chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: swelling in the injection site; 2 large areas with rash and 1 smaller area with rash; area with a bruise; herpetic looking blisters; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 47XJ3, expiry date 29th April 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 24th August 2020, refer case US2020219722).   On 3rd November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd November 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, rash, contusion and rash herpetiform. On an unknown date, the outcome of the injection site swelling, rash, contusion and rash herpetiform were unknown.   It was unknown if the reporter considered the injection site swelling, rash, contusion and rash herpetiform to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix in the right deltoid. The patient experienced swelling in the injection site, 2 large areas with rash and 1 smaller area with rash, area with a bruise and herpetic looking blisters. The pharmacist said that he believed the symptoms started on the afternoon of 3rd November 2020.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219722:same patient (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt ill after the first injection I don't want the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient felt ill after the first injection and did not want the 2nd dose.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eye irritation, Initial insomnia, Nausea, Pain
Clinical narrative: Nauseous; Dry-heaved; Feels weak; Low grade fever; Fever cause her eyes to burn; General aches; Trouble falling asleep and kept waking up; Restless night; This case was reported by a consumer via call center representative and described the occurrence of trouble falling asleep in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included thyroid disorder and palpitation. Concomitant products included liothyronine sodium (T3 (Liothyronine)).   On 5th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, 1 days after receiving Shingrix, the patient experienced nausea, dry heaves, weakness, fever, burning in eyes and general body pain. In November 2020, the patient experienced trouble falling asleep and restlessness. On an unknown date, the outcome of the trouble falling asleep, restlessness, nausea and dry heaves were unknown and the outcome of the weakness, fever, burning in eyes and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the trouble falling asleep, restlessness, nausea, dry heaves, weakness, burning in eyes and general body pain to be related to Shingrix. The reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient stated that she was started on T3 and they have been playing with thyroid for 3 to 4 months and every time she eats she will have heart palpitations. The age at vaccination was not reported. The patient received her 1st Shingrix shot in the left deltoid. and she reported that she had trouble falling asleep and kept waking up last night, had a restless night, but was not nauseous. When she woke up she was nauseous and dry-heaved.  The reporter asked her if the nausea had resolved now and she at first said yes but then said no and added that she feels weak (perhaps due to not eating). She also reported that she believed she had a low grade fever. She does not have a thermometer but she would estimate that her fever was probably less than 101. She says that the fever cause her eyes to burn. She says the eye burning had gotten better but has not fully resolved. She also reported that she was having general aches.  The patient was calling to see how long these side effects would last.  The patient was unable to locate the lot number on the paperwork provided but she did provide the contact information for the doctor's office where the shot was administered. The reporter consent to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Restlessness, Retching
Clinical narrative: Nauseous; Dry-heaved; Feels weak; Low grade fever; Fever cause her eyes to burn; General aches; Trouble falling asleep and kept waking up; Restless night; This case was reported by a consumer via call center representative and described the occurrence of trouble falling asleep in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included thyroid disorder and palpitation. Concomitant products included liothyronine sodium (T3 (Liothyronine)).   On 5th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, 1 days after receiving Shingrix, the patient experienced nausea, dry heaves, weakness, fever, burning in eyes and general body pain. In November 2020, the patient experienced trouble falling asleep and restlessness. On an unknown date, the outcome of the trouble falling asleep, restlessness, nausea and dry heaves were unknown and the outcome of the weakness, fever, burning in eyes and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the trouble falling asleep, restlessness, nausea, dry heaves, weakness, burning in eyes and general body pain to be related to Shingrix. The reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient stated that she was started on T3 and they have been playing with thyroid for 3 to 4 months and every time she eats she will have heart palpitations. The age at vaccination was not reported. The patient received her 1st Shingrix shot in the left deltoid. and she reported that she had trouble falling asleep and kept waking up last night, had a restless night, but was not nauseous. When she woke up she was nauseous and dry-heaved.  