chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Red bump with red and white circular areas surrounding. Started on 6/4, symptoms worsened on 6/5. Pt sought care on this day, was diagnosed with cellulitis and given Clindamycin.
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blister, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: On 2June14 pt was seen for red itchy spots all over his body. Pt was then prescribed Claritin and Benadryl. Pt returned to the clinic 4June14 reporting the rash got worse. Pt then had blisters with discharge. Pt was given Atarax and sent home on Quarters for 72 hours.
Age: 1.28
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Wheals along the lateral torso. No respiratory difficulty. No angioedema.  Referred to allergist for evaluation.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fevers up to 103, swelling pain and redness at the deltoid at the site of his injection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Optic neuritis, Viral infection, Visual impairment
Clinical narrative: Patient received her flu shot on Wednesday Sept. 18th, by Sunday 9/22/13 she had a hard time seeing out of her right eye.  On Wednesday Sept. 25th, went to see a local ophthalmologist and at that time she could not see out of her right eye.  The ophthalmologist send her to a specialist and was treated for optical neuritis.  The specialist felt it was a viral infection and possibly from the flu shot but was not 100% sure.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Mobility decreased, Red blood cell sedimentation rate increased
Clinical narrative: ARM BECAME RED AND SWOLLEN AND CHILD WAS UNABLE TO MOVE THE ARM.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin irritation
Clinical narrative: REDNESS, SWELLING, IRRITATION IN ARM INJECTION WAS ADMINISTERED. PCP CONTACTED - RX ORDERED FOR BENADRYL & HYDROCORTISONE. PT INSTRUCTED TO MONITOR FOR WORSENING OF SYMPTOMS OR UNRESOLVED REACTION.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema
Clinical narrative: ERYTHEMA TO LEFT INNER ASPECT OF THIGH 68MM, WARM COMPRESS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Within 15 minutes of receiving the vaccine, some mild redness and slight itching was reported by the patient at the injection site. She said it was mild, and I advised her that those were possible side effects, and that she should monitor their progression and treat with Benadryl if they become uncomfortable. She called me at around 1pm on 6/6 to report that the injection site had remained red and slightly warm, and that an area she described as the size of a deck of playing cards around the injection site was slightly firm and raised and that it was still itching slightly. She said the needle site was unidentifiable, and that there was no soreness, weeping, oozing or fever. She said the reaction responded to Benadryl, but she didn't like the drowsiness. I told her to treat again with Benadryl if it remained bothersome, or she could use cetirizine if she wanted a non-drowsy option. I advised her that if it continued to progress, or if she showed any signs of an allergic reaction to call her doctor or go to the ER. I called her primary care doctor and made them aware of the situation for their records.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: (R) deltoid region, red, hot swollen with small circular about 7 mm area with blister like lesions at site of Td booster with larger red, hard tissue surrounding inj site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, red, pain, hot injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Convulsion, Febrile convulsion, Seizure like phenomena
Clinical narrative: Febrile seizure - increased seizure-like activity. Pt has dx of seizures. Phenobarbital dose increased per neurologist order.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature increased, Borrelia test, Chills, Fatigue, Full blood count
Clinical narrative: Sudden onset fatigue, chills, piloerection approximately 10 hrs post vaccine: temp 100.7 initially 102.9 this AM afebrile; no cough.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Piloerection
Clinical narrative: Sudden onset fatigue, chills, piloerection approximately 10 hrs post vaccine: temp 100.7 initially 102.9 this AM afebrile; no cough.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient received these immunizations on 5/30/14 following day 5/31/14 she developed hives on hands and arms and legs. No respiratory symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Local reaction, Rash
Clinical narrative: Started getting red, itchy, reaction localized to injection site on 6/5/14. Shot given 6/2/14 rash better 6/6/14.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The top of child's right thigh became slightly red one day after vaccines given. Reddened area became progressively bigger area over next 2 days. Came for office visit and area was up to 8 cm at largest point. Area was hot to touch and tender as well.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Erythema, Fatigue
Clinical narrative: Case number PHEH2012US020887 is an initial spontaneous report received from a pharmacist on 17 Oct 2012 and a follow up report was received from Quality Assurance Department on 02 Jun 2014: This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination she experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, lightheadedness, rash on neck and arms and was unable to breathe. Hence she was taken to the emergency room. No further information about outcome, causality and seriousness was reported. Upon follow up, Quality Assurance Department stated that the provided batch number 1206161, was invalid and hence this request was considered as batch unknown and would not be investigated. Follow up report received from Quality Assurance Department on 02 Jun 2014: Batch number 1206161 has been removed, the batch number has been considered as invalid.
