chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 09-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 10-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 06-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 08-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 07-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 5 newborns (numbered 98, 99, 100, 101 and 102). Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time= 72 hours) that the temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 15-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 13-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 16-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 01-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 31-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 29-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 27-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 21-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 30-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 20-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 53 and 54). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 26-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered 49. 50 , 51 and 52). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 25-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborns(numbered 57). Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time= 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 28-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 23-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 24-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 22-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: 9/23 Evening of flu shot: chills, sweats, felt faint, dizzy, diarrhea. 9/27 All symptoms resolved.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hyperhidrosis, Injection site pain, Pain, Pyrexia
Clinical narrative: 9/23 Evening of flu shot: chills, sweats, felt faint, dizzy, diarrhea. 9/27 All symptoms resolved.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: 9/23 Evening of flu shot: chills, sweats, felt faint, dizzy, diarrhea. 9/27 All symptoms resolved.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Vomiting
Clinical narrative: Sept. 11, 3015 - 7:30 PM HIGH DOSE flu shot. Sept. 12-noon-lunch with Metformin, diabetes,drug, 3:00 pm - vomit and 7:00PM - vomit. Stomach cramps and diarrhea. Week Sun. 9/13. Ok Monday.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Sept. 11, 3015 - 7:30 PM HIGH DOSE flu shot. Sept. 12-noon-lunch with Metformin, diabetes,drug, 3:00 pm - vomit and 7:00PM - vomit. Stomach cramps and diarrhea. Week Sun. 9/13. Ok Monday.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Impaired work ability, Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of neck swelling in a female patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). On 2nd October 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced neck swelling (serious criteria disability), general malaise (serious criteria disability) and enlargement of lymph nodes (serious criteria disability). The patient was treated with ibuprofen. On an unknown date, the outcome of the neck swelling, general malaise and enlargement of lymph nodes were unknown. The reporter considered the neck swelling, general malaise and enlargement of lymph nodes to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was vaccinated with FLUARIX QUADRIVALENT in her left deltoid. She subsequently developed swelling of the neck, underarm and lymph nodes, as well as general malaise. There was no immediate reaction, but it is unknown how soon after getting this Flu vaccine the symptoms developed. However, when she reported to the employee health clinic at her place of employment, she said she could not perform her job duties and was sent home. Treatment included ibuprofen and application of ice. She was scheduled to see the nurse practitioner at the hospital clinic on 6th October 2015. As per the health care professional, the symptoms were felt to be related to the FLUARIX QUADRIVALENT.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Impaired work ability, Local swelling, Lymphadenopathy, Malaise, Oedema peripheral
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of neck swelling in a female patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). On 2nd October 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced neck swelling (serious criteria disability), general malaise (serious criteria disability) and enlargement of lymph nodes (serious criteria disability). The patient was treated with ibuprofen. On an unknown date, the outcome of the neck swelling, general malaise and enlargement of lymph nodes were unknown. The reporter considered the neck swelling, general malaise and enlargement of lymph nodes to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was vaccinated with FLUARIX QUADRIVALENT in her left deltoid. She subsequently developed swelling of the neck, underarm and lymph nodes, as well as general malaise. There was no immediate reaction, but it is unknown how soon after getting this Flu vaccine the symptoms developed. However, when she reported to the employee health clinic at her place of employment, she said she could not perform her job duties and was sent home. Treatment included ibuprofen and application of ice. She was scheduled to see the nurse practitioner at the hospital clinic on 6th October 2015. As per the health care professional, the symptoms were felt to be related to the FLUARIX QUADRIVALENT.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Weakness and pain in the arm injected, swelling, redness and heat around the injection site that spread around the upper arm and down to the elbow over 2 days. Fatigue and pain.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Weakness and pain in the arm injected, swelling, redness and heat around the injection site that spread around the upper arm and down to the elbow over 2 days. Fatigue and pain.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram head normal, Depression, Eye pain, Fatigue
Clinical narrative: Headaches, body aches, fatigue, irritability, depression, pain behind the eyes, numbness in the limbs.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Irritability, Pain
Clinical narrative: Headaches, body aches, fatigue, irritability, depression, pain behind the eyes, numbness in the limbs.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Hyperaesthesia, Pain of skin, Rash
Clinical narrative: I received the High Dose Flu Vaccine 2015-16 SYR Lot #UI428AB on Friday, Sept 25. On the following Tuesday, I noticed a rash appearing under my right breast. Eventually a rash also appeared on the right side of my back with accompanying pain on skin. I went to a doctor on October 8, and was diagnosed with shingles. I had been given the shingles vaccine in January, 2012. I received a prescription for valacyclovir which I am currently taking. The rash is slowly going away, but I still have pain and sensitive skin in the area of the rash. Prior to receiving the flu vaccine I was in good health and was not stressed.
