chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a patient who received BEXSERO. Concurrent medical conditions included migraine. Concomitant products included MENACTRA and Unspecified migraine medication. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. The reporter considered the headache to be unrelated to BEXSERO. Additional details were provided as follows: The physician reported to a field representative that a patient had a headache after receiving BEXSERO and MENACTRA. The physician did not believe the headache was related to BEXSERO, as the patient had a history of migraines.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site bruising
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 34-year-old male patient who received BOOSTRIX (batch number B4G4G, expiry date 5th November 2017). On 11th May 2016, the patient received BOOSTRIX .5 ml. On 12th May 2016, 1 days after receiving BOOSTRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site bruising to be related to BOOSTRIX.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 4-year-old male patient who received DPTa (batch number Z9Z4Y, expiry date 2nd July 2018). On 6the May 2016, the patient received BOOSTRIX .5 ml. On 6th May 2016, several hours after receiving BOOSTRIX, the patient experienced fever, accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that the 4 years old patient was accidentally vaccinated with BOOSTRIX vaccine instead of an INFANRIX. This led to wrong vaccine administered, inappropriate age at vaccine administration and accidental underdose. Later in the evening of the day of the vaccination, the patient was feverish. The batch number reported for BOOSTRIX did not exist and was updated to be Z9Z4Y, as per sales database.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received BOOSTRIX (batch number Z9Z4Y, expiry date 2nd July 2018). On 29th February 2016, the patient received BOOSTRIX (intramuscular). On 2nd March 2016, 2 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BOOSTRIX. Additional details were provided as follows: The patient received a dose of BOOSTRIX in left arm and experienced injection site pain. On 17th May 2016, the patient presented back to the pharmacist and indicated that the arm pain was existing and it became worse with stretching of the arm. The patient inquired the pharmacist how long the pain would last.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of injection site swelling in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to ENGERIX B. Additional details were provided as follows: About 4 years ago from the reporting date, the patient was vaccinated with a dose of ENGERIX-B. On an unspecified date, the patient experienced a swollen, red area around the injection site. On an unspecified date, the was patient recovered. No further information was provided.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received BEXSERO (batch number 151301D, expiry date 31st December 2016). On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe arm pain after vaccination. The representative did not have any patient identifiers.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Started 2 days ago, red swollen and very painful to touch. Pt stopped in office today to have checked.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 14-year-old female patient who received BEXSERO (batch number 148901A, expiry date September 2016). On 14th April 2016, the patient received the 1st dose of BEXSERO. On 14th April 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain (serious criteria other: serious as per reporter), feeling unwell, general body pain, fever and chills. In April 2016, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the feeling unwell, general body pain, fever and chills were unknown. It was unknown if the reporter considered the injection site pain, feeling unwell, general body pain, fever and chills to be related to BEXSERO. Additional details provided were as follows: This case was reported by a medical assistant. The reported injection site was right arm. The patient experienced fever, chills, body aches, general ill feeling within 4 hours of vaccination with BEXSERO. She also experienced soreness in her right arm at the injection site for 10 days. The symptoms resulted in an emergency room visit for the patient, but it was unknown if the patient was admitted to the hospital.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU3, HPV9, MENB, MNQ, FLU3, HPV4, MENB, MNQ
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. A 16-year-old female patient developed the first dose of TRUMENBA (Lot # M13066, Expiration Date Sep2016) and GARDASIL (Lot # L045711, Expiration Date 08May2017), both intramuscular in the right arm at 0.5 ml single on 14Mar2016 at 12:45. Medical history included upper respiratory allergies, food allergy, conjunctivitis associated with allergies, eczema associated with allergies, exercise induced asthma. The patient had allergy testing to diagnose allergies on 15Jan2010. Vaccines given on same date along with suspect vaccine included the 8th dose of FLUZONE (Sanofi) (Lot # U1506AB) and the second dose of MENACTRA (Sanofi) (Lot # U5260AA), both intramuscular in the left arm at 0.5 ml. At the time of vaccination, the patient was sick with one week of wheezing for the first three days but better now. The patient previously received three doses of CERVARIX. On 14Mar2016, the patient experienced redness, itchiness and swelling in the right arm. The adverse events required a doctor visit, but the patient was not hospitalized. The outcome of the events was recovered. Follow-up (18Apr2016): New information obtained from the same reporter reporting on behalf of a physician includes: lot # of FLUZONE updated, onset and outcome updated, additional medical history, dose number of TRUMENBA. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU3, HPV9, MENB, MNQ, FLU3, HPV4, MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. A 16-year-old female patient developed the first dose of TRUMENBA (Lot # M13066, Expiration Date Sep2016) and GARDASIL (Lot # L045711, Expiration Date 08May2017), both intramuscular in the right arm at 0.5 ml single on 14Mar2016 at 12:45. Medical history included upper respiratory allergies, food allergy, conjunctivitis associated with allergies, eczema associated with allergies, exercise induced asthma. The patient had allergy testing to diagnose allergies on 15Jan2010. Vaccines given on same date along with suspect vaccine included the 8th dose of FLUZONE (Sanofi) (Lot # U1506AB) and the second dose of MENACTRA (Sanofi) (Lot # U5260AA), both intramuscular in the left arm at 0.5 ml. At the time of vaccination, the patient was sick with one week of wheezing for the first three days but better now. The patient previously received three doses of CERVARIX. On 14Mar2016, the patient experienced redness, itchiness and swelling in the right arm. The adverse events required a doctor visit, but the patient was not hospitalized. The outcome of the events was recovered. Follow-up (18Apr2016): New information obtained from the same reporter reporting on behalf of a physician includes: lot # of FLUZONE updated, onset and outcome updated, additional medical history, dose number of TRUMENBA. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse and a contactable physician, who reported for 2 patients. This is the 1st report of the 2 reports. A 16-year-old male patient received TRUMENBA (lot M37314 Exp: 30Apr2017) at 0.5 ml single intramuscular in the left deltoid and the seventh dose of influenza vaccine (Flu, Manufacturer: GlaxoSmithKline, Lot#: 3343R) intramuscular in the left arm on 21Mar2016 at 11:19 AM. Medical history included ongoing attention deficit disorder. Concomitant medication included ADDERALL XR from Apr2015 and ongoing at 20 mg 1x/day for attention deficit disorder. The patient previously received 6 doses of influenza vaccine. On 21Mar2016 the patient experienced headache, fever at 101.7, chills, full body aches, neck ache and photophobia and on an unknown date he experienced dizziness. He received ALEVE as a fever and pain reliever. The patient did not undergo any laboratory test. The events did not require emergency room, physician visit and hospitalization. The outcome of all the events was recovered 23Mar2016. The outcome of dizziness was unknown. The physician stated that the patient provided information to him/her regarding the reported adverse events with the use of PREVNAR 13. The physician considered PREVNAR 13 had a causal effect to the adverse events. Follow up (15Apr2016): New information from a contactable Physician included: new events of acne and photophobia. TRUMENBA expiration dated; hour and site of administration; co-suspect vaccine and vaccination history; onset and stop date and outcome of the events. Follow up (06May2016): New information from a contactable Physician includes: time of vaccination with TRUMENBA, start and stop date of concomitant medications, value of fever, new event (dizziness), no emergency room, physician visit and hospitalization for the events, confirmation that the patient provided to the physician information regarding the reported adverse events with the use of PREVNAR 13, causality assessment. Follow-up (20May2016): This follow-up report is being submitted to amend previously reported information: Event "Fully body acnes, neck acne" changed to "Fully body aches, neck ache" re-ecoded as "ache".
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chills, Dizziness, Headache, Neck pain, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse and a contactable physician, who reported for 2 patients. This is the 1st report of the 2 reports. A 16-year-old male patient received TRUMENBA (lot M37314 Exp: 30Apr2017) at 0.5 ml single intramuscular in the left deltoid and the seventh dose of influenza vaccine (Flu, Manufacturer: GlaxoSmithKline, Lot#: 3343R) intramuscular in the left arm on 21Mar2016 at 11:19 AM. Medical history included ongoing attention deficit disorder. Concomitant medication included ADDERALL XR from Apr2015 and ongoing at 20 mg 1x/day for attention deficit disorder. The patient previously received 6 doses of influenza vaccine. On 21Mar2016 the patient experienced headache, fever at 101.7, chills, full body aches, neck ache and photophobia and on an unknown date he experienced dizziness. He received ALEVE as a fever and pain reliever. The patient did not undergo any laboratory test. The events did not require emergency room, physician visit and hospitalization. The outcome of all the events was recovered 23Mar2016. The outcome of dizziness was unknown. The physician stated that the patient provided information to him/her regarding the reported adverse events with the use of PREVNAR 13. The physician considered PREVNAR 13 had a causal effect to the adverse events. Follow up (15Apr2016): New information from a contactable Physician included: new events of acne and photophobia. TRUMENBA expiration dated; hour and site of administration; co-suspect vaccine and vaccination history; onset and stop date and outcome of the events. Follow up (06May2016): New information from a contactable Physician includes: time of vaccination with TRUMENBA, start and stop date of concomitant medications, value of fever, new event (dizziness), no emergency room, physician visit and hospitalization for the events, confirmation that the patient provided to the physician information regarding the reported adverse events with the use of PREVNAR 13, causality assessment. Follow-up (20May2016): This follow-up report is being submitted to amend previously reported information: Event "Fully body acnes, neck acne" changed to "Fully body aches, neck ache" re-ecoded as "ache".
