chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: presentation of hives; This case was reported by a other health professional via sales rep and described the occurrence of hives in a 56-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included seasonal allergy.   On 2nd July 2019, the patient received Boostrix .5 ml. On 5th July 2019, 3 days after receiving Boostrix, the patient experienced hives. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Boostrix.  Additional details were provided as follows: The case was reported by the practice manager. The NDC number was reported as 58160084243. The patient did not see any prior history of reactions to vaccine but patient had seasonal allergies. The patient received Boostrix in left deltoid and had presentation of hives. No other vaccines given at same time. The patient seen for follow up at another healthcare and urgent care site due to presentation of hives.  The reporter gave patient steroid and did not know if steroid injection or oral. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Anaphylactic reaction
Clinical narrative: Similar to Anaphylaxis; Several severe reactions / Symptoms may be severe; This case was reported by a pharmacist via sales rep and described the occurrence of anaphylaxis in an unknown number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant) and adverse reaction. On an unknown date, the outcome of the anaphylaxis and adverse reaction were unknown.   It was unknown if the reporter considered the anaphylaxis and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that several severe reactions after receiving a 2nd dose of Shingrix across multiple patients.  The reporter described one reaction similar to anaphylaxis. The patient also stated that the day was shot after receiving a dose. The symptoms might be severe. The reporter consented to follow up. This case been linked with the case US2020AMR102094 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR102094:1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Breast swelling
Clinical narrative: swelling of breast; This case was reported by a other health professional via interactive digital media and described the occurrence of breast swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced breast swelling. On an unknown date, the outcome of the breast swelling was unknown.   It was unknown if the reporter considered the breast swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient experienced breast swelling after shingrix vaccine administration. The reporter wanted to know could Shingrix cause swelling of breast.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter does not remember patient's name and just wanted to relay that experience. The patient developed shingles after a few days of receiving first dose of shingrix. The reporter did not consent to follow up.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: swelling in mid thigh region / area being swollen/the reaction was reportedly still as large as mother's hand; Itchy / itching; localized redness / red; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 20th May 2020, the patient received Pediarix. On 22nd May 2020, 2 days after receiving Pediarix, the patient experienced extensive swelling of vaccinated limb, pruritus and erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pruritus and erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pruritus and erythema to be related to Pediarix.  Additional details were reported as follows: The patient received Pediarix in right thigh and that evening developed localized redness and swelling in mid-thigh region.  The patient returned to the vaccinating facility and on 22nd May 2020 and with complaints of affected area being swollen, red and itchy. No anaphylaxis reported.  The patient returned to same vaccination facility again on 27th May 2020 and the reaction was reportedly still as large as mother's hand with redness, swelling and itching. It was reported they would conduct an allergy test to see if patient reacted to any of the inactive ingredients.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pruritus
Clinical narrative: swelling in mid thigh region / area being swollen/the reaction was reportedly still as large as mother's hand; Itchy / itching; localized redness / red; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 20th May 2020, the patient received Pediarix. On 22nd May 2020, 2 days after receiving Pediarix, the patient experienced extensive swelling of vaccinated limb, pruritus and erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pruritus and erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pruritus and erythema to be related to Pediarix.  Additional details were reported as follows: The patient received Pediarix in right thigh and that evening developed localized redness and swelling in mid-thigh region.  The patient returned to the vaccinating facility and on 22nd May 2020 and with complaints of affected area being swollen, red and itchy. No anaphylaxis reported.  The patient returned to same vaccination facility again on 27th May 2020 and the reaction was reportedly still as large as mother's hand with redness, swelling and itching. It was reported they would conduct an allergy test to see if patient reacted to any of the inactive ingredients.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: "flu" like symptoms; tired; "not sleeping"; "feels like an increased heart rate"; feeling "hit by a truck."; fever; left arm injection site "extremely sore"; swollen injection site; injection site red and hot; injection site red and hot; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 10th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th June 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and he woke up with flu like symptoms, fever, feeling tired, not sleeping, feeling an increased heart rate, feeling hit by a truck. The patient had extremely sore injection site and the injection site was swollen, red, and hot to the touch.  The reporter stated that these symptoms are extending below the injection site. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Malaise, Pyrexia
