chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Palpitations, Pyrexia
Clinical narrative: Heart racing; Super dizzy; Fever; Joints were killing me; Head was pounding; felt like I was being tortured; Super drained; Spontaneous report received on 25SEP2020.  A patient reported that he experienced "heart racing" (PT: Palpitations), "super-dizzy" (PT: Dizziness), "fever" (PT: Pyrexia), "joints were killing me" (PT: Arthralgia), "head was pounding; felt like I was being tortured" (PT: Headache), and "super-drained" (PT: Fatigue), following the administration of BioThrax (anthrax vaccine adsorbed) for post exposure prophylaxis (PEP). On 24SEP2020 at 09:00, the patient received second dose of BioThrax in his left arm. He reported that there was no illness prior to the injection and no issues on day of injection. He woke up at approximately 00:30 and reported that "heart racing, joints were killing me, head was pounding, felt like I was being tortured, super-drained and super dizzy".   It was reported that he woke up around 04:00 and checked his temperature and it was 101 so he took Motrin (ibuprofen) 800mg and his fever was reduced to around 99. He was told to "take lots of fluids, rest and continue Motrin all day and if it did not take his temperature down to call his doctor". He also stated that he took more Motrin around 11:30 or 12:00 on 25SEP2020 and the temperature was staying down. At the time of report, most of his symptoms were resolved but his head was still pounding   A follow up information was received on 29SEP2020, from the consumer. He reported that by Sunday evening (27SEP2020), 95 percent of his symptoms was resolved. He further stated that by Monday morning (28SEP2020), all of the symptoms were resolved, and he was ready to go back to work and currently not experiencing any adverse events. The patient was recovered from the reported events, at the time of report.  Concomitant medication included oral Ciprofloxacin (500mg twice daily) started for PEP on 10SEP2020.  He denied medical history and stated that he had no reaction after the first injection.  Company Comment: A consumer had palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue after receiving BioThrax. In response to the events, consumer took Motrin, lots of fluids, rest and all events recovered with in a few days. Considering the case information, and the potential of BioThrax to cause these events, the causality of palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue is assessed as possible.; Sender's Comments: A consumer had palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue after receiving BioThrax. In response to the events, consumer took Motrin, lots of fluids, rest and all events recovered with in a few days. Considering the case information, and the potential of BioThrax to cause these events, the causality of palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue is assessed as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: continued achiness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in January 2020. please refer the case US2020AMR103242).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Three weeks after receiving the 2nd dose of Shingrix vaccine the patient had some continued achiness, tiredness. The patient asked how long do shingles vaccine side effects last.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR103242:Same Patient
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Continues to have pain around the injection site in her right arm; Continues to have pain around the injection site in her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (first dose received around Spring 2019.refer linked case US2020166806).   In July 2019, the patient received the 2nd dose of Shingrix. In July 2019, immediately after receiving Shingrix, the patient experienced injection site pain and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had pain around the injection site in her arm. The pain was not on the injection site.  The pain was off and on and pain was there mostly when she wakes up from her sleep. The follow up consent was granted; Sender's Comments:  US-GLAXOSMITHKLINE-US2020166806:1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Functional gastrointestinal disorder, Nausea, Pain
Clinical narrative: Aching became more pronounced; Chills and Aching became more pronounced; bowel movement difficulty; nausea that worsened in 2019; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received in October 2018, Please refer the US2020175334).   In January 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, chills, bowel dysfunction and nausea aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, chills, bowel dysfunction and nausea aggravated were unknown.   It was unknown if the reporter considered the pain, chills, bowel dysfunction and nausea aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated the chills and aching became more pronounced after the second injection in January, 2019.  The patient reported nausea that worsened in 2019, and alleviated May 2020.  She started to feel better in April, 2020.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020175334:same patient
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Chills, Headache, Pain, SARS-CoV-2 test positive
Clinical narrative: Covid-19 (probable) / her new symptoms overlap with Covid; body aches; chills; Headache; This case was reported by a physician via call center representative and described the occurrence of suspected covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 12th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, 1 days after receiving Shingrix, the patient experienced suspected covid-19, general body pain, chills and headache. On an unknown date, the outcome of the suspected covid-19, chills and headache were unknown and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the suspected covid-19, general body pain, chills and headache to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the concerned patient. The age at vaccination was not reported. The reporter had the second dose of Shingrix administered on 12th November 2020 and someone at reporter's location had a positive test for COVID.  The physician pre and post medicated herself with Tylenol for her 2nd dose of Shingrix. Since the first dose provoked adverse reactions to the patient (left in bed for 3 days), and some of her new symptoms overlap with COVID, reporter wanted to know if the Shingrix vaccine could cause a false test result. The reporter called for information regarding the possibility of interference between the Shingrix vaccine and a COVID test. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225587:same patient.
