulting in a potential partial dose of ZOSTAVAX. No adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from a pharmacist referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2017, the patient received expired dose of M-M-R II (lot: M032153, expiry date: 22-APR-2017) (dose, frequency, indication not reported) subcutaneously. No adverse effects reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2017 the patient was vaccinated with expired dose of ROTATEQ (dosing details were not reported) (lot # L023870, expiry date: 20-APR-2017) orally for prophylaxis (expired vaccine used). No adverse effects were reported. There was no product quality complaint.   Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an adolescent patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date (reported as "younger than 15 years of age"), the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (dosing details unspecified). On an unknown date (reported as "older than 15 years of age", two years later), the patient was vaccinated with second dose of GARDASIL 9 for prophylaxis (dosing details unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report has been received from a Medical Assistant referring to a 53 year old male patient with asthma, hypertension and rhinitis allergic. The patient's medical history was not reported and he had not any other allergies or reactions. Concomitant therapies included albuterol sulfate(VENTOLIN), lisinopril (manufacturer unknown), famotidine(PEPCID), amlodipine besylate (NORVASC) and beclomethasone dipropionate (QVAR). On 24-APR-2017, the patient was vaccinated with PNEUMOVAX23 (strength and dose were not reported) intramuscular in an unspecified arm, lot #N003997 and expiration date on 20-OCT-2018, for prevention of pneumonia. Later, on that day, the patient began to experience injection site soreness and decreased range of motion in the arm where injection was received (unspecified arm). The patient called the physician and was given treatment (details not reported) for the events. No laboratories diagnostics were performed. Subsequently, on an unknown date in April 2017, the patient recovered from the events. No further information was provided. The causal relationship between the events and the suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Medical Assistant referring to an unknown number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly storage doses of GARDASIL for prophylaxis, lot # K016966 with expiration date of 12-MAY-2017 (dose, route and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 34.9 degrees Fahrenheit (F) for 4 hours. No previous temperature excursion was reported. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 28-APR-2016, the patient received an expired dose of PNEUMOVAX23 (strength, dose, frequency, route of administration, lot number and expiration date were not provided), lot # L017406 with expiration date of 26-FEB-2017, for prophylaxis. No adverse effects were reported. No further details provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (strength, dose, route and anatomical location were not reported) lot # M036728 and expiration date on 20-MAY-2018, for prophylaxis; which experienced a temperature excursion at 29.7 Fahrenheit degrees for 10 hours 52 minutes. No previous temperature excursions were reported. Data logger was involved. No adverse effect reported and no further information was provided. A product quality complaint was not involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site vesicles, Pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 64 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were reported as none. On 02-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Units (PFU), subcutaneously, in the left upper arm, lot # M033335 with expiration date 11-OCT-2017, for prevention of shingles. On the same day, the patient noticed some of the "regular adverse effects": tenderness, redness, pain and "skin was hard". The patient stated she must had been scratching the injection site at her sleep as she noticed "pus coming out of her injection site" that night. The patient also reported that her injection site was "blistery" and that the redness was spreading. It was stated that the patient treated the injection site with hydrogen peroxide topically. The patient had not consulted her primary healthcare provider and would have a visit to the pharmacy on 03-MAY-2017, so the pharmacist might examine the patient's injection site adverse symptoms. It was also reported that her healthcare professional was interested in a Varicella-zoster virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates. At the time of reporting the outcome of the adverse events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin induration, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 64 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were reported as none. On 02-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Units (PFU), subcutaneously, in the left upper arm, lot # M033335 with expiration date 11-OCT-2017, for prevention of shingles. On the same day, the patient noticed some of the "regular adverse effects": tenderness, redness, pain and "skin was hard". The patient stated she must had been scratching the injection site at her sleep as she noticed "pus coming out of her injection site" that night. The patient also reported that her injection site was "blistery" and that the redness was spreading. It was stated that the patient treated the injection site with hydrogen peroxide topically. The patient had not consulted her primary healthcare provider and would have a visit to the pharmacy on 03-MAY-2017, so the pharmacist might examine the patient's injection site adverse symptoms. It was also reported that her healthcare professional was interested in a Varicella-zoster virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates. At the time of reporting the outcome of the adverse events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Injection site reaction, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 64 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were reported as none. On 02-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Units (PFU), subcutaneously, in the left upper arm, lot # M033335 with expiration date 11-OCT-2017, for prevention of shingles. On the same day, the patient noticed some of the "regular adverse effects": tenderness, redness, pain and "skin was hard". The patient stated she must had been scratching the injection site at her sleep as she noticed "pus coming out of her injection site" that night. The patient also reported that her injection site was "blistery" and that the redness was spreading. It was stated that the patient treated the injection site with hydrogen peroxide topically. The patient had not consulted her primary healthcare provider and would have a visit to the pharmacy on 03-MAY-2017, so the pharmacist might examine the patient's injection site adverse symptoms. It was also reported that her healthcare professional was interested in a Varicella-zoster virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates. At the time of reporting the outcome of the adverse events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 64 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were reported as none. On 02-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Units (PFU), subcutaneously, in the left upper arm, lot # M033335 with expiration date 11-OCT-2017, for prevention of shingles. On the same day, the patient noticed some of the "regular adverse effects": tenderness, redness, pain and "skin was hard". The patient stated she must had been scratching the injection site at her sleep as she noticed "pus coming out of her injection site" that night. The patient also reported that her injection site was "blistery" and that the redness was spreading. It was stated that the patient treated the injection site with hydrogen peroxide topically. The patient had not consulted her primary healthcare provider and would have a visit to the pharmacy on 03-MAY-2017, so the pharmacist might examine the patient's injection site adverse symptoms. It was also reported that her healthcare professional was interested in a Varicella-zoster virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates. At the time of reporting the outcome of the adverse events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Rash, Rash erythematous, Streptococcus test positive
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 25 Apr 2017. This case involves a patient (age gender was not reported) who was vaccinated with a dose of DAPTACEL (batch number: C5148AA, expiry date: 09 Feb 2019) intramuscularly in right thigh on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, within 24 hours following the vaccination, the patient had developed redness to the right thigh, which developed into a welt from above the knee to the upper thigh, also developed a red, raised rash, not itchy, on the chest, back, and lower abdomen. On an unknown date, 10 days after vaccination, the patient had swollen tonsils. The patient was seen by physician. The patient's laboratory data included quick Rapid strep test showed positive result. The patient was treated with antibiotic (unspecified). On an unknown date, the patient was recovered from the events. Upon medical review, the case was considered as serious due to important medical event: swollen tonsils with a quick strep test was positive. List of documents held by sender: none. Sender's Comments: This case concerns a patient who was vaccinated with DAPTACEL and experienced Streptococcal tonsillitis, welts, localized erythema and erythropapular rash in trunk. There is a temporal relationship between the events and the vaccine. However, need additional information of medical history, further immune status at the time of vaccination, any concurrent infections, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be ruled out.
Sex: U
Vaccine: DTAP
Symptoms: Tonsillar hypertrophy, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 25 Apr 2017. This case involves a patient (age gender was not reported) who was vaccinated with a dose of DAPTACEL (batch number: C5148AA, expiry date: 09 Feb 2019) intramuscularly in right thigh on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, within 24 hours following the vaccination, the patient had developed redness to the right thigh, which developed into a welt from above the knee to the upper thigh, also developed a red, raised rash, not itchy, on the chest, back, and lower abdomen. On an unknown date, 10 days after vaccination, the patient had swollen tonsils. The patient was seen by physician. The patient's laboratory data included quick Rapid strep test showed positive result. The patient was treated with antibiotic (unspecified). On an unknown date, the patient was recovered from the events. Upon medical review, the case was considered as serious due to important medical event: swollen tonsils with a quick strep test was positive. List of documents held by sender: none. Sender's Comments: This case concerns a patient who was vaccinated with DAPTACEL and experienced Streptococcal tonsillitis, welts, localized erythema and erythropapular rash in trunk. There is a temporal relationship between the events and the vaccine. However, need additional information of medical history, further immune status at the time of vaccination, any concurrent infections, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be ruled out.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Bedridden, Crying, Fatigue, Feeding disorder, Feeling abnormal