Clinical narrative: "flu" like symptoms; tired; "not sleeping"; "feels like an increased heart rate"; feeling "hit by a truck."; fever; left arm injection site "extremely sore"; swollen injection site; injection site red and hot; injection site red and hot; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 10th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th June 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, insomnia, heart rate increased, feeling unwell, fever, injection site pain, injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and he woke up with flu like symptoms, fever, feeling tired, not sleeping, feeling an increased heart rate, feeling hit by a truck. The patient had extremely sore injection site and the injection site was swollen, red, and hot to the touch.  The reporter stated that these symptoms are extending below the injection site. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: complications; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix, due to complications the patient did not received her 2nd dose yet. The patient disconnected the call before any additional details could be collected. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Incorrect route of product administration, Skin warm, Swelling
Clinical narrative: via subcutaneous instead of Intramuscular; Hot to touch  R Tricep; Redness; Swollen; This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KM49, expiry date 26th November 2021) for prophylaxis.   On 12th June 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 12th June 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In June 2020, the patient experienced feeling hot, erythema and swelling. On an unknown date, the outcome of the feeling hot, erythema and swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the feeling hot, erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated they inadvertently administered Shingrix via subcutaneous instead of Intramuscular to a patient, which led to intramuscular formulation administered by other route. The patient experienced swollen, redness and hot to touch at right tricep and it was spreading. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nerve compression, Pain, Pain in extremity
Clinical narrative: impinged nerve (pinched nerve?) in one of his muscles; general malaise; left arm pain; Soreness/Normal pain/Pain never went away; This case was reported by a pharmacist via call center representative and described the occurrence of pinched nerve in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than 3 weeks after receiving Shingrix, the patient experienced pinched nerve, general malaise, pain in arm and pain. On an unknown date, the outcome of the pinched nerve, pain in arm and pain were not recovered/not resolved and the outcome of the general malaise was unknown.   It was unknown if the reporter considered the pinched nerve, general malaise, pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had general malaise and left arm pain and soreness, but attributed it to normal pain after an injection.  The reporter stated that from January until 16th March 2020, the patient continued his normal activity, which also included playing tennis, but the pain never went away.  The patient had a doctor's appointment and was then referred to physical therapy, where it was discovered that he had an impinged nerve in one of his muscles. They were unable to definitively provide a cause and could not say if it was related to the vaccine as it was not listed as a common adverse effect listed with the vaccine. The reporter consented to follow up and also provided the patient's name and telephone number as well for follow up with patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced shingles after dose one of Shingrix.  No additional details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness; This case was reported by a other health professional via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced dizziness following the Shingrix.  No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Injection site swelling, Pyrexia
Clinical narrative: bilateral headaches; Severe fatigue; Fever; Swelling at injection site; redness; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, injection site swelling, erythema, headache and fatigue. On an unknown date, the outcome of the fever, injection site swelling, erythema, headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, injection site swelling, erythema, headache and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced after 1st dose of Shingrix fever, swelling at injection site, redness,bilateral headaches an severe fatigue. The fever, swelling and redness gone in 3 to 4 days but fatigue and headaches for additional week. No additional details were given. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On 13th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were reported as follows: The pharmacist asked for information on dizziness experienced after the patient received 1st dose of Shingrix. The reporter consent to follow up. No further information was provided.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: on 5/7 patient called to report ongoing pain in the left arm with inability to lift the arm. She states the pain is ongoing since the vaccine was administered on 4/28.  On 6/18 with PCP visit continues to report soreness of the right arm.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Loss of consciousness, Tremor
Clinical narrative: patient was walked down the hallway and fell to the floor  shaking,  passed out  for  3 to 4 seconds.   Put my hand under his head and held him and talked to him to bring him back to consciousness. Once he woke I walked him to the room laid him on the bed and propped his feet. Gave him a cool drink of water and made him sit for 15 mins.