Age: 53.0
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 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months 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 patient received the 1st dose of Shingrix in her right arm and she had arm pain with that, which was resolved. For tolerance to 2nd dose of Shingrix, refer linked case US2020225597, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225597:same patient 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Mass, Swelling
Clinical narrative: Painful lump on my scalp; Shivering; Painful lump on my scalp; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling 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, 1 day after receiving Shingrix, the patient experienced local swelling, shivering and mass. On an unknown date, the outcome of the local swelling, shivering and mass were unknown.   It was unknown if the reporter considered the local swelling, shivering and mass to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient was wondering if a painful lump on scalp that appeared the day after second shot could be related to vaccination.  The patient was also experienced shivering.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Spreading rashes on feet and face; Rashes look very much like shingles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced rash and vesicular rash. On an unknown date, the outcome of the rash and vesicular rash were unknown.   It was unknown if the reporter considered the rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The age at vaccination was not reported. Three weeks before the date of reporting, the patient received 1st dose of Shingrix. The patient had rapidly spreading rashes that started on her feet and now on the face. The rashes look very much like shingles. The reporter asked if the vaccine had triggered them and if the patient should receive second dose.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: skin rash / skin reaction / body rash that covered her stomach and chest. / looked like a bad case of measles; irritation / skin reaction; like a bad case of measles; uncomfortable; pain, swelling, and redness at the injection site; swelling, and redness at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stiff joint and drug allergy (prior history of allergic reaction to Clopidogrel). Previously administered products included Shingrix with an associated reaction of injection site pain (please refer the 1st dose case US2020AMR160862).   On 7th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 9th August 2020, 2 days after receiving Shingrix, the patient experienced rash, skin irritation, measles-like rash and discomfort. In August 2020, the patient experienced injection site pain, injection site swelling and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, skin irritation, measles-like rash and discomfort were recovering/resolving and the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the rash, skin irritation, injection site pain, injection site swelling, injection site erythema, measles-like rash and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had arthrosclerosis, prior history of allergic reaction to clopidogrel.  The patient stated she was on clopidogrel for a blood clot about 2 to 3 years ago and after about 6 months using it she developed a body rash. On 7th August 2020, the patient received the 2nd dose of Shingrix in the left arm. The patient experienced pain, swelling, and redness at the injection site. On 9th August 2020, the patient got a body rash that covered her stomach and chest. She said it looked like a bad case of measles.  The patient said she called the Medicine Doctor and they told her to take Benadryl. She says the rash was  uncomfortable because she lives in where there was a lot of heat. The rash was improving. She stated that rash was now only slightly visible and was not painful.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR160862:2nd dose
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash morbilliform, Skin irritation
Clinical narrative: skin rash / skin reaction / body rash that covered her stomach and chest. / looked like a bad case of measles; irritation / skin reaction; like a bad case of measles; uncomfortable; pain, swelling, and redness at the injection site; swelling, and redness at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stiff joint and drug allergy (prior history of allergic reaction to Clopidogrel). Previously administered products included Shingrix with an associated reaction of injection site pain (please refer the 1st dose case US2020AMR160862).   On 7th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 9th August 2020, 2 days after receiving Shingrix, the patient experienced rash, skin irritation, measles-like rash and discomfort. In August 2020, the patient experienced injection site pain, injection site swelling and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, skin irritation, measles-like rash and discomfort were recovering/resolving and the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the rash, skin irritation, injection site pain, injection site swelling, injection site erythema, measles-like rash and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had arthrosclerosis, prior history of allergic reaction to clopidogrel.  