chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: 3 days of fever so far (103.6) and a spotted rash on trunk.
Age: 75.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Paraesthesia, Rash, Swollen tongue
Clinical narrative: Pt. states that reactions began hours after receiving vaccines. She reports having tingling of both arms, a generalized rash on her arms and torso, and a sensation of swelling of the tongue. Pt. states she went to her PCP the day after receiving vaccines, no further action was taken by the PCP. Pt. states symptoms subsided throughout the second day after receiving vaccines.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Pt came in next morning with severe swelling and rash noted to left arm.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus generalised
Clinical narrative: DESCRIBED "ITCHING ALL OVER BODY, WORSE ON BACK AND ARMS". THERE WAS NO RASH, HIVES, ERYTHEMA OR RAISED AREAS. (SKIN FLAT).
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: Intermittent nerve pain, numbness and tingling down the right arm and hand.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Rash macular
Clinical narrative: Patient presented to clinic with large 6 cm in diameter round macular/raised red rash and site tenderness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Full blood count normal
Clinical narrative: Fever 101, fatigue, BP 171/89, major headache, dizziness, weakness, heart rate 95, unable to catch breath.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Laboratory test normal, Pyrexia
Clinical narrative: Fever 101, fatigue, BP 171/89, major headache, dizziness, weakness, heart rate 95, unable to catch breath.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine was given in error. Not indicated for patient at this time.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Fall, Gait disturbance, Injection site nodule, Injection site rash, Pain
Clinical narrative: Golf ball size knots at all injection sites, rash, fever of 102 degrees for 3 days, trouble walking for 2 weeks (falling constantly and lots of pain) rash at injection sites.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Golf ball size knots at all injection sites, rash, fever of 102 degrees for 3 days, trouble walking for 2 weeks (falling constantly and lots of pain) rash at injection sites.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Severe sore throat, swelling in throat, swollen glands.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 17-year-old female patient who received BEXSERO. On 21st July 2017, the patient received BEXSERO. On 21st July 2017, less than a day after receiving BEXSERO, the patient experienced injection site pain. On 22nd July 2017, the patient experienced injected limb mobility decreased, injection site erythema and injection site lump. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, injection site erythema and injection site lump were not recovered/not resolved. The reporter considered the injected limb mobility decreased, injection site pain, injection site erythema and injection site lump to be related to BEXSERO. Additional details were provided as follows: The case was reported by the patient's mother. The injection site was very bad on Friday night and ice was applied. On next day, the patient could barely move her arm and the patient's mother put it in a sling. The area was red and there is a lump where the pain is located.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness in a leg in a 19-year-old female patient who received BEXSERO (batch number 159001A, expiry date unknown). On 25th May 2017, the patient received the 1st dose of BEXSERO. In May 2017, several hours receiving BEXSERO, the patient experienced numbness in leg. On an unknown date, the outcome of the numbness in leg was recovered/resolved. The reporter considered the numbness in leg to be almost certainly related to BESERO. Additional information was provided as follows: The patient experienced numbness in the legs for five days after being administered BEXSERO. The healthcare professional did not have expiry date.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Feeling cold, Pyrexia, Sleep terror, Tremor
Clinical narrative: 08/04/2017 at 09:40 AM mother called and spoke with RN. Mother stated child had an episode of shaking during sleep, appeared to partially wake up but was still partly asleep. Shaking lasted about 3 minutes. Mom stated she gave child MOTRIN after he received the vaccinations. Child had been running a slight temperature earlier in the evening and states he mentioned he felt cold; at this time she gave him more MOTRIN. Mother stated child does have a Hx of night terrors and does sometimes wake up in the middle of the night. She felt the shaking was different in this case. Client was told the temperature increase is a typical reaction but the other symptoms are not typical. Child seems okay today per parent. Let parent know report would be filed per RN on 08/04/2017. Client also had Hx febrile seizures as a toddler unrelated to vaccines per parent. Per parent, did not actually take child's temperature but stated he felt warm.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Loss of personal independence in daily activities
