chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Nausea, Photophobia
Clinical narrative: fatigue; headache; nausea; stiff neck; light sensitivity; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 22-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received the 1st dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced fatigue, headache, nausea, stiff neck and photophobia. On an unknown date, the outcome of the fatigue, headache, nausea, stiff neck and photophobia were unknown.   It was unknown if the reporter considered the fatigue, headache, nausea, stiff neck and photophobia to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received RabAvert for pre exposure prophylaxis and developed fatigue, nausea, a stiff neck, light sensitivity and a headache. The caller works in the facility which wrote the RX for the patient, but the patient was going to college in where she got the first dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020109772:same reporter
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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2020, the patient received the 1st dose of Shingrix. On 16th May 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced arm pain. The reporter did not consent to follow up.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Lethargy, Nausea, Photophobia
Clinical narrative: Patient experienced sensitivity to light, nausea, headaches, and lethargy starting 6/18/20. She reported 6/30/20 that the symptoms of headaches and lethargy have not gone away still. She will experience a good day followed by another day of severe headaches and lethargy.  Patient is planning to visit physician regarding side effects.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Hypersensitivity, Injection site cellulitis, Injection site warmth, Rash erythematous
Clinical narrative: 11:30 pm my son woke me with a red rash smaller than a dime. Checked it out gave benadryl went back to bed. Saturday,  June 27th my son woke up later than his normal wake up time complaining his arm is red. I took a marker circled area to see if it would spread gave benadryl, ice, and kept an eye on it. By 6:30 it was worse circling again called on call doctor she asked if the area on his right arm was warm to the touch as soon as I replied yes she advised bringing him immediately to a walk-in clinic or hospital. I had to drag him out to a hospital risking Covid to find out he had an allergic reaction to one or both the meningitis and tetanus vaccine. Then to top it off learn he had cellulitis from the injection site. They asked why did the nurse give both shots in the same arm. I replied I don't know believe because his writing arm is the left. They knew immediately what it was without running tests.
Age: 51.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; 51 year old male patient received a dose of Gardasil 9; This spontaneous report was received from a nurse practitioner and refers to a 51-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 19-JUN-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, exact dose, site and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no known adverse effect.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster shortly after vaccination; Information has been received from a lawyer regarding a case in litigation concerning currently an approximately 58-year-old female patient (pt). No information was received regarding the pt's medical history, concurrent conditions and concomitant medications. The pt was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider. On or about 05-OCT-2015, the pt was administered zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a provider(s) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster shortly after vaccination. The outcome of herpes zoster was unknown. The reporter considered the event of herpes zoster shortly after vaccination to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Fatigue
Clinical narrative: debilitated in bed for 5 days; exhausting reaction / experienced it with the initial shot; Debility; This case was reported by a consumer and described the occurrence of bedridden in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced bedridden, exhaustion and debility. On an unknown date, the outcome of the bedridden, exhaustion and debility were unknown.   It was unknown if the reporter considered the bedridden, exhaustion and debility to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. After receiving the 1st of vaccine the patient was totally debilitated in bed for 5 days.  The patient did not expect to have such an exhausting reaction to the booster shot, even though patient had experienced it with the initial shot. For tolerance after 2nd dose of Shingrix, refer case US2020AMR106672.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR106672:same patient (2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 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 case details were reported as follows: The age at vaccination was not reported. The patient stated after the first dose of Shingrix had a sore arm. The patient enquired about 2nd dose.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107060:Same reporter/same patient
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Oral administration complication, Regurgitation
Clinical narrative: after receiving a dose of Rotarix regurgitated it; after receiving a dose of Rotarix regurgitated it; This case was reported by a nurse via call center representative and described the occurrence of regurgitation in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number L5G93, expiry date 27th August 2021) for prophylaxis.   On 22nd June 2020, the patient received Rotarix lyophilized formulation (oral). On 22nd June 2020, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation and accidental underdose. On an unknown date, the outcome of the regurgitation and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation to be related to Rotarix lyophilized formulation.  Additional case details were reported as follows: The patient after receiving the dose of Rotarix regurgitated it, happened on the same day as reported. The reporter consent to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Sensory disturbance, Tremor
Clinical narrative: Vibration in her left breast / feel like when the cell phone is on vibrate; feel like when the cell phone is on vibrate; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   On 18th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st June 2020, 3 days after receiving Shingrix, the patient experienced tremor and feeling abnormal. On an unknown date, the outcome of the tremor and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the tremor and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The patient received the 2nd dose of Shingrix in left arm. On 21st June 2020, the patient started having vibrations in her left breast.  The reporter described it felt like when the cell phone is on vibrate. The vibrations started as very infrequent and then after that they were occurring more frequently.  Now they had gotten worse. The reporter consent to follow up.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 2 months patient was used an expired diluent on a patient/No AE; Initial information was received on 23-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional in the.  This case involves a two month old male patient who received expired diluent of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination and PARACETAMOL (PEDIATRIX).  On 22-Jun-2020, the patient received a 0.5ml first dose of suspect HIB (PRP/T) VACCINE (Lot number: UJ033AAC ,expiry date: 07-OCT-2020, Diluent: U6205AC expiry date: 22-APR-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired medical agent used. Caller stated that the Acthib vials and diluent have different expiration dates. they used an expired diluent on a patient.  At the time of report, no adverse event 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 and Module VI of the 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: 12.0
