chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received Shingrix. On 9th July 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced redness at the injection site. The reporter consented to follow up. The outcome reported in the structured field was not recovered and the outcome reported in the source document was recovering.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; pain; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (receiving Zostavax on an unknown date in August 2017).   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th July 2019, 50 days after receiving Shingrix, the patient experienced shingles and pain. The patient was treated with gabapentin and opioids {nos} (Opioid). On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional information received were as follows: The age at the vaccination was not reported. The patient received Shingrix on left deltoid. The patient experienced shingles and was prescribed by his healthcare provider gabapentin and unspecified opioid as treatment for pain associated with shingles.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: temperature; This case was reported by a nurse via call center representative and described the occurrence of fever in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Two years ago, the patient had temperature of 104 degree F for 48 hours after receiving Bexsero. The reporter consented to follow up. No lot or expiration date, as this was given at another location.      Lab Comments: On unknown date, body temperature was measured.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site haemorrhage, Muscle tightness, Pain
Clinical narrative: Pt had shingrix vaccination a couple months ago in left arm. His left arm swelled and had pain to his spine. . Immediately after he had 4 lesions that showed up on right upper arm. Until the last couple days, the lesions had been bleeding and oozing. They have just dried up and started getting smaller yesterday.  Patient has been having pain in hips and low back. He is getting the pain up to an 8/10 mostly on his right side. When he shifts and puts wt on his left side his hip, knee and low back pain shifts to that side. Sometimes the pain on the right side lets up a little when he shifts to his left side but it never goes away. When the pain is really bad, his muscle tighten up. He has pain that starts in his left knee and then goes up to his hip. He states the pain is very sharp pain, denies burning pain. This has all happened since his shingrix
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin lesion
Clinical narrative: Pt had shingrix vaccination a couple months ago in left arm. His left arm swelled and had pain to his spine. . Immediately after he had 4 lesions that showed up on right upper arm. Until the last couple days, the lesions had been bleeding and oozing. They have just dried up and started getting smaller yesterday.  Patient has been having pain in hips and low back. He is getting the pain up to an 8/10 mostly on his right side. When he shifts and puts wt on his left side his hip, knee and low back pain shifts to that side. Sometimes the pain on the right side lets up a little when he shifts to his left side but it never goes away. When the pain is really bad, his muscle tighten up. He has pain that starts in his left knee and then goes up to his hip. He states the pain is very sharp pain, denies burning pain. This has all happened since his shingrix
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chills, Mobility decreased, Pain, Pyrexia, Rash erythematous
Clinical narrative: Fever 100.5 shakes ,chills ,vomiting awake but couldn't move. Hot red rash growing over marked line very swollen very painful
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm, Swelling, Tremor, Vomiting
Clinical narrative: Fever 100.5 shakes ,chills ,vomiting awake but couldn't move. Hot red rash growing over marked line very swollen very painful
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Accidental exposure to product
Clinical narrative: patient was given bexsero by mistake,
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Discussed usual side effect to Shingrix Ice to area Keep an eye on effected area.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gait inability, Headache, Pain
Clinical narrative: Sever body pain (couldn't walk), severe headache, chills (it's100F outside), blurred vision, extreme fatigue
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Sever body pain (couldn't walk), severe headache, chills (it's100F outside), blurred vision, extreme fatigue
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 30-JUN-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider at a pharmacy. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider in a clinic for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pemphigoid, Pruritus, Rash vesicular, Tremor
