chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Lethargy, Unresponsive to stimuli
Clinical narrative: After vaccinations, baby was extremely lethargic, seemed "stunted", did not respond normally or even at all for about 4 to 5 days. Mother was worried that he would not come out of it. Did not smile and did not really cry, and seemed to "not be there". Mother thinks this also occurred with the 2 month shots but mom thought it was just him not feeling well, and it did not last as long the first time. Mother now feels like he has returned to normal. Does not want any further vaccines at this time since this was a very frightening event.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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 concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions, concomitant medication or known allergies provided. On 01-AUG-2018 (also reported as 01-AUG-2008), the patient was inadvertently administered a properly stored but expired dose of M-M-R II lot # M034856, expiry date 27-JUL-2018, for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
Age: 56.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 56-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 (concentration, dose, route of administration, lot number, expiration date and indication were not reported). No adverse effects were reported.
Sex: M
Vaccine: DTAP
Symptoms: Crying, Musculoskeletal stiffness, Pyrexia, Swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of stiffness in a adult male patient who received DTaP vaccine for prophylaxis. Previously administered products included DTaP vaccine with an associated reaction of musculoskeletal stiffness (For tolerance to the 1st dose received on an unknown date, refer case US2018GSK142082). On an unknown date, the patient received the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced stiffness, swelling, fever and crying. Rechallenge with DTaP vaccine was positive. On an unknown date, the outcome of the stiffness, swelling, fever and crying were recovered/resolved. It was unknown if the reporter considered the stiffness, swelling, fever and crying to be related to DTaP vaccine. Additional details were provided as follows: The age at the vaccination was not reported, however at the time of the event the patient's age group was infant. The healthcare professional stated, the patient's mother reported that when patient was infant and received dose of DTaP vaccine, the patient experienced lot of stiffness, swelling, high fever, inconsolable crying for couple days after the vaccination. The health care professional did not have vaccine information or if it was a GlaxoSmithKline vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown. It was unknown if the reporter considered the fatigue and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist left a message on after hours voice mail stating patient's husband came in 2 weeks before the date of reporting and reported that after getting her first shot of SHINGRIX she was in bed for 2 days. The patient had no fever. The patient had extreme fatigue and all of her upper body was extremely sore. No further information was left on after hours voice mail.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast swelling, Fatigue, Headache, Hypersomnia, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 15th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive. On an unknown date, the outcome of the axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive were recovered/resolved. It was unknown if the reporter considered the axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced injection site reaction consisting of redness of 4 inch circle around site and pain also experienced headache, swollen lymph node in left armpit and swelling that went from there across left chest to breast and was fatigued and slept for 3 days. The patient had denied permission to contact their physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lymphadenopathy, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 15th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive. On an unknown date, the outcome of the axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive were recovered/resolved. It was unknown if the reporter considered the axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced injection site reaction consisting of redness of 4 inch circle around site and pain also experienced headache, swollen lymph node in left armpit and swelling that went from there across left chest to breast and was fatigued and slept for 3 days. The patient had denied permission to contact their physician.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 78-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 29th July 2018, the patient received SHINGRIX .5 ml. On 29th July 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 30th July 2018, the patient experienced injection site rash, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site rash, injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site rash, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was inadvertently administered a dose of SHINGRIX in the side of the bicep not the deltoid, which led to vaccine administered at inappropriate site. One day after receiving vaccination, the patient developed a rash which was swollen and warm to touch, at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and sickness. On an unknown date, the outcome of the injection site pain and sickness were unknown. It was unknown if the reporter considered the injection site pain and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller initially called inquiring about the ingredients in the vaccine. She then mentioned that she was speaking to her pharmacist regarding the vaccine whom informed her that she had received the vaccine and got very sick. She probed further and she stated that the pharmacist mentioned that her arm was very painful at the injection site. She states that she mentioned some other things but she could not remember what those things were. She could not provide any additional information. No other demographics provided besides gender.