Clinical narrative: The end of April of 2014 My daughter and I went on a trip. I was told that it was mandatory to have yellow fever, Hep A and typhoid vaccines and anti malarials for the 7 days prior to leaving, the whole time we were to be there and 7 days after returning home. On January 28th we got the vaccines and paid for the antimalarial at that time. Soon after receiving the vaccines I started getting extreme fatigue but didn't connect it to the vaccines. On a Sunday the last week in April I took my first antimalarial in preparation for the trip a week later. Within hours of that first antimalarial I had the first panic attack in my life, my body went into a constant fight or flight. This started my train of doctors, the first one told me that it was a coincidence that it started with the antimalarial and I had actually just started perimenopause. I believed her and took her suggestions. The constant adrenaline calmed and I was able to go on the trip (it was almost canceled). But within less than 24 hours after arriving home my symptoms came on full force and I was in constant fight or flight, severe mood swings, something was being pulled from my frontal lobe, I felt like I was constantly being electrocuted, my body was constantly shaking on the inside but you couldn't see it from outside. Unable to eat anything without my body attacking myself, constant panic attacks, brain fog, racing thoughts, hallucinations, severe brain inflammation, body pain so bad I felt I couldn't tolerate another minute. I was bed bound! I lost 40lbs in a short period of a few weeks, I couldn't get from the bed to the bathroom and I felt like I was losing my mind. I couldn't handle sounds or smells or any electronics etc. My life was destroyed and I cried everyday! I had no will to live at this point and prayed constantly! My brain and body was in so much pain I prayed for God to take me everyday! This has been the most terrifying 3 years of my life, I'm slowly recovering with the help of agency and I can now write this out and report what has been done to me. There are many others like me and my report is for them as well. Please let people know of the possible side effects of this prescriptions. I was never told that my daughter (I thank God everyday my daughter didn't have a reaction like mine) or I could have our lives destroyed, and then not be believed by doctors that this is the cause.....being so very sick and not being believed is tragic, being so extremely sick and having to figure out how to help yourself is tragic too. I never knew people suffered like this. I asked my Doctor to also report my injuries but I'm not sure if she has. I had hired over 26 different doctors and so called specialist in those first 2 years. Please share my story if it can help someone, testing needs to be done first to see if your body can detox the additives, chemicals and metals.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Hallucination, Hyperacusis, Malaise, Menopause, Mood swings
Clinical narrative: The end of April of 2014 My daughter and I went on a trip. I was told that it was mandatory to have yellow fever, Hep A and typhoid vaccines and anti malarials for the 7 days prior to leaving, the whole time we were to be there and 7 days after returning home. On January 28th we got the vaccines and paid for the antimalarial at that time. Soon after receiving the vaccines I started getting extreme fatigue but didn't connect it to the vaccines. On a Sunday the last week in April I took my first antimalarial in preparation for the trip a week later. Within hours of that first antimalarial I had the first panic attack in my life, my body went into a constant fight or flight. This started my train of doctors, the first one told me that it was a coincidence that it started with the antimalarial and I had actually just started perimenopause. I believed her and took her suggestions. The constant adrenaline calmed and I was able to go on the trip (it was almost canceled). But within less than 24 hours after arriving home my symptoms came on full force and I was in constant fight or flight, severe mood swings, something was being pulled from my frontal lobe, I felt like I was constantly being electrocuted, my body was constantly shaking on the inside but you couldn't see it from outside. Unable to eat anything without my body attacking myself, constant panic attacks, brain fog, racing thoughts, hallucinations, severe brain inflammation, body pain so bad I felt I couldn't tolerate another minute. I was bed bound! I lost 40lbs in a short period of a few weeks, I couldn't get from the bed to the bathroom and I felt like I was losing my mind. I couldn't handle sounds or smells or any electronics etc. My life was destroyed and I cried everyday! I had no will to live at this point and prayed constantly! My brain and body was in so much pain I prayed for God to take me everyday! This has been the most terrifying 3 years of my life, I'm slowly recovering with the help of agency and I can now write this out and report what has been done to me. There are many others like me and my report is for them as well. Please let people know of the possible side effects of this prescriptions. I was never told that my daughter (I thank God everyday my daughter didn't have a reaction like mine) or I could have our lives destroyed, and then not be believed by doctors that this is the cause.....being so very sick and not being believed is tragic, being so extremely sick and having to figure out how to help yourself is tragic too. I never knew people suffered like this. I asked my Doctor to also report my injuries but I'm not sure if she has. I had hired over 26 different doctors and so called specialist in those first 2 years. Please share my story if it can help someone, testing needs to be done first to see if your body can detox the additives, chemicals and metals.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Nervousness, Noninfective encephalitis, Pain, Panic attack, Paraesthesia
