chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Full blood count normal, Hepatitis B core antibody negative, Hepatitis B surface antigen negative, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle weakness in a 36-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to e-mycin and sulfa allergy. Concurrent vaccination include IPOL (non-gsk); Sanofi ;unknown; unknown given on 10 August 2012. There were no concurrent medications. On 10 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 10 August 2012, less than one day after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The nurse reported the subject received the 1st dose of TWINRIX on 10 August 2012 and experienced muscle weakness, generalized muscle tenderness and difficulty lifting anything (example: subject has a hard time lifting 3-year old child). This continued through until 16 August 2012 and is unresolved. The nurse stated "she is only a tiny bit better today, but not much'. The subject was treated with ALEVE 800 mg for a couple of days, but now is taking ibuprofen (don't not specified), rest and drinking plenty of fluids. The subject had blood drawn on 16 August 2012 but results are still pending. The immunization series with TWINRIX was discontinued. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with TWINRIX. Follow-up information was received on 22 October 2012 via healthcare professional who reported the 36-year-old female subject who was vaccinated on 10 August 2012 with TWINRIX (1 ml, intramuscular, left deltoid). Additional medical history included postpartum depression. Additional concurrent medications included Multivitamins (OTC vitamins). and CELEXA. The subject suffered from post partum depression and took sertraline; youngest child is now 3-years old. The healthcare professional clarified that on 13 August 2012, 3 days after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The vaccination course with TWINRIX was discontinued. Subsequent vaccination with HAVRIX on 07 September 2012, she had no adverse signs/ symptoms following that dose. The reporting healthcare professional attributed the events to medical history/ concurrent illness; "the only thing we could identify was fatigue". On 17 August 2012 the subject reported complete recovery.
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Neck pain, Pain, Platelet disorder, Tenderness, Urine analysis normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle weakness in a 36-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to e-mycin and sulfa allergy. Concurrent vaccination include IPOL (non-gsk); Sanofi ;unknown; unknown given on 10 August 2012. There were no concurrent medications. On 10 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 10 August 2012, less than one day after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The nurse reported the subject received the 1st dose of TWINRIX on 10 August 2012 and experienced muscle weakness, generalized muscle tenderness and difficulty lifting anything (example: subject has a hard time lifting 3-year old child). This continued through until 16 August 2012 and is unresolved. The nurse stated "she is only a tiny bit better today, but not much'. The subject was treated with ALEVE 800 mg for a couple of days, but now is taking ibuprofen (don't not specified), rest and drinking plenty of fluids. The subject had blood drawn on 16 August 2012 but results are still pending. The immunization series with TWINRIX was discontinued. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with TWINRIX. Follow-up information was received on 22 October 2012 via healthcare professional who reported the 36-year-old female subject who was vaccinated on 10 August 2012 with TWINRIX (1 ml, intramuscular, left deltoid). Additional medical history included postpartum depression. Additional concurrent medications included Multivitamins (OTC vitamins). and CELEXA. The subject suffered from post partum depression and took sertraline; youngest child is now 3-years old. The healthcare professional clarified that on 13 August 2012, 3 days after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The vaccination course with TWINRIX was discontinued. Subsequent vaccination with HAVRIX on 07 September 2012, she had no adverse signs/ symptoms following that dose. The reporting healthcare professional attributed the events to medical history/ concurrent illness; "the only thing we could identify was fatigue". On 17 August 2012 the subject reported complete recovery.