The reporter asked her if the nausea had resolved now and she at first said yes but then said no and added that she feels weak (perhaps due to not eating). She also reported that she believed she had a low grade fever. She does not have a thermometer but she would estimate that her fever was probably less than 101. She says that the fever cause her eyes to burn. She says the eye burning had gotten better but has not fully resolved. She also reported that she was having general aches.  The patient was calling to see how long these side effects would last.  The patient was unable to locate the lot number on the paperwork provided but she did provide the contact information for the doctor's office where the shot was administered. The reporter consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in arm of injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On 31st August 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On 1st September 2020, 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 got his first Shingrix shot near the end of August 2020. The patient had pain in arm of injection which was resolved. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2020AMR221947.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221947:2nd dose, same patient
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: malaise; sore arm; This case was reported by a consumer via call center representative and described the occurrence of malaise in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arthritis. Concurrent medical conditions included heartbeats irregular.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced malaise and pain in arm. On an unknown date, the outcome of the malaise and pain in arm were recovered/resolved.   It was unknown if the reporter considered the malaise and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix (intramuscular) and expeienced soarness in arm and malaise,which was recovered in 2 days. The reporter consented to follow up. No further information was available. For further tolerance of 2nd dose refer case US2020221359.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221359:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Disorientation, Disturbance in attention, Dizziness
Clinical narrative: Felt like she had a temperature; Disoriented; Could not concentrate; ringing in ears; Not sure it was injected in the muscle / up towards her shoulder; Around the injection site was pain; Around the injection site / redness; Around the injection site / swelling; Dizzy; no appetite; had to get up at night to put water on face; headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd November 2020, the patient received the 2nd dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, dizziness, appetite absent, insomnia, headache, shivering and vaccine administered at inappropriate site. On 3rd November 2020, the patient experienced disorientation, concentration impaired and ringing in ears. On an unknown date, the patient experienced feeling of warmth. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, appetite absent, insomnia, shivering, feeling of warmth, disorientation, concentration impaired, ringing in ears and vaccine administered at inappropriate site were unknown and the outcome of the dizziness and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, dizziness, appetite absent, insomnia, headache, shivering, feeling of warmth, disorientation, concentration impaired and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient was not sure if the 2nd dose of Shingrix was injected in the muscle of her left arm; it was up towards her shoulder.  After receiving Shingrix, the patient experienced pain, redness and swelling around the injection site. 2.5 hours after 2nd dose of Shingrix, the patient was dizzy so bad that she was forced to lay down.  The patient had no appetite and had to get up and put water on her face.  She also had a headache, shivering and felt like she had a temperature.   The patient called her pharmacist in the morning and was disoriented and could not concentrate.  On 03rd November 2020, she still had dizziness and now ringing in ears and headache. Dizziness was less but overall, she had a horrible experience. The reporter did not consent to follow-up. For the tolerance of 1st dose, refer linked case US2020AMR222031.; Sender's Comments:  US2020AMR222031:1st dose US-GLAXOSMITHKLINE-US2020AMR222031:for 2nd dose