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain in arm, feeling unwell, fatigue and pain. In July 2018, the outcome of the influenza-like symptoms, pain in arm, feeling unwell, fatigue and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, pain in arm, feeling unwell, fatigue and pain to be related to SHINGRIX. Additional details were provided as follows: The patient dropped by the clinic and reported that he received his 2nd dose of SHINGRIX from another location and experienced the effects as noted within 24 to 36 hours after receiving the vaccine. The patient had mild sore arm and did not feel well. The symptoms resolved within 24 to 36 hours later.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of eyelid in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy and penicillin allergy. On 30th July 2018, the patient received SHINGRIX. On 1st August 2018, 2 days after receiving SHINGRIX, the patient experienced swelling of eyelid. On an unknown date, the outcome of the swelling of eyelid was not recovered/not resolved. It was unknown if the reporter considered the swelling of eyelid to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid, on Monday evening. On Wednesday, the patient realized that, her eyelids on the right eye were swollen which was not painful or red. The patient did not use anything to treat this adverse event and she was unsure if it was related to the SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported that the patient experienced an adverse event following administration of SHINGRIX, which was limited to the arm vaccinated. The healthcare professional refused to provide any details about the event.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 68-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th October 2020) for prophylaxis. On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts. The patient was treated with BENADRYL. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient had welts from her shoulder down to her elbow on the injected arm. The reporter asked if the patient should receive the 2nd dose. It was informed to the reporter that it would be best for the patient to follow up with her healthcare professional who knew her medical history, and that they cannot provide recommendations. The reporter stated that the patient did consult with her physician who recommended that she get the 2nd dose and take BENADRYL. The reporter was provided with information from the frequently asked questions (what if I had a reaction to the first injection, does that mean that I would also will have a worse reaction on the second injection). It was unknown by the reporter how soon after the injection the patient had the incidence or when or if they resolved.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 88-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 3rd July 2018, the patient received SHINGRIX. On 3rd July 2018, immediately after receiving SHINGRIX, the patient experienced numbness of upper extremities. On an unknown date, the outcome of the numbness of upper extremities was not recovered/not resolved. It was unknown if the reporter considered the numbness of upper extremities to be related to SHINGRIX. Additional details were provided as follows: On 9th April 2018, the patient received 1st dose of SHINGRIX and did not experience numbness. The patient received 2nd dose of SHINGRIX and ever since getting the 2nd dose, the patient had numbness in his arm that goes all the way down to his fingers. The numbness started right after the 2nd dose and patient was still experiencing the numbness all down his arms to fingers. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of hair loss in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown. It was unknown if the reporter considered the hair loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX and experienced 60 to 70 percent hair loss after dosing.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site nodule, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site nodule. On an unknown date, the outcome of the fever and injection site nodule were unknown. It was unknown if the reporter considered the fever and injection site nodule to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had fist size knots at injection site and fever. Because of adverse reaction, the patient was advised by the reporter's office that not to get 2nd dose. This case linked to US2018GSK142323, reported by the same reporter.