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Blood test, Muscular weakness, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle weakness in a 36-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to e-mycin and sulfa allergy. Concurrent vaccination include IPOL (non-gsk); Sanofi ;unknown; unknown given on 10 August 2012. There were no concurrent medications. On 10 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 10 August 2012, less than one day after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The nurse reported the subject received the 1st dose of TWINRIX on 10 August 2012 and experienced muscle weakness, generalized muscle tenderness and difficulty lifting anything (example: subject has a hard time lifting 3-year old child). This continued through until 16 August 2012 and is unresolved. The nurse stated "she is only a tiny bit better today, but not much'. The subject was treated with ALEVE 800 mg for a couple of days, but now is taking ibuprofen (don't not specified), rest and drinking plenty of fluids. The subject had blood drawn on 16 August 2012 but results are still pending. The immunization series with TWINRIX was discontinued. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with TWINRIX. Follow-up information was received on 22 October 2012 via healthcare professional who reported the 36-year-old female subject who was vaccinated on 10 August 2012 with TWINRIX (1 ml, intramuscular, left deltoid). Additional medical history included postpartum depression. Additional concurrent medications included Multivitamins (OTC vitamins). and CELEXA. The subject suffered from post partum depression and took sertraline; youngest child is now 3-years old. The healthcare professional clarified that on 13 August 2012, 3 days after vaccination with TWINRIX, the subject experienced muscle weakness, muscle tenderness and difficulty lifting. The vaccination course with TWINRIX was discontinued. Subsequent vaccination with HAVRIX on 07 September 2012, she had no adverse signs/ symptoms following that dose. The reporting healthcare professional attributed the events to medical history/ concurrent illness; "the only thing we could identify was fatigue". On 17 August 2012 the subject reported complete recovery.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Abdominal pain, Arthralgia, Back pain, Cardiac enzymes normal, Computerised tomogram normal
Clinical narrative: This spontaneous report was received from a 46 year old female consumer with high blood pressure and no drug reactions/allergies, who on 26-NOV-2012 was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No other co-suspects were reported. Concomitant medications included atenolol and LOTENSIN. The consumer reported that on 26-NOV-2012, within minutes of getting the vaccine, on 26-NOV-2012 she experienced severe pain and could not breath. She was given an epinephrine injection and a shot of BENADRYL at the office before being transported to another hospital; she was not kept overnight, but the patient underwent a blood work, a urine test and a CAT scan (result not provided). The patient was also given several shot (unspecified) and put on oxygen. The patient was feeling better but not fully recovered (reported as recovering). Upon internal review, the event of could not breath (hypersensitivity) treated with epinephrine was considered to be another important medical event. The patient received the vaccine shot at the Health Department and was transported by ambulance to the hospital. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Dyspnoea, Erythema, Laboratory test normal, Screaming
Clinical narrative: This spontaneous report was received from a 46 year old female consumer with high blood pressure and no drug reactions/allergies, who on 26-NOV-2012 was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No other co-suspects were reported. Concomitant medications included atenolol and LOTENSIN. The consumer reported that on 26-NOV-2012, within minutes of getting the vaccine, on 26-NOV-2012 she experienced severe pain and could not breath. She was given an epinephrine injection and a shot of BENADRYL at the office before being transported to another hospital; she was not kept overnight, but the patient underwent a blood work, a urine test and a CAT scan (result not provided). The patient was also given several shot (unspecified) and put on oxygen. The patient was feeling better but not fully recovered (reported as recovering). Upon internal review, the event of could not breath (hypersensitivity) treated with epinephrine was considered to be another important medical event. The patient received the vaccine shot at the Health Department and was transported by ambulance to the hospital. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Hypersensitivity, Pain
Clinical narrative: This spontaneous report was received from a 46 year old female consumer with high blood pressure and no drug reactions/allergies, who on 26-NOV-2012 was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No other co-suspects were reported. Concomitant medications included atenolol and LOTENSIN. The consumer reported that on 26-NOV-2012, within minutes of getting the vaccine, on 26-NOV-2012 she experienced severe pain and could not breath. She was given an epinephrine injection and a shot of BENADRYL at the office before being transported to another hospital; she was not kept overnight, but the patient underwent a blood work, a urine test and a CAT scan (result not provided). The patient was also given several shot (unspecified) and put on oxygen. The patient was feeling better but not fully recovered (reported as recovering). Upon internal review, the event of could not breath (hypersensitivity) treated with epinephrine was considered to be another important medical event. The patient received the vaccine shot at the Health Department and was transported by ambulance to the hospital. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Urine analysis
Clinical narrative: This spontaneous report was received from a 46 year old female consumer with high blood pressure and no drug reactions/allergies, who on 26-NOV-2012 was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No other co-suspects were reported. Concomitant medications included atenolol and LOTENSIN. The consumer reported that on 26-NOV-2012, within minutes of getting the vaccine, on 26-NOV-2012 she experienced severe pain and could not breath. She was given an epinephrine injection and a shot of BENADRYL at the office before being transported to another hospital; she was not kept overnight, but the patient underwent a blood work, a urine test and a CAT scan (result not provided). The patient was also given several shot (unspecified) and put on oxygen. The patient was feeling better but not fully recovered (reported as recovering). Upon internal review, the event of could not breath (hypersensitivity) treated with epinephrine was considered to be another important medical event. The patient received the vaccine shot at the Health Department and was transported by ambulance to the hospital. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Insomnia, Muscle spasms, Muscle tightness, Muscle twitching, Myalgia
Clinical narrative: Generalized muscle tightness/muscle spasms.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Muscle spasms, Muscle tightness, Neurological examination normal
Clinical narrative: Generalized muscle tightness/muscle spasms.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Incisional drainage, Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Initially red welt over injection site, advanced to 9cmx5cm reddened, swollen area. Hard to the touch in center. Severely painful. Warm to the touch. Dx as cellulitis. Swelling became worse over hard area in center, abscess, treated with an incision and drainage. Wound now has to be packed daily with gauze until healed.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Initially red welt over injection site, advanced to 9cmx5cm reddened, swollen area. Hard to the touch in center. Severely painful. Warm to the touch. Dx as cellulitis. Swelling became worse over hard area in center, abscess, treated with an incision and drainage. Wound now has to be packed daily with gauze until healed.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Wound treatment
Clinical narrative: Initially red welt over injection site, advanced to 9cmx5cm reddened, swollen area. Hard to the touch in center. Severely painful. Warm to the touch. Dx as cellulitis. Swelling became worse over hard area in center, abscess, treated with an incision and drainage. Wound now has to be packed daily with gauze until healed.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, HPVX
Symptoms: Eye swelling, Screaming, Urticaria
Clinical narrative: HIVES, SWELLING OF RIGHT PUPIL, SCREAMING NOT CALMING WHEN PICKED UP OR LISTEN TO FAMILIAR VOICES.