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Felt like she had a temperature; Disoriented; Could not concentrate; ringing in ears; Not sure it was injected in the muscle / up towards her shoulder; Around the injection site was pain; Around the injection site / redness; Around the injection site / swelling; Dizzy; no appetite; had to get up at night to put water on face; headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd November 2020, the patient received the 2nd dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, dizziness, appetite absent, insomnia, headache, shivering and vaccine administered at inappropriate site. On 3rd November 2020, the patient experienced disorientation, concentration impaired and ringing in ears. On an unknown date, the patient experienced feeling of warmth. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, appetite absent, insomnia, shivering, feeling of warmth, disorientation, concentration impaired, ringing in ears and vaccine administered at inappropriate site were unknown and the outcome of the dizziness and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, dizziness, appetite absent, insomnia, headache, shivering, feeling of warmth, disorientation, concentration impaired and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient was not sure if the 2nd dose of Shingrix was injected in the muscle of her left arm; it was up towards her shoulder.  After receiving Shingrix, the patient experienced pain, redness and swelling around the injection site. 2.5 hours after 2nd dose of Shingrix, the patient was dizzy so bad that she was forced to lay down.  The patient had no appetite and had to get up and put water on her face.  She also had a headache, shivering and felt like she had a temperature.   The patient called her pharmacist in the morning and was disoriented and could not concentrate.  On 03rd November 2020, she still had dizziness and now ringing in ears and headache. Dizziness was less but overall, she had a horrible experience. The reporter did not consent to follow-up. For the tolerance of 1st dose, refer linked case US2020AMR222031.; Sender's Comments:  US2020AMR222031:1st dose US-GLAXOSMITHKLINE-US2020AMR222031:for 2nd dose
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Tinnitus
Clinical narrative: Felt like she had a temperature; Disoriented; Could not concentrate; ringing in ears; Not sure it was injected in the muscle / up towards her shoulder; Around the injection site was pain; Around the injection site / redness; Around the injection site / swelling; Dizzy; no appetite; had to get up at night to put water on face; headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd November 2020, the patient received the 2nd dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, dizziness, appetite absent, insomnia, headache, shivering and vaccine administered at inappropriate site. On 3rd November 2020, the patient experienced disorientation, concentration impaired and ringing in ears. On an unknown date, the patient experienced feeling of warmth. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, appetite absent, insomnia, shivering, feeling of warmth, disorientation, concentration impaired, ringing in ears and vaccine administered at inappropriate site were unknown and the outcome of the dizziness and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, dizziness, appetite absent, insomnia, headache, shivering, feeling of warmth, disorientation, concentration impaired and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient was not sure if the 2nd dose of Shingrix was injected in the muscle of her left arm; it was up towards her shoulder.  After receiving Shingrix, the patient experienced pain, redness and swelling around the injection site. 2.5 hours after 2nd dose of Shingrix, the patient was dizzy so bad that she was forced to lay down.  The patient had no appetite and had to get up and put water on her face.  She also had a headache, shivering and felt like she had a temperature.   The patient called her pharmacist in the morning and was disoriented and could not concentrate.  On 03rd November 2020, she still had dizziness and now ringing in ears and headache. Dizziness was less but overall, she had a horrible experience. The reporter did not consent to follow-up. For the tolerance of 1st dose, refer linked case US2020AMR222031.; Sender's Comments:  US2020AMR222031:1st dose US-GLAXOSMITHKLINE-US2020AMR222031:for 2nd dose
Sex: F
Vaccine: MNQ
Symptoms: Underdose
Clinical narrative: patient was administered with 0.25 (half dose) of MENACTRA, no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who was administered with 0.25 (half dose) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6827BA and expiration date:18-Feb-2022) , via intramuscular route in the right deltoid for prophylactic vaccination on an unknown date (underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B ; HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and INFLUENZA VACCINE (INFLUENZA VACCINE) for prophylactic vaccination.  On It was an actual medication error case due to vaccine underdose (Same day latency).  No adverse event reported at the time of reporting.  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: 77.