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Generalised erythema, Pruritus, Rash
Clinical narrative: Case number PHEH2012US020887 is an initial spontaneous report received from a pharmacist on 17 Oct 2012 and a follow up report was received from Quality Assurance Department on 02 Jun 2014: This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination she experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, lightheadedness, rash on neck and arms and was unable to breathe. Hence she was taken to the emergency room. No further information about outcome, causality and seriousness was reported. Upon follow up, Quality Assurance Department stated that the provided batch number 1206161, was invalid and hence this request was considered as batch unknown and would not be investigated. Follow up report received from Quality Assurance Department on 02 Jun 2014: Batch number 1206161 has been removed, the batch number has been considered as invalid.
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Case number PHEH2012US020887 is an initial spontaneous report received from a pharmacist on 17 Oct 2012 and a follow up report was received from Quality Assurance Department on 02 Jun 2014: This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination she experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, lightheadedness, rash on neck and arms and was unable to breathe. Hence she was taken to the emergency room. No further information about outcome, causality and seriousness was reported. Upon follow up, Quality Assurance Department stated that the provided batch number 1206161, was invalid and hence this request was considered as batch unknown and would not be investigated. Follow up report received from Quality Assurance Department on 02 Jun 2014: Batch number 1206161 has been removed, the batch number has been considered as invalid.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Case number PHEH2012US020890 is an initial spontaneous report received from a pharmacist on 17 Oct 2012 and with a follow up information received from the quality assurance department on 02 Jun 2014. This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination she experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, lightheadedness, rash on neck and arms and was unable to breathe. Hence she was taken to the emergency room. No further information about outcome, causality and seriousness was reported. Upon follow up information from the quality assurance department, FLUVIRIN (batch number: 1206161) was not a valid batch number. Since the batch number was unknown, a batch specific review could not be performed. Follow up information received from quality assurance department on 02 Jun 2014: Reported batch number was removed.
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Generalised erythema, Pruritus, Rash, Urticaria
Clinical narrative: Case number PHEH2012US020890 is an initial spontaneous report received from a pharmacist on 17 Oct 2012 and with a follow up information received from the quality assurance department on 02 Jun 2014. This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination she experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, lightheadedness, rash on neck and arms and was unable to breathe. Hence she was taken to the emergency room. No further information about outcome, causality and seriousness was reported. Upon follow up information from the quality assurance department, FLUVIRIN (batch number: 1206161) was not a valid batch number. Since the batch number was unknown, a batch specific review could not be performed. Follow up information received from quality assurance department on 02 Jun 2014: Reported batch number was removed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Started with high fever (103.6 degrees F)within 12 hr and fussy MOTRIN and TYLENOL for fever - resolved in 356 hrs. No seizure activity, shaking, or staring spells.
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Case number PHEH2012US020892 is an initial spontaneous report received from a pharmacist on 17 Oct 2012, and with a follow up report received from QA department on 02 Jun 2014: This report refers to a male patient of unknown age group. He was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination he experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, light headedness, rash on neck and arms and was unable to breathe. Hence he was taken to the emergency room. No further information about outcome, causality and seriousness was reported. The batch number 1206161 provided in initial report was not a valid batch number. Therefore the batch investigation was not performed. Follow up report received from QA department on 02 Jun 2014: Batch number deleted (not valid). Therefore the batch investigation was not performed.