Age: 32.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Asthenia, Blood pressure increased, Cardiac enzymes normal, Chest X-ray normal, Chest pain
Clinical narrative: Information has been received from a consumer regarding her 32 year old husband. It was reported that her 32 year old husband received the M-M-R II, at an unknown dose, on 09-NOV-2012. He also received the FLUVIRIN (Novartis) and ENGERIX-B (GlaxoSmithKline), at unknown doses, at the same time on 09-NOV-2012. His relevant medical history included that he was given a "clean bill of health" prior to receiving the vaccines on 09-NOV-2012. He had no relevant concomitant medications. Concomitant medications included multivitamin. His past drug history included that he had received the M-M-R II, flu, and hepatitis B vaccines in the past without problems. On 18-NOV-2012, her husband experienced chest pain, tingling down the left side of his arm, dizziness, difficulty breathing, increased pulse and increased blood pressure nine days after receiving the M-M-R II, FLUVIRIN and ENGERIX-B and was taken to the emergency room (ER). On arrival at the ER, his pulse was 98 and his blood pressure was 150/100. Normally his blood pressure was 110-120/75-80. While in the ER, he had an electrocardiogram, urinalysis, drug test, heart enzymes, metabolic panel, complete blood count, and a chest x-ray which were all normal. He was given intravenous (IV) lorazepam while in the ER and everything resolved except the difficulty breathing and chest pain and was sent home. At that time it was unknown what was causing his symptoms. The next night on 19-NOV-2012 all of his previously mentioned symptoms returned and he was taken to a different ER. All of the same tests were done which were normal again and he was given more IV lorazepam. He was sent home with a prescription for oral lorazepam 1mg. On 21-NOV-2012, his symptoms returned and he was taken to an urgent care clinic. A chest x-ray was repeated which was normal and "everything else looked fine" so he was sent home again. On 22-NOV-2012, he continued to be weak and his left arm was tingling. On 24-NOV-2012, he was taken back to the urgent care clinic as he was experiencing shortness of breath and it was painful for him to breathe. He was told there was nothing else they could do and was sent home. One hour ago on 24-NOV-2012, he took some lorazepam. At the time of this call on 24-NOV-2012, all of his previously mentioned symptoms worsened and he developed shakiness and tremors. As of 24-NOV-2012, it was unknown if he would continue to receive the M-M-R II, flu vaccine, or hepatitis B vaccine in the future and all of the events continued. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Dizziness, Drug level, Dyspnoea, Electrocardiogram normal, Full blood count normal
Clinical narrative: Information has been received from a consumer regarding her 32 year old husband. It was reported that her 32 year old husband received the M-M-R II, at an unknown dose, on 09-NOV-2012. He also received the FLUVIRIN (Novartis) and ENGERIX-B (GlaxoSmithKline), at unknown doses, at the same time on 09-NOV-2012. His relevant medical history included that he was given a "clean bill of health" prior to receiving the vaccines on 09-NOV-2012. He had no relevant concomitant medications. Concomitant medications included multivitamin. His past drug history included that he had received the M-M-R II, flu, and hepatitis B vaccines in the past without problems. On 18-NOV-2012, her husband experienced chest pain, tingling down the left side of his arm, dizziness, difficulty breathing, increased pulse and increased blood pressure nine days after receiving the M-M-R II, FLUVIRIN and ENGERIX-B and was taken to the emergency room (ER). On arrival at the ER, his pulse was 98 and his blood pressure was 150/100. Normally his blood pressure was 110-120/75-80. While in the ER, he had an electrocardiogram, urinalysis, drug test, heart enzymes, metabolic panel, complete blood count, and a chest x-ray which were all normal. He was given intravenous (IV) lorazepam while in the ER and everything resolved except the difficulty breathing and chest pain and was sent home. At that time it was unknown what was causing his symptoms. The next night on 19-NOV-2012 all of his previously mentioned symptoms returned and he was taken to a different ER. All of the same tests were done which were normal again and he was given more IV lorazepam. He was sent home with a prescription for oral lorazepam 1mg. On 21-NOV-2012, his symptoms returned and he was taken to an urgent care clinic. A chest x-ray was repeated which was normal and "everything else looked fine" so he was sent home again. On 22-NOV-2012, he continued to be weak and his left arm was tingling. On 24-NOV-2012, he was taken back to the urgent care clinic as he was experiencing shortness of breath and it was painful for him to breathe. He was told there was nothing else they could do and was sent home. One hour ago on 24-NOV-2012, he took some lorazepam. At the time of this call on 24-NOV-2012, all of his previously mentioned symptoms worsened and he developed shakiness and tremors. As of 24-NOV-2012, it was unknown if he would continue to receive the M-M-R II, flu vaccine, or hepatitis B vaccine in the future and all of the events continued. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Heart rate increased, Metabolic function test normal, Painful respiration, Paraesthesia, Tremor
Clinical narrative: Information has been received from a consumer regarding her 32 year old husband. It was reported that her 32 year old husband received the M-M-R II, at an unknown dose, on 09-NOV-2012. He also received the FLUVIRIN (Novartis) and ENGERIX-B (GlaxoSmithKline), at unknown doses, at the same time on 09-NOV-2012. His relevant medical history included that he was given a "clean bill of health" prior to receiving the vaccines on 09-NOV-2012. He had no relevant concomitant medications. Concomitant medications included multivitamin. His past drug history included that he had received the M-M-R II, flu, and hepatitis B vaccines in the past without problems. On 18-NOV-2012, her husband experienced chest pain, tingling down the left side of his arm, dizziness, difficulty breathing, increased pulse and increased blood pressure nine days after receiving the M-M-R II, FLUVIRIN and ENGERIX-B and was taken to the emergency room (ER). On arrival at the ER, his pulse was 98 and his blood pressure was 150/100. Normally his blood pressure was 110-120/75-80. While in the ER, he had an electrocardiogram, urinalysis, drug test, heart enzymes, metabolic panel, complete blood count, and a chest x-ray which were all normal. He was given intravenous (IV) lorazepam while in the ER and everything resolved except the difficulty breathing and chest pain and was sent home. At that time it was unknown what was causing his symptoms. The next night on 19-NOV-2012 all of his previously mentioned symptoms returned and he was taken to a different ER. All of the same tests were done which were normal again and he was given more IV lorazepam. He was sent home with a prescription for oral lorazepam 1mg. On 21-NOV-2012, his symptoms returned and he was taken to an urgent care clinic. A chest x-ray was repeated which was normal and "everything else looked fine" so he was sent home again. On 22-NOV-2012, he continued to be weak and his left arm was tingling. On 24-NOV-2012, he was taken back to the urgent care clinic as he was experiencing shortness of breath and it was painful for him to breathe. He was told there was nothing else they could do and was sent home. One hour ago on 24-NOV-2012, he took some lorazepam. At the time of this call on 24-NOV-2012, all of his previously mentioned symptoms worsened and he developed shakiness and tremors. As of 24-NOV-2012, it was unknown if he would continue to receive the M-M-R II, flu vaccine, or hepatitis B vaccine in the future and all of the events continued. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Urine analysis normal
Clinical narrative: Information has been received from a consumer regarding her 32 year old husband. It was reported that her 32 year old husband received the M-M-R II, at an unknown dose, on 09-NOV-2012. He also received the FLUVIRIN (Novartis) and ENGERIX-B (GlaxoSmithKline), at unknown doses, at the same time on 09-NOV-2012. His relevant medical history included that he was given a "clean bill of health" prior to receiving the vaccines on 09-NOV-2012. He had no relevant concomitant medications. Concomitant medications included multivitamin. His past drug history included that he had received the M-M-R II, flu, and hepatitis B vaccines in the past without problems. On 18-NOV-2012, her husband experienced chest pain, tingling down the left side of his arm, dizziness, difficulty breathing, increased pulse and increased blood pressure nine days after receiving the M-M-R II, FLUVIRIN and ENGERIX-B and was taken to the emergency room (ER). On arrival at the ER, his pulse was 98 and his blood pressure was 150/100. Normally his blood pressure was 110-120/75-80. While in the ER, he had an electrocardiogram, urinalysis, drug test, heart enzymes, metabolic panel, complete blood count, and a chest x-ray which were all normal. He was given