chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Seizure like phenomena
Clinical narrative: On December 10th Patient was seen at Emergency Room for seizure like activity (4 Days after receiving the two immunizations listed above). Head Ct with contrast and blood work all negative and Patient was discharged the following day. She was seen for follow up at PCP's office on 12/11/2018 and additional testing was ordered (Brian MRI and EEG)  to find the cause of seizure activity. MD is unsure if two events are related but felt it needed to be brought to your attention.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Within 3 hours -Left arm pain, limited ROM, weakness. Patient evaluated. Physical therapy is improving symptoms, but still present at this time.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Redness, pain, warmth, Cellulitis.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Don't know name/type of FLU SHOT, I was at DR appt and was asked if I wanted to take a FLU SHOT. I said sure and the blood draw person gave me a flu shot. Arm was in pain at site of injection on day of and has remained constant. At this point it's the whole muscle and anytime I rest on that arm of lift or bend there is always some pain in the muscle.
Age: 29.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Patient describes "a tiny red itchy area with one bump that looks like a bug bite" in the area where vaccine was given. She is unsure if it is vesicular or just an elevated bump.
Age: 29.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pruritus, Rash
Clinical narrative: Patient describes "a tiny red itchy area with one bump that looks like a bug bite" in the area where vaccine was given. She is unsure if it is vesicular or just an elevated bump.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: Swelling of lips and eyes, full body hives.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: BENADRYL steroid.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 25-APR-2014, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions which was recommended and/or prescribed to the patient by her physician (dose, route, and lot # not provided). On or about 10 and 12-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Delusion, Erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of delusion in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced delusion, erythema of extremities and adverse reaction. On an unknown date, the outcome of the delusion and erythema of extremities were recovered/resolved and the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the delusion, erythema of extremities and adverse reaction to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient experienced a red band on the arm that lasted a week, including the general adverse events as described in the label. However, the concerning adverse event was he was slightly delusional for around 8 hours on the second day.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a female patient who received Flu vaccine for prophylaxis. Previously administered products included COMPAZINE with an associated reaction of allergic oedema, FLEXERIL with an associated reaction of pruritus allergic, ibuprofen with an associated reaction of gastric perforation (drug allergy: gastric tear) and NSAIDs with an associated reaction of gastric perforation (drug allergy: gastric tear). On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient had allergic reaction to the flu vaccines however, no reaction was listed.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pain of skin, Scar
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 87-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair). On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 123 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced scar, pain of skin and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the scar and pain of skin were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles, scar and pain of skin to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's wife. The patient had 10 dime sized scars on his back and he continued to had pain in his abdomen area where the shingles were. The patient was taking Advair about twice a week because of the pain and he does not usually use pain relievers at all. The patient had not gotten his 2nd dose of SHINGRIX till the reporting time, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Fatigue, Headache, Incomplete course of vaccination, Pain in extremity
Clinical narrative: is case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In April 2018, 12 hrs after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, headache and fatigue. On an unknown date, the patient experienced hair loss and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, headache and fatigue were recovered/resolved and the outcome of the hair loss and incomplete course of vaccination were unknown. It was unknown if the reporter considered the pain in arm, headache, fatigue and hair loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 55 or 56 years. The concomitant product includes vitamins unspecified. The patient experienced headache, sore arm and fatigue which lasted for about 2 to 3 days. The patient also reported that she noticed some hair loss, as evidenced by strands in her comb. The patient was scheduled to receive 2nd dose on 29th November 2018 and has past her 6 months indication time frame. Till the time of reporting, the patient did not receive 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The patient did not wish to provide demographics or participate in a safety report. The patient did not consent to follow-up.