The patient stated she was on clopidogrel for a blood clot about 2 to 3 years ago and after about 6 months using it she developed a body rash. On 7th August 2020, the patient received the 2nd dose of Shingrix in the left arm. The patient experienced pain, swelling, and redness at the injection site. On 9th August 2020, the patient got a body rash that covered her stomach and chest. She said it looked like a bad case of measles.  The patient said she called the Medicine Doctor and they told her to take Benadryl. She says the rash was  uncomfortable because she lives in where there was a lot of heat. The rash was improving. She stated that rash was now only slightly visible and was not painful.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR160862:2nd dose
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Conjunctival cyst, Eye irritation, Ocular discomfort
Clinical narrative: Felt like something was in her eye / annoying feeling; Ophthalmologist diagnosed her with a conjunctival cyst/Pink bump in the corner of her eye / It might be a little less red/bubble in the eye; not as irritating as it was on Saturday; This case was reported by a consumer via call center representative and described the occurrence of eye discomfort in a 76-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z59N7, expiry date 8th October 2022) for prophylaxis.   Concurrent medical conditions included glaucoma, drug allergy and latex allergy (for years (affecting different parts of her body such as her ear and her elbow, example like after receiving dental work)).   On 5th November 2020, the patient received Boostrix (intramuscular) .5 ml. On 7th November 2020, 2 days after receiving Boostrix, the patient experienced eye discomfort, conjunctival cyst and eye irritation. On an unknown date, the outcome of the eye discomfort and eye irritation were unknown and the outcome of the conjunctival cyst was not recovered/not resolved.   It was unknown if the reporter considered the eye discomfort, conjunctival cyst and eye irritation to be related to Boostrix.  Additional details were reported as follows: The patient herself reported the case. The age at vaccination was no reported. The patient received the Boostrix 0.5 milliliter intramuscularly in the right deltoid at pharmacy. On 7th November 2020 at afternoon, the patient felt like something was in her eye. The patient said it was not painful but it just was an annoying feeling as if there was an object in her eye(especially when she blinked). The patient lifted her lid and saw that there was a pink bump in the corner of her eye. The patient sent a picture to her ophthalmologist who diagnosed her with a conjunctival cyst. The physician instructed the patient to treat it with artificial tears. The patient said that about 36 hours later she stopped feeling the sensation that something was in her eye. On 11th november 2020 the cyst was about the same size. It might be a little less red. The patient was wondering if her conjuctival cyst could be a result of the Boostrix. he patient mentioned that the tip caps contain latex and she has been allergic to latex. On 13th November 2020, the patient reported that there was still a big bubble in her eye but it was not as irritating as it was on 7th November 2020. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: developed flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   In October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient herself was a physician. The age at vaccination was not reported. The patient received a flu vaccine about a month ago, unknown brand and the patient was unsure if she received the vaccine intramuscular or subcutaneous. The patient developed flu like symptoms within hours of receipt of vaccine that lasted for a day and a half then resolved. The patient was premedicated with Tylenol. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225583:same patient, Shingrix vaccine US-GLAXOSMITHKLINE-US2020AMR226311:same patient, Shingrix vaccine
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Eye swelling, Lacrimation increased
Clinical narrative: eye itching; eye tearing; eye swelling; This case was reported by a consumer via call center representative and described the occurrence of eye pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 10th November 2020, several weeks after receiving Shingrix, the patient experienced eye pruritus, eyes tearing and eye swelling. On an unknown date, the outcome of the eye pruritus, eyes tearing and eye swelling were unknown.   It was unknown if the reporter considered the eye pruritus, eyes tearing and eye swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by the girlfriend of the patient. The age at vaccination was not reported. The patient received the Shingrix vaccine a couple of weeks before the time of reporting. The reporter reported 3 days ago the patient had eye swelling, eye tearing, and eye itching. The reporter did not consent to follow up. The patient's consent to follow up with health care professional was not received.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Seeing increase in people saying they have a sore arm; This is a spontaneous report from a contactable pharmacist via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient seeing increase in people saying they have a sore arm on an unspecified date with outcome of unknown. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Peripheral coldness