intravenous (IV) lorazepam while in the ER and everything resolved except the difficulty breathing and chest pain and was sent home. At that time it was unknown what was causing his symptoms. The next night on 19-NOV-2012 all of his previously mentioned symptoms returned and he was taken to a different ER. All of the same tests were done which were normal again and he was given more IV lorazepam. He was sent home with a prescription for oral lorazepam 1mg. On 21-NOV-2012, his symptoms returned and he was taken to an urgent care clinic. A chest x-ray was repeated which was normal and "everything else looked fine" so he was sent home again. On 22-NOV-2012, he continued to be weak and his left arm was tingling. On 24-NOV-2012, he was taken back to the urgent care clinic as he was experiencing shortness of breath and it was painful for him to breathe. He was told there was nothing else they could do and was sent home. One hour ago on 24-NOV-2012, he took some lorazepam. At the time of this call on 24-NOV-2012, all of his previously mentioned symptoms worsened and he developed shakiness and tremors. As of 24-NOV-2012, it was unknown if he would continue to receive the M-M-R II, flu vaccine, or hepatitis B vaccine in the future and all of the events continued. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cyanosis, Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: Started showing signs of fever in the morning. Was sitting on the couch (3:30 PM) when he slumped over. After 15-30 seconds, we turned him over. He was blue and not breathing. Began administering CPR for about 1 min, when decided to take him to the ER. His color returned on the ride to the ER. Total of 4 mins between event and admission to ER.
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Dyspnoea
Clinical narrative: Case number PHEH2012US023410 is an initial spontaneous report received from a consumer on 27 Nov 2012. This case refers to a male patient of unspecified age. He was vaccinated with flu vaccine (manufacturer and batch number: not reported) at a dose of 0.5 ml intramuscularly on an unspecified date 2-3 weeks before the time of this report. On an unknown date after vaccination he experienced asthma like symptoms and severe breathing problem. It was also reported that it was not known if the patient received FLUVIRIN or another flu vaccine. The seriousness, outcome and causality of the events were not reported. No other information was available at the time of this report.
Age: 23.0
Sex: M
Vaccine: UNK, FLU3, PPV
Symptoms: Decreased appetite, Injection site cellulitis
Clinical narrative: 11/30/12 Patient presented to local urgent care facility with cellulitis of right arm - injection site was treated with 10 day course of KEFLEX. Presented to us on 12/ /12 for recheck. Exam c/w localized reaction, now resolved.
Age: 23.0
Sex: M
Vaccine: UNK, FLU3, PPV
Symptoms: Cellulitis, Injection site reaction, Local reaction
Clinical narrative: 11/30/12 Patient presented to local urgent care facility with cellulitis of right arm - injection site was treated with 10 day course of KEFLEX. Presented to us on 12/ /12 for recheck. Exam c/w localized reaction, now resolved.
Age: 45.0
Sex: M
Vaccine: JEV1, RAB
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for several hours, beginning 12 hours after vaccine was given.
Age: 13.0
Sex: M
Vaccine: JEV1, RAB
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Pt. complained of a stomach ache, vomited several times, about 12 hours after vaccines.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Renal failure
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 21-NOV-2012) concerns a 68-year-old female patient. Concomitant medications included folinic acid, methotrexate, indapamide, trazodone, SUBOXONE, hydrocodone, prednisone, simvastatin, gabapentin, omeprazole, lisinopril, tolterodine, metronidazole and metoprolol. On 09-Nov-2012 the patient received AFLURIA (batch number: 06549221A) injection at a dose of 0.5 mL intramuscularly. On 20-Nov-2012, 12 days after vaccination, the patient was admitted to hospital for kidney failure.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Renal failure
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 21-Nov-2012) concerns a 69-year-old male patient. Concomitant medications included omeprazole, ramipril, metoprolol, potassium chloride, isosorbide mononitrate, doxycycline. On 09-Nov-2012 the patient received AFLURIA (batch number: 06549221A) injection at a dose of 0.5 mL intramuscularly. On 20-Nov-2012, 12 days after vaccination, the patient was admitted to hospital for kidney failure. He was currently on dialysis.