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a male patient who received Hepatitis A vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced rash. Hepatitis A vaccine was discontinued. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Hepatitis A vaccine. Additional details were provided as follows: The reporting physician was the patient. The age at vaccination was not reported. The patient stated that he experienced a rash after receiving his 1st dose of Hepatitis A so he never received his second dose of Hepatitis A. The reporter did not agree to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of general body pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and polymyalgia. On an unknown date, the outcome of the general body pain and polymyalgia were recovered/resolved. It was unknown if the reporter considered the general body pain and polymyalgia to be related to SHINGRIX. Additional information was reported as follows: The patient had general pain and myalgia all over his body. The reporter could not remember any other details at the time of reporting. The nurse agreed to be followed up. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK137701.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, TDAP
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered
Clinical narrative: Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 weeks old female patient who experienced received a dose of vaccines PENTACEL lot C5466AB via intramuscular route in the left thigh and ADACEL lot U5581CA via intramuscular route in unknown administration site on 02-Aug-2018 at the same time. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ for Immunisation; and PREVNAR for Immunisation. It was a case of actual medication error due to Inappropriate age at vaccine administration and extra dose administered, as a 12 week old baby was given PENTACEL and ADACEL at the same time. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: PATIENT WAS GIVEN A TDAP INSTAED OF DTAP.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Decreased activity, Headache, Myalgia
Clinical narrative: Severe chills began 10 hours after injection -- 9:30 PM. Extremely violent shivering began 10 PM and continued until midnight. Slept dressed in two long-sleeved layers under 4 layers of bedding. Fever of 101 upon awakening in the morning (after awakening every hour all night long). Very achy muscles, back of neck especially, lower back pain, and pounding headache. Fever came down to 98.7 after a dose of 1300 mg TYLENOL in the morning. Reduced activity for three days following this event. NOTE: I had no reaction to the first dose given 2 months prior. Perhaps if I had waited 4-6 months to receive the second dose.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe chills began 10 hours after injection -- 9:30 PM. Extremely violent shivering began 10 PM and continued until midnight. Slept dressed in two long-sleeved layers under 4 layers of bedding. Fever of 101 upon awakening in the morning (after awakening every hour all night long). Very achy muscles, back of neck especially, lower back pain, and pounding headache. Fever came down to 98.7 after a dose of 1300 mg TYLENOL in the morning. Reduced activity for three days following this event. NOTE: I had no reaction to the first dose given 2 months prior. Perhaps if I had waited 4-6 months to receive the second dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Excessive eye blinking
Clinical narrative: The patient started having repetitive excessive eye blinking 4 days ago as above. This started several hours after getting his vaccines at the health department. He got the varicella, MMR, and KINRIX vaccines that day. He never had any fever or rash or other side effects from the vaccine. Since that time, he is continued to have repetitive eye blinking, almost continuously throughout the day. He has been feeling well, with good appetite and energy levels. He is sleeping well. He has never had a history of tic behaviors in the past. He has not had any recent illnesses or symptoms that they can recall.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pallor, Skin lesion, Skin warm
Clinical narrative: 5 cm x 6cm, erythematous lesion, blanching, slighlty warm, nontender.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial flutter, Blood magnesium, Chest X-ray, Electrocardiogram, Full blood count
Clinical narrative: Patient developped palpitations. Was in by me in the ER and was diagnosed with atrial flutter with rapid ventricular response which converted to a normal sinus rhythym with 0.25mg/kg of diltiazem.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Palpitations, Troponin
Clinical narrative: Patient developped palpitations. Was in by me in the ER and was diagnosed with atrial flutter with rapid ventricular response which converted to a normal sinus rhythym with 0.25mg/kg of diltiazem.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Patient received vaccine at 6:20pm on 8/6/18. Patient consent form indicated patient had not previously had a reaction to a vaccine. She waited near pharmacy area for 15-20 minutes and came by to let us know she was doing fine before she left. She called on 8/8/18 to inform us that shortly after she left the pharmacy (unknown duration of time), the left side of her face and her left arm started to swell to the point that she had to go to the Emergency Room. They gave her BENADRYL and she continued to take BENADRYL over the counter. She stated that she is doing fine, but the swelling is not going down very quickly. Tried to contact the patient later in the day to check on her, but her phone went straight to voicemail.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports general arm soreness, pain in left scapula, paresthesia descending length of left arm.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: After the initial SHINGRIX immunization, my right arm at the inside of my elbow broke out in an itchy rash.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Same day erythema consistent for 9 days on upper left thigh. Erythema measures 4 x 3 cm .