Clinical narrative: The end of April of 2014 My daughter and I went on a trip. I was told that it was mandatory to have yellow fever, Hep A and typhoid vaccines and anti malarials for the 7 days prior to leaving, the whole time we were to be there and 7 days after returning home. On January 28th we got the vaccines and paid for the antimalarial at that time. Soon after receiving the vaccines I started getting extreme fatigue but didn't connect it to the vaccines. On a Sunday the last week in April I took my first antimalarial in preparation for the trip a week later. Within hours of that first antimalarial I had the first panic attack in my life, my body went into a constant fight or flight. This started my train of doctors, the first one told me that it was a coincidence that it started with the antimalarial and I had actually just started perimenopause. I believed her and took her suggestions. The constant adrenaline calmed and I was able to go on the trip (it was almost canceled). But within less than 24 hours after arriving home my symptoms came on full force and I was in constant fight or flight, severe mood swings, something was being pulled from my frontal lobe, I felt like I was constantly being electrocuted, my body was constantly shaking on the inside but you couldn't see it from outside. Unable to eat anything without my body attacking myself, constant panic attacks, brain fog, racing thoughts, hallucinations, severe brain inflammation, body pain so bad I felt I couldn't tolerate another minute. I was bed bound! I lost 40lbs in a short period of a few weeks, I couldn't get from the bed to the bathroom and I felt like I was losing my mind. I couldn't handle sounds or smells or any electronics etc. My life was destroyed and I cried everyday! I had no will to live at this point and prayed constantly! My brain and body was in so much pain I prayed for God to take me everyday! This has been the most terrifying 3 years of my life, I'm slowly recovering with the help of agency and I can now write this out and report what has been done to me. There are many others like me and my report is for them as well. Please let people know of the possible side effects of this prescriptions. I was never told that my daughter (I thank God everyday my daughter didn't have a reaction like mine) or I could have our lives destroyed, and then not be believed by doctors that this is the cause.....being so very sick and not being believed is tragic, being so extremely sick and having to figure out how to help yourself is tragic too. I never knew people suffered like this. I asked my Doctor to also report my injuries but I'm not sure if she has. I had hired over 26 different doctors and so called specialist in those first 2 years. Please share my story if it can help someone, testing needs to be done first to see if your body can detox the additives, chemicals and metals.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Parosmia, Tachyphrenia, Weight decreased
Clinical narrative: The end of April of 2014 My daughter and I went on a trip. I was told that it was mandatory to have yellow fever, Hep A and typhoid vaccines and anti malarials for the 7 days prior to leaving, the whole time we were to be there and 7 days after returning home. On January 28th we got the vaccines and paid for the antimalarial at that time. Soon after receiving the vaccines I started getting extreme fatigue but didn't connect it to the vaccines. On a Sunday the last week in April I took my first antimalarial in preparation for the trip a week later. Within hours of that first antimalarial I had the first panic attack in my life, my body went into a constant fight or flight. This started my train of doctors, the first one told me that it was a coincidence that it started with the antimalarial and I had actually just started perimenopause. I believed her and took her suggestions. The constant adrenaline calmed and I was able to go on the trip (it was almost canceled). But within less than 24 hours after arriving home my symptoms came on full force and I was in constant fight or flight, severe mood swings, something was being pulled from my frontal lobe, I felt like I was constantly being electrocuted, my body was constantly shaking on the inside but you couldn't see it from outside. Unable to eat anything without my body attacking myself, constant panic attacks, brain fog, racing thoughts, hallucinations, severe brain inflammation, body pain so bad I felt I couldn't tolerate another minute. I was bed bound! I lost 40lbs in a short period of a few weeks, I couldn't get from the bed to the bathroom and I felt like I was losing my mind. I couldn't handle sounds or smells or any electronics etc. My life was destroyed and I cried everyday! I had no will to live at this point and prayed constantly! My brain and body was in so much pain I prayed for God to take me everyday! This has been the most terrifying 3 years of my life, I'm slowly recovering with the help of agency and I can now write this out and report what has been done to me. There are many others like me and my report is for them as well. Please let people know of the possible side effects of this prescriptions. I was never told that my daughter (I thank God everyday my daughter didn't have a reaction like mine) or I could have our lives destroyed, and then not be believed by doctors that this is the cause.....being so very sick and not being believed is tragic, being so extremely sick and having to figure out how to help yourself is tragic too. I never knew people suffered like this. I asked my Doctor to also report my injuries but I'm not sure if she has. I had hired over 26 different doctors and so called specialist in those first 2 years. Please share my story if it can help someone, testing needs to be done first to see if your body can detox the additives, chemicals and metals.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Abdominal pain, Abdominal pain upper, Crying, Dyskinesia, Erythema