Clinical narrative: tremor in his hand; Bullous pemphigoid; blistery rash all over; Blisters on abdomen, chest, back, arms and hands; Itching; This case was reported by a other health professional via sales rep and described the occurrence of bullous pemphigoid in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (1st dose received on 2nd January 2019 (for tolerance refer US2019AMR126789)).   On 4th April 2019, the patient received the 2nd dose of Shingrix. On 7th April 2019, 3 days after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant), blistery rash, blister and pruritus. On an unknown date, the patient experienced tremor of hands. The patient was treated with ranitidine hydrochloride, cetirizine hydrochloride (Cetrizine), prednisone, hydroxyzine and doxepin. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bullous pemphigoid, blistery rash, blister and pruritus were not recovered/not resolved and the outcome of the tremor of hands was unknown.   It was unknown if the reporter considered the bullous pemphigoid, blistery rash, blister, pruritus and tremor of hands to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 65 or 66 years old. The patient received Shingrix and had blisters presented on abdomen, chest, back and migrated down to arms and hands. The blisters were itchy and too numerous to count. The patient was treated with cetirizine and ranitidine and itching improved some. On 23rd May 2019, teleconference med consult with dermatologist diagnosed with bullous pemphigoid.  The patient was given 3 bursts of steroids over the next 6 weeks. The blisters improved while on the steroids but returned upon weaning off the steroids. The physician discontinued steroids during the 3rd course of treatment due to a developing tremor in his hand. In June 2019, the patient had emergency visit (no exact date provided) and was given hydroxyzine and doxepin for rash. Near this time dermatologist scheduled 12th July 2019 appointment for further evaluation of the rash.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: tremor in his hand; Bullous pemphigoid; blistery rash all over; Blisters on abdomen, chest, back, arms and hands; Itching; This case was reported by a other health professional via sales rep and described the occurrence of bullous pemphigoid in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (1st dose received on 2nd January 2019 (for tolerance refer US2019AMR126789)).   On 4th April 2019, the patient received the 2nd dose of Shingrix. On 7th April 2019, 3 days after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant), blistery rash, blister and pruritus. On an unknown date, the patient experienced tremor of hands. The patient was treated with ranitidine hydrochloride, cetirizine hydrochloride (Cetrizine), prednisone, hydroxyzine and doxepin. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bullous pemphigoid, blistery rash, blister and pruritus were not recovered/not resolved and the outcome of the tremor of hands was unknown.   It was unknown if the reporter considered the bullous pemphigoid, blistery rash, blister, pruritus and tremor of hands to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 65 or 66 years old. The patient received Shingrix and had blisters presented on abdomen, chest, back and migrated down to arms and hands. The blisters were itchy and too numerous to count. The patient was treated with cetirizine and ranitidine and itching improved some. On 23rd May 2019, teleconference med consult with dermatologist diagnosed with bullous pemphigoid.  The patient was given 3 bursts of steroids over the next 6 weeks. The blisters improved while on the steroids but returned upon weaning off the steroids. The physician discontinued steroids during the 3rd course of treatment due to a developing tremor in his hand. In June 2019, the patient had emergency visit (no exact date provided) and was given hydroxyzine and doxepin for rash. Near this time dermatologist scheduled 12th July 2019 appointment for further evaluation of the rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Erythema, Malaise, Peripheral swelling
Clinical narrative: fever; arm sweeled up; arm became red; arm hot to touch; felt dizzy; disoriented; does not feel right; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2019, 1 days after receiving Shingrix, the patient experienced fever, swelling arm, erythema of extremities, skin warm, dizziness, disorientation and feeling unwell. On an unknown date, the outcome of the fever, swelling arm, dizziness, disorientation and feeling unwell were unknown and the outcome of the erythema of extremities and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, swelling arm, erythema of extremities, skin warm, dizziness, disorientation and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The caller reported that she received Shingrix and felt fine for about 24 hours, then she got a fever and her arm swelled up and became red and hot to the touch. She felt dizzy and disoriented. This lasted for over 2 days before she started feeling better. At the time of reporting she still did not feel right and her arm was less swollen, but still red and hot to the touch.  The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: fever; arm sweeled up; arm became red; arm hot to touch; felt dizzy; disoriented; does not feel right; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2019, 1 days after receiving Shingrix, the patient experienced fever, swelling arm, erythema of extremities, skin warm, dizziness, disorientation and feeling unwell. On an unknown date, the outcome of the fever, swelling arm, dizziness, disorientation and feeling unwell were unknown and the outcome of the erythema of extremities and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, swelling arm, erythema of extremities, skin warm, dizziness, disorientation and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The caller reported that she received Shingrix and felt fine for about 24 hours, then she got a fever and her arm swelled up and became red and hot to the touch. She felt dizzy and disoriented. This lasted for over 2 days before she started feeling better. At the time of reporting she still did not feel right and her arm was less swollen, but still red and hot to the touch.  