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Back pain, Blood pressure increased, Cough, Dry throat
Clinical narrative: PATIENT INITIALLY REPORTED ITCHING ALL OVER HER BODY. SHE WAS ADMINISTERED 50MG OF BENADRYL BY MOUTH AND MONITORED. SHE WAS COUGHING AND HAD NO BEEN COUGHING PRIOR TO IMMUNIAATION. SHE STATED HER THROAT FELT DRY. HER BLOOD PRESSURE WAS SLIGHTLY ELEVATED OVER NORMAL. SHE BEGAN HAVING TREMORS AND ALSO BEGAN COMPLAINING OF EXTREME PAIN IN HER ABDOMEN. 911 WAS CALLED. SHE THEN SAID THE PAIN WAS IN HER BACK AS WELL AS HER ABDOMEN. SHE THEN STATED THAT BREATHING WAS BECOMING MORE DIFFICULT AND WAS THEN ADMINISTERED ONE 0.3MG DOSE OF EPINEPHRINE.  EMT'S THEN ARRIVED AND TRANSPORTED HER TO THE EMERGENCY ROOM.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Pruritus generalised, Tremor
Clinical narrative: PATIENT INITIALLY REPORTED ITCHING ALL OVER HER BODY. SHE WAS ADMINISTERED 50MG OF BENADRYL BY MOUTH AND MONITORED. SHE WAS COUGHING AND HAD NO BEEN COUGHING PRIOR TO IMMUNIAATION. SHE STATED HER THROAT FELT DRY. HER BLOOD PRESSURE WAS SLIGHTLY ELEVATED OVER NORMAL. SHE BEGAN HAVING TREMORS AND ALSO BEGAN COMPLAINING OF EXTREME PAIN IN HER ABDOMEN. 911 WAS CALLED. SHE THEN SAID THE PAIN WAS IN HER BACK AS WELL AS HER ABDOMEN. SHE THEN STATED THAT BREATHING WAS BECOMING MORE DIFFICULT AND WAS THEN ADMINISTERED ONE 0.3MG DOSE OF EPINEPHRINE.  EMT'S THEN ARRIVED AND TRANSPORTED HER TO THE EMERGENCY ROOM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Headache started in middle of night. Slight fever, extreme fatigue, weakness. Missed work and stayed in bed for 1.5 days. Felt back to normal by 8/5 (2.5 days after symptoms started).
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted within seconds following immunization with HPV vaccination. He regained consciousness within 10 seconds. No neurological changes, no changes in behavior, vital signs stable.
Age: 53.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Arthralgia, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms, body aches. Joint pain, fever 99.4. Tired.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site pruritus, Malaise, Pyrexia
Clinical narrative: Starting 8/4 early evening, low grade fever and chills, malaise. 8/5 still low grade fever less than 100 and malaise. 8/6 low grade fever less than 100 in the evening. 8/7 injections site and arm red and itchy, started BENADRYL, still fever in the evening. 8/8 injection site and arm red and itch, no fever present. Continuing to monitor.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Patient complained of fatigue, shivering, myalgia starting about 8 hours after vaccination. Patient treated with TYLENOL and hydration and condition improved over the next 24 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms: fever and chills.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Loss of consciousness, Nausea, Skin abrasion, Syncope
Clinical narrative: About 5 minutes after I gave the patient his MENACTRA vaccine, he started feeling nauseous. Shortly after, he fainted. He was sitting down and fell to the floor. He was unconscious for only a few moments. He woke up quickly and understood where he was, what year it was, and who the President is. He had rug burn on his face and knee. He remained laying down until EMS arrived.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: SEVERE FATIGUE, PATIENT FEELING UNWELL AFTER SHOT AND FOR COUPLE OF DAYS, PATIENT EVENTUALLY HOSPITALIZED AND THEN RELEASED.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Gait inability, Hypotension
Clinical narrative: SEVERE FATIGUE, PATIENT FEELING UNWELL AFTER SHOT AND FOR COUPLE OF DAYS, PATIENT EVENTUALLY HOSPITALIZED AND THEN RELEASED.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: SEVERE FATIGUE, PATIENT FEELING UNWELL AFTER SHOT AND FOR COUPLE OF DAYS, PATIENT EVENTUALLY HOSPITALIZED AND THEN RELEASED.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dyspnoea, Headache, Hypoaesthesia, Nausea
Clinical narrative: Patient states she had "violent reaction" after both SHINGRIX doses (I did not hear about the first one until now), w/ onset of fever over 100, nausea, vomiting, dry heaves and diarrhea starting 10 hours after vaccine, with slight numbness in both hands and slight shortness of breath, lasting 5-6 hours, and next day low grade temp and headache. Now better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: Patient states she had "violent reaction" after both SHINGRIX doses (I did not hear about the first one until now), w/ onset of fever over 100, nausea, vomiting, dry heaves and diarrhea starting 10 hours after vaccine, with slight numbness in both hands and slight shortness of breath, lasting 5-6 hours, and next day low grade temp and headache. Now better.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: Swelling in injected arm, difficulty moving injected arm, fever, chills.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Burning sensation, Depressed level of consciousness, Hypersomnia, Impaired driving ability