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: vaccine dripped out onto her glove and the floor , no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 77 years old female patient who was being vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (0.5 ml pre-filled syringe, lot UJ536AD and expiration date : 30-Jun-2021, via unknown route in the left deltoid , prophylactic vaccination) and while vaccination the vaccine dripped out onto and over the  glove and the floor on 29-Oct-2020 (underdose).  Medical history was not reported.  No other medications or vaccinations were given to the patient.  It was an actual medication error case due to vaccine underdose (same day latency).  Case description: when she went to remove the air from the syringe, the plunger would push in, it felt like there was pressure preventing it. when taking out the needle cap off they were able to remove the air in the syringe. And while attempting to administer 0.5 ml of the vaccine in the left deltoid. The caller stated that she doesn't think any of the vaccine went in.  No adverse event reported at the time of reporting.  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: 85.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Myalgia
Clinical narrative: Muscle pain
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Haemorrhage, Pain
Clinical narrative: Patient experience a lot of bleeding and pain after the shot was administered. The next day their arm started  having severe bruises and the patient reported it to the pharmacist on 11/10/2020, patient will see doctor if symptoms become more severe.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site paraesthesia, Injection site swelling
Clinical narrative: Bleeding, arm tingling, and swelling at injection site
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Hyperhidrosis, Injection site pain, Nausea, Pallor
Clinical narrative: She had eaten breakfast prior to the immunizations.  Within minutes of receiving the vaccinations she became nauseated.  She began dry heaving.  she became pale.  She laid down and with verbal stimuli she would open her eyes but her eyes were rolled back.  she became diaphoretic.  After about 5-10 minutes she was more alert, opened her eyes and was responding verbally to questions.  She was then able to sit up, color returned to her face and nausea subsided.  After 15-20 minutes she was back to baseline and feeling fine, with the exception of pain at injection site.  There have been no further adverse effects noted.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Retching
Clinical narrative: She had eaten breakfast prior to the immunizations.  Within minutes of receiving the vaccinations she became nauseated.  She began dry heaving.  she became pale.  She laid down and with verbal stimuli she would open her eyes but her eyes were rolled back.  she became diaphoretic.  After about 5-10 minutes she was more alert, opened her eyes and was responding verbally to questions.  She was then able to sit up, color returned to her face and nausea subsided.  After 15-20 minutes she was back to baseline and feeling fine, with the exception of pain at injection site.  There have been no further adverse effects noted.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Thrombotic thrombocytopenic purpura
Clinical narrative: Quarter-sized red area that enlarged.   SKIN: 12 cm x 10 cm area of macular erythema (blanching ) with slightly increased warmth, no induration or fluctuance, no drainage, slightly TTP, swelling of left upper arm
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Confusional state, Diarrhoea, Fall, Gait disturbance
Clinical narrative: 10/5 got shingles vaccine # 2 woke next AM with RLE feeling heavy dragging  R leg to walk, pain in left calf, feels weak from waist down today daughter notes more confused. he fell 2 times yesterday  Has lost 10 pounds since last ov  Has felt feverish .  Has had some diarrhea .
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity, Pyrexia, Weight decreased
Clinical narrative: 10/5 got shingles vaccine # 2 woke next AM with RLE feeling heavy dragging  R leg to walk, pain in left calf, feels weak from waist down today daughter notes more confused. he fell 2 times yesterday  Has lost 10 pounds since last ov  Has felt feverish .  Has had some diarrhea .
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient called and complained that "it is hard to use her left arm". She will check with her doctor and let us know.
Age: 1.33
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: gave double does of VAR. Called mother informed of error. she did not say if child had any side affects as she did not let me finish explaining side effects
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient described swelling and heat at injection site that started as a 4"x4"  area the day following vaccination. On Day 2 following  the vaccination, the patient stated that the redness and swelling had doubled in size, but her arm did not seem as hot as the day before.
Age: 80.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test, Dizziness, Magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Patient had a dizzy spell, then on the 15th had problems with both legs. A lot of pain and tingling like needle pricks and water running down her legs. Pt mentioned receiving the wrong dose.