The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at injection site (left arm); This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 4th March 2019, 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received the first of the Shingrix in their left arm and had a injection site sore for a couple of days and then resolved. The batch number reported for Shingrix(L7SYN) did not exist and was updated to L7SY9, as per sales database. The reporter was unable to provide any additional information. This case has been linked with case US2019125917, reported by the same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain, not being able to raise arm over shoulder, tried some Aleve with minimal relief. Scheduled follow-up appointment with PCP
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Nausea, Pyrexia
Clinical narrative: Severe chills and shivering for 2-3 hours followed by fever for 4-5 hours. Now just lethargic and queazy.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Full blood count, Immune thrombocytopenic purpura, Injection site erythema, Laboratory test abnormal
Clinical narrative: Patient started having fever and joint pain on 7/5/19, redness to left upper arm in the area of the injection.  on 7/8/19 she developed a rash. Labs were drawn and she was found to have acute ITP, neutropenia, and trhombocytopenia.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Neutropenia, Pyrexia, Rash, Thrombocytopenia
Clinical narrative: Patient started having fever and joint pain on 7/5/19, redness to left upper arm in the area of the injection.  on 7/8/19 she developed a rash. Labs were drawn and she was found to have acute ITP, neutropenia, and trhombocytopenia.
Age: 20.0
Sex: F
Vaccine: IPV, UNK
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Wrong product administered
Clinical narrative: nurse accidentally pulled ipv up instead of ppd solution and administered it in left forearm 0.01 ml intradermal. then realized entering the lot # that it was ipv not ppd. nurse drew ppd solution and administered it in right forearm 0.01 ml intradermal. pt to return to clinic 7/19/19.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted for a few seconds two times, gave water, juice, layed down for 30 min, vitals checked every 5 minutes.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: My 8 year old daughter has never received the MMR vaccine. Within about a week after I received the vaccine, she started showing symptoms of mumps. Flu like symptoms, mild rash, swollen lymph nodes. I took her in to urgent care and the doctor suspected the same diagnosis. My daughter never had any of these symptoms before with the exception of the flu. There is no chance that this was just a coincidence. It can only be spread supposedly through feces except our hygiene practices are pretty up to par and we don't play in each other's poop.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Fever 101.8  Body stiffness  Headache Sore arm
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure increased, Heart rate increased, Syncope
Clinical narrative: Pt did not wait 15 min after immunization. Pt walking in hallway with mother and was witnessed fainting. did not lose consciousness. Doctor assessed patient. Blood pressure,  117/98, heart rate 103 beats per minute, blood sugar 101. Patient provided with snack and water and laid on exam table. Doctor reassessed after 20 minutes and discharged patient
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypotension, Malaise, Pain, Swelling
Clinical narrative: Essentially he had local swelling and pain. Over the subsequent hours some malaise and noted hypotension/tachycardia. Pressures as low as  97/60 after showering with pulses between 100-120 with fatigue. Following day 6/8 pulse and no in normal range but feeling ?wiped out?. 130am 100/64 p 76. Following 6am 107/69 p 72. 7am 128/65 after 120pushups and 20 sit-ups 128/65 p 89. Rest of day felt fine but wiped out. By 6/9 back to normal
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Essentially he had local swelling and pain. Over the subsequent hours some malaise and noted hypotension/tachycardia. Pressures as low as  97/60 after showering with pulses between 100-120 with fatigue. Following day 6/8 pulse and no in normal range but feeling ?wiped out?. 130am 100/64 p 76. Following 6am 107/69 p 72. 7am 128/65 after 120pushups and 20 sit-ups 128/65 p 89. Rest of day felt fine but wiped out. By 6/9 back to normal
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection Site Reaction - Large Red Bump and Swollen
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Inflammation, Swelling