Clinical narrative: Responses: Monday, when I was at work for my second shift, I almost passed out more than four to five times. I left early. I had to rest in the car for ten minutes, before I felt safe to drive home which is ten minutes away. Even so, I had to pull over on the way home for a few minutes to rest, again. Also, I could not bend over without starting to fall. Each day, from Friday to Tuesday, I slept about sixteen hours to recover along with necessary several hour naps during the day. Until today, I was unable to do dishes without dropping them. I also got blurred vision in the evening. Pain: On Thursday, I got a vaccine on my right upper arm. My arm burned after the shot which I assume is normal. On Thursday night, I could not move my arm especially my upper arm without pain. Thorough out the evening I got short two to three burning sensations in my arm. On Friday to Saturday, I could not move my upper arm away from my body without 8 out of 10 sore pain along with touching anything like a couch or lay on my upper arm without 6 out of 10 sore pain. On Monday, I had hard time working at my waitressing job, I lifted some heavy objects that caused my arm to be in extreme pain 9 out of 10 sore pain which caused me to be unable to work my second shift. Today Wednesday August 8, 2018; I am feeling better, I was able to modify a yoga 10 minute exercise before my shift in the morning. At work, I only used my left arm. In the afternoon, I am starting to be able to use my right arm again, do dishes and laundry at home, with just 3 out of 10 sore pain.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Responses: Monday, when I was at work for my second shift, I almost passed out more than four to five times. I left early. I had to rest in the car for ten minutes, before I felt safe to drive home which is ten minutes away. Even so, I had to pull over on the way home for a few minutes to rest, again. Also, I could not bend over without starting to fall. Each day, from Friday to Tuesday, I slept about sixteen hours to recover along with necessary several hour naps during the day. Until today, I was unable to do dishes without dropping them. I also got blurred vision in the evening. Pain: On Thursday, I got a vaccine on my right upper arm. My arm burned after the shot which I assume is normal. On Thursday night, I could not move my arm especially my upper arm without pain. Thorough out the evening I got short two to three burning sensations in my arm. On Friday to Saturday, I could not move my upper arm away from my body without 8 out of 10 sore pain along with touching anything like a couch or lay on my upper arm without 6 out of 10 sore pain. On Monday, I had hard time working at my waitressing job, I lifted some heavy objects that caused my arm to be in extreme pain 9 out of 10 sore pain which caused me to be unable to work my second shift. Today Wednesday August 8, 2018; I am feeling better, I was able to modify a yoga 10 minute exercise before my shift in the morning. At work, I only used my left arm. In the afternoon, I am starting to be able to use my right arm again, do dishes and laundry at home, with just 3 out of 10 sore pain.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Responses: Monday, when I was at work for my second shift, I almost passed out more than four to five times. I left early. I had to rest in the car for ten minutes, before I felt safe to drive home which is ten minutes away. Even so, I had to pull over on the way home for a few minutes to rest, again. Also, I could not bend over without starting to fall. Each day, from Friday to Tuesday, I slept about sixteen hours to recover along with necessary several hour naps during the day. Until today, I was unable to do dishes without dropping them. I also got blurred vision in the evening. Pain: On Thursday, I got a vaccine on my right upper arm. My arm burned after the shot which I assume is normal. On Thursday night, I could not move my arm especially my upper arm without pain. Thorough out the evening I got short two to three burning sensations in my arm. On Friday to Saturday, I could not move my upper arm away from my body without 8 out of 10 sore pain along with touching anything like a couch or lay on my upper arm without 6 out of 10 sore pain. On Monday, I had hard time working at my waitressing job, I lifted some heavy objects that caused my arm to be in extreme pain 9 out of 10 sore pain which caused me to be unable to work my second shift. Today Wednesday August 8, 2018; I am feeling better, I was able to modify a yoga 10 minute exercise before my shift in the morning. At work, I only used my left arm. In the afternoon, I am starting to be able to use my right arm again, do dishes and laundry at home, with just 3 out of 10 sore pain.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Woke up morning of 7/28 with "chills" and body aches and pains unlike anything she has ever experienced with a vaccine before, this was gone by the next morning. Then, starting sometime on 7/28 she had redness and itchiness around the injection site, the size of the affected area was approximately the size of her hand, this was gone by 7/31. Additionally, sometime on 7/30 she developed redness of the skin on her chest, it was not itchy or raised, but was like a persistent flush. She did seek treatment at an urgent care for what she thought was an allergic reaction, but that was ruled out. The redness was gone by 7/31.