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Photophobia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse and a contactable physician, who reported for 2 patients. This is the 1st report of the 2 reports. A 16-year-old male patient received TRUMENBA (lot M37314 Exp: 30Apr2017) at 0.5 ml single intramuscular in the left deltoid and the seventh dose of influenza vaccine (Flu, Manufacturer: GlaxoSmithKline, Lot#: 3343R) intramuscular in the left arm on 21Mar2016 at 11:19 AM. Medical history included ongoing attention deficit disorder. Concomitant medication included ADDERALL XR from Apr2015 and ongoing at 20 mg 1x/day for attention deficit disorder. The patient previously received 6 doses of influenza vaccine. On 21Mar2016 the patient experienced headache, fever at 101.7, chills, full body aches, neck ache and photophobia and on an unknown date he experienced dizziness. He received ALEVE as a fever and pain reliever. The patient did not undergo any laboratory test. The events did not require emergency room, physician visit and hospitalization. The outcome of all the events was recovered 23Mar2016. The outcome of dizziness was unknown. The physician stated that the patient provided information to him/her regarding the reported adverse events with the use of PREVNAR 13. The physician considered PREVNAR 13 had a causal effect to the adverse events. Follow up (15Apr2016): New information from a contactable Physician included: new events of acne and photophobia. TRUMENBA expiration dated; hour and site of administration; co-suspect vaccine and vaccination history; onset and stop date and outcome of the events. Follow up (06May2016): New information from a contactable Physician includes: time of vaccination with TRUMENBA, start and stop date of concomitant medications, value of fever, new event (dizziness), no emergency room, physician visit and hospitalization for the events, confirmation that the patient provided to the physician information regarding the reported adverse events with the use of PREVNAR 13, causality assessment. Follow-up (20May2016): This follow-up report is being submitted to amend previously reported information: Event "Fully body acnes, neck acne" changed to "Fully body aches, neck ache" re-ecoded as "ache".
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Muscle spasms, Tremor
Clinical narrative: This is a spontaneous report from a contactable nurse reported for two patients. This is the 2nd report of the two reported. A 16-year-old female patient received TRUMENBA, Expiry Date Apr 2017: lot M37314) on 21MAR2016, 09:22 AM at 0.5 ml intramuscular in left deltoid. Medical history included diabetes mellitus Type 1 since age of 2 years,  hyperlipidemia and asthma.  Concomitant medication included LANTUS at 100 IU/ml for diabetes , PROAIR HFA at 180 ug for asthma and oral simvastatin for hyperlipidemia at 10 mg. In the past the patient experienced muscle pain/trembling and chills with previous (unspecified vaccinations). On 21MAR2016, the patient experienced chills and leg cramps with outcome of recovered. Follow up (11APR2016): New information from a contactable physician includes medical history, concomitant medication, past history. Follow  up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable nurse reported for two patients. This is the 2nd report of the two reported. A 16-year-old female patient received TRUMENBA, Expiry Date Apr 2017: lot M37314) on 21MAR2016, 09:22 AM at 0.5 ml intramuscular in left deltoid. Medical history included diabetes mellitus Type 1 since age of 2 years,  hyperlipidemia and asthma.  Concomitant medication included LANTUS at 100 IU/ml for diabetes , PROAIR HFA at 180 ug for asthma and oral simvastatin for hyperlipidemia at 10 mg. In the past the patient experienced muscle pain/trembling and chills with previous (unspecified vaccinations). On 21MAR2016, the patient experienced chills and leg cramps with outcome of recovered. Follow up (11APR2016): New information from a contactable physician includes medical history, concomitant medication, past history. Follow  up attempts completed. No further information expected.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, MNQ
Symptoms: Cough, Dry throat, Throat tightness
Clinical narrative: Initial unsolicited report received from a non-health care professional on 16 May 2016. This case involves a male patient (age was not reported) who was vaccinated with a first dose of MENACTRA (batch number U5415AA, expiration date, dose, route and site of administration was not reported) and second dose of GARDASIL-9 (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, within 5 minutes following vaccination, patient had throat feeling dry like it was closing and developed a repetitive dry cough. It was reported that there was no visible facial, tongue, or lip swelling, no hives, chest was clear to auscultation and no tachycardia. Lab data and corrective treatment was not reported. Patient was recovering from events as it was reported that symptoms began to resolve within 15 minutes. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Alopecia