Clinical narrative: Pt is suffering from lower back pain. Does not want to get out of bed.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Fatigue, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Received an HPV vaccine on 7/18. That evening got a very sharp LUQ pain, felt like a poking sharp sensation. No other symptoms. Lasted for about 10 minutes. Then 3 days later, legs started to feel numb and tingling. Legs feeling like this and feel really tired with stair climbing or other exertion. Left arm and right hand intermittently tingly. The bump at the injection site is still present and then a week ago the entire right side of neck and tops of shoulder hurting. The size of the bump at injection site has enlarged. Started Rifampin July 10.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Neck pain, Paraesthesia
Clinical narrative: Received an HPV vaccine on 7/18. That evening got a very sharp LUQ pain, felt like a poking sharp sensation. No other symptoms. Lasted for about 10 minutes. Then 3 days later, legs started to feel numb and tingling. Legs feeling like this and feel really tired with stair climbing or other exertion. Left arm and right hand intermittently tingly. The bump at the injection site is still present and then a week ago the entire right side of neck and tops of shoulder hurting. The size of the bump at injection site has enlarged. Started Rifampin July 10.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Slight fever, chill, redness on injection site and arm pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. In July 2017, the patient received the 2nd dose of BEXSERO. On an  unknown date, 1 day after receiving BEXSERO, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the  injection site erythema and injection site pain to be related to BEXSERO. Additional details were provided as follows: In June 2017, the patient received 1st dose of BEXSERO. In July 2017, the patient received 2nd dose of BEXSERO and developed pain and erythema at injection site about 2 inches in diameter. The patient required emergency room visit and returned to doctor's office the next day for further assessment of the area following the reaction. No further information was reported regarding the event.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional information was provided as follows: The age at vaccination was not reported. The patient developed high fever and body temperature was recorded as 105 F. The healthcare professional was unsure if BEXSERO was the reason for the adverse reaction, another vaccine was also administered that day. No further information was reported regarding the event.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: 7/31/17 Pea size palpable lump under skin upper left thigh. Immunization administered 7/26/17. After administration red, purple rash surrounding injection site, resolved.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling, Pruritus
Clinical narrative: Stiffness, itching, redness, swelling from shoulder to below elbow.
Age: 12.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Mom reported redness, warmth and swelling in affected extremity: instructed to use ice, TYLENOL or MOTRIN and to seek medical attention if needed.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling, blistering of back of arm where vaccine was administered. 2 days following administration, patient went to ER and received pain meds, antibiotics and steroids.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: On 9/30/16, This 4 yo C/U with MMR-V and KINRIX administered. . On 9/30/16, as per Mother, pt has pain and mild swelling at (L) thigh. On 10/02/16, area spread and was red, hot, hard and painful. Pt. developed fever (and chills) and spiked to 104 degree F overnight. Pt also C/O stomach ache and throat pain. 10/03/16 - on exam (L) Anterior thigh redness + 71/2 in ling x 8 in medially to anterior lateralis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth, Oropharyngeal pain, Pyrexia
Clinical narrative: On 9/30/16, This 4 yo C/U with MMR-V and KINRIX administered. . On 9/30/16, as per Mother, pt has pain and mild swelling at (L) thigh. On 10/02/16, area spread and was red, hot, hard and painful. Pt. developed fever (and chills) and spiked to 104 degree F overnight. Pt also C/O stomach ache and throat pain. 10/03/16 - on exam (L) Anterior thigh redness + 71/2 in ling x 8 in medially to anterior lateralis.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose increased, Dyskinesia, Unresponsive to stimuli