Clinical narrative: inflammed; hot; Raised; This case was reported by a pharmacist via sales rep and described the occurrence of inflammation in a 72-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, several hours after receiving Shingrix, the patient experienced inflammation, feeling hot and swelling. On an unknown date, the outcome of the inflammation, feeling hot and swelling were unknown.   It was unknown if the reporter considered the inflammation, feeling hot and swelling to be related to Shingrix.  Additional details were provided as follows: Within 48 hours the 1st administration patient reported to reporter that she feels hot, raised, inflamed.  Referred to provider, provider decide that she could proceed with 2nd dose. The reporter agreed to follow up from GlaxoSmithKline.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Product supply issue
Clinical narrative: inappropriate schedule of; sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2018).   On 5th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. At the time of reporting, the patient was experiencing a sore arm where Shingrix was administered. The patient was unable to receive the 2nd dose of Shingrix within the 2 to 6 month window due to supply issues. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness, pain and tenderness at the injection site; redness, pain and tenderness at the injection site; redness, pain and tenderness at the injection site; This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. This nurse reported similar events for three patients (nurse's mother and two patients in the office). This is the second of three reports.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, pain and tenderness at the injection site. The patient also experienced flare on unspecified date. The patient was given antibiotics and steroids for symptoms. Outcome of the events was unknown.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019296477 different patient, same drug and event
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site swelling, Nausea
Clinical narrative: Nausea/nauseous patient unable to eat or drink for 3-4 days; Swelling in her left arm from the elbow to the shoulder; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc.   A Pharmacy Technician (non HCP) reported that a female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; Lot Number:  W81747, Expiration Date:  01Sep2020) , intramuscular in the left arm on an unspecified date at single dose for immunisation .  The patient medical history  and concomitant medications were not reported.  The patient experienced nausea on an unknown date with outcome of unknown and  swelling in her left arm from the elbow to the shoulder (non serious) on an unspecified date with outcome of unknown. Nausea, prevented  the patient from eating or drinking for 3 or 4 days. The Patient did seek treatment, but no further details were available as to whom she saw and what treatment was given. No additional information provided.
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: local arm pain at Trumenba injection site; limitation of arm movement continuing to day after administration; This is a spontaneous report from contactable physician via Pfizer Sales Representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  It was reported that patient experienced local arm pain at Trumenba injection site including limitation of arm movement continuing to day after administration. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: TD
Symptoms: Injection site bruising, Pruritus
Clinical narrative: Patient stated she had some itching that started about two days after the shot and also had some small bruising around the injection site that she thought may have been due to her itching but was unsure.  The patient was counseled to take OTC antihistamines to help with itching.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported that on the third day post vaccination she developed a case of shingles on the back of a leg. No further details were provided.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Headache, Injection site swelling, Laboratory test, Lethargy
Clinical narrative: 5 continuous days of injection site swelling, lethargy, loss of appetite, visual disturbances, severe headache/body ache, testicluar swelling and tenderness, and high grade fever of 105 that began in evenings and lasted through the night.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Pyrexia, Tenderness, Testicular swelling, Ultrasound testes
Clinical narrative: 5 continuous days of injection site swelling, lethargy, loss of appetite, visual disturbances, severe headache/body ache, testicluar swelling and tenderness, and high grade fever of 105 that began in evenings and lasted through the night.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Visual impairment
Clinical narrative: 5 continuous days of injection site swelling, lethargy, loss of appetite, visual disturbances, severe headache/body ache, testicluar swelling and tenderness, and high grade fever of 105 that began in evenings and lasted through the night.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Anaphylactic reaction, Nausea, Oropharyngeal pain, Paraesthesia oral, Urticaria
Clinical narrative: Anaphylaxis (tongue tingle, sore throat, nausea, diffuse hives)