Sex: U
Vaccine: FLU3
Symptoms: Influenza virus test positive
Clinical narrative: Initial report was received from a health care professional on 20 November 2012. "Between 10.20.12 and 11.18.12, 13 pediatric patients under age 21 were tested positive for flu A and 15 who were not vaccinated were tested positive for flu A. 8 vaccinated FLUZONE (lot number not reported) were tested positive for flu B and 10 not vaccinated were tested positive for flu B. Several staff member have also been positive after vaccination." The date of vaccination for these "multiple patients" was also reported as "10/12" and the adverse event onset was reported as "10/12." No further information was available at the time of the report. The outcome of the patients were not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial report was received from a health care professional on 23 November 2012. A male patient of unknown age had received FLUZONE High Dose, lot number unknown (route, site and date of administration not reported) and after an unspecified time had a "severe reaction and is now in the hospital fighting for his life." No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: DTaP administered to child instead of Tdap; no adverse reactions/or symptoms.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Computerised tomogram normal, Dysphemia, Dystonia, Headache
Clinical narrative: This case was reported by a physician and described the occurrence of inability to speak in a 27-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2012 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm). On 10 October 2012, within hours of vaccination with FLUARIX, the subject experienced headache and arm pain. On 15 October 2012, five days after vaccination with FLUARIX, the subject experienced inability to speak, stuttering speech and numbness in arms and legs. On 16 October 2012, six days after vaccination with FLUARIX, the subject experienced worsening inability to speak and went to the emergency department where a dystonic reaction was suspected. At the time of the report, the subject was currently in the ED because of worsening ability to speak. A computed tomography scan was performed and normal. The mother of the subject reported to the primary care physician, that the ED was "saying it may be a dystonic reaction caused by flu vaccine"; the subject never had a flu vaccine before. At the time of reporting the inability to speak was worse; stuttering speech and headache were unresolved. The dystonic reaction, numbness in arm and leg and arm pain were not specified. The physician considered the numbness in the arms and legs as unrelated to vaccination with FLUARIX. Follow-up information was received on 26 November 2012 via healthcare professional who reported the events occurred on 15 October 2012 resolved on an unspecified date. The healthcare professional considered the event serious and the subject required hospitalization.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of inability to speak in a 27-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2012 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm). On 10 October 2012, within hours of vaccination with FLUARIX, the subject experienced headache and arm pain. On 15 October 2012, five days after vaccination with FLUARIX, the subject experienced inability to speak, stuttering speech and numbness in arms and legs. On 16 October 2012, six days after vaccination with FLUARIX, the subject experienced worsening inability to speak and went to the emergency department where a dystonic reaction was suspected. At the time of the report, the subject was currently in the ED because of worsening ability to speak. A computed tomography scan was performed and normal. The mother of the subject reported to the primary care physician, that the ED was "saying it may be a dystonic reaction caused by flu vaccine"; the subject never had a flu vaccine before. At the time of reporting the inability to speak was worse; stuttering speech and headache were unresolved. The dystonic reaction, numbness in arm and leg and arm pain were not specified. The physician considered the numbness in the arms and legs as unrelated to vaccination with FLUARIX. Follow-up information was received on 26 November 2012 via healthcare professional who reported the events occurred on 15 October 2012 resolved on an unspecified date. The healthcare professional considered the event serious and the subject required hospitalization.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Immediate post-injection reaction, Laboratory test normal, Lethargy, Pyrexia, Rash generalised
Clinical narrative: This case was reported in a literature article and described the occurrence of respiratory distress in a 2-month-old male subject who was vaccinated with DTPA-IPV-HIB (manufacturer unspecified), Poliomyelitis vaccine (manufacturer unspecified) and Hepatitis B vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTPA-IPV-HIB (unknown route, unknown injection site). After vaccination, the subject developed respiratory distress, seizure-like stiffening, and fever. He was hospitalized for 5 days with an extensive negative work up. Two months after this event, the subject received unspecified dose of Poliomyelitis vaccine (unknown route, unknown injection site). Immediately after administration, the subject developed lethargy, a full body macular papular rash and fever. Three weeks later he was hospitalized for respiratory distress, and fever following the Hepatitis B vaccine (unknown route, unknown injection site). The subject had not been vaccinated since these episodes. Currently, standardized testing for ingredients in vaccines is not available. Skin testing with the vaccine was offered. At the time of reporting the outcome of the events was unspecified. Reactions to vaccines can be local or systemic and immediate or delayed. Decision to revaccinate should be made on an individual basis, depending on the importance of revaccination and nature of previous reaction.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Rash maculo-papular, Respiratory distress, Seizure like phenomena
Clinical narrative: This case was reported in a literature article and described the occurrence of respiratory distress in a 2-month-old male subject who was vaccinated with DTPA-IPV-HIB (manufacturer unspecified), Poliomyelitis vaccine (manufacturer unspecified) and Hepatitis B vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTPA-IPV-HIB (unknown route, unknown injection site). After vaccination, the subject developed respiratory distress, seizure-like stiffening, and fever. He was hospitalized for 5 days with an extensive negative work up. Two months after this event, the subject received unspecified dose of Poliomyelitis vaccine (unknown route, unknown injection site). Immediately after administration, the subject developed lethargy, a full body macular papular rash and fever. Three weeks later he was hospitalized for respiratory distress, and fever following the Hepatitis B vaccine (unknown route, unknown injection site). The subject had not been vaccinated since these episodes. Currently, standardized testing for ingredients in vaccines is not available. Skin testing with the vaccine was offered. At the time of reporting the outcome of the events was unspecified. Reactions to vaccines can be local or systemic and immediate or delayed. Decision to revaccinate should be made on an individual basis, depending on the importance of revaccination and nature of previous reaction.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Anticonvulsant drug level therapeutic, Electrocardiogram normal, Grand mal convulsion, Mental status changes, Pain
Clinical narrative: Fever --> body aches --> altered mental status --> grand mal seizure --> taken to hospital --> transferred to hospital for neuro. consult and observation (on date of vaccine admin.)
