chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Injection site swelling, Malaise
Clinical narrative: Injection site Swells up- Softball size and makes me ill; Injection site Swells up- Softball size and makes me ill; Drug Allergies; This is a spontaneous report from a contactable physician. A 49-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site swells up- softball size and made her ill on an unspecified date, and patient also experienced drug allergies with the pneumonia vaccine on an unspecified date. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: 1)  No swelling but Grade 3 adverse reaction at injection site, including severe pain for 2 days, then moderate pain for 2 days, then limited use of range of left arm (injected arm) for another 2 days; 2)  Sever systemic Grade 3 adverse reaction including fatigue, malaise, extreme chills and teeth chattering for hours, even under electric blanket, nausea, night sweats, headache, difficulty sleeping due to pain.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Nausea, Night sweats, Pain
Clinical narrative: 1)  No swelling but Grade 3 adverse reaction at injection site, including severe pain for 2 days, then moderate pain for 2 days, then limited use of range of left arm (injected arm) for another 2 days; 2)  Sever systemic Grade 3 adverse reaction including fatigue, malaise, extreme chills and teeth chattering for hours, even under electric blanket, nausea, night sweats, headache, difficulty sleeping due to pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Decreased appetite, Irritability, Poor quality sleep, Pyrexia
Clinical narrative: Developed fever and rash on 5/26 (6days following administration of vaccine) with Tmax of 102.  Fever and rash associated with increased irritability, poor appetite and poor sleep.  Was seen in the office on 5/28 (rash described as erythematous maculopapular) and was felt that this was reaction to vaccine.  Seen again today on 5/30 due to ongoing fever (however temperature curve improved with Tmax of only around 100 last 24 hours) and worsening of rash.  Today the rash reamins diffuse with classic target lesions and areas of post-inflammatory hyperpigmentation.  Otherwise child was well-appearing; smiling at times during exam.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash erythematous, Rash maculo-papular, Skin hyperpigmentation, Streptococcus test negative, Target skin lesion
Clinical narrative: Developed fever and rash on 5/26 (6days following administration of vaccine) with Tmax of 102.  Fever and rash associated with increased irritability, poor appetite and poor sleep.  Was seen in the office on 5/28 (rash described as erythematous maculopapular) and was felt that this was reaction to vaccine.  Seen again today on 5/30 due to ongoing fever (however temperature curve improved with Tmax of only around 100 last 24 hours) and worsening of rash.  Today the rash reamins diffuse with classic target lesions and areas of post-inflammatory hyperpigmentation.  Otherwise child was well-appearing; smiling at times during exam.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Limb discomfort, Nausea, Vomiting
Clinical narrative: The vaccine was administered at approximately 0830. That night, before the child went to bed, he became nauseous. According to his mother, he went outside into the cooler air to cool down. He had one "session" of vomiting that consistent of vomiting multiple times. After, he felt a lot better. He went to bed. The following day, his mother kept him home from school. He felt exhausted. He also had a sore arm. His mother reported it was not red, not warm, not swollen. The child reported the pain as a 5 out of 10.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Strong ache/pain  in shoulder neck and both arms and hands. Tired feeling and stomach upset.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Adverse reaction, Cow's milk intolerance, Drug hypersensitivity, Eczema, Food allergy
Clinical narrative: Patient developed eczema patches within a few days of her vaccinations.  We returned to her doctor after a month and were given a topical steroid cream.  Patient later developed an adverse reaction, also classified as an addiction to the steroid cream and suffered raw, bleeding, oozing, crusty skin for about a year of her life.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Haemorrhage, Scab, Skin erosion, Temperature intolerance, Wound secretion