Age: 80.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray
Clinical narrative: Patient had a dizzy spell, then on the 15th had problems with both legs. A lot of pain and tingling like needle pricks and water running down her legs. Pt mentioned receiving the wrong dose.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspepsia, Fatigue, Headache, Nausea
Clinical narrative: Fatigue, nausea, gastric distress,  headache, achy, chills, sore arm
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Fatigue, nausea, gastric distress,  headache, achy, chills, sore arm
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye movement disorder, Head injury, Muscle rigidity, Opisthotonus
Clinical narrative: Patient was in exam room with older brother. She received the immunization first. Brother received his after.  The Medical Assistant subsequently left the room and not more than 1 minute later, brother called for assistance. Pt was found unresponsive on the ground with rigid body, arched back and eyes rolled. She had urinated. She did hit her head; some symptoms might be related to that. Provider rubbed pt's sternum for 15-20 seconds until patient regained consciousness. Pt complained that she could not see or breathe. 2 liters of O2 was administered and 911 contacted. Pt was brought to the ED.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli, Urinary incontinence, Visual impairment
Clinical narrative: Patient was in exam room with older brother. She received the immunization first. Brother received his after.  The Medical Assistant subsequently left the room and not more than 1 minute later, brother called for assistance. Pt was found unresponsive on the ground with rigid body, arched back and eyes rolled. She had urinated. She did hit her head; some symptoms might be related to that. Provider rubbed pt's sternum for 15-20 seconds until patient regained consciousness. Pt complained that she could not see or breathe. 2 liters of O2 was administered and 911 contacted. Pt was brought to the ED.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Pt reported a metallic taste in his mouth several minutes after receiving the shigrix vaccination. He was able to speak normally, exhibited no signs of shortness of breath. Lips and tongue were normal size, no difficulty swallowing. Pt monitored for 15 additional minutes. Reported no further symptoms. Denies dizziness. Pulse was at 71, and oxygen level at 96.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Headache, Peripheral swelling, Rash, Urticaria
Clinical narrative: (1) Hives/redness/swelling in (L) arm (L) - tx: Claritin, calamine lotion (2) Headache/vomiting - Zofran, ibuprofen - (next morning/day)  (3) diffuse used rash all over upper torso/bilateral  arm - Benadryl, tac clean (next day)
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: (1) Hives/redness/swelling in (L) arm (L) - tx: Claritin, calamine lotion (2) Headache/vomiting - Zofran, ibuprofen - (next morning/day)  (3) diffuse used rash all over upper torso/bilateral  arm - Benadryl, tac clean (next day)
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no adverse event; an unspecified patient received a dose of expired VAQTA; This spontaneous report was received from a Medical assistant via office manager, and refers to a 24 year old female patient. the patient's concurrent conditions, pertinent medical history, drug allergies or reactions were not provided.  On 03-NOV-2020, the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated (VAQTA) which had a lot # S017741 with expiration date on 26-AUG-2020, (route of administration and anatomical rout of administration were not reported) for prophylaxis.  The hepatitis a vaccine, inactivated (VAQTA) was stored at the appropriate storage condition, specified in the product label through the date of administration. However, no adverse events were reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S017741; expirationdate: 26-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLuzone High dose vaccine was given to a 60 year old patient/No AE; FLuzone High dose vaccine was given to a 60 year old patient/No AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 60 years old male patient who was given a 0.5 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] lot number: UJ499AB, expiry date: 30-JUN-2021 via intramuscular route in the left arm on 02-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No other vaccines was administered at the day of medication error.   It was a case of an actual medication error case due inappropriate age at vaccine administration and a case of overdose. (latency: same day).  At the time of reporting, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 11 years-old patient was vaccinated with Flublok/ no AE; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist (Reference number- 00327558) and transmitted to Sanofi on 23-Oct-2020.  This case is linked with case 2020SA301053 (same reporter).  This case involves a 11-years-old male patient who was vaccinated with 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2029 expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 17-Oct-2020 for prophylactic vaccination (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  No concomitant medication was given.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  At the time of reporting, patient had no adverse event.  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: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received FLUBLOK QI/ NO AE; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist (Reference number- 00329784) and transmitted to Sanofi on 23-Oct-2020.  