Clinical narrative: not feeling good; he fell off a ladder last Friday; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) reported that a 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 12Nov2020 at single dose for immunization; pregabalin (LYRICA, 75 mg Capsule, lot number: CM6411, NDC: 0007110146, expiry date: 31Mar2022), orally from an unspecified date and ongoing at 75 mg, 3x/day for diabetic nerve pain and foot neuropathy. Concomitant drug included flu shot from Nov2020. Patient saw two other doctors a year and a half ago because he could not sleep. Both feet felt like they were getting electric shocks or like they were in a bucket of ice. He had diabetic nerve pain and foot neuropathy. He had a flu shot a week and half ago before he received the pneumonia shot. He did not know the name of it. Caller stated he was not feeling good today. He added that he started not feeling good after he fell off a ladder last Friday (13Nov2020). He also had a pneumonia shot last Thursday. It could have been from that. He started taking pregabalin over a year ago. If he doesn't take it he never sleeps. His legs and feet feel like they are being soaked in ice. Since he has been taking pregabalin he will fall down around 3 to 4 in the evening. The medication relaxes his legs so much. The action taken in response to the events pregabalin was dose not changed. Outcome of not feeling good was recovering, and outcome of other event was unknown.   No follow up attempts are needed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Vaccination failure
Clinical narrative: Failure of pneumococcal 13-val conj vac (dipht crm197 protein); This is a spontaneous report from a contactable Health Care Professional.  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. It was reported failure of pneumococcal 13-val conj vac (dipht crm197 protein). Clinical outcome was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results, vaccination schedule and the details on vaccine preventable disease are needed for full medical assessment.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from contactable Physician via Pfizer Sales Representative.  A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash for 10 days (non-serious) on an unspecified date. Patient visited a physician for concern over rash. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13, UNK
Symptoms: Magnetic resonance imaging, Nerve conduction studies, Neuralgia
Clinical narrative: I did have a reaction to a vaccination/huge reaction; nerve pain in right arm; Parsonage Turner; This is a spontaneous report from a contactable consumer (patient). A female patient (age: 65, unit: unknown) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at right arm on an unspecified date at single dose for immunization; influenza vaccine, via an unspecified route of administration at left arm on an unspecified date at unspecified dose and frequency for immunization. Concomitant medications and past drug/medical history were not reported. Patient reported she did have a reaction to a vaccination when she turned 65. She got a pneumonia shot in right arm, she didn't know the name of the pneumonia vaccine. She also got a double flu vaccine in left arm, with a huge reaction. Her nerve pain in right arm started about 2 months after this (dates not specified). Doctors did two nerve conduction studies and multiple MRIs. Patient was put on pregabalin (LYRICA) by one of doctors for pain down right arm. She did not have a firm diagnosis. One possible diagnosis was Parsonage Turner. The patient's outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769, 2020SA310708 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue
Clinical narrative: FLUZONE HIGH-DOSE was administered to a patient and some of the vaccine did leak out where the needle connects to the syringe with no adverse event; Initial information regarding this unsolicited non-valid non-serious case via agency (reference number: 00317908) was received from pharmacist and transmitted to Sanofi 15-Oct-2020.  This case involved a patient who was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and some of the vaccine did leak out where the needle connects to the syringe (Syringe issue).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ512AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination and some of the vaccine did leak out where the needle connects to the syringe (syringe issue).  Pharmacist said it may be a faulty needle or something.   No adverse event was reported at the time of reporting.  Relevant laboratory test was not reported.  Final diagnosis was Not Applicable fluzone high-dose was administered to a patient and some of the vaccine did leak out where the needle connects to the syringe with no adverse event.