Clinical narrative: Patient developed eczema patches within a few days of her vaccinations.  We returned to her doctor after a month and were given a topical steroid cream.  Patient later developed an adverse reaction, also classified as an addiction to the steroid cream and suffered raw, bleeding, oozing, crusty skin for about a year of her life.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64-year-old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot#, expiration date, dose and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes Zoster. On an unspecified date, the patient was treated by a physician for Herpes Zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for long-term prevention of shingles and zoster-related conditions. On or around 15-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot#, expiration date, dose and route of administration were not specified). On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. On or about 18-MAY-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received improperly stored PROQUAD; This spontaneous report was received from registered nurse and refers to an approximately 4-year-old patient (reported as most likely around 4 years) of unknown gender. The patient's concurrent condition and medical history were not reported. On 28-MAY-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) from lot # R026351 with expiry date 15-MAR-2020 for prophylaxis (dose, route, and anatomical location were not reported) (product storage error). Concomitant therapy included properly stored sterile diluent (lot # S000130, expiry date: 23-AUG-2021). The vaccine was exposed to a temperature excursion of 6 degree Fahrenheit (F) to 14 F (6.4 F) for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality compliant (PQC) was reported.  This is one of the three reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received improperly stored PROQUAD; This spontaneous report was received from registered nurse and refers to an approximately 4-year-old patient (reported as most likely around 4 years) of unknown gender. The patient's concurrent conditions and medical history were not reported. On 28-MAY-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) from lot # R026351 with expiry date 15-MAR-2020 for prophylaxis (dose, route, and anatomical location were not reported) (product storage error). Concomitant therapy included properly stored sterile diluent (lot # S000130, expiry date: 23-AUG-2021). The vaccine was exposed to a temperature excursion of 6 degree Fahrenheit (F) to 14 F (6.4 F) for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality compliant (PQC) was reported.  This is one of the three reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: shingles; painful/burning rash/painful, burning rash in upper right chest / shoulder area; This case was reported by a physician via sales rep and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and painful rash. On an unknown date, the outcome of the shingles and painful rash were unknown.   It was unknown if the reporter considered the shingles and painful rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 59 or 60 years. The patient experienced shingles episode with evidence of mildly painful, burning rash in upper right chest or shoulder area within 2 days of receipt of dose 1 of vaccine that he got at a local pharmacy.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site discolouration, Skin discolouration
Clinical narrative: headaches; discoloration on right and left arm/ reddish-purple discoloration at the injection site/ discoloration on the back of her right arm; discoloration on right and left arm/ reddish-purple discoloration at the injection site/ discoloration on the back of her right arm; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 5th June 2021) for prophylaxis.   On 15th May 2019, the patient received Boostrix (intramuscular) .5 ml. On 16th May 2019, 1 days after receiving Boostrix, the patient experienced headache, skin discoloration and injection site discoloration. On an unknown date, the outcome of the headache, skin discoloration and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the headache, skin discoloration and injection site discoloration to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix on left arm. The day after the patient received the Boostrix vaccine, she developed a reddish-purple discoloration at the injection site that has increased in size over the weekend. The patient also developed this same discoloration at another spot on her left arm and on the back of her right arm. Since receiving the Boostrix vaccine, the patient was experiencing headaches at night.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Malaise
Clinical narrative: Headache; Malaise; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix. On 18th May 2019, 1 days after receiving Shingrix, the patient experienced headache, malaise and influenza-like symptoms. On 18th May 2019, the outcome of the headache, malaise and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the headache, malaise and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported he experienced slight flu like symptoms, such as malaise and headache. The healthcare professional noted that the headache and malaise completely resolved by the afternoon of the day they began. The healthcare professional could not provide lot number and expiration date. This case has been linked with US2019092210, reported by same reporter.