Age: 14.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Abdominal distension, Asthma, Condition aggravated, Cow's milk intolerance, Dry skin
Clinical narrative: I cannot say when an "event" occurred but it started the same month as the vaccine was given.  Mouth and lips swelling to fruits (apples, watermelon, peaches, etc).  Increase in eczema as well.  Became much worse after second Gardasil since I didn't realize it was related to the first Gardasil (and chicken pox booster and meningococcal vaccine).  She also developed a different skin issue that caused her skin on her face to look and feel rough (like sandpaper) but without the redness usually associated with her eczema.  She also developed asthma which she had never had before.  She also had GI issues, gas, bloating, gluten and dairy intolerance.
Age: 14.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Eczema, Flatulence, Food allergy, Gastrointestinal disorder, Gluten sensitivity
Clinical narrative: I cannot say when an "event" occurred but it started the same month as the vaccine was given.  Mouth and lips swelling to fruits (apples, watermelon, peaches, etc).  Increase in eczema as well.  Became much worse after second Gardasil since I didn't realize it was related to the first Gardasil (and chicken pox booster and meningococcal vaccine).  She also developed a different skin issue that caused her skin on her face to look and feel rough (like sandpaper) but without the redness usually associated with her eczema.  She also developed asthma which she had never had before.  She also had GI issues, gas, bloating, gluten and dairy intolerance.
Age: 14.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Hepatic enzyme increased, Lip swelling, Mouth swelling
Clinical narrative: I cannot say when an "event" occurred but it started the same month as the vaccine was given.  Mouth and lips swelling to fruits (apples, watermelon, peaches, etc).  Increase in eczema as well.  Became much worse after second Gardasil since I didn't realize it was related to the first Gardasil (and chicken pox booster and meningococcal vaccine).  She also developed a different skin issue that caused her skin on her face to look and feel rough (like sandpaper) but without the redness usually associated with her eczema.  She also developed asthma which she had never had before.  She also had GI issues, gas, bloating, gluten and dairy intolerance.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site hypersensitivity, Injection site swelling, Pyrexia
Clinical narrative: Fever 100.8, extreme chills with no relief, large "goose egg" swelling at injection site with excessive sensitivity.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia oral
Clinical narrative: Client reported "tingling sensation of lips" 1/2 hour after receiving vaccine. She refused to have vital signs taken, refused to seek treatment.  Nurse supervising immunizations spoke with client 4 hours later.  At that time client said symptom had lessened, she still had not taken any allergy med, such as Benadryl & had not called her doctor because she "wasn't concerned about the mild reaction" despite nurse urging client to seek attention.  Client knew risks involved with vaccine (She read the VIS).  The next day I spoke to client and all symptoms had subsided.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX QUADRIVALENT (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX QUADRIVALENT. Additional details were receiving as follows: Patient's age range went from around 25 - 55 years of age. In September 2015, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX QUADRIVALENT (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX QUADRIVALENT. Additional details were receiving as follows: Patient's age range went from around 25 - 55 years of age. In September 2015, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: Body wide hives, itching and throat tightening.  Patient reports taking Benadryl 25 mg PO @ 6 hours x 4 doses and pre-prescribed steroid injection x 2.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial flutter, Ocular hyperaemia
Clinical narrative: Atrial Flutter. On 10/11/15 upon rising - Ocular Hyperemia.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Diarrhea for 36 hours. Loss of appetite, tiredness.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Ct. called on 10/12/15 complaining of severe pain in left shoulder. States unable to lift that arm above shoulder level. Referred to PCP for follow-up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness size of 50 cent piece.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pruritus generalised, Urticaria
Clinical narrative: Itching, Hives over entire body with inflammation.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Oropharyngeal pain, Upper respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Woke up with sore throat and head cold.  I had a lot of drainage which in two days turned into an upper respiratory infection.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema multiforme, Injection site swelling, Joint swelling
Clinical narrative: Widespread erythema multiforme rash following localized swelling to injection site day prior which had resolved within a few hours. Did not respond to Benadryl. Also had mild joint swelling to bilateral ankles. Resolved in < 72 hours without lasting impact.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Severe soreness in shoulder around area of vaccine administration.  Has continued for almost 3 weeks now.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient's mother called in that patient "was covered head to toe in hives.  The family called his Dr. who put him on Medrol dose pak".