Clinical narrative: Pt received MENACTRA vaccine in Lt deltoid at 1030-at 1035 pt became unresponsive with involuntary movements of her ext-lasted < 20 sec.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Malaise, Mobility decreased, Muscular weakness
Clinical narrative: Pt started feeling sick 48 hrs after injection. She spent 2 days in bed with achy body and general malaise. She continues to have profound fatigue, body aches, weakness. But is improving, slowly, leg muscles are weak. She has difficulty getting up from chair. No respiratory issues.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pt started feeling sick 48 hrs after injection. She spent 2 days in bed with achy body and general malaise. She continues to have profound fatigue, body aches, weakness. But is improving, slowly, leg muscles are weak. She has difficulty getting up from chair. No respiratory issues.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Decreased appetite, Dysphagia, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: 2-3d after injection, developed leg and arm pains, arm weakness, vision blurring, loss of appetite dysphagia, overall feeling of unwellness. No difficulty walking, no numbness tingling. No gait changes. No difficulty breathing nor inability to swallow. These symptoms persisted for about 7 days, then were improved upon evaluation by me on 8-3-17. At evaluation she still had vision blurring, leg pains but arms were normal, dysphagia resolved; leg pains are improved. Pt does not appear to be Guillain Barre at this time, but she is 2 weeks out from the vaccine at this time.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Vision blurred
Clinical narrative: 2-3d after injection, developed leg and arm pains, arm weakness, vision blurring, loss of appetite dysphagia, overall feeling of unwellness. No difficulty walking, no numbness tingling. No gait changes. No difficulty breathing nor inability to swallow. These symptoms persisted for about 7 days, then were improved upon evaluation by me on 8-3-17. At evaluation she still had vision blurring, leg pains but arms were normal, dysphagia resolved; leg pains are improved. Pt does not appear to be Guillain Barre at this time, but she is 2 weeks out from the vaccine at this time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at injection site of the KINRIX vaccine, hot to the touch w/small bruise at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site. Warmth. Swelling.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: 20 mm of induration, s/s of redness and swelling. No treatment necessary.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Tremor
Clinical narrative: Pt's mother reports that pt received a series of three vaccines at a primary care visit earlier in the day. Pt's family was driving on highway and witnessed pt having a "full body, arms, and head shaking" for less than 1 minute. EMS was called and pt did have a temperature 100.8°F at that time. Pt had temperature in ED of 101.8°F. Pt had not been treated with any anti-pyretics.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Mobility decreased, Pain, Swelling
Clinical narrative: Diagnosed as cellulitis at Urgent care. Nurse practioner on Wed August 2nd. A great deal of swelling and pain especially the night of and the day after. Unable to move my arm. Given antibiotics for 10 days. August 4th swelling is going down and pain almost gone. Worst shot I ever had.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: Patient received ZOSTAVAX while taking HUMIRA.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Patient returned to the pharmacy two days after injection. Injection site had "hard bump", was warm, itching and localized.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Malaise, Pruritus, Skin warm, Swelling
Clinical narrative: LOCALIZED REACTION ON ARM THAT VACCINATION WAS GIVEN (RED, RAISED, WARM TO THE TOUCH, ITCHY AREAS) AND A GENERAL FEELING OF MALAISE STARTED WITHIN 18 HOURS OF INJECTION. SHE WILL USE COLD COMPRESSES AND BENADRYL TO RELIEVE THE ITCH AND IBUPROFEN TO RELIEVE THE GENERAL ILL FEELING. NO FEVER.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Feeling abnormal, Nausea, Pain, Pain in extremity
Clinical narrative: Not only is patient experiencing extreme pain the arm that was vaccinated but widespread aches/pain. Patient is experiencing severe nausea that started at 1am-2am the day after received vaccine. Patient is concerned and feels bad enough he is going to seek medical attention. Patient requested we make a note of the illness both in his profile and to report the incident.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Decreased activity, Feeling abnormal
Clinical narrative: Patient stated he felt arthritis-like symptoms and "felt like hell."  He normally is very active and has been resting in bed since, which is unusual for him because he normally has high energy.