Sex: U
Vaccine: UNK
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Allergies:  Pneumococcal Vaccines; Allergies: Pneumococcal Vaccines- Swelling; This is a spontaneous report from a contactable nurse via a Pfizer sponsored program. A 69-year-old patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (Unknown manufacturer), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient medical history includes allergies: penicillins, milk related compounds and tape. The patient's concomitant medications were not reported.  The patient previously took aspirin (experienced allergies, hives); tramadol and codeine (experienced allergies). The patient experienced allergies: pneumococcal vaccines- swelling on an unspecified date. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Arthritis bacterial, C-reactive protein increased, Crying, Differential white blood cell count normal, Drooling
Clinical narrative: Started with fever 5/25/2019. Drooling increased. Woke with right thumb swollen over joint. Fussy. Had to be held. Seen 5/28/2019 seen in office. Walking ok and then would fall. But if touched feet would pull away and cry. 05/29/2019 mom called c/o muscle weakness. not wanting to walk or crawl. Mom had to leave work due to fussiness. Referred to ER. Xrays of hip, leg, and foot all normal. Sed rate, crp and wbc count normal. Dx septic arthritis and admitted. IV antibiotics started. MRI scheduled and ortho to consult.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Fall, Feeling abnormal, Full blood count normal, Gait disturbance, Irritability
Clinical narrative: Started with fever 5/25/2019. Drooling increased. Woke with right thumb swollen over joint. Fussy. Had to be held. Seen 5/28/2019 seen in office. Walking ok and then would fall. But if touched feet would pull away and cry. 05/29/2019 mom called c/o muscle weakness. not wanting to walk or crawl. Mom had to leave work due to fussiness. Referred to ER. Xrays of hip, leg, and foot all normal. Sed rate, crp and wbc count normal. Dx septic arthritis and admitted. IV antibiotics started. MRI scheduled and ortho to consult.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Started with fever 5/25/2019. Drooling increased. Woke with right thumb swollen over joint. Fussy. Had to be held. Seen 5/28/2019 seen in office. Walking ok and then would fall. But if touched feet would pull away and cry. 05/29/2019 mom called c/o muscle weakness. not wanting to walk or crawl. Mom had to leave work due to fussiness. Referred to ER. Xrays of hip, leg, and foot all normal. Sed rate, crp and wbc count normal. Dx septic arthritis and admitted. IV antibiotics started. MRI scheduled and ortho to consult.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: X-ray limb normal, X-ray normal, X-ray of pelvis and hip normal
Clinical narrative: Started with fever 5/25/2019. Drooling increased. Woke with right thumb swollen over joint. Fussy. Had to be held. Seen 5/28/2019 seen in office. Walking ok and then would fall. But if touched feet would pull away and cry. 05/29/2019 mom called c/o muscle weakness. not wanting to walk or crawl. Mom had to leave work due to fussiness. Referred to ER. Xrays of hip, leg, and foot all normal. Sed rate, crp and wbc count normal. Dx septic arthritis and admitted. IV antibiotics started. MRI scheduled and ortho to consult.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint range of motion decreased, Joint swelling, Mobility decreased, Pain
Clinical narrative: Pt received MMR vaccine on 5-10-19.  May 24th developed Right knee pain and swelling for 24 hours, limited mobility, On 5-26-19 Right hand, fingers and wrist pain, swelling, tingling, limited range of motion, Left hand index fingers pain in joint, pain when bending and tingling, On 5-28-19 pt saw family Dr. RX given for Medrol dose pack.  On the 29th all symptoms resolved except tingling in right hand index finger.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt received MMR vaccine on 5-10-19.  May 24th developed Right knee pain and swelling for 24 hours, limited mobility, On 5-26-19 Right hand, fingers and wrist pain, swelling, tingling, limited range of motion, Left hand index fingers pain in joint, pain when bending and tingling, On 5-28-19 pt saw family Dr. RX given for Medrol dose pack.  On the 29th all symptoms resolved except tingling in right hand index finger.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Swelling, redness, pain, warmth at injection site with pain and swelling  down right arm into hand. Pt sent to clinic for evaluation and treatment. Diagnosed with cellulitis and prescribed Keflex 500mg Q.I.D, and Voltaren 75mg B.I.D with 24 hr followup
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Swelling, redness, pain, warmth at injection site with pain and swelling  down right arm into hand. Pt sent to clinic for evaluation and treatment. Diagnosed with cellulitis and prescribed Keflex 500mg Q.I.D, and Voltaren 75mg B.I.D with 24 hr followup
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea
Clinical narrative: Can the new Shingles vaccine cause diarrhea? I got the 2nd dose of the new Shingles vaccine last night and this morning I have diarrhea. I know stomach issues are one of the side effects but does that include diarrhea too?  Thank you....