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Mobility decreased, Pain in extremity, White blood cell count, X-ray
Clinical narrative: Unable to move both legs. Extreme pain to legs.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Systemic Rash. Patient was given Medrol dose pak by occupational medicine.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pain in extremity, Retching
Clinical narrative: Dry heaves, chills, diarrhea, arm pain.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Influenza virus test, Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: Left arm/shoulder extremely sore and getting hard to raise. 5pm- extremely sensitive & hot to touch, immobile, whole body feverish. Aleve for pain & hot baths/cold compresses all night. Dr in the morning.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Streptococcus test
Clinical narrative: Left arm/shoulder extremely sore and getting hard to raise. 5pm- extremely sensitive & hot to touch, immobile, whole body feverish. Aleve for pain & hot baths/cold compresses all night. Dr in the morning.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Feeling hot, Nasal congestion, Ocular hyperaemia, Pyrexia
Clinical narrative: Patient called and stated that at about 3pm his eyes became bloodshot and started mattering.  His face was warm and he had nasal congestion.  He did not take his temperature but said he felt feverish.  He took Tylenol at 3pm and again about 6 hours later when he went to bed.  He woke up without symptoms.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient came by and say that she could only lift her left arm half way.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: PT INITIALLY NOTICED LUMP IN AREA WHERE VACCINATED, AREA BEGAN SWELLING THROUGHOUT MORNING - AREA AFFECTED IS FROM LEFT SHOULDER TO LEFT ELBOW. OVERNIGHT, AREA BECAME VERY ITCHY AND UNCOMFORTABLE. SHE STATES AREA THIS MORNING IS VERY RED, HOT TO TOUCH, LOOKS LIKE A VERY LARGE HIVE. SHE CALLED THE PHARMACY TODAY 10/12/15 AT 1030AM TO ASK IF SHE COULD TAKE TYLENOL. UPON DISCUSSING SYMPTOMS, I TOLD HER SHE NEEDS TO CONTACT DOCTOR TODAY FOR EVALUATION AND ASKED HER TO CALL US BACK WHEN SHE GETS MORE INFORMATION.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: PT INITIALLY NOTICED LUMP IN AREA WHERE VACCINATED, AREA BEGAN SWELLING THROUGHOUT MORNING - AREA AFFECTED IS FROM LEFT SHOULDER TO LEFT ELBOW. OVERNIGHT, AREA BECAME VERY ITCHY AND UNCOMFORTABLE. SHE STATES AREA THIS MORNING IS VERY RED, HOT TO TOUCH, LOOKS LIKE A VERY LARGE HIVE. SHE CALLED THE PHARMACY TODAY 10/12/15 AT 1030AM TO ASK IF SHE COULD TAKE TYLENOL. UPON DISCUSSING SYMPTOMS, I TOLD HER SHE NEEDS TO CONTACT DOCTOR TODAY FOR EVALUATION AND ASKED HER TO CALL US BACK WHEN SHE GETS MORE INFORMATION.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Respiratory distress, Vomiting
Clinical narrative: Respiratory distress, vomiting & flu like symptoms.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site bruising, Injection site haemorrhage, Injection site pain, Muscular weakness
Clinical narrative: Initially: immediate pain. Felt like nurse buried the needle. Felt like fire when vaccine was injected. Pain steadily worsened throughout the evening and night despite my taking naproxen and ibuprofen. In the morning, trying to get ready for work, I literally could not move my arm w/o crying, could not get dressed or lift my arm above my head. I was forced to call off work that day because of the excruciating pain. Since I am an RT at a small. I contacted the Dr's office that day to explain the situation. They were not overly concerned once I told them my arm was not red, swollen, or hot. I was advised to ice the area and come back to the office if it didn't get any better. I don't know the lot # or manufacturer. This has never happened to me before with any type of vaccine. One thing I did notice is that there was much more dried blood on the bandage when I removed it, than with my other previous vaccine (normally just a speck if any at all). This bandage was almost totally saturated - the site bled quite a bit. As I write this my arm feels better, but still tender and weak. I sought advice from a medical professional at my job who think she may have hit my nerve, and/or the vac. itself actually attacked my muscle tissue. The injection site is still bruised. I still have soreness if I use this arm for anything strenuous (I am right handed so always get vaccinated in my left arm). I can honestly say this was the worst pain I've ever experienced in my life next to childbirth.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Tenderness