Age: 33.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A customer that is 33 years old comes in for GARDASIL 9; No additional adverse effects reported; This spontaneous report was received from a pharmacist and refers to a 33-year-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lo# and expiry date were not provided) for prophylaxis (product administered to patient of inappropriate age). The patient did not come back for the second dose until 4 months. The reporter wanted to know when should the patient back for the third dose. No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had side effects. The reporter asked would the patient had the side effects the day after the injections. The reporter would contact his/her physician if still felt this way tomorrow.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dysphagia, Hypertension, Oropharyngeal discomfort, Tinnitus
Clinical narrative: Buzzy ear/Buzzy nose/Buzzy lips/Buzzy tongue; felt shaky; felt thickness in her tongue; Trouble swallowing/throat felt weird as her swallowing was not as smooth with slight stopping; blood pressure was at 190/85; throat felt weird; This case was reported by a consumer via call center representative and described the occurrence of ear buzzing in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M774A, expiry date 30th June 2020) for prophylaxis.   On 22nd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 22nd October 2019, immediately after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of. The patient was treated with prednisone and salbutamol (Albuterol Nebulizer). On an unknown date, the outcome of the ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of were recovered/resolved.   It was unknown if the reporter considered the ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient stated that she was at her gynecologist office for a regular visit.  The patient received Fluarix Quadrivalent 2019-2020 season and within a minute after getting the vaccine she experienced buzzing in her ears, nose, mouth, lips, and tongue. She also felt shaky, and felt thickness in her tongue and her throat felt weird as her swallowing was not as smooth with slight stopping and at down and drank some water. The feeling started to intensify, she was taken down to the urgent care downstairs right away after. Upon checking her blood pressure was at 190/85 at the urgent care.  The patient was given IV prednisone and albuterol nebulizer treatment at the urgent care. Within half an hour her system calmed down and everything resolved. The patient was given prednisone to take orally for 5 days and next day she went to her general practitioner and was told that she needs to finish the 5 days oral course of prednisone so there was no rebound.  The patient also followed up with her allergist and was recommended to not get the Flu vaccine until she goes through baseline blood test and was scheduled for serum triptase baseline blood test next week. The reporter consented to follow up. No other details were provided. The reporter did not have the doctor's name.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Tongue disorder, Tremor
Clinical narrative: Buzzy ear/Buzzy nose/Buzzy lips/Buzzy tongue; felt shaky; felt thickness in her tongue; Trouble swallowing/throat felt weird as her swallowing was not as smooth with slight stopping; blood pressure was at 190/85; throat felt weird; This case was reported by a consumer via call center representative and described the occurrence of ear buzzing in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M774A, expiry date 30th June 2020) for prophylaxis.   On 22nd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 22nd October 2019, immediately after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of. The patient was treated with prednisone and salbutamol (Albuterol Nebulizer). On an unknown date, the outcome of the ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of were recovered/resolved.   It was unknown if the reporter considered the ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient stated that she was at her gynecologist office for a regular visit.  The patient received Fluarix Quadrivalent 2019-2020 season and within a minute after getting the vaccine she experienced buzzing in her ears, nose, mouth, lips, and tongue. She also felt shaky, and felt thickness in her tongue and her throat felt weird as her swallowing was not as smooth with slight stopping and at down and drank some water. The feeling started to intensify, she was taken down to the urgent care downstairs right away after. Upon checking her blood pressure was at 190/85 at the urgent care.  The patient was given IV prednisone and albuterol nebulizer treatment at the urgent care. Within half an hour her system calmed down and everything resolved. The patient was given prednisone to take orally for 5 days and next day she went to her general practitioner and was told that she needs to finish the 5 days oral course of prednisone so there was no rebound.  The patient also followed up with her allergist and was recommended to not get the Flu vaccine until she goes through baseline blood test and was scheduled for serum triptase baseline blood test next week. The reporter consented to follow up. No other details were provided. The reporter did not have the doctor's name.
Sex: U
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Pain and fever; Pain and fever; This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative.  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced pain and fever. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Malaise, Pain in extremity, Pyrexia