Age: 73.0
Sex: M
Vaccine: TD
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Patient had 4cm contusion with localized swelling and erythema traveling down inner bicep.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye pain, Injection site pain, Injection site rash
Clinical narrative: Patient reports that the day after injection, she had site reactions, a little pain, controlled with ibuprofen. was not spreading at the time. today, 8/5/17, patient reported spreading of the injection site reaction down the arm. Patient also reported left lower eye pain. Upon examination, the injection site itself was not red but there was a rash above the patients left bicep. I will be following up with patient personally over the next two days. If it continues to spread or get any worse, i instructed patient to contact the doctor.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Urticaria
Clinical narrative: Rash at injection site - 1.5" x 1.5". Raised welt underneath.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Pt given vaccine in am, reaction started same eve shot given. Ppt came in 8/5/2017. Rph gave oral benadryl caps to take, and also told pt to ice area. Sent pt home with extra benadry caps if needed. Rph told pt to seek medical advice if reaction worsens or diffulcty breathing. Rph to follow up with pt 8/6/2017. Also before shot given, got okay from md to proceed with ZOSTAVAX even though possible reaction cause pt on methotrexate.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in left shoulder. Cannot lift arm over shoulder.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Patient's wife reported patient being nauseated and vomiting this afternoon after flu shot. She explained they did go to a restaurant after the flu shot. The patient ate, she did not. She feels fine.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Disability, Injection site pain, Insomnia, Muscle twitching
Clinical narrative: That afternoon I received the shot I had pain all down my arm and in my shoulder front and back and neck and into my left chest area. As the night went on the pain was so intense and hurting in my left arm I had a very hard time sleeping.  Have progressed to 16 disability in my left hand arm now. Have twitching of my left arm constantly now.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: That afternoon I received the shot I had pain all down my arm and in my shoulder front and back and neck and into my left chest area. As the night went on the pain was so intense and hurting in my left arm I had a very hard time sleeping.  Have progressed to 16 disability in my left hand arm now. Have twitching of my left arm constantly now.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure
Clinical narrative: Patient had full seizure for 2 minutes. She recovered fully to alert and oriented x 3 within 10 minutes. Able to walk, talk completely oriented and independent.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Nausea, Pyrexia
Clinical narrative: Redness, nausea, fever, chills, fatigue started 2 hrs after receiving vaccine - got better with time but symptoms lasted approximately 1 1/2 days.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: Patient developed hives/swelling all over the body. Patient was diagnosed as having an allergic reaction to the flu vaccine. Patient was prescribed Medrol dose pack for the symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness, painful to right arm.
Age: 0.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: TDap was given to term neonate instead of Hep B vaccine. Increased frequency of vital sign monitoring. No physical reaction occurred. Vital signs remained stable and he got his normal Hep B vaccine the next day with out difficulty.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized induration/redness overlying injection site.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Enuresis
Clinical narrative: Woke up next AM while wetting bed.
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Fall, Foaming at mouth, Head injury, Laboratory test, Loss of consciousness
Clinical narrative: Upon leaving immunizations clinic pt had labs drawn and had approximately 3 vials of blood drawn. He was waiting in the waiting room to see a provider and fell out of his chair and bumped his head on the floor. Upon approaching pt he was lying on the floor and he appeared to unconscious. Upon speaking to him, he began to foam at the mouth. At that time we turned him to his side and before we could completely get him back on his side, he regained consciousness. Upon obtaining vitals on him, they were all stable and he stated that he felt fine. Dr. examined pt, and diagnosed him as having a vasovagal reaction; however, with the fact that he has to drive to get home, the severity of the impact when he bumped his head, and the fact that he displayed seizure like activity, we asked the pt to go to the hospital to be evaluated.
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Presyncope, Seizure like phenomena
Clinical narrative: Upon leaving immunizations clinic pt had labs drawn and had approximately 3 vials of blood drawn. He was waiting in the waiting room to see a provider and fell out of his chair and bumped his head on the floor. Upon approaching pt he was lying on the floor and he appeared to unconscious. Upon speaking to him, he began to foam at the mouth. At that time we turned him to his side and before we could completely get him back on his side, he regained consciousness. Upon obtaining vitals on him, they were all stable and he stated that he felt fine. Dr. examined pt, and diagnosed him as having a vasovagal reaction; however, with the fact that he has to drive to get home, the severity of the impact when he bumped his head, and the fact that he displayed seizure like activity, we asked the pt to go to the hospital to be evaluated.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Was given IMZ on 7/30/17. On 8/2/17 she felt "pain all over, all the way down to her finger tips". Then she woke up on 8/6/17 with her immunized arm hot, swollen and very red, and a bit itchy.  When asked if she had a fever, she responded "not much".
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Was given IMZ on 7/30/17. On 8/2/17 she felt "pain all over, all the way down to her finger tips". Then she woke up on 8/6/17 with her immunized arm hot, swollen and very red, and a bit itchy.  When asked if she had a fever, she responded "not much".