Age: 55.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Fever --> body aches --> altered mental status --> grand mal seizure --> taken to hospital --> transferred to hospital for neuro. consult and observation (on date of vaccine admin.)
Age: 55.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Anticonvulsant drug level therapeutic, Convulsion, Pyrexia
Clinical narrative: Fever --> body aches --> altered mental status --> grand mal seizure --> taken to hospital --> transferred to hospital for neuro. consult and observation (on date of vaccine admin.)
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Rash that had a sudden onset. It was present at his chin, trunk, & leg which included redness but no associated fever.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: Patient reports headache and fever, redness at vaccine site.
Age: 1.29
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Chest X-ray, Febrile convulsion, Influenza virus test, Pneumonitis, Pyrexia
Clinical narrative: Child was running a fever and had to be picked up from daycare. I gave her 5ml of children's Advil (fever reducer) around 12:30 PM. About 8:30 PM child had febrile seizure and was taken to the emergency room. Child received a dose of Tylenol. Attending nurse practitioner diagnosed febrile fever and pneumonitis.
Age: 1.29
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Respiratory syncytial virus test
Clinical narrative: Child was running a fever and had to be picked up from daycare. I gave her 5ml of children's Advil (fever reducer) around 12:30 PM. About 8:30 PM child had febrile seizure and was taken to the emergency room. Child received a dose of Tylenol. Attending nurse practitioner diagnosed febrile fever and pneumonitis.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Severe pain and swelling in left arm where injection site is, raised red lesions from injection site down to the elbow, hives to the face and trunk, severe headache and mouth sores.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth ulceration, Skin lesion, Urticaria
Clinical narrative: Severe pain and swelling in left arm where injection site is, raised red lesions from injection site down to the elbow, hives to the face and trunk, severe headache and mouth sores.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Within a few hours of vaccination pt experienced sore arm, rash to upper body, then fever.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Low grade fever that night. Next day had stiff neck, body aches, Headaches. Had 104 degree fever on Tuesday nite.  Off work on Wednesday--treated with Tylenol & Ibuprofen.  Back to work on Thursday.  Had congestion/cough on Friday. Feels back to normal self today.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Low grade fever that night. Next day had stiff neck, body aches, Headaches. Had 104 degree fever on Tuesday nite.  Off work on Wednesday--treated with Tylenol & Ibuprofen.  Back to work on Thursday.  Had congestion/cough on Friday. Feels back to normal self today.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Depressed level of consciousness, Eye movement disorder, Hypotonia, Pyrexia, Urine analysis normal
Clinical narrative: Fever, eyes rolled back, limp body, child unfocused.  911 was called. Child began to cry but still wasn't focused.  Fever or 101.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: X-ray normal
Clinical narrative: Fever, eyes rolled back, limp body, child unfocused.  911 was called. Child began to cry but still wasn't focused.  Fever or 101.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Laser therapy, Musculoskeletal pain, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: Shoulder pain in rotator cuff area.  Unable to perform certain functions dressing and doing routine chores.   Still on-going.  Have had cold laser treatments - xrays.  Still hurts as bad as it did when I receive injection.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Feeling hot, Gastrointestinal pain
Clinical narrative: Within first 5 mins felt dizzy which lasted about an hour, then felt very hot for about 15 mins.  Afterwards, dizzy with slight headache the rest of afternoon.  Had taken Allegra morning of shot.  Next day did not take Allegra.  Aroung 9/9:30 had severe weakness with strong/severe GI cramping with diarrhea.  Took 2 Benadryl around 10:15 and sx's eventually resolved.  Rash on face over weekend beginnning to resolve today as well.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Rash
Clinical narrative: Within first 5 mins felt dizzy which lasted about an hour, then felt very hot for about 15 mins.  Afterwards, dizzy with slight headache the rest of afternoon.  Had taken Allegra morning of shot.  Next day did not take Allegra.  Aroung 9/9:30 had severe weakness with strong/severe GI cramping with diarrhea.  Took 2 Benadryl around 10:15 and sx's eventually resolved.  Rash on face over weekend beginnning to resolve today as well.