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: vesicular eruption; fever; This literature marketed report has been received from the authors of a published literature article, and refers to a male patient of unknown age. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vesicular eruption with fever. The outcome of the events was not provided. The authors considered the events to be related to varicella virus vaccine (manufacturer unknown) as the events occurred after vaccination.   This is one of two reports derived from the same literature article and concerning the same patient (cross referenced with #1907USA003553). A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-1907USA003553:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On  14-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 17-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 20-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 23-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 30-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous report was received from a pharmacist, who was also the patient's mother via company representative and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date , around 20:00 or 21:00, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that by 03:00 he was vomiting. The outcome of the vomiting was unknown.    The causality assessment between the event and the suspect therapy was not provided.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dysphagia, Swallow study abnormal
Clinical narrative: difficulty swallowing; This case was reported by a physician via sales rep and described the occurrence of swallowing difficult in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX657AA, expiry date unknown) for prophylaxis.   On 15th February 2019, the patient received the 1st dose of Bexsero. On 27th February 2019, 12 days after receiving Bexsero, the patient experienced swallowing difficult. On an unknown date, the outcome of the swallowing difficult was unknown.   It was unknown if the reporter considered the swallowing difficult to be related to Bexsero.  Additional details were provided as follows: The patient experienced difficulty swallowing.  The physician concerned that patient said food was getting stuck in patient's throat. Testing was done and report came back that it was low percentage of environmental. The reporter was agreed to follow up.      Lab Comments: On an unknown date in 2019, the patient underwent testing and the report showed that it was low percentage of environmental.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller was a patient who reported that she was seen by her gynecologist recently and her gynecologist reported to her that she received Shingrix and experienced arm pain. The reporter did not consent to follow up. The caller declined to provide any contact information.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: achy at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number B327C, expiry date 4th July 2020) for prophylaxis.   On 30th April 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient arm was achy at the injection site for a day or two after receiving the first dose of the Shingrix vaccine. The reporter was unable to provide any additional information. This case has been linked with cases US2019AMR126801 and US2019125917, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness; Injection site warmth; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had a injection site reaction to Shingrix. The reporter stated that just underneath the injection site was warm and red, no swelling nor breathing problems.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Patient experienced itching in arm below injection site radiating to fingers
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Erythema, Gait inability, Swelling
Clinical narrative: Patient came to the clinic with a red, swollen area with blister like area in the middle of the area that was swollen. Parent stated that patient was unable to walk. Patient was sent to the local emergency room at Hospital
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on chest, arms, legs
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Swelling, reddness, pain in arm (painful to touch)
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; 6-month old patient inadvertently received one dose of VARIVAX subcutaneously in the right thigh; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 27-JUN-2019, the patient inadvertently received one dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the right tight, lot # R030606, expiration date 23-OCT-2020 (exact dose was not reported) for prophylaxis. No adverse event was reported.  The reporter informed that she submitted this information to the Vaccine Adverse Event Reporting System (VAERS).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient stated that her arm was extremely sore after the Shingrix vaccination. The patient did not want a follow up with the health care professional as she believes this would be a hassle and unnecessary.  No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Injection site bruising; This case was reported by a pharmacist via sales rep and described the occurrence of injection site bruising in a 61-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 a year after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had bruising effect on the arm at the site of the injection. Still visible 10 weeks following 1st injection.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: ocular shingles; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional information was provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient received the first dose of Shingrix and 1-2 weeks after receiving the vaccine, the patient had a recurrence of ocular shingles.