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Exfoliative rash, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 86-year-old male patient who received SHINGRIX for prophylaxis. In November 2018, the patient received SHINGRIX (intramuscular). In November 2018, 7 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, rash scaly and blister. The patient was treated with valaciclovir hydrochloride (Valacyclovir), gabapentin and hydrocortisone. On an unknown date, the outcome of the ophthalmic herpes zoster, rash scaly and blister were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, rash scaly and blister to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's wife. The patient received SHINGRIX on the left arm. Approximately a week later, a scaly rash presented at the top of the right side of his head. It traveled down to the right eye brow, right eye lid and right cheek bone. A few days later the blisters appeared in these areas. The right eye ball was also affected. The patient had seen a physician assistant in a dermatology office and an ophthalmologist. Both healthcare professional diagnosed it as shingles. The reporter said that the pharmacist could provide the batch number in follow up. The reporter gave consent to follow up. This is 1 of the 3 linked cases, reported by the same reporter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 2nd dose of SHINGRIX. On 15th September 2018, 30 days after receiving SHINGRIX, the patient experienced shoulder pain, arthralgia and low back pain. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the shoulder pain, arthralgia and low back pain were unknown. It was unknown if the reporter considered the shoulder pain, arthralgia and low back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. In the middle of September, the patient experience pain in both shoulders, into his left wrist and in lower back. The patient noted the pain does feel like it was in the joints. The patient denied any previous arthritic or joint pain before this incidence. The patient stated that Aleve does helped the pain, but it would awaken him at night and does not resolve until the morning when he was able to get up and move about. The patient has not discussed it with his physician but was encouraged to do so during call. The patient denied to provided healthcare professional information at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (On an unknown date 1st dose received). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were unknown. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient woke up this morning and had a sore arm and redness at injection site. The reporter states this did not happen with his 1st dose of SHINGRIX. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthropod bite, Chills, Diarrhoea, Fall
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of syncope in a 64-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date unknown) for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a month after receiving SHINGRIX, the patient experienced red rash, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure. On 17th February 2018, the patient experienced syncope (serious criteria GSK medically significant), mast cell activation syndrome (serious criteria GSK medically significant), fall and alpha-gal allergy. On an unknown date, the outcome of the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills, low blood pressure and alpha-gal allergy were unknown. The reporter considered the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure to be related to SHINGRIX. It was unknown if the reporter considered the alpha-gal allergy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Eight days after receiving SHINGRIX, the patient went to the emergency room because he fell and hit his head due to syncope. The patient was sent to the clinic and was diagnosed as having a mast cell activation syndrome -alpha gal allergy.  At the emergency room he was noted to has an erythematous rash, abdominal pain, diarrhea, global urticaria, fever, chills, and he had very low blood pressure which was believed to had caused the syncopal episode. The physician believed that the SHINGRIX vaccination triggered the event. In April 2018, the patient did go back to the clinic as a follow up checkup. The reporter was unable to obtain additional information. As per reporter the patient had the alpha gal allergy from a tick bite.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Food allergy, Head injury, Hypotension, Mast cell activation syndrome, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of syncope in a 64-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date unknown) for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a month after receiving SHINGRIX, the patient experienced red rash, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure. On 17th February 2018, the patient experienced syncope (serious criteria GSK medically significant), mast cell activation syndrome (serious criteria GSK medically significant), fall and alpha-gal allergy. On an unknown date, the outcome of the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills, low blood pressure and alpha-gal allergy were unknown. The reporter considered the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure to be related to SHINGRIX. It was unknown if the reporter considered the alpha-gal allergy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Eight days after receiving SHINGRIX, the patient went to the emergency room because he fell and hit his head due to syncope. The patient was sent to the clinic and was diagnosed as having a mast cell activation syndrome -alpha gal allergy.  At the emergency room he was noted to has an erythematous rash, abdominal pain, diarrhea, global urticaria, fever, chills, and he had very low blood pressure which was believed to had caused the syncopal episode. The physician believed that the SHINGRIX vaccination triggered the event. In April 2018, the patient did go back to the clinic as a follow up checkup. The reporter was unable to obtain additional information. As per reporter the patient had the alpha gal allergy from a tick bite.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Syncope, Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of syncope in a 64-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date unknown) for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a month after receiving SHINGRIX, the patient experienced red rash, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure. On 17th February 2018, the patient experienced syncope (serious criteria GSK medically significant), mast cell activation syndrome (serious criteria GSK medically significant), fall and alpha-gal allergy. On an unknown date, the outcome of the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills, low blood pressure and alpha-gal allergy were unknown. The reporter considered the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure to be related to SHINGRIX. It was unknown if the reporter considered the alpha-gal allergy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Eight days after receiving SHINGRIX, the patient went to the emergency room because he fell and hit his head due to syncope. The patient was sent to the clinic and was diagnosed as having a mast cell activation syndrome -alpha gal allergy.  