Age: 8.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness and swelling in the right and left deltoid injection sites. Denies further symptoms. Mother reports the swelling started today and got significantly worse in a short period of time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient stated that almost a week after receiving the vaccine she developed a rash and noticable bump at the injection site. She stated that before calling on 8/8/2018 the affected area had got noticably larger (she stated the rash extended about 2 inches around the injection site). The area is not painful unless presuure is applied. Pt has not experience any other adverse events.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Confusional state, Feeling cold
Clinical narrative: Patient rec'd 1st dose of SHINGRIX 8/8/18 at 14:45 pm. Remained in store at least 10 minutes (approx.) and appeared fine. His companion brought him back through drive thru around 1530 stating he had become cold, clammy and confused. She was also concerned that since patient is diabetic, these symptoms could have been caused by a drop in blood sugar, however they did not have a glucometer. I advised them to seek care at ER.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient received first dose of SHINGRIX on 4/9/18. Came to pharmacy on 8/5/18 to report "improper injection in lower portion of arm" to pharmacist.
Age: 38.0
Sex: F
Vaccine: DTP
Symptoms: Rash
Clinical narrative: Skin Rash.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Presyncope, Seizure
Clinical narrative: Approx 10 seconds of body jerks/seizure activity consistent with a vasovagal convulsion. She did not bite her tongue or experience urinary incontinence. Symptoms resolved and she return to her baseline in approx 1 minute.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood pressure decreased, Confusional state, Fall, Head injury, Nausea
Clinical narrative: 8/8/2018 Patient fainted after applying TRUMENBA. Explaining to patient all the symptoms (gave her the VIS form) to look for after receiving shot, the brother had a question so I turned around for not even 3 seconds and patient stood up and fell face first (got a bump to her left side of forehead). She then stood up and looked very confused, sleepy, felt like vomiting, and she said she had bit her tongue. Blood pressure was checked and was 67/34-5 minutes later she started focusing and was answering our questions. Ambulance arrived at 1:15, patient refused to go in the ambulance, brother will take her to hospital. Patient left clinic at 1:25.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Somnolence, Syncope, Tongue biting
Clinical narrative: 8/8/2018 Patient fainted after applying TRUMENBA. Explaining to patient all the symptoms (gave her the VIS form) to look for after receiving shot, the brother had a question so I turned around for not even 3 seconds and patient stood up and fell face first (got a bump to her left side of forehead). She then stood up and looked very confused, sleepy, felt like vomiting, and she said she had bit her tongue. Blood pressure was checked and was 67/34-5 minutes later she started focusing and was answering our questions. Ambulance arrived at 1:15, patient refused to go in the ambulance, brother will take her to hospital. Patient left clinic at 1:25.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: 7 x 3 cm erythematous rash on (L) thigh, 1 x 1 cm on (R) thigh - symptoms appeared 12 hours after vaccinations.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Vision blurred, Vomiting
Clinical narrative: Patient was walking home with mother, when he said his vision was blurry and he passed out. Upon waking up 30-60 seconds later, he vomited. Later this afternoon, mom reports he is playing normally. She says he did not hit his head or joints with the fall.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Hyperhidrosis, Rash
Clinical narrative: Rash noted by parents about 30 hours after vaccination and during bath time. The rash was on his chest at first at daycare. Today the rash was found to have spread to entire torso and into diaper area. Daycare worker noted her to be very sweaty.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Severe headache, shivering, nausea, dizziness, fever, hives all over the body (arms, torso, legs). I spent 24 hours in my bed, unable to do anything. The worst  post-vaccination adverse effects ever. Dose #1, administered on April 10, at Facility: a walk in the park. Dose #2, administers on Aug. 7, 2018 at Pharmacy: a total disaster.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Severe headache, shivering, nausea, dizziness, fever, hives all over the body (arms, torso, legs). I spent 24 hours in my bed, unable to do anything. The worst  post-vaccination adverse effects ever. Dose #1, administered on April 10, at Facility: a walk in the park. Dose #2, administers on Aug. 7, 2018 at Pharmacy: a total disaster.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, VARZOS
Symptoms: Contusion, Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: PATIENT DEVELOPED CELLULITIS IN THE ARM IN WHICH PNEUMOVAX WAS GIVEN, EXTENDING FROM THE INJECTION SITE DOWN TO THE HAND. PATIENT REPORTS VISITING THE ED AFTER THE DEVELOPMENT OF CELLULITIS (2 DAYS) AND BEING PRESCRIBED A COURSE OF STEROIDS THAT SUCCESSFULLY REDUCED THE REDNESS AND SWELLING OVER THE COURSE OF TREATMENT (DURATION UNKNOWN).
Age: 69.0
Sex: M
Vaccine: PPV, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Swelling
Clinical narrative: PATIENT DEVELOPED CELLULITIS IN THE ARM IN WHICH PNEUMOVAX WAS GIVEN, EXTENDING FROM THE INJECTION SITE DOWN TO THE HAND. PATIENT REPORTS VISITING THE ED AFTER THE DEVELOPMENT OF CELLULITIS (2 DAYS) AND BEING PRESCRIBED A COURSE OF STEROIDS THAT SUCCESSFULLY REDUCED THE REDNESS AND SWELLING OVER THE COURSE OF TREATMENT (DURATION UNKNOWN).
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: CSF test normal, Computerised tomogram head normal, Electroencephalogram, Endotracheal intubation, Laboratory test normal
Clinical narrative: Information has been received from a nurse via a company representative referring to a 6 month old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with ROTATEQ (oral; dose, lot # and expiration date were not reported), PREVNAR 13 (dose, route, lot # and expiration date were not reported) and PEDIARIX (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the nurse reported that post-vaccination the patient experienced febrile seizures on unspecified dates. The outcome of the event was reported as recovered. The causality assessment between the event and ROTATEQ, PREVNAR 13, PEDIARIX was not reported.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Lethargy, Seizure
Clinical narrative: Information has been received from a nurse via a company representative referring to a 6 month old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with ROTATEQ (oral; dose, lot # and expiration date were not reported), PREVNAR 13 (dose, route, lot # and expiration date were not reported) and PEDIARIX (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the nurse reported that post-vaccination the patient experienced febrile seizures on unspecified dates. The outcome of the event was reported as recovered. The causality assessment between the event and ROTATEQ, PREVNAR 13, PEDIARIX was not reported.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Computerised tomogram normal, Endotracheal intubation, Intensive care, Lumbar puncture normal, Seizure
Clinical narrative: Information has been received from a nurse via a company representative referring to a 6 month old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with ROTATEQ (oral; dose, lot # and expiration date were not reported), PREVNAR 13 (dose, route, lot # and expiration date were not reported) and PEDIARIX (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the nurse reported that post-vaccination the patient experienced febrile seizures on unspecified dates. The outcome of the event was reported as recovered. The causality assessment between the event and ROTATEQ, PREVNAR 13, PEDIARIX was not reported.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a nurse via a company representative referring to a 6 month old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with ROTATEQ (oral; dose, lot # and expiration date were not reported), PREVNAR 13 (dose, route, lot # and expiration date were not reported) and PEDIARIX (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the nurse reported that post-vaccination the patient experienced febrile seizures on unspecified dates. The outcome of the event was reported as recovered. The causality assessment between the event and ROTATEQ, PREVNAR 13, PEDIARIX was not reported.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Dyspnoea, Tachycardia
Clinical narrative: Patient developed an allergic reaction following her Pneumovax on 7/20/2018. Pt indicated that her arm was swollen, hard & painful, her heart was racing and she had to use her inhaler.