Clinical narrative: Initial unsolicited report received from a non healthcare professional on 12-May-2016. This case involves an 11-year-old male patient who was vaccinated with a first dose of MENACTRA (batch number U5186AA, expiry date: 14-Mar-2017) by intramuscular route in the left deltoid on 7-Apr-2016. Patient's illness at time of vaccination was reported as "reporter stated well child visit". Preexisting physician diagnosed allergies, birth defects, medical conditions included recent stress and anxiety issues (unspecified). Concomitant medications were not reported. On an unspecified date, following the vaccination experienced hair loss which the physician stated was due to his stress and anxiety issues. The patient was evaluated on 02-May-2016 and the areas of his hair loss patches showed signs of hair regrowth. It was reported that the patient required ER or doctor visit (unspecified date). Laboratory investigations and corrective treatment was reported as none. The outcome of the event was reported as unknown. It was determined by the physician that the patient's hair loss was not related to vaccine. List of documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Echocardiogram, Injection site reaction
Clinical narrative: Patient contacted vaccine administrator at 0130 05/26/2016 and stated that he had been having chest pain.  Member woke up at 0130 05/25/2016 with chest pain. Tried stretching and moving around to reduce pain.  Member woke up 0130 05/26/2016 with sharp chest pain that was worse when taking a breath.  Member had shortness of breath, dizzy, lightheaded, tingling on top head and left arm. Member was directed to go to local ER.  Patient was transferred to another facility.  Patient was admitted to CCU to undergo further testing.  Patient currently still admitted.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Local reaction, Pericarditis
Clinical narrative: Patient contacted vaccine administrator at 0130 05/26/2016 and stated that he had been having chest pain.  Member woke up at 0130 05/25/2016 with chest pain. Tried stretching and moving around to reduce pain.  Member woke up 0130 05/26/2016 with sharp chest pain that was worse when taking a breath.  Member had shortness of breath, dizzy, lightheaded, tingling on top head and left arm. Member was directed to go to local ER.  Patient was transferred to another facility.  Patient was admitted to CCU to undergo further testing.  Patient currently still admitted.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest X-ray, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Patient contacted vaccine administrator at 0130 05/26/2016 and stated that he had been having chest pain.  Member woke up at 0130 05/25/2016 with chest pain. Tried stretching and moving around to reduce pain.  Member woke up 0130 05/26/2016 with sharp chest pain that was worse when taking a breath.  Member had shortness of breath, dizzy, lightheaded, tingling on top head and left arm. Member was directed to go to local ER.  Patient was transferred to another facility.  Patient was admitted to CCU to undergo further testing.  Patient currently still admitted.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram, Electrocardiogram, Intensive care, Painful respiration, Paraesthesia
Clinical narrative: Patient contacted vaccine administrator at 0130 05/26/2016 and stated that he had been having chest pain.  Member woke up at 0130 05/25/2016 with chest pain. Tried stretching and moving around to reduce pain.  Member woke up 0130 05/26/2016 with sharp chest pain that was worse when taking a breath.  Member had shortness of breath, dizzy, lightheaded, tingling on top head and left arm. Member was directed to go to local ER.  Patient was transferred to another facility.  Patient was admitted to CCU to undergo further testing.  Patient currently still admitted.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin
Clinical narrative: Patient contacted vaccine administrator at 0130 05/26/2016 and stated that he had been having chest pain.  Member woke up at 0130 05/25/2016 with chest pain. Tried stretching and moving around to reduce pain.  Member woke up 0130 05/26/2016 with sharp chest pain that was worse when taking a breath.  Member had shortness of breath, dizzy, lightheaded, tingling on top head and left arm. Member was directed to go to local ER.  Patient was transferred to another facility.  Patient was admitted to CCU to undergo further testing.  Patient currently still admitted.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Immediately after giving Tdap vaccine (ADACEL), patient has some bleeding, which is stopped by cotton balls. Patient has injection site swelling within minutes of the vaccination. When I checked with her in half an hour, she said she has some soreness on the injection site. No other symptoms other than swelling and soreness. Patient was advised to use ice to reduce swelling.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Allergy to animal, Anxiety, Asthma, Depression
Clinical narrative: Broke out in little red bumps all over my body, had a fever and stomach ache and nausea and headache. Within the next 6 months I developed many life-altering health issues including: outdoor allergies, animal allergies, mold allergies, food allergies, asthma, anxiety and depression, weight gain, lethargy, full body hives if exposed to certain allergens, asthma attack to the point of ER visits if exposed to certain allergens. I am still dealing with all of these and finally just looking into chelation therapy.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Food allergy, Headache, Hypersensitivity, Lethargy, Mycotic allergy