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient reports vesicular rash on chest, back and inner thighs. No other disease signs/symptoms present. Patient seen by primary care provider, who advised her to treat the rashes with topical hydrocortisone and/or oral diphenhydramine. Upon follow-up approximately 15 days post-vaccination patient reports rash has improved significantly.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Allergy to vaccine, Erythema, Injection site reaction, Nausea, Peripheral swelling
Clinical narrative: Patient called 2 days after the vaccinations and said her arm was red and swollen with a "ridge" around the area. She also stated she was nauseous and had vomiting that day. I spoke with her again 4 days after the immunization. She said her arm was getting better and she was not nauseous any more. She had gone to urgent care. They told her it was probably an "allergy" to the flu shot and gave her something for nausea, but she did not need it anymore.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Patient called 2 days after the vaccinations and said her arm was red and swollen with a "ridge" around the area. She also stated she was nauseous and had vomiting that day. I spoke with her again 4 days after the immunization. She said her arm was getting better and she was not nauseous any more. She had gone to urgent care. They told her it was probably an "allergy" to the flu shot and gave her something for nausea, but she did not need it anymore.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site pain, Injection site rash
Clinical narrative: Patient awoke with painful rash on right upper arm just inferior to vaccine injection site. This afternoon, also noted chills and joint aches. Took 800mg ibuprofen about 5PM, feels better now.
Age: 32.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Erythema
Clinical narrative: PATIENT DESCRIBED HAVING ONE RED SPOT ON ONE OF HER HANDS YESTERDAY (08/05/2017) AND TWO ON EACH HAND TODAY (08/06/2017). NO FURTHER COMPLAIN STATED BY THE PATIENT.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Complex regional pain syndrome, Pain
Clinical narrative: Patient had wrist fracture in May 2017. She was given Pneumovax in same arm 7/5/2017. She was no longer wearing a cast. Patient had no pain until a few days later. The doctor diagnosed her with complex regional pain syndrome caused by introducing pain or trauma (including drawing blood or vaccination) into a patient who has suffered from a fracture recently.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness, pain at injection site.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Low grade fever (99 degrees F) beginning on 8/2. Mid afternoon on 8/5 fever jumped up to 102-103, but got down to 99-100 with medication. Fever has continued to be very high (102-103) on 8/6, but is brought down to 99-100 with medication. He is not interested in eating, and vomited on 8/6 around 4 PM.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Blindness, Hypotension, Rash
Clinical narrative: Rash on neck and trunck, following my severe hypotension, loss of vision a few minutes after leaving urgent care clinic (~10 minutes after injection administered).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Pt has new symptom after 6/2014.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, and redness in vaccinated arm from shoulder down to elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced pain at time of injection. Started to itch the day after. Now experiencing redness about 4 inches long with severe itchy, sore arm and warm at the site. Swelling at site also. Has used topical hydrocortisone and BENADRYL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Patient experienced pain at time of injection. Started to itch the day after. Now experiencing redness about 4 inches long with severe itchy, sore arm and warm at the site. Swelling at site also. Has used topical hydrocortisone and BENADRYL.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Pt. described a high fever that lasted 2 days.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Injection site scab, Laboratory test, Loss of personal independence in daily activities, Nervous system disorder
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 68-year-old male patient. The patient's pertinent medical history was unknown by the reporter. He had no drug reactions or allergies. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # K021624, expiration date: 28-FEB-2016, subcutaneously, in the left arm (dose was not provided), for shingles prevention, which was reconstituted with sterile diluent. He did not take concomitant medications. Approximately on 12-FEB-2015 (reported as one week later), he experienced a "scab" at the injection site. The pharmacist reported that the scabs were "burned off" by an unspecified physician. Approximately on the same day (1 week after ZOSTAVAX was administered), he developed a "knot" on his right arm that was 1.5 inches in diameter and was tender to touch. Approximately since 2015 (reported that in 2 years), the patient had not been able to work or carry out his daily activities since receiving ZOSTAVAX and his nerves were shot. On an unknown date, he was diagnosed with "nonspecific skin erosion necrosis" and was