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Generalised erythema, Rash, Rash pruritic, Urticaria
Clinical narrative: Case number PHEH2012US020892 is an initial spontaneous report received from a pharmacist on 17 Oct 2012, and with a follow up report received from QA department on 02 Jun 2014: This report refers to a male patient of unknown age group. He was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination he experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, light headedness, rash on neck and arms and was unable to breathe. Hence he was taken to the emergency room. No further information about outcome, causality and seriousness was reported. The batch number 1206161 provided in initial report was not a valid batch number. Therefore the batch investigation was not performed. Follow up report received from QA department on 02 Jun 2014: Batch number deleted (not valid). Therefore the batch investigation was not performed.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: Patient was given rx for hepatitis B vaccine 5/22. Vaccine (ENGERIX-B) was administered Weds 5/28/14. On Saturday 5/31 pt called to report possible allergic reaction - red, swollen feet. Legs red with white patches. Localised to legs only. Rph advised her to go to ER.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Breast swelling, Chills, Headache, Local swelling
Clinical narrative: 12-15 hours after injection no fever, chills, signif, swelling, swelling on (L) lat neck, upper (L) chest and breast, pain in bones and headache. Tested severely for 48 hours and now 5 d after 50% better.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 12-15 hours after injection no fever, chills, signif, swelling, swelling on (L) lat neck, upper (L) chest and breast, pain in bones and headache. Tested severely for 48 hours and now 5 d after 50% better.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatinine increased
Clinical narrative: Case number PHHY2014US066985 is an initial literature report received on 29 May 2014. The authors discussed about a rare case of ADEM (acute disseminated encephalomyelitis) after seasonal flu vaccination and its radiographic response to plasma exchange. This report refers to an 83-year-old female patient. Her medical history included hypertension, stroke and diabetes mellitus. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown. One day after vaccination, she experienced increasing somnolence, lower extremity paresthesia and generalized weakness. She also had fever (103.5), tachycardia. and tachypnea. She was not following commands, withdrew only to pain and had diffuse hyperreflexia. CT (computerized tomography) of her head was normal. Her condition deteriorated requiring emergent intubation. MRI showed diffuse abnormal FLAIR signal in the periventricular white matter, splenium of the corpus callosum, sub cortical structures and brainstem. She had an elevated creatinine of 1.5, AST (aspartate aminotransferase) of 98 and ALT (alanine aminotransferase) of 89. CSF (cerebro spinal fluid) showed 33 WBCs, 3 RBCs, protein 136 and glucose 108. She was treated with empiric antibiotics and antivirals. When all cultures were negative, she received five days of high dose steroids for post-vaccination ADEM. There was no clinical response and an MRI brain showed worsening FLAIR changes. She was subsequently treated with plasma exchange (PE) and a repeat MRI brain showed significant radiographic improvement. The author concluded that influenza vaccination has been rarely linked to ADEM. Due to a low-incidence of the disease, there are no established treatment guidelines. Our patient did not respond to steroids but showed marked radiographic improvement with PE. PE should be considered for refractory ADEM after influenza vaccination.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: CSF cell count increased, CSF glucose increased, CSF protein increased, CSF white blood cell count negative, Computerised tomogram head normal
Clinical narrative: Case number PHHY2014US066985 is an initial literature report received on 29 May 2014. The authors discussed about a rare case of ADEM (acute disseminated encephalomyelitis) after seasonal flu vaccination and its radiographic response to plasma exchange. This report refers to an 83-year-old female patient. Her medical history included hypertension, stroke and diabetes mellitus. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown. One day after vaccination, she experienced increasing somnolence, lower extremity paresthesia and generalized weakness. She also had fever (103.5), tachycardia. and tachypnea. She was not following commands, withdrew only to pain and had diffuse hyperreflexia. CT (computerized tomography) of her head was normal. Her condition deteriorated requiring emergent intubation. MRI showed diffuse abnormal FLAIR signal in the periventricular white matter, splenium of the corpus callosum, sub cortical structures and brainstem. She had an elevated creatinine of 1.5, AST (aspartate aminotransferase) of 98 and ALT (alanine aminotransferase) of 89. CSF (cerebro spinal fluid) showed 33 WBCs, 3 RBCs, protein 136 and glucose 108. She was treated with empiric antibiotics and antivirals. When all cultures were negative, she received five days of high dose steroids for post-vaccination ADEM. There was no clinical response and an MRI brain showed worsening FLAIR changes. She was subsequently treated with plasma exchange (PE) and a repeat MRI brain showed significant radiographic improvement. The author concluded that influenza vaccination has been rarely linked to ADEM. Due to a low-incidence of the disease, there are no established treatment guidelines. Our patient did not respond to steroids but showed marked radiographic improvement with PE. PE should be considered for refractory ADEM after influenza vaccination.