Age: 1.42
Sex: M
Vaccine: TYP
Symptoms: Wrong product administered
Clinical narrative: On the afternoon of 5/28/2019, patient was brought to the clinic by his father for rabies vaccine was but mistakenly given the inactivated typhoid vaccine. The staff member who gave the injection notified the reporter. The reporter searched but was unable to find information on the possible adverse outcomes related to giving the vaccine to a patient under the age of 2. She then notified another provider in the clinic, but were unsuccessful in the attempt to contact CDC to get more information. Eventually, the following day, clinic manager was able to communicate with someone at CDC's Immunization Services Division. Today (05/30/2019), the mother was notified by the clinic and she reported that her son is "fine." The clinic is reviewing the process of vaccine administration to ensure this does not occur again.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Inadvertently forgot to mix HIB with DTAP-IPV.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTS REDNESS, PAIN, & SWELLING AT SITE OF INJECTION WITH FLU LIKE SYMPTOMS X 3 DAYS.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: Patient had an inflamed bump near back of delt. It was not red, no rash. Patient was counseled to place a cold compress on and take ibuprofen, if no contraindications, and to monitor over the next couple of days.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted right after administration of HPV vaccine for a couple seconds.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, C-reactive protein increased, Injection site cellulitis, White blood cell count increased
Clinical narrative: - Cellulitis @ injection site  - admitted for IV abx - discharged w/in 48hrs, improved quickly
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered improperly stored VAQTA; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.  On 22-MAY-2019, the patient received an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R034339 with expiration date 23-NOV-2019 (strength, dose, route of administration were not reported), for prophylaxis. The dose of hepatitis a vaccine, inactivated (VAQTA) was exposed to a temperature excursion above 47 degrees Fahrenheit (°F) (9 degrees Centigrade (°C)) (49.3 F) during a timeframe of 44 minutes, which was not detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.    This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011328:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse (also reported as office manger) regarding a patient of unknown age and gender. Information on patient's medical history, concurrent conditions and concomitant therapies was not reported. On 28-MAY-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S009945, expiration date: 10-AUG-2020, strength, dose, frequency were not reported) via unknown route for prophylaxis. On 28-MAY-2019 the patient was administered an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(product storage error). No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC). Temperature Lowest temperature below 36 degree Fahrenheit (32 degree Fahrenheit) Time frame 72 hours There was no involvement of previous temperature excursion. Digital data logger was involved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Nausea
Clinical narrative: (R) facial droop nausea for 2-3 DAys - onset about 3 DAys after vaccination
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pain in extremity, Swelling, Tenderness
Clinical narrative: Patient returned today to clinic - Had vaccine adm 5/28/19. Sought Tx 5/29/19 at urgent care for arm pain and received rx for ATB. Today for exam area red, swollen and painful to touch - Localized reaction
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Neuropathy peripheral
Clinical narrative: flank pain, feels neuropathic in nature
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Havrix, adult hepatitis A, was administered as the second dose in a hepatitis A series to a pediatric patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Pt reported a pulling sensation on her left arm that felt deep and does not subside. Sensation mimics the sensation of someone grabbing your arm and pulling it. Pt reports no pain, no tingling, no numbness.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Pt presented to urgent care clinic on 3/28/19 with severe herpes zoster rash on left scalp and face, reporting that the rash started on 3/26/19, one day after receiving Shingrix.  Pt has continued to have herpetic neuropathy of left scalp, face and left eye following resolution of rash, requiring multiple urgent care and optometry visits for ongoing evaluation and pain control.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: ITCH, RASH, HIVES  BEGINNING ON 05/23/2019 ENDING 05/28/2019  TREATED WITH BENADRYL 50MG PO AND PREDISONE  MAY 23 THROUGH MAY 27 2019