At the emergency room he was noted to has an erythematous rash, abdominal pain, diarrhea, global urticaria, fever, chills, and he had very low blood pressure which was believed to had caused the syncopal episode. The physician believed that the SHINGRIX vaccination triggered the event. In April 2018, the patient did go back to the clinic as a follow up checkup. The reporter was unable to obtain additional information. As per reporter the patient had the alpha gal allergy from a tick bite.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin cancer, Skin neoplasm excision, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin cancer in a 86-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 28th February 2021) for prophylaxis. Co-suspect products included valsartan for an unknown indication. The patient's past medical history included cataract extraction and skin cancer (years ago the patient had cancer removed from the same spot on the right collar bone area). Previously administered products included ZOSTAVAX. Concurrent medical conditions included glaucoma. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient started valsartan 320 mg once daily (320 mg daily). On 13th September 2018, 1 days after receiving SHINGRIX and an unknown time after starting valsartan, the patient experienced skin cancer (serious criteria GSK medically significant), localized erythema and pruritus. In November 2018, the patient experienced blurred vision. On 6th December 2018, the patient experienced glaucoma aggravated (serious criteria GSK medically significant). The action taken with valsartan was unknown. On an unknown date, the outcome of the skin cancer, blurred vision and glaucoma aggravated were unknown and the outcome of the localized erythema and pruritus were recovered/resolved. It was unknown if the reporter considered the skin cancer, blurred vision, glaucoma aggravated, localized erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient had glaucoma and cataract surgery in the past before she received SHINGRIX vaccine. The patient received SHINGRIX in the right arm. About a month ago she noticed that she was not seeing as clearly from one eye. The patient went to her ophthalmologist and 85 days after receiving vaccination, it was noticed that the pressure in one of her eyes was going up. The patient does not remember what eye. The day after getting the vaccine she had red spot on her right collar bone area which was flared up and itching. Years ago she had cancer removed from the same spot on the right collar bone area. Within few days after the patient visited her skin physician, he did a biopsy of the skin and it was diagnosed as skin cancer. A surgery was done and 2 by 2 inch of area was removed. During the time of surgery another biopsy was done for the area on the skin right below the elbow, about half way up the forearm area. This was diagnosed as skin cancer as well and it was removed. The patient also stated that she was on Valsartan 320mg one tablet every day manufactured by other manufacturer. The pharmacy had told her that they cannot refill the Valsartan for her since they were going to stop selling it due to concerns of it causing cancer. Therefore patient thought it could also be the Valsartan that could be causing the skin cancer. The reporter did not consent to follow-up. The Emergency visit was required. The patient had a follow up appointment with her skin doctor on 28th December 2018.
Sex: F
Vaccine: FLUX
Symptoms: Allergic reaction to excipient, Autoimmune disorder, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant), allergic reaction and allergic reaction to drug excipient. On an unknown date, the outcome of the autoimmune disorder, allergic reaction and allergic reaction to drug excipient were unknown. It was unknown if the reporter considered the autoimmune disorder, allergic reaction and allergic reaction to drug excipient to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The patient received unknown manufacturer's flu vaccine and had an allergic reaction to the formaldehyde and almost died. The reporter stated the patient now had an auto-immune disorder since having the flu vaccine. This case was linked with US2018221757, reported by the same reporter.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain down his arm, not up or shoulder pain for the past 3 months.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Pain in extremity, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Red rash 41 mm in diameter, hot and painful to the touch and painful when move arm. Red bump noticed about 24 hours after shot. Pain started a few hours after shot given.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Tenderness
Clinical narrative: Red rash 41 mm in diameter, hot and painful to the touch and painful when move arm. Red bump noticed about 24 hours after shot. Pain started a few hours after shot given.
Age: 0.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Cough, Wheezing
Clinical narrative: S/P anaphylactic RXN due to vaccines given (DTap-IPV, MMR, Var) - (currently pt ongoing daily desensitization oral Tx 9mo)- within 1minute cough/wheeze/pulse ox 91%- all S/Sx improved somewhat with albuterol & then S/Sx completely resolved & ASYX after EPI given (mom's pen)   pt asymptomatic after EPI given, then paramedics arrived onsite & brought pt to ER for further monitoring pt's allergist contacted after departure to inform re: anaphylactic episode, agreed with above Tx, was okay for vaccines given but informed in general, known increased risk of anaphylaxis at anytime due to many possible 'triggers' while ongoing daily oral desensitization Tx.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site nodule
Clinical narrative: Vaccines given 9/17/18. Patient returned to clinic 12/13/18 with an ~5 mm subcutaneous nodule on left lateral thigh at site of injection. Unknown how large lump originally was after injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Patient has a mild contact dermatitis reaction at the injection site, redness and itch. No fever!