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Culture negative, Endotracheal intubation, General physical health deterioration, Hyperreflexia, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Case number PHHY2014US066985 is an initial literature report received on 29 May 2014. The authors discussed about a rare case of ADEM (acute disseminated encephalomyelitis) after seasonal flu vaccination and its radiographic response to plasma exchange. This report refers to an 83-year-old female patient. Her medical history included hypertension, stroke and diabetes mellitus. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown. One day after vaccination, she experienced increasing somnolence, lower extremity paresthesia and generalized weakness. She also had fever (103.5), tachycardia. and tachypnea. She was not following commands, withdrew only to pain and had diffuse hyperreflexia. CT (computerized tomography) of her head was normal. Her condition deteriorated requiring emergent intubation. MRI showed diffuse abnormal FLAIR signal in the periventricular white matter, splenium of the corpus callosum, sub cortical structures and brainstem. She had an elevated creatinine of 1.5, AST (aspartate aminotransferase) of 98 and ALT (alanine aminotransferase) of 89. CSF (cerebro spinal fluid) showed 33 WBCs, 3 RBCs, protein 136 and glucose 108. She was treated with empiric antibiotics and antivirals. When all cultures were negative, she received five days of high dose steroids for post-vaccination ADEM. There was no clinical response and an MRI brain showed worsening FLAIR changes. She was subsequently treated with plasma exchange (PE) and a repeat MRI brain showed significant radiographic improvement. The author concluded that influenza vaccination has been rarely linked to ADEM. Due to a low-incidence of the disease, there are no established treatment guidelines. Our patient did not respond to steroids but showed marked radiographic improvement with PE. PE should be considered for refractory ADEM after influenza vaccination.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Plasmapheresis, Pyrexia, Red blood cells CSF positive, Somnolence
Clinical narrative: Case number PHHY2014US066985 is an initial literature report received on 29 May 2014. The authors discussed about a rare case of ADEM (acute disseminated encephalomyelitis) after seasonal flu vaccination and its radiographic response to plasma exchange. This report refers to an 83-year-old female patient. Her medical history included hypertension, stroke and diabetes mellitus. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown. One day after vaccination, she experienced increasing somnolence, lower extremity paresthesia and generalized weakness. She also had fever (103.5), tachycardia. and tachypnea. She was not following commands, withdrew only to pain and had diffuse hyperreflexia. CT (computerized tomography) of her head was normal. Her condition deteriorated requiring emergent intubation. MRI showed diffuse abnormal FLAIR signal in the periventricular white matter, splenium of the corpus callosum, sub cortical structures and brainstem. She had an elevated creatinine of 1.5, AST (aspartate aminotransferase) of 98 and ALT (alanine aminotransferase) of 89. CSF (cerebro spinal fluid) showed 33 WBCs, 3 RBCs, protein 136 and glucose 108. She was treated with empiric antibiotics and antivirals. When all cultures were negative, she received five days of high dose steroids for post-vaccination ADEM. There was no clinical response and an MRI brain showed worsening FLAIR changes. She was subsequently treated with plasma exchange (PE) and a repeat MRI brain showed significant radiographic improvement. The author concluded that influenza vaccination has been rarely linked to ADEM. Due to a low-incidence of the disease, there are no established treatment guidelines. Our patient did not respond to steroids but showed marked radiographic improvement with PE. PE should be considered for refractory ADEM after influenza vaccination.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Tachypnoea, Unresponsive to stimuli
Clinical narrative: Case number PHHY2014US066985 is an initial literature report received on 29 May 2014. The authors discussed about a rare case of ADEM (acute disseminated encephalomyelitis) after seasonal flu vaccination and its radiographic response to plasma exchange. This report refers to an 83-year-old female patient. Her medical history included hypertension, stroke and diabetes mellitus. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown. One day after vaccination, she experienced increasing somnolence, lower extremity paresthesia and generalized weakness. She also had fever (103.5), tachycardia. and tachypnea. She was not following commands, withdrew only to pain and had diffuse hyperreflexia. CT (computerized tomography) of her head was normal. Her condition deteriorated requiring emergent intubation. MRI showed diffuse abnormal FLAIR signal in the periventricular white matter, splenium of the corpus callosum, sub cortical structures and brainstem. She had an elevated creatinine of 1.5, AST (aspartate aminotransferase) of 98 and ALT (alanine aminotransferase) of 89. CSF (cerebro spinal fluid) showed 33 WBCs, 3 RBCs, protein 136 and glucose 108. She was treated with empiric antibiotics and antivirals. When all cultures were negative, she received five days of high dose steroids for post-vaccination ADEM. There was no clinical response and an MRI brain showed worsening FLAIR changes. She was subsequently treated with plasma exchange (PE) and a repeat MRI brain showed significant radiographic improvement. The author concluded that influenza vaccination has been rarely linked to ADEM. Due to a low-incidence of the disease, there are no established treatment guidelines. Our patient did not respond to steroids but showed marked radiographic improvement with PE. PE should be considered for refractory ADEM after influenza vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site papule, Papule
Clinical narrative: Crops of papules on suprapubic area, axillae, arms and legs.