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: mmr-v was administered IM instead of SQ
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site pain
Clinical narrative: extreme soreness at point of injection, restricted movement of left arm above shoulder level, temperature - (for about 24 hours).  Highest temp reached was 99.6 degrees. elevated. all symptoms resolved in about 48 hours
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Eye movement disorder, Hypotonia, Laboratory test, Lip discolouration
Clinical narrative: Post well child check and immunization patient was acting normal. Mom states that at dinner time approx. 7 pm she was sitting in her highchair finished with dinner but still in chair when dad saw her get stiff, go limp and eyes rolled back. He alerted mom that something was wrong. Mom picked her up out of her chair and was trying to keep her attention but she was limp in mom's arm. Mom did note that she was breathing at that time. They live near a fire station so she ran her to the station to see if they could help. Her lips were dusky and had ashen colored skin tones. They put O2 on her and she pinked right up. They called 911 and an ambulance came and took her to the ED. Patient arrived at ED around 750 pm. Patient had a temp of 100.3. Patient was given 136.5 mg of Tylenol. Labs were drawn. Concluded possible febrile seizure or breath holding spell. Patient discharged home to monitor.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Musculoskeletal stiffness
Clinical narrative: Post well child check and immunization patient was acting normal. Mom states that at dinner time approx. 7 pm she was sitting in her highchair finished with dinner but still in chair when dad saw her get stiff, go limp and eyes rolled back. He alerted mom that something was wrong. Mom picked her up out of her chair and was trying to keep her attention but she was limp in mom's arm. Mom did note that she was breathing at that time. They live near a fire station so she ran her to the station to see if they could help. Her lips were dusky and had ashen colored skin tones. They put O2 on her and she pinked right up. They called 911 and an ambulance came and took her to the ED. Patient arrived at ED around 750 pm. Patient had a temp of 100.3. Patient was given 136.5 mg of Tylenol. Labs were drawn. Concluded possible febrile seizure or breath holding spell. Patient discharged home to monitor.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Injection site reaction, Local reaction
Clinical narrative: 12 month old female infant had delayed reaction to vaccines listed above. large local reactions to right thigh. reaction happened almost a hour after administration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Pain
Clinical narrative: Chills, body aches and "general" discomfort for 48hrs.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anticoagulation drug level, Asthenia, Blood gases, Blood magnesium, Blood pressure immeasurable
Clinical narrative: Weakness, extreme fatigue, unable to walk or breathe, pulse at 226, Clinic unable to secure blood pressure reading, nausea.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood thyroid stimulating hormone, Brain natriuretic peptide, Chest X-ray, Differential white blood cell count, Dyspnoea
Clinical narrative: Weakness, extreme fatigue, unable to walk or breathe, pulse at 226, Clinic unable to secure blood pressure reading, nausea.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Full blood count, Gait inability
Clinical narrative: Weakness, extreme fatigue, unable to walk or breathe, pulse at 226, Clinic unable to secure blood pressure reading, nausea.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Lipids, Metabolic function test, Nausea, Platelet count
Clinical narrative: Weakness, extreme fatigue, unable to walk or breathe, pulse at 226, Clinic unable to secure blood pressure reading, nausea.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Thyroxine free
Clinical narrative: Weakness, extreme fatigue, unable to walk or breathe, pulse at 226, Clinic unable to secure blood pressure reading, nausea.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Fatigue
Clinical narrative: Weakness, extreme fatigue, unable to walk or breathe, pulse at 226, Clinic unable to secure blood pressure reading, nausea.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills, fatigue, body aches from "head to toe."