treated with mupirocin 2% ointment, mupirocin 2% cream and triamcinolone steroid cream for 4 and 1/2 months. At the same time (date unspecified), he developed a "strawberry red rash" on both arms and chest, with "intense itching". On an unknown date, the rash also appeared on his abdomen but did not itch. The pharmacist reported that "the rash might go away for a day but generally reappears 2 days later." Since an unspecified date, the patient had intermittent pain in both arms that were unbearable and awakened him from his sleep. It was reported that the patient received treatment for the events and unspecified lab work was performed but the pharmacist stated that the results were unspecified. The patient sought medical attention. Product quality complaint was not involved. The outcome of the events was reported as unrecovered. The relatedness between the events and the suspect vaccine was not reported. The reporter considered the events to be disabling. Upon internal review, the event of skin necrosis was determined to be medically significant.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nodule, Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 68-year-old male patient. The patient's pertinent medical history was unknown by the reporter. He had no drug reactions or allergies. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # K021624, expiration date: 28-FEB-2016, subcutaneously, in the left arm (dose was not provided), for shingles prevention, which was reconstituted with sterile diluent. He did not take concomitant medications. Approximately on 12-FEB-2015 (reported as one week later), he experienced a "scab" at the injection site. The pharmacist reported that the scabs were "burned off" by an unspecified physician. Approximately on the same day (1 week after ZOSTAVAX was administered), he developed a "knot" on his right arm that was 1.5 inches in diameter and was tender to touch. Approximately since 2015 (reported that in 2 years), the patient had not been able to work or carry out his daily activities since receiving ZOSTAVAX and his nerves were shot. On an unknown date, he was diagnosed with "nonspecific skin erosion necrosis" and was treated with mupirocin 2% ointment, mupirocin 2% cream and triamcinolone steroid cream for 4 and 1/2 months. At the same time (date unspecified), he developed a "strawberry red rash" on both arms and chest, with "intense itching". On an unknown date, the rash also appeared on his abdomen but did not itch. The pharmacist reported that "the rash might go away for a day but generally reappears 2 days later." Since an unspecified date, the patient had intermittent pain in both arms that were unbearable and awakened him from his sleep. It was reported that the patient received treatment for the events and unspecified lab work was performed but the pharmacist stated that the results were unspecified. The patient sought medical attention. Product quality complaint was not involved. The outcome of the events was reported as unrecovered. The relatedness between the events and the suspect vaccine was not reported. The reporter considered the events to be disabling. Upon internal review, the event of skin necrosis was determined to be medically significant.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin erosion, Skin necrosis, Sleep disorder, Tenderness
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 68-year-old male patient. The patient's pertinent medical history was unknown by the reporter. He had no drug reactions or allergies. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # K021624, expiration date: 28-FEB-2016, subcutaneously, in the left arm (dose was not provided), for shingles prevention, which was reconstituted with sterile diluent. He did not take concomitant medications. Approximately on 12-FEB-2015 (reported as one week later), he experienced a "scab" at the injection site. The pharmacist reported that the scabs were "burned off" by an unspecified physician. Approximately on the same day (1 week after ZOSTAVAX was administered), he developed a "knot" on his right arm that was 1.5 inches in diameter and was tender to touch. Approximately since 2015 (reported that in 2 years), the patient had not been able to work or carry out his daily activities since receiving ZOSTAVAX and his nerves were shot. On an unknown date, he was diagnosed with "nonspecific skin erosion necrosis" and was treated with mupirocin 2% ointment, mupirocin 2% cream and triamcinolone steroid cream for 4 and 1/2 months. At the same time (date unspecified), he developed a "strawberry red rash" on both arms and chest, with "intense itching". On an unknown date, the rash also appeared on his abdomen but did not itch. The pharmacist reported that "the rash might go away for a day but generally reappears 2 days later." Since an unspecified date, the patient had intermittent pain in both arms that were unbearable and awakened him from his sleep. It was reported that the patient received treatment for the events and unspecified lab work was performed but the pharmacist stated that the results were unspecified. The patient sought medical attention. Product quality complaint was not involved. The outcome of the events was reported as unrecovered. The relatedness between the events and the suspect vaccine was not reported. The reporter considered the events to be disabling. Upon internal review, the event of skin necrosis was determined to be medically significant.