Age: 0.99
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 11 month old patient (gender unknown). On 21-APR-2014 the patient was vaccinated with the first dose of M-M-R II (lot#, strength, dose, frequency, route not provided) and (Oka/Merck) VARIVAX (lot#, strength, dose, frequency, route not provided. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, MMRV, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via Medical Record refers to a 13 months old female patient with no known drug allergies (NKDA). The patients current conditions included: gastro esophageal reflux disease (GERD) and umbilical hernia. On 17-MAR-2013, the patient was vaccinated with the First dose of Hepatitis B virus vaccine (unspecified) for Hep B. On 22-MAY-2013, the patient was vaccinated with the first dose of PEDIARIX; First dose of ACTHIB; First dose of PREVENAR 13; First dose of ROTARIX. On 19-JUL-2013, the patent was vaccinated with the second dose of DAPTACEL; second dose of ACTHIB; Second dose of PREVENAR 13; Second dose of ROTARIX. On 26-SEP-2013, the patient was vaccinated with the Third dose of PEDIARIX; third dose of ACTHIB; Third dose of PREVENAR 13. On 17-JAN-2014, the patient was vaccinated with the First dose of FLUZONE; Third dose of IPOL. On 24-MAR-2014 at 09:45 am, the patient was vaccinated with the first dose of (Oka/Merck) PROQUAD (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the first dose of HAVRIX; Second dose of FLUZONE; Fourth dose of PREVENAR 13 and (Oka/Merck) VARIVAX (dose and lot# not reported). On 28-APR-2014, the patient was vaccinated with PEDVAXHIB. This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from the registered nurse via Medical Record refers to a currently 13 month old male patient with eczema and no known drug allergies (NKDA). On 19-MAR-2013, the patient was vaccinated with the first dose of HepB (unspecified) for HepB. On 20-MAY-2013, the patient was vaccinated with the first dose (also reported as second dose) of PEDIARIX for DTP/aP; First dose of PREVNAR 13 for PCV; First dose of ROTARIX for Rotavirus; First ACTHIB for Hib. On 23-JUL-2013, the patient was vaccinated with the second dose of DAPTACEL for DTP/aP; Second dose of ACTHIB for Hib; Second dose of PREVNAR 13 for PCV; Second dose of ROTARIX for Rotavirus. On 20-SEP-2013, the patient was vaccinated with the second (also reported as third) dose of PEDIARIX for DTP/aP; Third dose of ACTHIB for Hib; third dose of PREVNAR 13 for PCV. On 11-DEC-2013, the patient was vaccinated with the third dose of IPOL for Polio. On 26-MAR-2014 at 10:05:46 am the patient was vaccinated with the first dose of PROQUAD (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the first dose of HAVRIX for HepA; Fourth dose of PEDVAXHIB for Hib; Fourth dose of PREVNAR 13 for PCV and VARIVAX (Merck) for Varicella. This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse via Medical Record refers to a currently 4 year old male patient with no known drug allergies (NKDA). On 23-JAN-2010, the patient was vaccinated with the first dose of hepatitis B virus vaccine (unspecified) for Hep B. On 16-APR-2010, the patient was vaccinated with the first dose of PENTACEL for DTP/aP; First dose of pneumococcal vaccine (unspecified) for PCV. On 16-APR-2010, the patient was vaccinated with the second dose of hepatitis B virus vaccine unspecified) for Hep B; first dose of pneumococcal vaccine (unspecified) for PCV. On 16-JUN-2010, the patient was vaccinated with the second dose of PENTACEL for DTP/aP.On 10-AUG-2010, the patient was vaccinated with the third dose of PENTACEL for DTP/aP; Third dose of pneumococcal vaccine (unspecified) for PCV. On 20-OCT-2010, the patient was vaccinated with the third dose of hepatitis B virus vaccine (unspecified) for Hep B, First dose of influenza virus vaccine (unspecified) for influenza. On 20-NOV-2010, the patient was vaccinated with the second dose of influenza vaccine (unspecified) for influenza. On 21-JAN-2011, the patient was vaccinated with the first dose of hepatitis A virus vaccine (unspecified) for Hep A; Fourth dose of PREVNAR 13 for PCV. On 05-MAY-2011, the patient was vaccinated with the first dose of M-M-R II for measles. On 26-AUG-2011, the patient was vaccinated with the fourth dose of PENTACEL; Second dose of hepatitis A virus vaccine (unspecified) for Hep A; Booster dose of influenza virus vaccine (unspecified) for influenza. On 06-DEC-2011, the patient was vaccinated with the fourth dose of PENTACEL. On 14-MAR-2014 at 02:17:07 pm, the patient was vaccinated with the second dose of PROQUAD (Merck) (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the fifth dose of DAPTACEL; Fourth dose of IPOL and VARIVAX (Merck) (lot# and route not reported). This is one of several reports from the same source.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: Patient experienced nausea, dizziness and chills w/o fever 2-3 hours after vaccine and symptoms have continued to today.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: Hepatitis B vaccine was administered. Patient had previously had series of 3. Hepatitis A should have been given.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local swelling, Lymphadenopathy, Pain
Clinical narrative: Swelling, redness - entire upper arm lymph node swelling, fever, pain diagnosed by MD - cellulitis.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling, redness - entire upper arm lymph node swelling, fever, pain diagnosed by MD - cellulitis.