Clinical narrative: Broke out in little red bumps all over my body, had a fever and stomach ache and nausea and headache. Within the next 6 months I developed many life-altering health issues including: outdoor allergies, animal allergies, mold allergies, food allergies, asthma, anxiety and depression, weight gain, lethargy, full body hives if exposed to certain allergens, asthma attack to the point of ER visits if exposed to certain allergens. I am still dealing with all of these and finally just looking into chelation therapy.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pyrexia, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Broke out in little red bumps all over my body, had a fever and stomach ache and nausea and headache. Within the next 6 months I developed many life-altering health issues including: outdoor allergies, animal allergies, mold allergies, food allergies, asthma, anxiety and depression, weight gain, lethargy, full body hives if exposed to certain allergens, asthma attack to the point of ER visits if exposed to certain allergens. I am still dealing with all of these and finally just looking into chelation therapy.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Weight increased
Clinical narrative: Broke out in little red bumps all over my body, had a fever and stomach ache and nausea and headache. Within the next 6 months I developed many life-altering health issues including: outdoor allergies, animal allergies, mold allergies, food allergies, asthma, anxiety and depression, weight gain, lethargy, full body hives if exposed to certain allergens, asthma attack to the point of ER visits if exposed to certain allergens. I am still dealing with all of these and finally just looking into chelation therapy.
Age: 0.95
Sex: M
Vaccine: HIBV
Symptoms: Blood ketone body increased, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient's grandmother) on 03-May-2016. This case involves a 13-months-old (reported as one year old) male patient who was vaccinated with a dose of ACTHIB (batch number: unknown, expiry date, route and site of administration: not reported) on 28-Apr-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions included- allergies: unknown and medical history of diabetes. Patient was previously vaccinated with DTaP Vaccine in Nov-2015. Patient did not receive any other vaccinations. Concomitant medications were not reported. On 30-Apr-2016, two days post vaccination, the patient experienced fever of 101.7 Fahrenheit, dehydration and diarrhea. Laboratory investigations included elevated ketones. Patient's corrective treatment included TYLENOL. (It was reported that the "fever went down with TYLENOL but went right back up".) The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyskinesia, Eye movement disorder, Full blood count, Hypotonia, Platelet count increased
Clinical narrative: Initial unsolicited report received from non- healthcare professional on 13 May 2016. This case involves a six-month-old female patient who was vaccinated with a third dose of PENTACEL (batch number C5137AA), third dose of PREVNAR 13 and a third dose of ROTATEQ (batch number, expiration date, and route of administration were not reported), in the left thigh on 10 May 2016. The patient illness at the time of vaccination was reported as yeast rash in diaper and also had received previously two doses of above mentioned vaccines (details not provided). Patient was allergic to amoxicillin and Ceftin. Concomitant medications were not reported. On 11 May 2016, one day (during the night) following the vaccination, the patient experienced seizure with generalized jerking of extremities, "the eye rolled back in her head". It was also reported that patient went limp and unresponsive for approximately 15 minutes. Patient required ER visit. Lab data included White blood cells test, Complete Blood Count test and Urine Analysis test. The patient corrective treatment was not reported. The outcomes of the events were reported as unknown. List of documents held by sender: none. Sender's Comments: This case refers to 7 months old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE, simultaneously with two other vaccines PNEUMOCOCCAL POLYSACCHARIDE VACCINE and ROTAVIRUS VACCINE. Next day (within less than 48 hours) patient experienced seizures with generalized jerking of extremities, eye rolled back in her head and she went limp and unresponsive for approximately 15 minutes. Patient had no history of seizures in the past, however patient had yeast diaper rash at the time of vaccination. In the absence of any alternative explanation and considering the positive temporal relationship, and although three vaccines were administered simultaneously the contributory role of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE cannot be ruled out.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure, Unresponsive to stimuli, Urine analysis, White blood cell count increased