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Very sore red swollen right arm for 4 days, fever to 101 degrees for 2-3 days. achey all over, sick enough to stay in bed and cancel commitments for 3 days.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, X-ray
Clinical narrative: Increasing pain and difficulty raising arm beginning 2 days after receiving immunization. Pain continued for 2-3 weeks. Steroids prescribed at week 3. Pain subsided while on oral steroids. Pain returned when course of steroids ended.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscle fatigue, Musculoskeletal pain
Clinical narrative: Patient is continuing to experience pain in her shoulder with decreased range of motion and muscle fatigue ever since vaccination (about one month ago).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills, body aches-treated with NSAID.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt did not appear to have a adverse reaction. Pt is a stem cell patient and came in requesting a tetanus shot. The patient came in 12/10/18 requesting pneumonia shot and showed a list of shots he needed. Another pharmacist saw patient got BOOSTRIX shot on 11/8/18 but the patient needed a Dtap shot.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dry mouth, Grip strength decreased, Influenza like illness, Muscular weakness
Clinical narrative: 1st shot: no problems. 2nd shot developed full body muscle ache and joint pain. Flu-like pain without being sick. Beginning about 48 hrs after shot. Muscle ache lasted about a week, but both elbows have remained painful. I have diminished gripping, lifting, and pull strength in my hands where there was no problem before vaccination. Exertion with hands and arms intensifies elbow pain. Had hoped it would eventually subside but it has not. 2nd symptom is a dryness on the inside of my upper/lower lip causing skin to drag or stick to front teeth. Have needed to use my tongue to moisten area. This was not needed before.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: 1st shot: no problems. 2nd shot developed full body muscle ache and joint pain. Flu-like pain without being sick. Beginning about 48 hrs after shot. Muscle ache lasted about a week, but both elbows have remained painful. I have diminished gripping, lifting, and pull strength in my hands where there was no problem before vaccination. Exertion with hands and arms intensifies elbow pain. Had hoped it would eventually subside but it has not. 2nd symptom is a dryness on the inside of my upper/lower lip causing skin to drag or stick to front teeth. Have needed to use my tongue to moisten area. This was not needed before.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: 06/07/2019: The patient developed a reaction to BOTH vaccinations he received of SHINGRIX, detailed below. I have the lot number for his 06/19/18 dose but it is not available for the 02/23/18 dose. I hope this information helps. 6/19/2018: 0.5 ml, Rt deltoid, IM, SKB, X3M27.  Patient has had chronic pain at the sites of injection that started immediately after injection of first dose of SHINGRIX in left arm  and has persisted now for 10 months. He had 2nd injection in the contralateral arm 06/2018 and had the same reaction. Now has daily, bilateral arm pain. He describes it as "nerve pain" in both arms. Functionally no limitations.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Lethargy, Nausea
Clinical narrative: Injection site swelling, redness, swelling. Fatigue, nausea, lethargic.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Influenza dose of 3 years and older given instead of 6-35 months. Mother and provider notified of incorrect dosage, child was monitored for 25 minutes in office. No reactions noted.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen red sore arm, difficulty lifting arm.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Pyrexia, Rash
Clinical narrative: It was one of the tetanus vaccines. About 2-3 hours after injection, he began to have a seizure. At that time, we also noticed a rash/swelling was on his leg surrounding injection site. The rash spread to both legs & up his abdomen. He continued to seize every few hours or so. When we took him back in, they informed us that they would not do anything until he had been seizing for 15+ min. He also spiked a fever of 103 that would only go down while on MOTRIN/TYLENOL alternating per Dr recommendation. We noticed on Thursday that there was a hard bump under the injection site. He continued to have seizures for several days. The fever finally stopped on Sunday, the 9th. The seizures stopped on Monday the 10th. The rash & swelling also started clearing on the 10th.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Seizure
Clinical narrative: It was one of the tetanus vaccines. About 2-3 hours after injection, he began to have a seizure. At that time, we also noticed a rash/swelling was on his leg surrounding injection site. The rash spread to both legs & up his abdomen. He continued to seize every few hours or so. When we took him back in, they informed us that they would not do anything until he had been seizing for 15+ min. He also spiked a fever of 103 that would only go down while on MOTRIN/TYLENOL alternating per Dr recommendation. We noticed on Thursday that there was a hard bump under the injection site. He continued to have seizures for several days. The fever finally stopped on Sunday, the 9th. The seizures stopped on Monday the 10th. The rash & swelling also started clearing on the 10th.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Child was given Varicella and PROQUAD. Child was monitored in clinic for 15 minutes and sent home. Staff not aware of clinical error until 330 PM. Unable to contact family for follow up, message left on phone number on file.