Age: 0.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Rash over face and trunk almost immediately following immunization. ER was called for Benadryl dose and child was given 4ml of Benadryl 12.5mg per tsp. Appointment made for child at clinic, attended, was told to continue Benadryl.
Age: 63.0
Sex: M
Vaccine: YF
Symptoms: Blood test, Burning sensation, Dyspnoea, Pain, Pyrexia
Clinical narrative: Body Ache, breathing difficulty with burning sensation, intermittent low grade fever. Treatment rest, fluids, regular perspiration.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 6cm-8cm induration and redness around the injection site (Left arm). Area is itchy and warm to the touch.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: The day after receiving my over 65 flu shot my blood sugar was 420.  It continued to be in the 400 range for days, despite not eating and increasing insulin dosages.   This went on for 2 weeks.  This has never happened to me in 37 years of being a diabetic.  The doctor and I ruled out all other possibilities.  It had to have been the flu shot.
Age: 1.62
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: When mom woke up she noticed a rash all around the injection site. They were little red bumps (not oozing or bleeding).
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Member states pain heat and hard lump at injection site. Rash developed on left arm and remained for two weeks plus left arm pain.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Pain
Clinical narrative: Redness and pain in injection site. Fever and muscle aches and pain lasting 3 days. Fatigue.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Redness and pain in injection site. Fever and muscle aches and pain lasting 3 days. Fatigue.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Surgery
Clinical narrative: Pt had intussusception and had surgical repair at Hospital.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever 101.4 degrees Saturday & Sunday, and Red localized rash Still present.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Gait disturbance, Headache, Hypoaesthesia, Lumbar puncture
Clinical narrative: Began w/numbness and tingling in right arm, seen at urgent care, no diagnosis made, worsening symptoms with numbness and tingling on left side, stumbling gait, headache, went to ED on 10/31/2012.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Began w/numbness and tingling in right arm, seen at urgent care, no diagnosis made, worsening symptoms with numbness and tingling on left side, stumbling gait, headache, went to ED on 10/31/2012.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Chills, Dyspnoea, Erythema, Muscle tightness
Clinical narrative: 3 hours after shot Left arm felt heavy and sore, fever, and achy, chills. Arm painful from midnight on. Muscle felt knotted up. 2nd day arm turned really red and was better within 4 days. Went to doctor and started on anti-inflammatory medication. Chest tight and hard to breathe, Dr. Prescribed Z-pak.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Sensation of heaviness
Clinical narrative: 3 hours after shot Left arm felt heavy and sore, fever, and achy, chills. Arm painful from midnight on. Muscle felt knotted up. 2nd day arm turned really red and was better within 4 days. Went to doctor and started on anti-inflammatory medication. Chest tight and hard to breathe, Dr. Prescribed Z-pak.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling and knot at injection site with lymph swelling under left arm.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: On 11/30/12 went to bed and as laid down on back felt pain under left scapular area.  Took no pain meds.  In AM left arm ached and pain was no better.  Went to doctor and given Rx for Cataflam TID.  On 12/2/12 noticed redness and swelling 3 inches below injection site.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dysphonia, Erythema, Throat tightness
Clinical narrative: Pt started coughing, his voice got really high-pitched, and his face got red. Pt's airway was evaluated by APRN and she could tell that it was physically closing. Treatment included: First Epipen was injected IM; Second 25mg Benadryl was given; Third 125mg SoluMedrol was given; Last pt received Albuterol Nebulizer Treatment in office.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Hearing impaired
Clinical narrative: Hearing affected (felt like I was in an echo chamber or somewhat similar to airplane descent) lasted about 6 hours. No treatment.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy
Clinical narrative: Patient called complaining of lymph node swelling on the left side (same side as both injections) moving into his jaw.  I recommended emergency room visit.