Age: 10.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 10 year old patient was vaccinated with Flublok, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agency (Reference number- 00333429) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 10 year old female patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2053, expiry: 30-Jun-2021) once via unknown route in the right arm for prophylactic vaccination on 27-Oct-2020 (product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccinations or medications   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Anaphylactic shock
Clinical narrative: Patient called on phone stating she was having an anaphylactic shock reaction. Was told by her primary doctor to contact us since she had received vaccine in the past couple of days and inform us we may have a bad batch. I have reached back out to patient to follow up, but have received no response, thus far.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Gait disturbance, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: visit note 11/18/2020: HISTORY: Patient is a 4 y.o. female, who presents with vaccine reaction.    A lot of pain in the left leg Left leg is very swollen, no give to the skin, skin is very taught and tight.  If anyone touches the leg she screaming.    Had quadracel in left thigh yesterday at well visit check up with Dr..    Second shot was given refused to walk, has done this before. When she has had leg pain in the past she has refused to walk.    Thought let might be swelling yesterday but was wearing pants so didn't notice.    Woke up with pain last night after going to bed, pain was in left leg.  Left leg is really swollen this morning.  Briefly had some red splotchiness over body while screaming, then resolved and is no longer present.   Having to bribe her to stop screaming.  Not drinking very much.    Ibuprofen about 6 hours ago.    Skin is warm to the touch but no fever.  Has decreased appetite.  Never had a vaccine reaction before   Exposures: no known sick contacts
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Screaming, Skin tightness, Skin warm
Clinical narrative: visit note 11/18/2020: HISTORY: Patient is a 4 y.o. female, who presents with vaccine reaction.    A lot of pain in the left leg Left leg is very swollen, no give to the skin, skin is very taught and tight.  If anyone touches the leg she screaming.    Had quadracel in left thigh yesterday at well visit check up with Dr..    Second shot was given refused to walk, has done this before. When she has had leg pain in the past she has refused to walk.    Thought let might be swelling yesterday but was wearing pants so didn't notice.    Woke up with pain last night after going to bed, pain was in left leg.  Left leg is really swollen this morning.  Briefly had some red splotchiness over body while screaming, then resolved and is no longer present.   Having to bribe her to stop screaming.  Not drinking very much.    Ibuprofen about 6 hours ago.    Skin is warm to the touch but no fever.  Has decreased appetite.  Never had a vaccine reaction before   Exposures: no known sick contacts
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Blood pressure normal, Fatigue, Nausea, Syncope
Clinical narrative: I woke up the morning after I received the shot and I fainted. After I started feeling better. I went to the restroom and then went back to bed. Around 8am I got up again to use the restroom and i fainted again. Throughout the day I felt fatigued and nauseous. I spoke with my PCP and he stated to let him know if I have any other problems. Went to GYN Thursday and mentioned the reaction and they checked my blood sugar, blood pressure, and urine. GYN stated all tests were normal.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: I woke up the morning after I received the shot and I fainted. After I started feeling better. I went to the restroom and then went back to bed. Around 8am I got up again to use the restroom and i fainted again. Throughout the day I felt fatigued and nauseous. I spoke with my PCP and he stated to let him know if I have any other problems. Went to GYN Thursday and mentioned the reaction and they checked my blood sugar, blood pressure, and urine. GYN stated all tests were normal.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Sore arm after administration for three days and limited range of motion
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Magnetic resonance imaging, Paraesthesia, Peripheral coldness, X-ray