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: 12 hours after injection I developed a fever with malaise
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersensitivity, Myalgia, Peripheral swelling
Clinical narrative: Adverse event   Allergic reactions a rash with swelling on my torso, face, arms, chest and stomach.  other side effects were headache, muscle pain, low grade fever and tiredness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Swelling, Swelling face
Clinical narrative: Adverse event   Allergic reactions a rash with swelling on my torso, face, arms, chest and stomach.  other side effects were headache, muscle pain, low grade fever and tiredness.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: REDNESS AT VACCINE SITE HOT TO TOUCH PAIN/TENDERNESS  4x5 CM
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received expired Daptacel vaccine/ no AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143977 and 2019SA143976, same reporter.  This case involves a 5 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, and family history were not provided.  Concomitant medications included IPOL and PROQUAD VACCINE.  On 21-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019,  via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used.  It was reported that patient received expired Daptacel vaccine.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received expired Daptacel vaccine/ no AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143976 and 2019SA143962 (same reporter).  This case involves a 4 years old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, and family history were not provided.  Concomitant medications included IPOL and PROQUAD VACCINE.  On 21-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019,  via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used.  It was reported that patient received expired Daptacel vaccine.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is related to cases 2019SA144003, 2019SA143997, 2019SA144005, 2019SA144006, 2019SA144007, 2019SA144008, same reporter.  This case involves a 17 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-May-2019, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AE, expiry date 30-Jun-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: given a dose of Fluzone MDV from a vial that was at 18.6 C for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144005, 2019SA144004, 2019SA144008, 2019SA144007 and 2019SA144006 (same reporter).  This case involves a 5 years old female patient who received 0.5 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] which was stored at 18.6 degree C for 6.5 hours.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 16-May-2019, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Formulation: unknown, lot: UJ005AE, expiry date: 30-Jun-2019) via intramuscular route in the right arm.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: REDNESS, SWELLING AND HEAT SPREADED TO OUTER PART OF UPPER ARM ( FROM SHOULDER TO CLOSE TO ELBOW).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I was an employee and received Zostavax at the specific site or either at the health center at in 2011-2012. I do not remember the date. In May of this year, 2019, I develop shingles as diagnosed by Dr. at clinic. Dr. has been treating my shingles as Dr. was out when I came in for my appointment. Dr. has continued my treatment including valcyclovir and Lyrica.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Tender swollen area, warm to touch.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Pain in extremity
Clinical narrative: Arm pain and heart arryhthmia started the night of vaccination.  Has had arrythmia in the past.  She called cardiologist who said to come in if arrhythmia persists.  Felt better when I called on 3/30/19.  She did not go to cardiologist.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Cough, Diarrhoea, Febrile convulsion, Ill-defined disorder, Pyrexia
Clinical narrative: 15 days after vaccine , child seen in ER for febrile seizure along  with fever, congestion, cough and eventually after 3 days of illness had diarrhea
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Respiratory tract congestion
Clinical narrative: 15 days after vaccine , child seen in ER for febrile seizure along  with fever, congestion, cough and eventually after 3 days of illness had diarrhea
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Endotracheal intubation, Febrile convulsion, Lumbar puncture normal, Pyrexia, Viral test negative
Clinical narrative: Fever, Febrile Seizure
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain upper, Adverse reaction, Dizziness, Headache, Injected limb mobility decreased
Clinical narrative: Patient Spanish speaking, used language line for interpretation: Right arm - I  haven't been able to move it, it's swollen, has thick parts that are hot and red.  It's getting better, today I can move my arm but it still hurts.   Have a fever, dizziness, and headache that started on Saturday.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient Spanish speaking, used language line for interpretation: Right arm - I  haven't been able to move it, it's swollen, has thick parts that are hot and red.  It's getting better, today I can move my arm but it still hurts.   Have a fever, dizziness, and headache that started on Saturday.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Rash, Scleritis, Tachypnoea
Clinical narrative: approx. 15 min after vaccination patient started experiencing mild chest pain, redness of sclera and tachypnea along with a small rash on (L) upper chest area.