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 68-year-old male patient. The patient's pertinent medical history was unknown by the reporter. He had no drug reactions or allergies. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # K021624, expiration date: 28-FEB-2016, subcutaneously, in the left arm (dose was not provided), for shingles prevention, which was reconstituted with sterile diluent. He did not take concomitant medications. Approximately on 12-FEB-2015 (reported as one week later), he experienced a "scab" at the injection site. The pharmacist reported that the scabs were "burned off" by an unspecified physician. Approximately on the same day (1 week after ZOSTAVAX was administered), he developed a "knot" on his right arm that was 1.5 inches in diameter and was tender to touch. Approximately since 2015 (reported that in 2 years), the patient had not been able to work or carry out his daily activities since receiving ZOSTAVAX and his nerves were shot. On an unknown date, he was diagnosed with "nonspecific skin erosion necrosis" and was treated with mupirocin 2% ointment, mupirocin 2% cream and triamcinolone steroid cream for 4 and 1/2 months. At the same time (date unspecified), he developed a "strawberry red rash" on both arms and chest, with "intense itching". On an unknown date, the rash also appeared on his abdomen but did not itch. The pharmacist reported that "the rash might go away for a day but generally reappears 2 days later." Since an unspecified date, the patient had intermittent pain in both arms that were unbearable and awakened him from his sleep. It was reported that the patient received treatment for the events and unspecified lab work was performed but the pharmacist stated that the results were unspecified. The patient sought medical attention. Product quality complaint was not involved. The outcome of the events was reported as unrecovered. The relatedness between the events and the suspect vaccine was not reported. The reporter considered the events to be disabling. Upon internal review, the event of skin necrosis was determined to be medically significant.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Rash, redness, heat occurred 7 days after injection.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: Rash, redness, heat occurred 7 days after injection.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Blood pressure decreased, Dizziness, Ear discomfort, Hyperhidrosis, Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 18 year old male patient. The patient was allergic to cats. He had no pertinent medical history and concomitant medication. On 27-JUL-2017 at 13:30, the patient was vaccinated with first dose (dose 1) GARDASIL 9 lot # M043731 with expiry date 22-JUN-2019, (0.5 ml once, intramuscular) for prevention of human papillomavirus (HPV) in one arm and MENACTRA (Second dose (dose 2), dose, route and lot# not reported) in the opposite arm for prophylaxis. On the same day, the patient experienced a syncopal episode, was pale and diaphoretic and blood pressure was low, at 90/60 (units not reported), two minutes after receiving the GARDASIL 9. The patient received treatment for the events. No lab diagnostics were done. Physician assistant reported blood pressure was 98/70 (units not reported), after ten minutes and patient had recovered after 15 minutes and was "doing well". Causality assessment was not provided by the reporter. There was no Product Quality Complaint (PQC) involved.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Orthostatic hypotension, Pallor, Syncope
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 18 year old male patient. The patient was allergic to cats. He had no pertinent medical history and concomitant medication. On 27-JUL-2017 at 13:30, the patient was vaccinated with first dose (dose 1) GARDASIL 9 lot # M043731 with expiry date 22-JUN-2019, (0.5 ml once, intramuscular) for prevention of human papillomavirus (HPV) in one arm and MENACTRA (Second dose (dose 2), dose, route and lot# not reported) in the opposite arm for prophylaxis. On the same day, the patient experienced a syncopal episode, was pale and diaphoretic and blood pressure was low, at 90/60 (units not reported), two minutes after receiving the GARDASIL 9. The patient received treatment for the events. No lab diagnostics were done. Physician assistant reported blood pressure was 98/70 (units not reported), after ten minutes and patient had recovered after 15 minutes and was "doing well". Causality assessment was not provided by the reporter. There was no Product Quality Complaint (PQC) involved.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Hyperhidrosis, Hypotension, Pallor, Syncope