This case is linked with case 2020SA300754 (same reporter).  This case involves a 16-year-old male patient who was vaccinated with 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2029 and expiry date 30-Jun-2021) via an intramuscular route in the left deltoid on 16-OCT-2020 for prophylactic vaccination (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  No other vaccines were given.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  At the time of reporting, patient had no adverse event.  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: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a double dose of Fluzone Quadrivalent High Dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via  (Reference number- 00334421) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 76 years old male patient who was inadvertently administered with double dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ510AB, expiration date: 30-Jun-2021, dose: 0.7 mL) via unknown route at an unknown administration site for prophylactic vaccination on 27-Oct-2020 (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on the same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: patient reported entire body itching with some rash beginning shortly after vaccination and continuing until time reported on 11/11/2020 at 2:30pm
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Condition aggravated, Diarrhoea, Gastric disorder, Gastrointestinal bacterial overgrowth
Clinical narrative: I fevered and muscles ached fri -sunday then my stomach started to hurt with severe pain and diarrhea. I'm 17 days out from shot and still experiencing  severe pain. I have accute stomach problems that had been well managed until the shot. This problem is above and beyond my normal illness.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia
Clinical narrative: I fevered and muscles ached fri -sunday then my stomach started to hurt with severe pain and diarrhea. I'm 17 days out from shot and still experiencing  severe pain. I have accute stomach problems that had been well managed until the shot. This problem is above and beyond my normal illness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Cognitive disorder, Cough, Dizziness, Dyspnoea
Clinical narrative: Shortly after receiving flu shot, sensation of being physically unbalanced, slightly dizzy and impaired cogitatively (ie: feeling of sudden tiredness and difficulty thinking). These symptoms persisted throughout the afternoon but seemed to be diminishing. Approx. 4 hours later, raised hives developed in a ring around neck and a wheezing, dry, reflux cough developed. Shortly after this I was having a difficult time breathing and had tightness in throat. I went to local Urgent Care. During my time at Urgent Care both eyes became swollen and itchy, bloodshot along with nausea.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Fatigue, Injection site urticaria, Nausea, Ocular hyperaemia
Clinical narrative: Shortly after receiving flu shot, sensation of being physically unbalanced, slightly dizzy and impaired cogitatively (ie: feeling of sudden tiredness and difficulty thinking). These symptoms persisted throughout the afternoon but seemed to be diminishing. Approx. 4 hours later, raised hives developed in a ring around neck and a wheezing, dry, reflux cough developed. Shortly after this I was having a difficult time breathing and had tightness in throat. I went to local Urgent Care. During my time at Urgent Care both eyes became swollen and itchy, bloodshot along with nausea.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: Shortly after receiving flu shot, sensation of being physically unbalanced, slightly dizzy and impaired cogitatively (ie: feeling of sudden tiredness and difficulty thinking). These symptoms persisted throughout the afternoon but seemed to be diminishing. Approx. 4 hours later, raised hives developed in a ring around neck and a wheezing, dry, reflux cough developed. Shortly after this I was having a difficult time breathing and had tightness in throat. I went to local Urgent Care. During my time at Urgent Care both eyes became swollen and itchy, bloodshot along with nausea.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: patient reported feeling dizzy and needed to sit on the ground a minute after receiving the shot. patient requested some water, which has been provided to. patient reported with no difficulty breathing. when I was about to take his blood pressure , the patient was gone.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: patient received vaccine 10/9/2020; called today and reported continuing arm pain and limited mobility with arm of injection. Filled out incident/adverse report 1723
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Rash
Clinical narrative: Patient developed small red bumps/rash on legs, then spread to body, arms, and face less than 5 minutes after vaccine administration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise, Pain in extremity
Clinical narrative: SECOND DOSE OF SHINGRIX WAS GIVEN AFTER ONLY 28 DAYS - PATIENT EXPERIENCED SORE ARM AND GENERALIZED MALAISE
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Discomfort, Peripheral swelling, Skin exfoliation
Clinical narrative: Swelling, discomfort, and flaking skin of bilateral hands.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Swelling face