Clinical narrative: States he was hospitalized for a neurological disorder d/t toxification ingested on a paint job he was performing.  Upon his discharge the nurse offered the vaccination.  States he got the vaccination and was discharged.  The next morning he woke up feeling like he was having a stroke in his stomach.  Its a super weird mesh raised feeling in his stomach which feels like cat hairs are raised up in his stomach.  States this scared him so bad causing him to go to the ER and a MRI and x-ray with contrast was performed but this was for the neurological disorder he was admitted to hospital for but nothing has been done about his stomach and the issues are still an issue still over 2 months later.  States both arms are super cold and it feels like the needles are still in his arm.  States this didn't begin until after he got the vaccination and has still been an issue to date since the vaccination.  States his doctor sent him to have a sonogram on his arm where the needles were inserted but they still hadn't got the results back yet.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure fluctuation, Cardiac pacemaker insertion, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: I have never had a flu shot before but thought with COVID, it would be smart to get one. I did have the flu in Feb 2020 for the first time in over 20 years.  Oct 8, 2020 Within 20 minutes of receiving the vaccine I felt flushed and a bit dizzy. By the end of the day I was very fatigued. Oct 9 felt fatigued and noticed a red patch at the shot site that was very tender. Oct 10 shot site is size of baseball and red. Had "episode" where I felt flushed, jittery and thought I was going to pass out. Oct 11 symptoms worse, almost passed out while in backyard and had to sit on the ground until I could get help. Oct 12 Almost passed out at work, was very red in the face and thought I might be having something happening with blood pressure. Called DR and was told to get a COVID test. Bought a BP cuff and BP was 165/80 and heart rate was 45. This continued for a week. I went to a Urgent Care clinic and was told to see a cardiologist asap.  Pulse continued to be very low and BP high. This has never happened to me. I have never had high BP and my heart rate has been in the 50's-60's over the last couple of years but not considered a problem.  Cardiologist (10-20, 2020) ran tests, put me on a BP medication and concluded that I needed a pacemaker as my pulse was in the high 30's-50 range and not getting better. The BP medication helped lower my numbers but my heart rate stayed low. No one can explain why my heart rate was so low. With the fatigue and dizzyness I was unable to work or do everyday tasks for this entire time.  10-26 after heart echo the cardiologist called to say my heart looked fine but I needed a pacemaker. The process started. 11-9-2020 Pacemaker insertion. Since the pacemaker has been installed I feel wonderful, back to my full functioning self. No one believes that the flu shot caused this but I know in my body that something happened. The tingles and flushing and dizzyness hit me as soon as I got off of the table after the shot. Prior to the shot my BP was 120/80 and heart rate in the 60's.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling jittery, Flushing, Injection site erythema, Injection site pain
Clinical narrative: I have never had a flu shot before but thought with COVID, it would be smart to get one. I did have the flu in Feb 2020 for the first time in over 20 years.  Oct 8, 2020 Within 20 minutes of receiving the vaccine I felt flushed and a bit dizzy. By the end of the day I was very fatigued. Oct 9 felt fatigued and noticed a red patch at the shot site that was very tender. Oct 10 shot site is size of baseball and red. Had "episode" where I felt flushed, jittery and thought I was going to pass out. Oct 11 symptoms worse, almost passed out while in backyard and had to sit on the ground until I could get help. Oct 12 Almost passed out at work, was very red in the face and thought I might be having something happening with blood pressure. Called DR and was told to get a COVID test. Bought a BP cuff and BP was 165/80 and heart rate was 45. This continued for a week. I went to a Urgent Care clinic and was told to see a cardiologist asap.  Pulse continued to be very low and BP high. This has never happened to me. I have never had high BP and my heart rate has been in the 50's-60's over the last couple of years but not considered a problem.  Cardiologist (10-20, 2020) ran tests, put me on a BP medication and concluded that I needed a pacemaker as my pulse was in the high 30's-50 range and not getting better. The BP medication helped lower my numbers but my heart rate stayed low. No one can explain why my heart rate was so low. With the fatigue and dizzyness I was unable to work or do everyday tasks for this entire time.  10-26 after heart echo the cardiologist called to say my heart looked fine but I needed a pacemaker. The process started. 11-9-2020 Pacemaker insertion. Since the pacemaker has been installed I feel wonderful, back to my full functioning self. No one believes that the flu shot caused this but I know in my body that something happened. The tingles and flushing and dizzyness hit me as soon as I got off of the table after the shot. Prior to the shot my BP was 120/80 and heart rate in the 60's.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: I have never had a flu shot before but thought with COVID, it would be smart to get one. I did have the flu in Feb 2020 for the first time in over 20 years.  