Clinical narrative: Initially: immediate pain. Felt like nurse buried the needle. Felt like fire when vaccine was injected. Pain steadily worsened throughout the evening and night despite my taking naproxen and ibuprofen. In the morning, trying to get ready for work, I literally could not move my arm w/o crying, could not get dressed or lift my arm above my head. I was forced to call off work that day because of the excruciating pain. Since I am an RT at a small. I contacted the Dr's office that day to explain the situation. They were not overly concerned once I told them my arm was not red, swollen, or hot. I was advised to ice the area and come back to the office if it didn't get any better. I don't know the lot # or manufacturer. This has never happened to me before with any type of vaccine. One thing I did notice is that there was much more dried blood on the bandage when I removed it, than with my other previous vaccine (normally just a speck if any at all). This bandage was almost totally saturated - the site bled quite a bit. As I write this my arm feels better, but still tender and weak. I sought advice from a medical professional at my job who think she may have hit my nerve, and/or the vac. itself actually attacked my muscle tissue. The injection site is still bruised. I still have soreness if I use this arm for anything strenuous (I am right handed so always get vaccinated in my left arm). I can honestly say this was the worst pain I've ever experienced in my life next to childbirth.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Cheilitis, Injection site pain, Nausea, Pharyngeal oedema
Clinical narrative: C/O Swelling of throat along with severe tenderness to site, fever, aches and nausea.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: C/O Swelling of throat along with severe tenderness to site, fever, aches and nausea.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Decreased appetite, Headache, Injection site pain, Pain in extremity
Clinical narrative: Scratchy throat, left upper arm pain, pain later moved down entire left arm to all fingers in both hands, later developed trembling (trembling resolved after 3 hours), mild abdominal pain, decreased appetite, headache.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Tremor
Clinical narrative: Scratchy throat, left upper arm pain, pain later moved down entire left arm to all fingers in both hands, later developed trembling (trembling resolved after 3 hours), mild abdominal pain, decreased appetite, headache.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: My stomach and back start to become extremely sensitive to touch and what I thought at the time was hives developed on part of my back. Over the next few days this became worse and much more painful.  I went to urgent care on 10/11 and was diagnosed with Shingles.  I have never had shingles before and was feeling fine before taking the shot.  I am now on medication for treatment.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 10/10/15 STARTED HAVING A LITTLE DISCOMFORT AND HARDENING TO RIGHT AC AREA, ON 10/11/15 AREA BECAME REDDENED/ITCHY, AND ENLARGED, DONOR PRESENTED TO CENTER TODAY 10/12/15 AREA HARDENED ABOUT 2 INCHES, SKIN REDDENED ABOUT 3 INCHES IN DIAMETER AND TENDER TO PALPATION AND ITCHY, DONOR ENCOURAGED TO VISIT DOCTOR FOR EVALUATION AND TREATMENT.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: 10/10/15 STARTED HAVING A LITTLE DISCOMFORT AND HARDENING TO RIGHT AC AREA, ON 10/11/15 AREA BECAME REDDENED/ITCHY, AND ENLARGED, DONOR PRESENTED TO CENTER TODAY 10/12/15 AREA HARDENED ABOUT 2 INCHES, SKIN REDDENED ABOUT 3 INCHES IN DIAMETER AND TENDER TO PALPATION AND ITCHY, DONOR ENCOURAGED TO VISIT DOCTOR FOR EVALUATION AND TREATMENT.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain in extremity, Pruritus
Clinical narrative: Patient stated her arm started to hurt and itch badly.  Then when she woke up she felt like a "mac truck"  had run her over.  Took allergy pill (loradine?) and iced arm.  Has appt with doctor this morning (10/12/2015). She will notify us of what MD said.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Severe worsening pain with movement of any kind of my right arm. Intermittent numbness and tingling, extreme weakness of right arm.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Discomfort, Dyspnoea, Heart rate increased
Clinical narrative: Received call from pt. she had a PREVNAR13 and Flu shot this AM and she's having trouble breathing, it feels very heavy and she has a very rapid heartbeat. I advised pt call 911 and get to the ER pt's granddaughter was with her and pt said she would have her take her to the ER.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at injection site. Has not gone away. No redness or warmth to touch. Patient is medicating with pain meds for some relief.