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Paleness, sweating, light headedness, weakness.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: Pt c/o headache x 3 days after vaccine.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blister, Discomfort, Erythema, Herpes zoster, Irritability
Clinical narrative: Shingles - irritable, uncomfortable band of vesicular erythematous base.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pruritus, Skin warm
Clinical narrative: Patient got ZOSTAVAX vaccine on 6/3/14 evening. On 6/4/14 in the evening, she developed itchiness. Patient scratched the area for relief on Thursday 6/5/14 the area became swollen and hot.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 29-MAY-2014, the patient was vaccinated with RECOMBIVAX HB 2.5/0.5, lot# 1106AA; Secondary and concomitant therapies were not reported. Pharmacy technician reported that the patient received an expire dose of RECOMBIVAX HB on 29-MAY-2014 (reported as 29-MAY-2013). Pharmacy technician reported that the RECOMBIVAX HB did not have any previous temperature excursion. No adverse symptoms reported. Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Discomfort, Insomnia, Irritability, Pain, Rash
Clinical narrative: He woke up from his nap covered on his stomach and face with tiny red bumps. He was very fussy and we called after hour clinic that evening and they said bug bites possibly by our description.  By late evening he had huge hives covering his entire body and head.  Took him to doctor the next day and they said it had to be the shot.  Went back the next week for checkup and (the hives were still out of control) they claimed we couldn't know for sure it was the shot.  He had hives that lasted 2 months.  The first month they covered him head to toe.  The second month, they lessened and he only broke out when he would get upset, get too hot, etc.  The first couple of weeks we were told to watch him 24 hrs a day to make sure swelling didn't begin internally and breathing stop.  That never happened, thank goodness. He screamed....a lot in pain.  Main symptoms major hives, screaming, sleeplessness, discomfort.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Rash erythematous, Screaming, Urticaria
Clinical narrative: He woke up from his nap covered on his stomach and face with tiny red bumps. He was very fussy and we called after hour clinic that evening and they said bug bites possibly by our description.  By late evening he had huge hives covering his entire body and head.  Took him to doctor the next day and they said it had to be the shot.  Went back the next week for checkup and (the hives were still out of control) they claimed we couldn't know for sure it was the shot.  He had hives that lasted 2 months.  The first month they covered him head to toe.  The second month, they lessened and he only broke out when he would get upset, get too hot, etc.  The first couple of weeks we were told to watch him 24 hrs a day to make sure swelling didn't begin internally and breathing stop.  That never happened, thank goodness. He screamed....a lot in pain.  Main symptoms major hives, screaming, sleeplessness, discomfort.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Injection site reaction, Injection site swelling
Clinical narrative: I developed a severe skin cellulites (infection) at injection site with swelling, redness, heat.  I was required to seek medical attention and placed on Keflex for the reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Skin reaction
Clinical narrative: I developed a severe skin cellulites (infection) at injection site with swelling, redness, heat.  I was required to seek medical attention and placed on Keflex for the reaction.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood test, Borrelia test, Ligament injury
Clinical narrative: About 1 year after receiving ZOSTAVAX vaccination I began getting joint pain and tendon weakness, also ligament damage. My Dr. said or blamed my age, I told him there was 100% change in the last year, he said this was normal. I said people don't get vaccination till they are over 60 years old which hides the side effects of the vaccination as old age. Please look into this, it's a hidden adverse reactions to this vaccination ZOSTAVAX.
Age: 60.0
Sex: F
Vaccine: HPV2
Symptoms: Asthenia, Bursitis, Fatigue, Gastrointestinal disorder, Injection site pain
Clinical narrative: 2 days after shot, of course arm sl. tender. Then pain moved up from injection site to shoulder, had very specific areas affected, but moved around shoulder area. Told MD's this at appts. Finally had MRI earlier this year. Showed severe rotator cuff tear with bursitis. Too weak for surgery due to leg weakness and fatigue, GI problems. Severe pain for 9 mos., used ibuprofen. Pain persists, saw ortho MD 2 mos. ago. Received type of inflammation med thru injection directly into shoulder. Helped very much, rare pain, but I am very inactive and do no lifting.
Age: 60.0
Sex: F
Vaccine: HPV2
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: 2 days after shot, of course arm sl. tender. Then pain moved up from injection site to shoulder, had very specific areas affected, but moved around shoulder area. Told MD's this at appts. Finally had MRI earlier this year. Showed severe rotator cuff tear with bursitis. Too weak for surgery due to leg weakness and fatigue, GI problems. Severe pain for 9 mos., used ibuprofen. Pain persists, saw ortho MD 2 mos. ago. Received type of inflammation med thru injection directly into shoulder. Helped very much, rare pain, but I am very inactive and do no lifting.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Nausea, headache, body aches, extreme fatigue, ringing in ears, tight knot in stomach, diarrhea, fever.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: Nausea, headache, body aches, extreme fatigue, ringing in ears, tight knot in stomach, diarrhea, fever.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Red raised rash on back.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site infection, Injection site pain
Clinical narrative: Red painful swollen hard bump on left thigh that was dime sized. By 6/6/2014 bump was quarter sized hot swollen hard painful.  Cold compressed area and gave Tylenol at 3am.  At 9:30am called peds office.  Had 11:15am appt & child examined.  Fnp advised cellulitis & to give Benadryl & Tylenol & to monitor infection.  If spreading occurred further antibiotic would be administered.  Fnp not sure which injection caused infection.  Pneumoccocal or hib or hep.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Red painful swollen hard bump on left thigh that was dime sized. By 6/6/2014 bump was quarter sized hot swollen hard painful.  Cold compressed area and gave Tylenol at 3am.  At 9:30am called peds office.  Had 11:15am appt & child examined.  Fnp advised cellulitis & to give Benadryl & Tylenol & to monitor infection.  If spreading occurred further antibiotic would be administered.  Fnp not sure which injection caused infection.  Pneumoccocal or hib or hep.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Blood test normal, Bradyphrenia, Burning sensation, Chest discomfort
Clinical narrative: Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Diplopia, Dizziness, Dysarthria
Clinical narrative: Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Dyspnoea, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Heart rate increased, Hyperacusis, Increased upper airway secretion, Injection site pain
Clinical narrative: Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Joint crepitation, Mental impairment, Migraine, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Nuclear magnetic resonance imaging normal, Paraesthesia, Photophobia, Speech disorder
Clinical narrative: Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus, Vertigo, Vision blurred, X-ray normal
Clinical narrative: Severe headache, soreness at injection site, weakness in legs, fatigue, rapid heartbeat, difficulty breathing, stiff and clicking neck, clicking jaw, dizziness, light headedness, heavy chest, thick mucus production in throat and chest area, itching and tingling in scalp area, light and noise sensitivity, migraine and vertigo symptoms, double vision, blurry vision at times, feeling faint, ear ringing, easily fatigued during normal activity, elevated heart rate just during normal walking (124 BPM), jerky movements, neck pain at base of skull, neck stiffness, pain on left side of neck, neck clicking, burning sensation at base of skull, thoughts are jumbled, speech jumbled/slurred at times, slow thinking, chills, diarrhea, very sore arm at site injection (right arm), feeling like my head is detaching from my body, can't walk far distances anymore (fatigue easily, fast heartbeat, gait is off, off balance most of the time, dizziness and rapid heartbeat occurs everyday.
Sex: M
Vaccine: FLU3
Symptoms: Mechanical ventilation
Clinical narrative: On respirator 2-24-14. Still in treatment as of today 06-06-14.