Oct 8, 2020 Within 20 minutes of receiving the vaccine I felt flushed and a bit dizzy. By the end of the day I was very fatigued. Oct 9 felt fatigued and noticed a red patch at the shot site that was very tender. Oct 10 shot site is size of baseball and red. Had "episode" where I felt flushed, jittery and thought I was going to pass out. Oct 11 symptoms worse, almost passed out while in backyard and had to sit on the ground until I could get help. Oct 12 Almost passed out at work, was very red in the face and thought I might be having something happening with blood pressure. Called DR and was told to get a COVID test. Bought a BP cuff and BP was 165/80 and heart rate was 45. This continued for a week. I went to a Urgent Care clinic and was told to see a cardiologist asap.  Pulse continued to be very low and BP high. This has never happened to me. I have never had high BP and my heart rate has been in the 50's-60's over the last couple of years but not considered a problem.  Cardiologist (10-20, 2020) ran tests, put me on a BP medication and concluded that I needed a pacemaker as my pulse was in the high 30's-50 range and not getting better. The BP medication helped lower my numbers but my heart rate stayed low. No one can explain why my heart rate was so low. With the fatigue and dizzyness I was unable to work or do everyday tasks for this entire time.  10-26 after heart echo the cardiologist called to say my heart looked fine but I needed a pacemaker. The process started. 11-9-2020 Pacemaker insertion. Since the pacemaker has been installed I feel wonderful, back to my full functioning self. No one believes that the flu shot caused this but I know in my body that something happened. The tingles and flushing and dizzyness hit me as soon as I got off of the table after the shot. Prior to the shot my BP was 120/80 and heart rate in the 60's.
Age: 71.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Feeding disorder, Injection site erythema, Injection site pruritus
Clinical narrative: On Friday the 11/20 woke with terrible muscle aches. Swelling in arm at injection site. Warm and itchy. A little bit of chill. Fatigue. Unable to eat. Achy. 4 inches of redness on injection site that radiated to elbow. Started eating soup on Sunday. Redness is better today, but still itchy. Have been using ice packs for the itching.
Age: 71.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pain
Clinical narrative: On Friday the 11/20 woke with terrible muscle aches. Swelling in arm at injection site. Warm and itchy. A little bit of chill. Fatigue. Unable to eat. Achy. 4 inches of redness on injection site that radiated to elbow. Started eating soup on Sunday. Redness is better today, but still itchy. Have been using ice packs for the itching.
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Later in the day after I received the vax I started having right arm pain so I applied ice to my arm . When I woke up the pain was still there. The pain has now turned into weakness in right arm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Fatigue, Feeling cold, Heart rate increased
Clinical narrative: This time I took a NSAID when I got home (Ketorolac 10 mg) which blunted the arm pain and hives like I had after the first dose. But by bedtime, I developed extreme chills and have never been so cold in my life. I developed chest wall pains that were moderately severe, some shortness of breath and rapid heart rate. I felt ill but did sleep after midnight. I did not have fever or nausea. I was not dizzy. The next day, I felt much better, though very fatigued and not yet back to normal. I told my friend that this time was shorter and was pretty much over. But by evening of the second day, I developed fever of 101. No additional symptoms returned. By the third day, I was fine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal chest pain, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: This time I took a NSAID when I got home (Ketorolac 10 mg) which blunted the arm pain and hives like I had after the first dose. But by bedtime, I developed extreme chills and have never been so cold in my life. I developed chest wall pains that were moderately severe, some shortness of breath and rapid heart rate. I felt ill but did sleep after midnight. I did not have fever or nausea. I was not dizzy. The next day, I felt much better, though very fatigued and not yet back to normal. I told my friend that this time was shorter and was pretty much over. But by evening of the second day, I developed fever of 101. No additional symptoms returned. By the third day, I was fine.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness from injection site halfway down arm. told pharmacy 11/21/20 told pt to seek md attention
Age: 34.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 11/19/2020 I administered an MMRV vaccine to the above client. The client should have been given a seperate MMR and varicella vaccine due to her age. The client was notified of the Error on 11/23/2020 by this nurse. The client denies any adverse symptoms and denies any treatment.