Clinical narrative: Swelling of right side of face, two inch wide from ear to neck.  Swelling started 2 hours after shot. Called doctor about 3-4 hours after injection.  Bought Benydrl but never took it because the swelling did not progress further.   Next day, swelling went down (about 80-90%) but not fully gone.  Also had acute diarrhea the day of vaccine.   Had not eaten anything that day because was fasting for a blood test.  Nothing eaten prior to 10pm the night before.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Encephalitis, Pyrexia, Seizure
Clinical narrative: Acute onset of fever and seizure, found to have meningoencephalitis
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Feeling cold, Pain
Clinical narrative: Right arm red, swollen, itchy. Evening after vaccination, body felt chilled, shivers rest of the evening. Shook all night, no appetite the next morning, body aches. Symptoms lasted about a week. Took about 7 days to feel better. Patient stated your breathing was stable. Patient uses FITBIT and feels that her body has recovered, but slowly. Patient thinks she has flu shot more then a month before shingrex administered
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus, Tremor
Clinical narrative: Right arm red, swollen, itchy. Evening after vaccination, body felt chilled, shivers rest of the evening. Shook all night, no appetite the next morning, body aches. Symptoms lasted about a week. Took about 7 days to feel better. Patient stated your breathing was stable. Patient uses FITBIT and feels that her body has recovered, but slowly. Patient thinks she has flu shot more then a month before shingrex administered
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Induration
Clinical narrative: large red indurated area
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of the left shoulder,   5cm area plus redness
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Limb mass, Pain in extremity
Clinical narrative: After receiving the vaccine, had stomach pain. The pain is going down to elbows in both arms., across shoulders and upper back. Still has a big lump in arm. White blood count stays up since having the vaccine. Getting more pain from it all the time. Did not go the hospital.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: After receiving the vaccine, had stomach pain. The pain is going down to elbows in both arms., across shoulders and upper back. Still has a big lump in arm. White blood count stays up since having the vaccine. Getting more pain from it all the time. Did not go the hospital.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Erythema, Inflammation
Clinical narrative: pt claims red & inflamed over whole bicep, & increased blood pressure (pt says she went to ER)
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Patient came in for a flu vaccine with her father.  Patient was given flu vaccine and instructed to wait after injection. Shortly after vaccine given father called out from the room for help. One of the office staff went to room where father stated she had felt dizzy and fell off of exam bed and hit head on floor. Physician was called into room to exam. Father did report the patient had not yet eaten. Patient waited additional time before leaving office. Parent has not called back since to report any additional concerns.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient is experiencing bruising, swelling and redness at injection site.  Redness is radiating down the upper arm to above the bend of the arm.  Patient is monitoring adverse reaction.
Age: 11.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Individual fainted approximately within 10 minutes of receiving these vaccines. Individual's face was pale. Individual was alert, aware of surroundings, and communicative following fainting spell. Individual and her parents indicated that she has a strong aversion to getting shots. Father of individual reported that he caught individual while fainting. Individual rested and drank water and she and her parents expressed that she was doing well following her fainting spell.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia, Rash, Vomiting
Clinical narrative: Morning after shots patient got a very bad headache, slight fever, sore arm and rash right arm and vomiting.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: Left thigh wheal, 8x4cm, erythema, induration, nontender
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient states still having pain in left arm following vaccination beginning day after vaccination. Pain/numbness radiates up to neck and down to wrist. Recommended patient seek advice of her primary doctor and use over the counter tylenol and heat to manage pain
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient recieved Proquad ( MMR+Varicella) and was supposed to recieve MMR
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The arm at the site of injection was slightly red, looked mildly swollen, and the patient stated that it felt hot. Patient was informed at the time of injection that if discomfort occurred to take either TYELNOL or Ibuprofen. When patient came in to show us the reaction he was informed to take an anti-histamine, to use a cold compress, and if the reaction got worse to contact his doctor.
Age: 84.0
Sex: M
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Erythema
Clinical narrative: APPROXIMATELY TWO WEEKS AFTER VACCINATION THE PATIENT EXPERIENCED A REDDNESS THE APPEARED ON HIS FACE THAT HAS PERSISTED UNTIL PRESENT WITH NOT MUCH PROGRESSION OR REGRESSION. NO COMPLAINT OF PAIN OR DISCOMFORT. PATIENT REPORTED USING DESONIDE CREAM PRESCRIBED FOR OTHER CONDITIONS THAT APPEARED TO HELP.