Age: 7.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Allergy to vaccine, Swelling face, Urticaria
Clinical narrative: Per interview of mother: This reaction occurred when the child received her first dose of these vaccines but was not as severe. Hence, she did not think about it prior to getting the second dose not alert the provider. On 12/9/18, patient broke out in hives. Parent gave BENADRYL for symptoms. On the 10th, hives turned into large welts. Parent took patient to her family doctor 12/11/18 who recommended more BENADRYL vitamin C, and Oranges; and diagnosed the child with an allergy to the vaccines. Doctor told parent that child should not get any more vaccines in the future. Parent called Health Dept. on 12/13/18 and reported the event. Child was way better on that date with a bit of swelling on the face.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Disorientation, Fatigue, Tremor
Clinical narrative: 11/26/2018 @ about 2:30 began to feel exhausted and weak, then at about midnight that day, chills came over me and I began to uncontrollable shake and shiver, lasted about an hour, when I fell asleep, I woke up very disoriented, thought it was night but it was daytime. Rested for two days, on third day the symptoms subsided.
Age: 1.17
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Ultrasound scan, Weight bearing difficulty
Clinical narrative: Inability to bear weight, low grade fever 2-3 days after vaccine, increased swelling in right thigh and increase in warmth, possible hematoma developing and possible synovitis.
Age: 1.17
Sex: M
Vaccine: HIBV, PNC13
Symptoms: X-ray of pelvis and hip
Clinical narrative: Inability to bear weight, low grade fever 2-3 days after vaccine, increased swelling in right thigh and increase in warmth, possible hematoma developing and possible synovitis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Patient experienced labored breathing and a swollen left eye starting the day after the vaccine was given and lasted about a day.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Malaise, loss of appetite, fever, chills, muscle aches, headache, fatigue, pain at injection site. Began within 1-2 hours and worsened into evening, when severe symptoms became evident. 24 hours in bed, resolved by day 2.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Malaise, loss of appetite, fever, chills, muscle aches, headache, fatigue, pain at injection site. Began within 1-2 hours and worsened into evening, when severe symptoms became evident. 24 hours in bed, resolved by day 2.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: Patient had a flare up of spinal nerve pain after receiving 2 dose of SHINGRIX series. He has had a history of this type of pain, but was stable for a long period of time previous to this vaccination. He was not sure if it is related, but wanted to put the report in for data in case there is a correlation
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Extreme pain at injection site and extending to elbow of affected arm; headache; chills or shivering.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient received both vaccines in his left arm approx an inch apart on 10/16/18. On 12/11/18 he stated that his arm was still sore/ in pain from the vaccines and that he went to his primary care doctor and received a "steroid injection" to help reduce the pain. He did not state specifically when this happened or what time of injection he received.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: Patient receive SHINGRIX on 11/24/18 patient called pharmacy on 11/29/2018  stating he is developing rash and itch around face and upper torso. Patient was advised to take some BENADRYL and talk with his PCP. Patient primary care doctor prescribed MEDROL DOSEPAK  thinking delayed adverse reaction. On 12/02/2018 patient rash was not gone and patient ended up going to urgent care where Dr. diagnose him with chicken pox and gave him VALTREX and KEFLEX. Patient also took 7 day off from work. In mean time we also called manufacture and report the adverse event. Patient had a follow up visit with PCP on 12/07/2018 where PCP also confirm the diagnosis of chicken pox.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Mobility decreased, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient came to the pharmacy 4 days after the administration and the arm appeared swollen, painful  and a rash was present. Pt unable to move the arm above the shoulder. I verified that the ADR was localized to the arm. Patient instructed to apply ice and take ibuprofen for the pain/swelling. Patient instructed to take BENADRYL for the rash. Patient instructed to follow up with an urgent care if the reaction worsens over the weekend. Patient instructed to follow up with the PCP if the reaction is not better by Monday (12/17/18).