Age: 49.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Dysuria, Injection site erythema, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Developed painful urination around noon and then resolved after an increase in fluids. Then toward the evening noticed that arm started to feel tight and noticed swelling to injection site along with warm and redness to injection site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: Approximately 5 minutes after receiving imm., patient became pale, clammy and had a syncope episode that lasted for a few seconds. Staff layed patient on soft mat on floor and raised her feet above her heart. Her vital signs were normal (B/P 90/60, heartrate 80). Patient had not had breakfast..staff gave her apple juice. When patient felt well enough to sit up, she was also given peanut butter and crackers. Staff continued to monitor patient's condition and vitals. Seemed back to normal around 10:30 and patient discharged.
Age: 54.0
Sex: F
Vaccine: ANTH
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swelling and itching of left arm which improved 10/10/15.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching, treating with antihistamines.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Significant swelling around the injection site. Patient saw his doctor, who prescribed a zithromycin 250mg dose pack for 5 days. Patient was back to normal within two days.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site painful, red and swollen. The following day developed 102 fever.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PATIENT EXPERIENCED REDNESS, SWELLING, AND WARMTH TO THE TOUCH ON THE INJECTED ARM.  THE PATIENT CAME TO THE PHARMACY ON 10/9/15 AT 7PM TO THE PHARMACIST.  HER ARM WAS RED, SWOLLEN, AND WARM TO THE TOUCH. SHE HAD BEEN TAKING MOTRIN OVER THE COUNTER WHICH SHE SAID HAD BEEN HELPING.  PHARMACIST RECOMMENDED TAKING SOME BENADRYL AS WELL AND REPORTING TO HER PCP.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Red spot at injection site; red rash on upper arm above the elbow; mild itching; soreness in upper arm for one day.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Dizzy, light-headed, body aches, fever, sore/red arm, vomiting.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Dizzy, light-headed, body aches, fever, sore/red arm, vomiting.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
Clinical narrative: At 2:00pm patient was given both the FLUVIRIN and PNEUMOVAX administered IM in the left arm spaced about 1 inch apart into the deltoid muscle. Later in the day he developed a stiff arm but still had full range of movement. He slept on his right side to avoid the painful arm that night. The following night by 8:30pm he had developed headache, myalgia, pain upon moving the arm and a painful (not itchy) red raised rash on his arm in the area between the shoulder and elbow. The largest of the patches was about 3-4 inches round. The rash did not appear directly at the injection site but it did appear below it. His on call doctor suspected cellulitis so has prescribed cephalexin for the time being and to follow up with his doctor after the weekend.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: At 2:00pm patient was given both the FLUVIRIN and PNEUMOVAX administered IM in the left arm spaced about 1 inch apart into the deltoid muscle. Later in the day he developed a stiff arm but still had full range of movement. He slept on his right side to avoid the painful arm that night. The following night by 8:30pm he had developed headache, myalgia, pain upon moving the arm and a painful (not itchy) red raised rash on his arm in the area between the shoulder and elbow. The largest of the patches was about 3-4 inches round. The rash did not appear directly at the injection site but it did appear below it. His on call doctor suspected cellulitis so has prescribed cephalexin for the time being and to follow up with his doctor after the weekend.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site erythema, Injection site irritation, Injection site nodule, Injection site pain
Clinical narrative: I woke up with pain in left shoulder and neck.  As the day went on noticed I had a knot that was red where I was injected in left arm. Pain shoots through shoulder and neck when I make certain movements and even sometimes when I take a deep breath. Over the course of the weekend, the not became more noticeable, red and warm to touch and had numbness and tingling in fingers on left hand.  The site of injection was even itchy with a burning sensation. It is now Monday and the pain does not seem to be getting better even thought the injection sight does not seem to be as irritated.