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 18 year old male patient. The patient was allergic to cats. He had no pertinent medical history and concomitant medication. On 27-JUL-2017 at 13:30, the patient was vaccinated with first dose (dose 1) GARDASIL 9 lot # M043731 with expiry date 22-JUN-2019, (0.5 ml once, intramuscular) for prevention of human papillomavirus (HPV) in one arm and MENACTRA (Second dose (dose 2), dose, route and lot# not reported) in the opposite arm for prophylaxis. On the same day, the patient experienced a syncopal episode, was pale and diaphoretic and blood pressure was low, at 90/60 (units not reported), two minutes after receiving the GARDASIL 9. The patient received treatment for the events. No lab diagnostics were done. Physician assistant reported blood pressure was 98/70 (units not reported), after ten minutes and patient had recovered after 15 minutes and was "doing well". Causality assessment was not provided by the reporter. There was no Product Quality Complaint (PQC) involved.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Complex regional pain syndrome, Hypoaesthesia, Motor dysfunction, Pain, Swelling
Clinical narrative: CRPS, pain, numbness, swelling, loss of motor control.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Computerised tomogram, Gastric emptying study, Hepatobiliary scan, Malaise
Clinical narrative: Patient fell suddenly ill after first (before second) injection and experienced severe abdominal pain, muscle cramps and other symptoms (on file at Medical Group).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Muscle spasms, Nuclear magnetic resonance imaging, Tryptase, Ultrasound scan, Urine analysis
Clinical narrative: Patient fell suddenly ill after first (before second) injection and experienced severe abdominal pain, muscle cramps and other symptoms (on file at Medical Group).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: X-ray
Clinical narrative: Patient fell suddenly ill after first (before second) injection and experienced severe abdominal pain, muscle cramps and other symptoms (on file at Medical Group).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received on 13-JUL-2017 from a nurse via a company employee regarding 2 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The nurse reported that 2 unspecified patients were administered doses of RECOMBIVAX HB(lot numbers and expiration unknown), intramuscular for prophylaxis on unknown dates. The nurse reported that on unknown dates the patients, both now in their 20s, had titers drawn and they were low. The outcome of had titers drawn and they were low was reported as not recovered/not resolved. The causality was not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history of the patients was not provided. On unknown date(s), the patients were vaccinated with improperly stored GARDASIL 9 (lot # L037554, expired date 25-DEC-2017, dose and route was not provided) for prophylaxis. No adverse effects reported. The vaccine was stored between 9 Celsius degree to 25 Celsius degree (20C) for 9 hours and 30 minutes. Previous temperature excursion was between 9 Celsius degree to 25 Celsius degree (20C) for 11 hours.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 23 year old female patient. It was reported that patient had no concomitant medications and medical history. The patient's concurrent conditions and past drugs were not reported. On an unknown date reported as "when she was younger", the patient was vaccinated with RECOMBIVAX HB 3 complete dose series for immunization whose dose, frequency were not reported. The lot number, route and expiration date were unknown. On an unspecified date, the patient had hepatitis B titers (serum hepatitis B surface antibody) were drawn and the titers were negative. The outcome and causal relationship of the event with RECOMBIVAX HB vaccination was not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (dose and route were not reported) lot# M029230 with expiration date 08-JUN-2018, lot# M035389 with expiration date 02-AUG-2018, lot# M036544 with expiration date 15-AUG-2018, lot# M039914 with expiration date 26-SEP-2018, for prophylaxis. The vaccines were exposed to temperature excursion of 9 degrees Celsius to 25 degrees Celsius for 2 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA000379: US-009507513-1708USA000378.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 28-JUL-2017, the patient was vaccinated with a dose of VARIVAX lot # M046926, expiration date: 28-NOV-2018 (dose and route of administration were not reported) which was reconstituted with sterile diluent (lot # L025374, expiration date: 27-MAR-2018), instead of a dose of ZOSTAVAX vaccine. No adverse effects were reported. Product quality complaint was not presented.
Sex: U
Vaccine: MMR
Symptoms: Peripheral swelling, Product storage error
Clinical narrative: This spontaneous report as received from a non health care professional (office manager) refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II recombinant human albumin (rHA) or human serum albumin (HSA) (Strength, dose, frequency, route, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute M-M-R II injection, which was stored properly. On an unknown date, the patient experienced swelling of the upper arm. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 9 hours; 32 to 35 Fahrenheit degree (F) for 168 hours and 31 or colder (30) Fahrenheit degree (F) for 96 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no product quality complaint involved. The outcome of the event of swelling of the upper arm was unknown. The causality assessment was not provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002329: US-009507513-1708USA002330: