chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX on 12/5/2019, that had been improperly stored.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). Information about pertinent medical history, drug reactions or allergies was not provided.   On 05-DEC-2019, the patient was inadvertently vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S021926, expiration date 15-JUL-2021; dosage detail, strength and route were not reported ) for prophylaxis. The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. Administered doses of vaccine experienced temperature excursion of 1.2 degrees Celsius (C) for 3 hours 9 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Retinal artery occlusion, Vision blurred
Clinical narrative: central retinal artery occlusion; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 27-DEC-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden blurred vision in her right eye and was diagnosed with central retinal artery occlusion. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event central retinal artery occlusion was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events central retinal artery occlusion to be disability.  Upon internal review, central retinal artery occlusion was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: Drug allergy; This spontaneous report was received from a physician via Pfizer regarding an elderly female patient of an unknown age. Information on pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot/batch number and expiry date were not reported) for prophylaxis. On an unknown date the patient experienced drug allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (drug hypersensitivity). Outcome of the event was unknown. Causality of the event was related to the suspect therapy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Phenergan with an associated reaction of pain, Phenergan with an associated reaction of swelling and Phenergan with an associated reaction of nerve injury (Nerve damage in right shoulder that has resolved). Concurrent medical conditions included drug allergy (injected in righ deltoid). Concomitant products included Herpes zoster (Shingrix), ascorbic acid (Vitamin C) and zinc.   On 11th October 2019, the patient received the 2nd dose of Shingrix. On 11th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. In October 2019, the outcome of the pain in arm was resolved with sequelae.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: in 2000, the patient had an allergic reaction to a phenergan injection that was injected in the righ deltoid. It caused soreness and swelling and resulted in nerve damage in the right shoulder that has resolved The patient received 2nd dose of Shingrix vaccine in left arm and experienced sore arm on the same day which was lasted for 2 to 3 days. The patient received echincea as concomitant. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pyrexia
Clinical narrative: fever; headache; Swelling at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever, headache and injection site swelling. On an unknown date, the outcome of the fever, headache and injection site swelling were resolved with sequelae.   It was unknown if the reporter considered the fever, headache and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient experienced fever, headache and swelling at the injection site. The symptoms lasted a few days after the 1st shot. The reporter consented to follow up. For tolerence to the 2nd dose, refer case US2020014933.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: pain in the left at muscle/This did happen with the first; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. On 27th January 2020, less than a day after receiving Shingrix, the patient experienced muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain in the left at muscle not relieved with Tylenol. For tolerances of 2nd dose, refer case US2020AMR015700, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Chest discomfort
Clinical narrative: slight tightness in chest; This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness was unknown.   It was unknown if the reporter considered the chest tightness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and cause tightness in chest. Not severe but slight tightness.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Palpitations
Clinical narrative: extremely dizzy; My heart was racing; stomach cramps ugh is the normal; This case was reported by a other health professional via interactive digital media and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness, heart racing and stomach cramps. On an unknown date, the outcome of the dizziness, heart racing and stomach cramps were unknown.   It was unknown if the reporter considered the dizziness, heart racing and stomach cramps to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and heart was racing, extremely dizzy, stomach cramps and reported wanted to know was this normal.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Slight fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received Shingrix. On 28th January 2020, 1 days after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had slight fever and chills. The reporter asked how long should this side effect last.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Experienced lesser side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse event in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (recieved 1st dose on unknown date, refer case US2020AMR014607).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received Shingrix stated that the doctors at her workplace are stating that it was their general finding in their clinical setting that patients who got the 2nd dose further apart from the 1st dose experienced lesser side effects. The reporter consented to follow up. This case linked with US2020AMR014606 and US2020013944, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Arm soreness; Jan 21 to come in to get my first shot / Jan. 24 that I could come in to get my second shot; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 24th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On 24th January 2020, the patient experienced drug dose administration interval too short. Rechallenge with Shingrix was positive. In January 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: On 21st January 2020, patient received 1st dose of Shingrix in left arm. The patient received 2nd dose of Shingrix on right arm, before than the recommended interval, which led to shortening of vaccination schedule. She experienced arm soreness in each arm for a couple of days following the shots. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovering/resolving.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st Shingrix vaccination at an unspecified time and stated that it was a little itchy. The reporter declined to provide further demographic information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Throat began to tighten up; This case was reported by a consumer via call center representative and described the occurrence of throat tightness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than an hour after receiving Shingrix, the patient experienced throat tightness. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the throat tightness was recovered/resolved.   It was unknown if the reporter considered the throat tightness to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix two to three months ago from reporting date. Her throat began to tighten up 30 to 45 minutes after the vaccination. She took Benadryl and felt fine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Insomnia, Myalgia
Clinical narrative: extreme fatigue; temperature of 102.2 Fahrenheit; muscle pain- involving her whole body; chills /shivering; muscle pain that prevented her from sleeping; red patch; This case was reported by a consumer via call center representative and described the occurrence of skin red in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included trigeminal neuralgia (had trigeminal neuralgia which occurred many years ago.).   On 25th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced skin red. On 25th January 2020, the patient experienced fatigue, fever, myalgia, chills and sleeplessness. The patient was treated with naproxen. On an unknown date, the outcome of the skin red, fever, myalgia, chills and sleeplessness were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the skin red, fatigue, fever, myalgia, chills and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left deltoid. She stated she had a red patch, about 2.5-3 inches, below the injection site, which has resolved. Patient states that same evening she started to experience extreme fatigue, shivering, chills, muscle pain involving her whole body, which prevented her from sleeping, and, she had a temperature of 102.2 Fahrenheit.  The patient took 220 mg naproxen, two tablets every 4-6 hours which helped with the fever.  All the adverse events have resolved except the fatigue. The patient did not remember which she got the 1st dose of the Shingrix. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: extreme fatigue; temperature of 102.2 Fahrenheit; muscle pain- involving her whole body; chills /shivering; muscle pain that prevented her from sleeping; red patch; This case was reported by a consumer via call center representative and described the occurrence of skin red in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included trigeminal neuralgia (had trigeminal neuralgia which occurred many years ago.).   On 25th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced skin red. On 25th January 2020, the patient experienced fatigue, fever, myalgia, chills and sleeplessness. The patient was treated with naproxen. On an unknown date, the outcome of the skin red, fever, myalgia, chills and sleeplessness were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the skin red, fatigue, fever, myalgia, chills and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left deltoid. She stated she had a red patch, about 2.5-3 inches, below the injection site, which has resolved. Patient states that same evening she started to experience extreme fatigue, shivering, chills, muscle pain involving her whole body, which prevented her from sleeping, and, she had a temperature of 102.2 Fahrenheit.  The patient took 220 mg naproxen, two tablets every 4-6 hours which helped with the fever.  All the adverse events have resolved except the fatigue. The patient did not remember which she got the 1st dose of the Shingrix. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: was diagnosed with shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 4749N, expiry date 14th November 2021) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. On 25th January 2020, 87 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that, the patient received a dose of Shingrix and sometime this weekend the day of reporting diagnosed with shingles. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of Shingrix. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; nausea; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder soreness (soreness in shoulder in 2000 due to phenergan injection), swollen joints (shoulder swelling in 2000 due to phenergan injection) and nerve damage (Nerve damage in shoulder in 2000 due to phenergan injection, that has resolved.). Previously administered products included phenergan injection. Concurrent medical conditions included allergy (in 2000 the patient had an allergic reaction to a phenergan injection). Concomitant products included ascorbic acid (Vitamin C) and zinc.   On 1st August 2019, the patient received the 1st dose of Shingrix. On 1st August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 2nd August 2019, the patient experienced fever and nausea. On an unknown date, the outcome of the pain in arm, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received vitamin c, zinc and echincea as a concomitant medication. After vaccination with 1st dose of Shingrix, the patient experienced sore arm on the same day and lasted for 2 to 3 days. The patient experienced fever and nausea on next day of vaccination. The reporter consented to follow up. This case has been linked with case US2020AMR015497 and US2020AMR015496, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: rash on his face and scalp; This case was reported by a nurse via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, immediately after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Shortly after vaccination in late September 2019, and since then the patient had experienced a rash on his face and scalp which comes and goes. The patient was due for the second dose of Shingrix but the reporter was unsure if they should give that vaccine to the patient. The reporter was not sure if the rash came from Shingrix. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: arm pain/ arm pain in the injected right arm/pain from the top of the arm to the elbow; arm pain/ arm pain in the injected right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in elbow in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, immediately after receiving Shingrix, the patient experienced pain in elbow and pain in arm. On an unknown date, the outcome of the pain in elbow and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pain in elbow and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine in September 2019. Immediately after the vaccination she had arm pain in the injected right arm. The patient described it as pain from the top of the arm to the elbow. The pain in arm persisted till the time of reporting. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: breakthrough of shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a breakthrough of shingles after receiving the first dose of Shingrix vaccine. No further details were provided. This case has been linked with US2019229315, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced Shingles 11 days after 1st dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) and (batch number 9B23Y, expiry date 31st January 2022) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In January 2020, 11 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient patient experienced Shingles 11 days after receiving 1st dose of Shingrix. The reporter was concerned about proceeding with 2nd dose of shingrix. The batch number for suspect was reported as KX526 however it was captured as KX52G as per sales data sheet. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: Redness around the injection site; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were reported as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received the a dose of Shingrix and a week later still had redness around the injection site. The reporter was concerned whether patient should receive 2nd dose of vaccine or not. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Skin discolouration
Clinical narrative: pain at injection site; redness at injection site; pink spots on skin in different areas; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema and skin discoloration. On an unknown date, the outcome of the injection site pain, injection site erythema and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The patient experienced pink spots that would appear on her skin in different areas and would go away and then reappear and this happened for 4 months after the dose. The reporter denies that the pink spots were raised, they did not itch and were not painful. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: pain in left arm; swelling left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (breast cancer removed). Concurrent medical conditions included lymphadenectomy (lymph nodes removed from right arm).   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, immediately after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and shortly after receiving the vaccine, she developed pain and swelling in her left arm. The swelling was recovered, however the pain did not resolved till the time of reporting. The patient stated that every time she lifts her arm, it hurts. The reporter consented to follow up.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pruritus, Skin mass
Clinical narrative: small subcutaneous nodule at injection site and itching x 5 months later
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Injection site inflammation, Injection site pain
Clinical narrative: Patient came in yesterday 2/5/2020 for a TB test. I inadvertently used Typhoid vaccine (.1cc intradermally) and applied it to her R forearm. I realized my mistake when documenting the injection. I told her what happened and then proceeded to do another TB test on her Left forearm using the correct ppd fluid. Patient wasn't very upset at the time. I told her that more than likely she would have a reaction at the site of the Typhoid injection. I received a call from the patient this morning. The site of the Typhoid injection was inflamed and painful. The site of the ppd (Left forearm was also reactive). Patient seemed more concerned about the ppd site as this was her 2nd test in a few weeks and her first test was completely non-reactive. I explained to her that we would wait until Friday 2/7/2020 to read the TB test. I encouraged her to put ice on the site of the Typhoid injection and also possibly take some Benadryl to help lessen the inflammation. She stated that she took Benadryl last night but it didn't seem to help. She stated she had a headache but no other adverse symptoms.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Fatigue, Feeling abnormal, Nasal congestion
Clinical narrative: Runny nose and light cough day 1 stuffy and runny nose, aches, sleepy, shaky, cotton head, dizzy day 2 and 3 aches, tired, cotton head day 4 tired, achy, stuffy nose and light productive cough returned day 5 and 6 stuffy, tired and light cough day 7 and 8
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nervousness, Pain, Productive cough, Rhinorrhoea, Somnolence
Clinical narrative: Runny nose and light cough day 1 stuffy and runny nose, aches, sleepy, shaky, cotton head, dizzy day 2 and 3 aches, tired, cotton head day 4 tired, achy, stuffy nose and light productive cough returned day 5 and 6 stuffy, tired and light cough day 7 and 8
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Musculoskeletal disorder
Clinical narrative: other Contraindication/precaution/immunity not listed (must add text component with description) Pt arm swelled up from the shoulder down to the elbow.  It was hot to touch with redness.  Pt was in pain and would not use arm.  Pt had a hard mass in arm that went from the shoulder to the elbow.  Pt mother stated that after 2 weeks he developed a rash on the lower left arm that went to his abdomen.  Mother stated that he has had that off and on since October.  Mother has been treating with cortisone cream, lotion, ice pack, and vinegar (to draw heat out).  Mother was informed to seek medical attention if any other reactions occur.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pain, Rash
Clinical narrative: other Contraindication/precaution/immunity not listed (must add text component with description) Pt arm swelled up from the shoulder down to the elbow.  It was hot to touch with redness.  Pt was in pain and would not use arm.  Pt had a hard mass in arm that went from the shoulder to the elbow.  Pt mother stated that after 2 weeks he developed a rash on the lower left arm that went to his abdomen.  Mother stated that he has had that off and on since October.  Mother has been treating with cortisone cream, lotion, ice pack, and vinegar (to draw heat out).  Mother was informed to seek medical attention if any other reactions occur.
Age: 0.33
Sex: F
Vaccine: HIBV, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram, Staring, Tremor
Clinical narrative: Beginning on December 18th, I noticed that my daughter's head would shake uncontrollably while being fully supported. I figured it was normal baby shakes and was told that by multiple people not to worry. As December came to an end, I noticed she would blank out and when she would come back to reality, patient's body would vibrate. Starting December 31, 2019 - I noticed her arms and legs would jerk a bit more often when sleeping. I called and canceled her vaccinations on January 2nd and when asked why I told the nurse about the shaking and vibrating. We met with staff on January 3, 2019 to discuss what was going on. We scheduled an EEG for January 17th. It is now February 6, 2020 and I have yet to receive any information/results of the test. I have called multiple times and now found out the neurologist has been on vacation and hasn't been able to read it. Patient met with her pediatrician, staff on  January 29, 2019 for her wellness check. She referred us to the same neurologist as Patient continues to have episodes (have not heard from them to schedule an appointment). Refused to vaccinate any further with shots, however Patient did receive last dose of Rotavirus to complete that series.
Age: 6.0
Sex: F
Vaccine: DT
Symptoms: Wrong product administered
Clinical narrative: No adverse reaction occured. DT was administered instead of DTAP. Was advised by coordinator to complete VAERS form.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Eye swelling, Mouth swelling, Rash, Swelling face
Clinical narrative: Patient began breaking out in a rash on his neck and left arm about two hours after receiving the shot. The rash had dissipated some by morning, but became widespread within 24 hours of receiving the shot. This widespread reaction included a diffuse rash of his neck, trunk and arms, as well as facial swelling; particularly around his mouth and eyes. He also developed a small cough.  Patient received a three-day course of oral steroids and a 30-day course of antihistamines to treat the reaction.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; improperly store PNEUMOVAX 23 was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 12-DEC-2019, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) subcutaneously, lot # S017430, expiration date 18-MAY-2020 (dose and frequency were not reported) for prophylaxis. No additional adverse effects reported. The temperature excursion was 30.78 degrees Fahrenheit (F) for 15 minutes. Previously, vaccine experienced temperature excursion with the lowest temperature below 36 F (30.78 F) 311 cycles. Data logger was not involved.  This is one of two reports received from the same reporter (cross-linked with MARRS# 2001USA005288).; Sender's Comments:  US-009507513-2001USA005288:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; improperly store PNEUMOVAX 23 was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-DEC-2019, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) subcutaneously, lot # S017430, expiration date 18-MAY-2020 (dose and frequency were not reported) for prophylaxis. No additional adverse effects reported. The temperature excursion was 30.78 degrees Fahrenheit (F) for 15 minutes. Previously, vaccine experienced temperature excursion with the lowest temperature below 36 F (30.78 F) 311 cycles. Data logger was not involved.  This is one of two reports received from the same reporter (cross-linked with MARRS# 2001USA005259).; Sender's Comments:  US-009507513-2001USA005259:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: The patient was administered a dose of MMR II (expiration date: 08-JAN-2020)/expired vaccine administered; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender.   Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported.   On 29-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at a dose of 0.5 milliliter (therapy type: rHA, route of administration was not reported) (lot # R000551, expiry date: 08-JAN-2020) for prophylaxis (expired product administered). The outcome of the event was unknown.
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Injection site induration
Clinical narrative: Hardening under skin at the injection site; This spontaneous report was received from a pharmacist regarding a 13-year-old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 03-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2, via intramuscular (strength, dose) for prophylaxis. Lot number (R028380) is an invalid lot number for [hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On the same day patient received influenza virus vaccine (unspecified) (strength, dose, frequency, route, lot # and expiry date were not reported) in the same arm. It was reported that on 31-JAN-2020, patient called pharmacy to report hardening under skin at injection site (injection site induration), but patient has no pain, warmth, or swelling. On 31-JAN-2020, the patient experienced injection site induration. The outcome of injection site induration was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.   In on around 22-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prevention of shingles (dose, route, lot number and expiration date were not reported).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)"), she experienced multiple, severe and painful rashes on the back and buttocks, she was diagnosed with herpes zoster. The patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). As a result of zoster vaccine live (ZOSTAVAX), the patient had severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries. The outcome of herpes zoster was not recovered. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX). The event was considered a disabling event.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse event; patient was administered VARIVAX via intramuscular route; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # S012036 and expiration date 17-APR-2021 (exact dose was not reported) for prophylaxis, via intramuscular route. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection, intramuscularly, lot # S012824 and expiration date 18-DEC-2021 (strength, dose and frequency were not reported) for prophylaxis. No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was administered the first dose of ROTATEQ (Lot: 1660148 Exp: 09/16/2020) in the series today, 02/04/2020, and the patient is 6 months old; This spontaneous report was received from a physician referring to a 6 month old patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 04-FEB-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form of lot # 1660148 with expiry date 16-SEP-2020 (route unknown) for prophylaxis (product administered to patient of inappropriate age). No product quality complaint was involved.
Sex: U
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received Prevenar and PNEUMOVAX 23 on the same day (instead of 1 yr apart); This spontaneous report was received from a pharmacist and refers to a adult patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, lot #, expiration date, , anatomical location and route of administration were not reported) for prophylaxis. On the same day (instead of 1 year apart), at a different medical office, the patient was also vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) (dose, dose number, lot #, expiration date, anatomical location and route of administration were not reported) for prophylaxis (inappropriate schedule of vaccine administration). The physician wanted to know if it was necessary to administer pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again to assure protection, because the patient needed both vaccines before travel to another country.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: Client 45 at time of Dose #1 ofGardisil .... Missed #2 and #3---now 46; Client 45 at time of Dose #1 ofGardisil .... Missed #2 and #3---now 46; This spontaneous report was received from a nurse and refers to a 46-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, reported as when the patient was 45 years old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis.  On unknown dates, the patient missed the second and third dose of the suspect vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Musculoskeletal pain, Pain in extremity, Secretion discharge
Clinical narrative: some achiness on the left side above and below the scapula; she had some mucus in her throat around the time of the 3rd vaccine; patient had 3 doses of SHINGRIX; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included phenergan with an associated reaction of pain, phenergan with an associated reaction of swelling, phenergan with an associated reaction of nerve injury (nerve damage in the right shoulder that has resolved) and Shingrix with an associated reaction of pain in extremity (For tolerance after 2nd dose refer case US2020AMR015496). Concurrent medical conditions included drug allergy (received in right deltoid). Concomitant products included ascorbic acid (Vitamin C) and zinc.   On 15th January 2020, the patient received the 3rd dose of Shingrix. On 15th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, mucus discharge and extra dose administered. On 26th January 2020, the patient experienced scapula pain. Rechallenge with Shingrix was positive. In January 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the scapula pain and mucus discharge were recovering/resolving and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the pain in arm, scapula pain and mucus discharge to be related to Shingrix.  Additional details were reported as follows: in 2000, the patient had an allergic reaction to a phenergan injection that was injected in the righ deltoid. It caused soreness and swelling and resulted in nerve damage in the right shoulder that has resolved. The patioent reported that that she had some mucus in her throat around the time of the 3rd vaccine but it was clearing up. The patient received 3rd dose of Shingrix vaccine in left arm and experienced sore arm on the same day which was lasted for 2 to 3 days. Within the last few days she also experienced some achiness on the left side above and below the scapula. The patient received echincea as concomitant. The patient had scheduled regeneten bioinductive implant on the right side in a few weeks from reporting date. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Malaise, Mobility decreased
Clinical narrative: I'm so sick; feel like I have the flu; can't move my arm hurts so much; can't move my arm hurts so much; my temp is 101; i have headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering. On an unknown date, the outcome of the sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering to be related to Shingrix.  Additional case details were reported as follows: The patient got sick and felt  like the flu after receiving Shingrix. The patient could not move the arm it hurt so much, and had fever (101 degree C). The patient also experienced headache and shivering after receiving Shingrix. The patient asked getting a 2nd dose or would all the events get worse.