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: On 10/3/2018 pt received the 1st SHINGRIX vaccine. She called pharmacy 12/14/2018 and wanted to know whether or not she should get the 2nd SHINGRIX vaccine because the first vaccine caused quite significant shoulder pain. The day after the vaccine she could not move her arm due to the pain, the next day she could move it a little below the elbow and then each successive day it gradually got a little bit better. She also said that on the third day she started to notice that her teeth were chattering.  Teeth chattering could be a response to having the chills and chills are part of the symptoms that sometimes accompany flu like symptoms after a vaccine. However, she said that she did not have chills just the teeth chattering. She said that the teeth chattering went away but that sometimes now she still gets them. I am not aware that SHINGRIX can cause that side effect. She did not see her doctor about the reaction she had to the vaccine. I called the doctor's office and notified them of the patient's comments. They said that they will follow up with her.
Age: 32.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Back pain, Condition aggravated, Dizziness, Ill-defined disorder, Pain
Clinical narrative: Night after vaccination I began to experience Illness to include fever, aches and pains on first night. For next five days had significant back pain, as if entire back was in vise to the point it woke me up multiple times each night. Bouts of Dizziness/vertigo were also experienced for two days. Also saw tremors pronounced in left hand that still haven't gone away. Have had tremors in hands since 2010 when the they lost my shot records and vaccinated me twice within a short period of time. Recent vaccinations instigated more pronounced tremors that are slowly beginning to normalize again. I reported this reaction to the PA two days after the vaccination located at clinic.
Age: 32.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Pyrexia, Sleep disorder, Tremor, Vertigo
Clinical narrative: Night after vaccination I began to experience Illness to include fever, aches and pains on first night. For next five days had significant back pain, as if entire back was in vise to the point it woke me up multiple times each night. Bouts of Dizziness/vertigo were also experienced for two days. Also saw tremors pronounced in left hand that still haven't gone away. Have had tremors in hands since 2010 when the they lost my shot records and vaccinated me twice within a short period of time. Recent vaccinations instigated more pronounced tremors that are slowly beginning to normalize again. I reported this reaction to the PA two days after the vaccination located at clinic.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin tightness
Clinical narrative: PATIENT STATED SHE HAD MILD ARM SORENESS ABOUT 8 -10 HOURS AFTER BEING VACCINATED, THE NEXT DAY HAS SOME ITCHING AND TIGHTNESS, DAY TWO WENT TO URGENT CARE DUE TO REDNESS ON INNER BICEP THAT RAN TO HER WRIST, PRESENTED WARM AND TIGHT WITH SOME SWELLING. SHE DENIED SEVERE PAIN. DESCRIPTED PAIN AS MILD TO MODERATE WITH TIGHTNESS.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: PATIENT STATED SHE HAD MILD ARM SORENESS ABOUT 8 -10 HOURS AFTER BEING VACCINATED, THE NEXT DAY HAS SOME ITCHING AND TIGHTNESS, DAY TWO WENT TO URGENT CARE DUE TO REDNESS ON INNER BICEP THAT RAN TO HER WRIST, PRESENTED WARM AND TIGHT WITH SOME SWELLING. SHE DENIED SEVERE PAIN. DESCRIPTED PAIN AS MILD TO MODERATE WITH TIGHTNESS.