Clinical narrative: Student received TD, Hepb-ped, IPV, Var and MMR at 11:15am, began to c\o back of itchy throat, abdominal pain within 10-15 min. Noted reddened skin, swollen bottom lip. received 12.5mg benedryl by mouth then another 12.5mg benedryl by mouth within 10min. Student continue to c/o not feeling better, crying out, thrashing around, called 911 then who observed child for 5 min before transporting her to the nearest hospital. Child left the clinic talking, moaning about stomach hurting.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Lip swelling, Moaning, Throat irritation
Clinical narrative: Student received TD, Hepb-ped, IPV, Var and MMR at 11:15am, began to c\o back of itchy throat, abdominal pain within 10-15 min. Noted reddened skin, swollen bottom lip. received 12.5mg benedryl by mouth then another 12.5mg benedryl by mouth within 10min. Student continue to c/o not feeling better, crying out, thrashing around, called 911 then who observed child for 5 min before transporting her to the nearest hospital. Child left the clinic talking, moaning about stomach hurting.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Lethargy, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: By 2:30 PM the day of the vaccine, he looked tired, fatigued, sleepy. Placed him in his crib. He did not get up & looked lethargic. By evening, he was running a fever of 103.3. The fever peaked at 103.5 the next day; and by evening  the fever fell. However, by Sunday evening into Monday morning, he developed a red rash all over his body: arms, torso, groin, legs, and red spots appeared on right ear. The rash disappeared within 48 hrs.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Somnolence
Clinical narrative: By 2:30 PM the day of the vaccine, he looked tired, fatigued, sleepy. Placed him in his crib. He did not get up & looked lethargic. By evening, he was running a fever of 103.3. The fever peaked at 103.5 the next day; and by evening  the fever fell. However, by Sunday evening into Monday morning, he developed a red rash all over his body: arms, torso, groin, legs, and red spots appeared on right ear. The rash disappeared within 48 hrs.
Age: 10.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise, Pharyngitis streptococcal, Seizure, Syncope
Clinical narrative: Felt sick for several weeks after shot.  Then in January started fainting when got strep.  And by March started having full on seizures.  Was in perfect health prior to the flu shot.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a pharmacist, referring to a 60 year old female patient. The patient's medical history and concomitant therapies were not reported. Concurrent conditions included seasonal allergy. On 24-APR-2017, the patient was vaccinated (unspecified arm) with ZOSTAVAX lot # M037015 with an expiration date on 22-NOV-2017, administered subcutaneously (dose and anatomical location were not reported) for prophylaxis. On 26-APR-2017 (reported as "two days later"), the patient returned to the pharmacy two days later with a welt that had a "raised border 2 inches long and was painful to touch at the injection site" of an unspecified arm. It was confirmed that the patient did not seek medical attention for the events. The outcome of all the events was unknown and the causality between the aforementioned events and the vaccination with ZOSTAVAX was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a multiple unspecified patients of unknown age and genders. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved, time frame and previous temperature excursion were unknown by the reporter. A data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 18 year old (reported as "18.5 years old") female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 15-OCT-2007, the patient received the first dose of GARDASIL (strength, route, anatomical location, lot number and expiration date were not provided)  for prophylaxis. On 14-JAN-2008, the patient received the second dose of GARDASIL and on 01-APR-2008 the patient received the third dose of GARDASIL, however the patient did not experienced an adverse event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: Information had been received on 03-MAY-2017 from a pharmacist who reported that an unspecified patient (age and gender not reported) who received ZOSTAVAX vial 19400 PFU (dose and lot#/expiration not reported) with sterile diluent on 02-MAY-2017 was scheduled to start therapy with prednisone on 03-MAY-2017. Pharmacist was not certain of the reason but stated "it could be an acute inflammatory process". Pharmacist could not clarify whether this issue started after patient received ZOSTAVAX so this adverse event was being filed as a precaution. Outcome of acute inflammatory process was not reported. No additional information is available. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site rash, Palmar erythema, Pruritus, Rash
Clinical narrative: Shortly after KINRIX and PROQUAD were administered, patient began to complain of itching, especially on the palms of his hands. Palms of his hands turned red as well as his ears. Next a rash was noted on his arms, chest, back and abdomen.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Erythema, Headache, Nodule
Clinical narrative: Large (3inX2in) red welted area.  Evening of 4/27/17 excruciating pain began in joints, headache, fever. Morning of 4/28/17 welted area spread and became painful, nodules developed on L hand.  Paint in joints -both wrists. L shoulder, L back area, both ankles and in both knees that had joint replacements.