Clinical narrative: PATIENT CALLED MONDAY MORNING,06/22/20 AND REPORTED HER ADVERSE EVENTS. SHE RECEIVED HER SECOND DOSE SHINGRIX ON 06/18/2020 AROUND 11:30AM, SHE STARTED TO FEEL SORENESS ON HER LEFT ARM AROUND 2PM SAME DAY THEN AROUND 5PM STARTED TO FEEL LITTLE UNDER THE WEATHER KIND OF AND THEN SYMPTOMS CONTINUED TO PROGRESS WITH REDNESS ON HER ARM. DIDN'T CHECK TEMPERATURE BUT FELT FEVERISH. FROM FRIDAY AFTERNOON ON SHE WAS IN BED WENT TO URGENT CARE ON SUNDAY MORNING HAD SLIGHT FEVER 99.7. MD PRESCRIBED KEFLEX FOR CELLULITIES. NOW FEELING BETTER HAS A FOLLOW UP VISIST WITH PCP ON TUESDAY 06/23/2020. PATIENT WENT TO URGENT CARE.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pain + swelling around injection site, raised, erythematous, itchy hives around injection site, body aches + swelling in throat. No SOB or difficulty breathing. Admits headache as well. Lasted approx. 72 hrs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pain, Pharyngeal swelling
Clinical narrative: pain + swelling around injection site, raised, erythematous, itchy hives around injection site, body aches + swelling in throat. No SOB or difficulty breathing. Admits headache as well. Lasted approx. 72 hrs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: patient had high fever 102 and injection site reactions
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe Chills, 6 hours Fever of 102,  gradually decreasing, 48 hours Headache, several hours Body Pain , 48 hours
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: severe abdominal cramping that started on 6/19 and still continuing on 6/22 when reported
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Rash pruritic
Clinical narrative: In less than 24 hrs developed non-raised, non-itchy pink rash extending in 3-4 different sites on outside of right arm; from injection site to elbow.  Spots were approximately 2"x4" in size .  Next day experienced extreme fatigue where Pt uncharacteristically slept all day.  Symptoms resolved by next day.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Malaise, Nausea, Polymerase chain reaction
Clinical narrative: 24-48 hours of nausea with vomiting, headache, dizziness, fever, and malaise
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: 24-48 hours of nausea with vomiting, headache, dizziness, fever, and malaise
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Chills, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm for 10 days. Flu like symptoms for three days; bedridden for two days. Chills, every joint ached, felt like I was beaten with a baseball bat.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient complains of rash on right arm. patient received shingrix injection on 3/15/18, states about ten days after injection , he  noticed a burning sensation in right arm lasting about until 3/30/18, once the burning stopped he noticed a rash on arms and back on right side with the appearance of a pattern. Pt seen by MD who prescribed Acyclovir for possible shingles
Age: 49.0
Sex: M
Vaccine: MMR
Symptoms: Dermatitis contact, Rash, Rash pruritic, Rash vesicular
Clinical narrative: After receiving MMR vaccine on September 17th,patient presented with a reddened, itchy rash on his arms and stomach on September 19th. Methylprednisolone was administered. On September 23rd, patient reported blistering rash on arms, legs, and abdomen. PCP referred to ED, where patient was diagnosed with poison ivy. Patient was given IV benadryl and prednisone and by 09/26/19, the rash was documented to have been improving. It is unclear if the initial presentation of rash was due to poison ivy as well.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Pruritus, Urticaria
Clinical narrative: ErythemaMultiform & UrticariaPruritus
Sex: M
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Immediate post-injection reaction
Clinical narrative: I had a bad reaction (stroke) right after my last pneumonia vaccine.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  A 69-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date for immunisation.   The patient medical history and concomitant medications were not reported.  The patient had a bad reaction (stroke) right after the last pneumonia vaccine on an unspecified date.  The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient is late for her second in the series and coming in on day 11 for her second dose, no AE; Initial information received on 16-Jun-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 23 years old female patient who is late for her 1.0 ml second dose in the series of RABIES (HDC) VACCINE [IMOVAX RABIES] ] (lot R1C71, Expiry date 30-Apr-2020, route and site of administration were not reported) for unknown indication on 16-Jun-2020. it is reported that she is coming in on day 11 for her second dose.  Medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to Inappropriate schedule of vaccine administered.  At the time of reporting, no adverse event was reported.  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.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 2 year old patient recieved an expired dose of Ipol, no AE; Initial information received on 16-Jun-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional (office staff).  This case involves a 2 years 6 months 15 days years old male patient who received a 0.5 ml fourth dose of an expired vaccine IPV (VERO) [IPOL] (P1A371M, Expiration date: 27-Apr-2020), via intramuscular route in the left thigh as prophylactic vaccination on 12-Jun-2020 [Expired product administered].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Exposure during pregnancy
Clinical narrative: lightheadedness; pregnant patient who received the Tdap vaccine; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient who experienced lightheadedness (dizziness), following the administration of  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was reported that she received vaccine while she was pregnant.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On 08-Jun-2020, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE, the patient experienced non-serious event of lightheadedness (dizziness).  It was also the case of vaccine exposure during pregnancy.   Details of laboratory data are not reported.  Final diagnosis was dizziness.   It was not reported if the patient received any corrective treatment.  Outcome of lightheadedness was not reported.  Pregnancy outcome was unknown at the time of report.