Clinical narrative: Initial unsolicited report received from non- healthcare professional on 13 May 2016. This case involves a six-month-old female patient who was vaccinated with a third dose of PENTACEL (batch number C5137AA), third dose of PREVNAR 13 and a third dose of ROTATEQ (batch number, expiration date, and route of administration were not reported), in the left thigh on 10 May 2016. The patient illness at the time of vaccination was reported as yeast rash in diaper and also had received previously two doses of above mentioned vaccines (details not provided). Patient was allergic to amoxicillin and Ceftin. Concomitant medications were not reported. On 11 May 2016, one day (during the night) following the vaccination, the patient experienced seizure with generalized jerking of extremities, "the eye rolled back in her head". It was also reported that patient went limp and unresponsive for approximately 15 minutes. Patient required ER visit. Lab data included White blood cells test, Complete Blood Count test and Urine Analysis test. The patient corrective treatment was not reported. The outcomes of the events were reported as unknown. List of documents held by sender: none. Sender's Comments: This case refers to 7 months old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE, simultaneously with two other vaccines PNEUMOCOCCAL POLYSACCHARIDE VACCINE and ROTAVIRUS VACCINE. Next day (within less than 48 hours) patient experienced seizures with generalized jerking of extremities, eye rolled back in her head and she went limp and unresponsive for approximately 15 minutes. Patient had no history of seizures in the past, however patient had yeast diaper rash at the time of vaccination. In the absence of any alternative explanation and considering the positive temporal relationship, and although three vaccines were administered simultaneously the contributory role of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE cannot be ruled out.
Sex: U
Vaccine: UNK
Symptoms: Erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from non-healthcare professional via other company (Pfizer) on 12 May 2016. Manufacturer Report Number: 2016244653. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of (TDAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported.  On an unknown date, following the vaccination, the patient had developed skin redness and a little swelling at the injection site. The patient's laboratory and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: DT
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a consumer on 16-May-2016. This case involves a 12-months-old (reported as one year old) female patient (who was vaccinated with a first dose of Diphtheria/Tetanus (batch number: unknown, expiry date, route and site of administration: not reported) on an unspecified date in around 1941. Patient denied illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Diptheria. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had swelled all up. It was reported that since then, the patient took only Tetanus containing vaccine as told by the doctor. On an unspecified date, the patient required emergency room/doctor visit. Laboratory investigations and corrective treatment was not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a pharmacist on 18 May 2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of YF VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On an unspecified date post vaccination, the patient had a seizure. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event: seizure. List of documents held by sender: none. Sender's Comments: Based on the available information temporal relationship between the suspect vaccine and the reported event cannot be established, also very limited information is provided in this case, hence due to lack of information causality cannot be assessed for now.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Mobility decreased
Clinical narrative: Initial unsolicited report received from a physician on 18 May 2016. This case involves a 16-years-old male patient who was vaccinated with a dose of Meningitis vaccine (batch number, expiry date, route of administration and site was not reported) on unspecified date. The patient medical history and concomitant medications were not reported. On unspecified date, after administration of following the vaccination, the patient had experienced lost the use of arm for two weeks. Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Acute kidney injury, Cardiac failure, Computerised tomogram thorax abnormal, Confusional state, Decreased appetite
Clinical narrative: Increased shortness of breath and mild fever of 99 which eventually increased to 104 over 3 days. Acute breathing problems, body aches and flu like symptoms, confusion, loss of appetite. Pneumonia ensued, acute renal, pulmonary and cardiac failure. Hospitalized and has weeks to live as advised by attending drs. at Hospital ICU unit. I believe this was an AE and feel it's important to report. I'm his wife.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Influenza like illness, Intensive care, Pain, Pneumonia
Clinical narrative: Increased shortness of breath and mild fever of 99 which eventually increased to 104 over 3 days. Acute breathing problems, body aches and flu like symptoms, confusion, loss of appetite. Pneumonia ensued, acute renal, pulmonary and cardiac failure. Hospitalized and has weeks to live as advised by attending drs. at Hospital ICU unit. I believe this was an AE and feel it's important to report. I'm his wife.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Respiratory failure
Clinical narrative: Increased shortness of breath and mild fever of 99 which eventually increased to 104 over 3 days. Acute breathing problems, body aches and flu like symptoms, confusion, loss of appetite. Pneumonia ensued, acute renal, pulmonary and cardiac failure. Hospitalized and has weeks to live as advised by attending drs. at Hospital ICU unit. I believe this was an AE and feel it's important to report. I'm his wife.