Age: 51.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dermatitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's arm was very swollen, red, and sore. Called the pharmacy to alert the pharmacist regarding the reaction. Patient was advised to go seek medical care in case of infection. Patient followed up with medical doctor and was diagnosed with dermatitis from post-injection. Patient was prescribed cephalexin 500mg every 12 hours for 10 days for treatment.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Dizziness, Injection site pain, Muscle spasms, Oropharyngeal pain
Clinical narrative: Soreness at the injection site from the onset. Developed a sore throat around 10am on 12/14. Began feeling faint around 4:30 pm on 12/14. Began experiencing fever and chills around 8:00 pm on 12/14. Began experiencing mild back cramps around 9:30 pm on 12/14.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Soreness at the injection site from the onset. Developed a sore throat around 10am on 12/14. Began feeling faint around 4:30 pm on 12/14. Began experiencing fever and chills around 8:00 pm on 12/14. Began experiencing mild back cramps around 9:30 pm on 12/14.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: Felt slightly off a bit dizzy immediately after shot, resolved in 5-10 minutes. Felt fatigue 2 hours after and soreness at injection. Dizziness, headache, nausea began and persists 9 hours after shot with low grade fever.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Felt slightly off a bit dizzy immediately after shot, resolved in 5-10 minutes. Felt fatigue 2 hours after and soreness at injection. Dizziness, headache, nausea began and persists 9 hours after shot with low grade fever.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Feeling abnormal, Headache, Respiration abnormal
Clinical narrative: Employee reports approx. 20 - 30 minutes post vaccination and states "I feel like I'm high". "When I walk I feel like I'm gonna fall". "It is not my same breathing" and the back of my head and left eye feel like they are going to hurt per employee.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Left shoulder pain with numbness/tingling.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Abdominal pain, Abdominal rigidity, Arthralgia, Back pain
Clinical narrative: Following vaccine - Oct. 30 - couldn't get up from chair - severe abdominal pain and cramps, bloating. Hospital AM. CT scan, bloodwork, urine work, x-ray. Back pain - from hip area to lower back, then upper back to shoulder, to neck. Severe neck pain..stiff neck, inability to turn head in any direction. Did next exercises stretching for next 10 days. Dec. 3 Saw Dr - therapy for neck.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Following vaccine - Oct. 30 - couldn't get up from chair - severe abdominal pain and cramps, bloating. Hospital AM. CT scan, bloodwork, urine work, x-ray. Back pain - from hip area to lower back, then upper back to shoulder, to neck. Severe neck pain..stiff neck, inability to turn head in any direction. Did next exercises stretching for next 10 days. Dec. 3 Saw Dr - therapy for neck.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Urine analysis, X-ray
Clinical narrative: Following vaccine - Oct. 30 - couldn't get up from chair - severe abdominal pain and cramps, bloating. Hospital AM. CT scan, bloodwork, urine work, x-ray. Back pain - from hip area to lower back, then upper back to shoulder, to neck. Severe neck pain..stiff neck, inability to turn head in any direction. Did next exercises stretching for next 10 days. Dec. 3 Saw Dr - therapy for neck.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Redness and induration at injection site not related to Cellulitis 1-2 days after injection. Resolved. The patient is a 69 year old female who presents with a complaint of "Arm pain". Note for "Arm pain": Pt. is here due to redness and swelling in her left bicep. Red, warm, swelling, painful. Has gotten better, first noticed Wednesday and received Flu shot in the same arm on the 27th. Wondering if it could be from the flu shot or a blood clot. Tender left arm - with redness the next 2 days. Last night - went to strength training - suggested. Better today - wasn't able to sleep on the arm the last two night but was last night. Redness better too.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Redness and induration at injection site not related to Cellulitis 1-2 days after injection. Resolved. The patient is a 69 year old female who presents with a complaint of "Arm pain". Note for "Arm pain": Pt. is here due to redness and swelling in her left bicep. Red, warm, swelling, painful. Has gotten better, first noticed Wednesday and received Flu shot in the same arm on the 27th. Wondering if it could be from the flu shot or a blood clot. Tender left arm - with redness the next 2 days. Last night - went to strength training - suggested. Better today - wasn't able to sleep on the arm the last two night but was last night. Redness better too.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Mobility decreased
Clinical narrative: Very bad headaches; nausea; chills; no strength: could hardly get up out of bed; ached. I believe I had fever but did not take my temperature. However, I broke out in sweat the second day after vaccination. Took TUMS and ADVIL. I am concerned as to if I should take the 2nd shot!
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Very bad headaches; nausea; chills; no strength: could hardly get up out of bed; ached. I believe I had fever but did not take my temperature. However, I broke out in sweat the second day after vaccination. Took TUMS and ADVIL. I am concerned as to if I should take the 2nd shot!
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: Still has arm pain and decreased range of motion 4 1/2 months after SHINGRIX administered. Had pain immediately after receiving vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) leg redness, warm, tenderness started 24 hours after immunizations and getting larger on 12/14 10 cm x 4 cm.