Age: 25.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Exposure during pregnancy, Laboratory test normal, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: Prior to establishing at our facility, pt was seen at an outside clinic where she was inadvertently administered Varicella vaccine and Hepatitis A vaccine on 4/9/19 (at approx 18.3WGA). I was notified of this error by her previous provider who also planned to make a vaccine report. Pt remains pregnant and has had no identifiable adverse effects at this time. Due date is 9/7/19.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Received the shot on Monday morning. Started feeling flu like tiredness in late afternoon. Redness and soreness at sight of injection. Felt flu like fatigue all week long and needed to get by on alternating doses of Advil and Tylenol. By Friday the symptoms seemed to subside. OK after that, but it was a tough week.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Patient complaining of muscle aches, fever, and fatigue two weeks after getting the Shingrix immunization. I offered to call the patient's physician. She declined and refuse to provide her MD information. I told her I will contact the manufacture.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Laboratory test, Scan
Clinical narrative: SOME REDNESS/INFLAMMATION ON LEFT ARM AROUND INJECTION SITE, FEELS LIKE A LUMP TO TOUCH
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient started having pain/stiffness of neck 2 days after vaccination which continued for about one week and then resolved
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: PATIENT'S WIFE CALLED, STATED SHE WAS A REGISTERED NURSE, AND HAD CONCERNS ABOUT THE INJECTION SITE BEING TOO HIGH IN THE ARM SINCE PATIENT EXPERIENCED SIGNIFICANT PAIN YESTERDAY EVENING AND THROUGH OUT THE NIGHT. SHE OFFERED TO SEND A PICTURE OF THE INJECTION SITE AND ALSO WHERE NURSES ARE TRAINED TO GIVE THE VACCINE (VIA DRAWING ON PATIENT'S ARM)
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain, Pyrexia
Clinical narrative: Had a strong fever that lasted for about a day, but it was quite severe. This is in addition to headaches, body ache and upset stomach. I took Tylenol which helped to bring down the fever. I recovered 24 hours from time of shot.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Skin warm, Swelling
Clinical narrative: Patient said she had excessive swelling and heat from the swelling with this.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Haematoma, Head injury, Headache, Loss of consciousness
Clinical narrative: This patient had a syncopal episode appoximately 15 to 30 seconds after she received her second Gardasil in the office today. She had  no adverse events with her first Gardasil immunization. The patient was sitting on the exam table at the time of vaccine administration and when she had the syncopal event. She feel forward off the exam table and struck the right frontal part of her head sustaining a hematoma in the area. After the patient regain conscienceness, she had a headache and nausea. No emesis has occurred since the injury.   The patient was re-examined and monitored. She was administered acetominophen and Pedialyte. Mother reported that she had not eaten breakfast prior to her office visit. It took greater than hour for the patient to feel strong enough to ambulate from the office. Follow up this afternoon revealed that patient continues to have a headache and neck pain. Will continue to montior mental status and concussion symptoms.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Neck pain, Syncope
Clinical narrative: This patient had a syncopal episode appoximately 15 to 30 seconds after she received her second Gardasil in the office today. She had  no adverse events with her first Gardasil immunization. The patient was sitting on the exam table at the time of vaccine administration and when she had the syncopal event. She feel forward off the exam table and struck the right frontal part of her head sustaining a hematoma in the area. After the patient regain conscienceness, she had a headache and nausea. No emesis has occurred since the injury.   The patient was re-examined and monitored. She was administered acetominophen and Pedialyte. Mother reported that she had not eaten breakfast prior to her office visit. It took greater than hour for the patient to feel strong enough to ambulate from the office. Follow up this afternoon revealed that patient continues to have a headache and neck pain. Will continue to montior mental status and concussion symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chills, Insomnia, Tachyphrenia, Temperature intolerance
Clinical narrative: Patient reports 6 hours after receiving her 2nd dose of Shingrix, she developed severe rigors, cold intolerance, insomnia and anxiety "mind was racing". Symptoms lasted approximately 12 hours and resolved spontaneously.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: swelling, hardness at injections site, redness extending along 2/3 of upper arm that lasted for 5 days