Age: 1.09
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Breath holding, Electroencephalogram normal, Mobility decreased, Nuclear magnetic resonance imaging normal, Staring
Clinical narrative: 2/1/16 Mom called reporting staring spells; will stand motionless, unresponsive to voice almost daily (office visit HPI). He did not lose tone, no abnormal movements. 2/4/16 Evaluated: EEG and MRI normal. Neuro consult: Dx breath holding (doctors agreed with dx.) 4/12/16 Mom expressed concern about vaccine 11/2/15 triggered events above.
Age: 1.09
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: 2/1/16 Mom called reporting staring spells; will stand motionless, unresponsive to voice almost daily (office visit HPI). He did not lose tone, no abnormal movements. 2/4/16 Evaluated: EEG and MRI normal. Neuro consult: Dx breath holding (doctors agreed with dx.) 4/12/16 Mom expressed concern about vaccine 11/2/15 triggered events above.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt reported back to clinic 1 day after vaccine with redness and swelling (approx. 5 inches diameter) on left arm just below injection site for Hep A & MENACTRA. Pt was seen by a clinic provider 5/26/16 who treated patient for cellulitis with KEFLEX.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Rash on abdomen, spread to back, legs and hands. Fever.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Anaphylactic shock, Death, Endotracheal intubation, Intensive care
Clinical narrative: This is a spontaneous report from a contactable physician. A 94-year-old female patient received a single dose of PREVNAR 13, on 09May2016 at in the left deltoid. Medical history included type 2 diabetes mellitus, high blood pressure, high cholesterol, coronary atherosclerosis and glaucoma. Concomitant medication (all prescribed by cardiologist) included: baby aspirin at 81 mg daily, simvastatin at 20 mg daily, CARTIA XT 240, per 24 hours, cilostazol at 50 mg 2x/day, lisinopril at 10 mg daily, glimepiride at 2 mg 1x/day, oxybutynin 5 mg daily and nitroglycerin 0.4 mg, as needed sublingual. Past drug history included allergy to CELEBREX. On Mar2012 patient took PNEUMOVAX without any complications and with no problems and on unknown date patient had flu shots with no problems. On 09May2016 after giving the PREVNAR 13, the patient had a shock (anaphylactic shock) and she began to swell later in evening. She was admitted to the hospital on 09May2016 with anaphylactic shock. It was also reported that the patient had developed pneumonitis and her face and lips were swelling. The patient was intubated. She was in Intensive Care on the ventilator, and was in the emergency room for about 3 hours and the patient was given SOLU-MEDROL, BENADRYL and fresh frozen plasma. The patient subsequently died on 19May2016 due to anaphylactic reaction to PREVNAR 13. No autopsy was performed. The outcome of the other events was unknown.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Lip swelling, Mechanical ventilation, Pneumonitis, Swelling, Swelling face
Clinical narrative: This is a spontaneous report from a contactable physician. A 94-year-old female patient received a single dose of PREVNAR 13, on 09May2016 at in the left deltoid. Medical history included type 2 diabetes mellitus, high blood pressure, high cholesterol, coronary atherosclerosis and glaucoma. Concomitant medication (all prescribed by cardiologist) included: baby aspirin at 81 mg daily, simvastatin at 20 mg daily, CARTIA XT 240, per 24 hours, cilostazol at 50 mg 2x/day, lisinopril at 10 mg daily, glimepiride at 2 mg 1x/day, oxybutynin 5 mg daily and nitroglycerin 0.4 mg, as needed sublingual. Past drug history included allergy to CELEBREX. On Mar2012 patient took PNEUMOVAX without any complications and with no problems and on unknown date patient had flu shots with no problems. On 09May2016 after giving the PREVNAR 13, the patient had a shock (anaphylactic shock) and she began to swell later in evening. She was admitted to the hospital on 09May2016 with anaphylactic shock. It was also reported that the patient had developed pneumonitis and her face and lips were swelling. The patient was intubated. She was in Intensive Care on the ventilator, and was in the emergency room for about 3 hours and the patient was given SOLU-MEDROL, BENADRYL and fresh frozen plasma. The patient subsequently died on 19May2016 due to anaphylactic reaction to PREVNAR 13. No autopsy was performed. The outcome of the other events was unknown.