Age: 55.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Incorrect route of product administration, Injection site pain, Wrong product administered
Clinical narrative: a patient received a 0.5ml dose of Tubersol instead of TDAP vaccine; patient received 0.5ml of Tubersol via intramuscular route into the right deltoid; patient received 0.5ml of Tubersol IM into the right deltoid; right arm was hurting at the injection site, all the way up into her neck; Initial information and additional information was received on 16-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional (Physicians Assistant).  This case involves a 55-year-old female patient who experienced right arm was hurting at the injection site, all the way up into her neck (pain in extremity), while she was tested with TUBERCULIN TEST [TUBERSOL] and received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDap].  Medical history, medical treatment, vaccination and family history were not provided. No concomitant therapies were given.  On 12-Jun-2020, the patient was tested with a 0.5 mL TUBERSOL (TUBERCULIN TEST) (lot number: C5588AA, expiry date: 17-Jun-2021) via intramuscular at the right deltoid for Tuberculin test. On an unknown date, the patient received a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer), (lot number and expiry date not reported) via unknown route at the left deltoid for prophylactic vaccination.  On 15-Jun-2020, the patient was complaining that her right arm was hurting, all the way up into her neck (pain in extremity), three days following the first dose intake of TUBERCULIN TEST.   It was also a case of overdose and an actual medication error due, wrong product administered, inappropriate route of vaccination. The patient was tested with 0.5 mL TUBERSOL via intramuscular at the right deltoid (overdose and incorrect route of product administration). This event was assessed non-serious event.  It was reported that, patient received 0.5ml of TUBERSOL, rather than the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. When the mistake was realized, the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE was properly administered in the left deltoid.   Details of laboratory data not reported.  Final diagnoses was pain in extremity.  It was not reported if the patient received any corrective treatment.  The event outcome was not reported for pain in extremity.  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.  There will be no information available on the lot number for this case.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: child received a dose of Pentacel without the DTaP IPV portion, and the Hib portion was reconstituted with sterile water, no AE; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four month old female patient who received a 0.5 ml once dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217AAA and Exp. Date 22-Jan-2022) via an unknown route in an unknown administration site on 12-Jun-2020 for prophylactic vaccination, without the DTaP IPV portion, and the HIB portion was reconstituted with sterile water (ActHIB Lot number- UJ217AA, DTaP IPV Lot number- U6540AA,) (product preparation issue). The reporter also mentioned the child was a little behind schedule and was in for their month 4 immunizations.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ (PCV) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  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.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 12 year male patient received expired Ipol vaccine which was expired on 02May2020, no AE; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case received from a office staff via medical assistant.  This case involves a 12 year old male patient who received an expired dose of vaccine IPV (VERO) [IPOL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for prophylactic vaccination.  On 17-Jun-2020, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) (lot number: P1A25 and expiry date: 02-May-2020) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  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.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm for 3 days. Flu like symptoms for 2 days. Chills, every joint ached like I had been beaten. It wasn't as bad as the first dose, but still horrible:(
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Gastrooesophageal reflux disease, Infantile spitting up
Clinical narrative: Frequent increased reflux. Per Mom, dramatic change from before to after the visit. Describes significant spit up, out of mouth and nose, with each feed, which did not occur prior to the visit. No change in formula type, volume, or frequency. No concern for pyloric stenosis (remains hydrated, good UOP and stool production). Managing with reflux precautions.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: arm swollen and red, headaches, body aches for 5 days
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: His arm blew up to the size of a baseball, red, itchy, burning. Also spiked fever of 100 (his normal temp is 97.8)
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: fever, headache, fatigue, nausea acetaminaphine eased symptoms felt totally fine next day
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old patient presented as a new patient to clinic and behind on documented immunizations. There was no documentation that DTaP and IPV had been administered at 4 years of age. Patient was administered Kinrix on that date. It was later realized that the age indication was restricted to 4-6 years. Patient's grandmother was contacted, who confirmed that patient had no adverse reactions to immunization. Was advised that immunization was given outside of age indication and 2 separate immunizations should have been administered instead. Grandmother verbalized understanding. Was advised if there were any further questions to please contact the office.
Age: 0.08
Sex: F
Vaccine: RV1, RV1
Symptoms: Haematochezia
Clinical narrative: BLOODY STOOLS
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Communication disorder, Confusional state, Crying, Food aversion, Language disorder
Clinical narrative: crying at time of shot.  increased later to unconsolable crying and wailing within a few hours.  Never happened before with previous  vaccines in the past.  Onset of fever within hours of the shot that increased throughout the afternoon.  Nausea and aversion to food. Aversion to any soothing mechanisms.  The most alarming was that her receptive and expressive language was affected.  She went from knowing 10+ different signs in Sign Language and communicating nonverbally effectively with us for months, to losing this ability the day of the shot.  At first we thought she still wasn't feeling well from the shots but this carried on with so much confusion on her end and it took months and lots of work for her to relearn all what she lost.  In the work I do, I had never seen a setback like this in a healthy child who only showed developmental progress until this time.   It was a major setback in her communication and learning.  Stopped communicating with caregivers nonverbally, despite knowing and performing Sign Language for months.  Would only do one sign and looked confused.