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Bilevel positive airway pressure, Dyspnoea, Dysstasia, Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from a contactable Physician via sales representative (vaccine territory manager). During the conference a physician reported to the sales representative the events for a patient. A 82-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5 ml, single on 13Apr2016. The reporting physician is not the prescribing provider. The patient medical history was not reported. The concomitant medications included unspecified blood pressure medication and the patient used a CPAP. No other vaccines were given and there have been no medication changes. The patient lived alone and was physically fit. The patient experienced suspected Guillain-Barre syndrome on 24Apr2016, weakness on 22Apr2016, was not able to stand on 22Apr2016, breathing issues on an unspecified date. Course of events. The patient presented to the primary care of the physician on 22Apr2016 with symptoms of weakness and was not being able to stand. The symptoms at that point were disregarded by the primary care provider, then 2 days later, on 24Apr2016, the patient was hospitalized for suspected Guillain-Barre. Approximate hospitalization dates are 24Apr2016 to 30Apr2016. While hospitalized, the patient was changed from a CPAP over to a BIPAP because if breathing issues. The patient was then discharged to rehabilitation for 2 weeks prior to be re-hospitalized on 19May2016. The events suspected Guillain-Barre, weakness and not able to stand were reported as worsened. The outcome of event breathing issues was unknown.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Full blood count, Glycosylated haemoglobin, Lipids, Metabolic function test
Clinical narrative: This is a spontaneous report from a contactable consumer (office manager) who reported the same event for two patients. This is the first of two reports. A 74-year-old female patient received PREVNAR 13 (NDC # 0005197102, Lot # M60993, Expiry Date Jul2017), via an unspecified route of administration on 13May2016 at 0.5 ml, single. Medical history was not reported. Concomitant medications included NORVASC, pravastatin and cefdinir. The patient experienced cellulitis on an unspecified date with outcome of unknown. The doctor gave her BACTRIM as treatment for the event. The patient had undergone lab work on 16May2016, which included lipid panel, CBC, haemoglobin A1C, urine analysis, CMP and vitamin D.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Urine analysis, Vitamin D
Clinical narrative: This is a spontaneous report from a contactable consumer (office manager) who reported the same event for two patients. This is the first of two reports. A 74-year-old female patient received PREVNAR 13 (NDC # 0005197102, Lot # M60993, Expiry Date Jul2017), via an unspecified route of administration on 13May2016 at 0.5 ml, single. Medical history was not reported. Concomitant medications included NORVASC, pravastatin and cefdinir. The patient experienced cellulitis on an unspecified date with outcome of unknown. The doctor gave her BACTRIM as treatment for the event. The patient had undergone lab work on 16May2016, which included lipid panel, CBC, haemoglobin A1C, urine analysis, CMP and vitamin D.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (office manager) who reported the same event for two patients. This is the second of two reports. A 65-year-old female patient received PREVNAR 13 (lot/batch number M60993, NDC # 0005197102, Expiry Date Jul2017), via an unspecified route of administration on 09May2016 at 0.5 ml, single. The patient had no medical history. Concomitant medications included atorvastatin (unknown manufacturer), HUMALOG, JANUVIA, LANTUS, LIALDA, metformin (unknown manufacturer), omeprazole (unknown manufacturer) and ramipril (unknown manufacturer). The patient experienced cellulitis on 13May2016. The doctor gave her BACTRIM as treatment for the event. No laboratory work was performed. The antibiotic was working, cellulitis was still red and slightly swollen but the pain was gone and it was getting better. The patient was recovering from the event.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Blood test abnormal, Leukopenia, Malaise
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 20-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 19Feb2016 at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced leukopenia and became ill on an unspecified date with outcome of unknown. On 26Feb2016 leukopenia was found.