Sex: F
Vaccine: HPVX, IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was supposed to get HPV vaccine and gave IPOL instead accidentally/ No AE; Initial information was received on 25-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old female patient who accidentally received 0.5 mL dose of suspect IPV (VERO) [IPOL]  (lot P1F541M and expiry date 07-Dec-2020) via intramuscular route in the right deltoid for prophylactic vaccination but was supposed to get HPV VACCINE (not produced by Sanofi Pasteur, lot number  and expiry date not reported) instead (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Immunisation.  Details of laboratory data was not reported.   It was an actual medication error case due to wrong vaccine administered.  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 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: 47.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Intermittent tingling of face.  comes and goes.  no other symptoms.  started about 24h after getting shot. still present 1 wk later
Age: 2.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave HPV to client age 2 - inadvertant
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling hot, Headache, Injection site pain, Injection site reaction
Clinical narrative: Sore arm, slight headache, slight nausea, aching joints, and an internal feeling of overheating overnight from 28Jun2020 to 29Jun2020. Sore arm and swollen red rash on left arm near site of injection on 29Jun2020. No treatment, side effects have subsided as of 30Jun2020 except for slight sore arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain in extremity, Rash erythematous
Clinical narrative: Sore arm, slight headache, slight nausea, aching joints, and an internal feeling of overheating overnight from 28Jun2020 to 29Jun2020. Sore arm and swollen red rash on left arm near site of injection on 29Jun2020. No treatment, side effects have subsided as of 30Jun2020 except for slight sore arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Headache, Pruritus, Rash, Rash erythematous
Clinical narrative: Few spots developed 2 days ago, on face and abdomen. Red spots. Today spread to face. No fever. Normal energy OK. Appetite went down. Complaining of HA. NO abd pain, diarrhea or vomiting. Itchy- benadryl helps with itching.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Enema administration, Intestinal obstruction, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Baby had vomiting starting 6/26/20 that persisted until 6/27/20 when she was sent to the emergency room for evaluation of bowel obstruction. She had ultrasound of the abdomen that diagnosed intussusception which was reduced with air enema. Baby was able to tolerate feeding of pedialyte at that time and discharged home.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: erythema and edema to the injection site 2.5cm Round 24 hours After injection Benadryl 6mg by mouth given. Prednisone 15mg/5ml given 3ml every Day for 3 Days. Ibuprofen 50mg Three times a Day
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Pt broke out into chickenpox like rash all over body within a hour of leaving office with LGF. Rash lasted few days with the fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Muscle pain in arm (tolerable)  Headache, Muscle pain all over and shivering  while attempting to sleep 11 hours after the vaccination
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Urticaria
Clinical narrative: Within 5 minutes of receiving vaccine, developed intense abdominal pain/cramping.  Then developed urticarial rash on face and chest.  All of these resolved within 1 hour and received no medication.  Was evaluated by both EMS and in emergency department.   Had no recurrence after.  Has not had vaccine reactions in past.   Never with breathing problems, facial swelling, vomiting or diarrhea
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Cholelithiasis, Nausea, Vomiting
Clinical narrative: Patient said she developed nausea/vomiting. Her vomiting worsened 6/29/20 and she went to ER to get treated.  Patient  said ER doctor found underlying gallstones that patient was unaware of and she said doctor thought the vaccine may have aggravated her condition.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: started to have fever 8 days after vaccine and then whole body , maculopapular rash 9 days after vaccine. fever has now resolved but rash still present. rash not appearing to be vesicular or with any crusts. no one else in household with similar symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Diarrhoea, Fatigue, Flatulence, Immediate post-injection reaction
Clinical narrative: First shot 2/24/2020. Second shot 6/15/2020. Felt ill right away, nausea, tired, painful arm. Lasted about a week. Got sick again for another week, worse symptoms. Got better, and then sick again for 2 weeks, diarrhea, fever, and others above. Got better, and then sick again for a week, same symptoms as above and gassy. Finally went to Hospital ER. 2nd shot 6/15/2020, sick one week, better, sick one week again, same symptoms as above. Then went to Hospital. Elevated blood pressure. Tested at hospital for COVID, results negative.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: First shot 2/24/2020. Second shot 6/15/2020. Felt ill right away, nausea, tired, painful arm. Lasted about a week. Got sick again for another week, worse symptoms. Got better, and then sick again for 2 weeks, diarrhea, fever, and others above. Got better, and then sick again for a week, same symptoms as above and gassy. Finally went to Hospital ER. 2nd shot 6/15/2020, sick one week, better, sick one week again, same symptoms as above. Then went to Hospital. Elevated blood pressure. Tested at hospital for COVID, results negative.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: patient developed Bells Palsey about 6 weeks after receiving vaccine
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Patient had the adverse reaction of hives/rash on his chest, stomach. His symptoms started the day after he received the vaccination (6/30). Patient was instructed to try Zyrtec or Benadryl (mom given correcting dosing). Patient's mom will call the office back with any worsening symptoms and the ED with any difficulty breathing, facial swelling, etc.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Rash on bilateral lower extremities for 2-3 weeks.  Now has diffuse rash sparing soles, palms, and face x3 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Paraesthesia
Clinical narrative: Patient was experiencing tingling in her right arm and hand and her lips were numb. She was given 50mg of Benadryl at 4:10pm.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Fatigue, Loss of consciousness, Nausea, Seizure, Syncope
Clinical narrative: Patient received Gardasil first and then Menactra. Shortly after the Menactra was administered, he fainted and lost consciousness for about one minute. Then, he started to seize for less than fifteen seconds and became conscious again. Shortly after, he became nauseous and threw up and reported that he felt better after he threw up. We monitored him for 15 minutes and gave him water and had him sit down and rest until he was fully recovered and alert again. We did call his prescribing doctor, Dr., to report the incident and the doctor's office stated that if the patient is feeling fine, he is free to go. I called to check on him 4 hours later and spoke to his mother, and his mother stated he is feeling tired and is resting in bed. I told them to give the doctor a call if the patient feels any adverse symptoms and to take Tylenol if he has fever or pain.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Vomiting
Clinical narrative: Patient received Gardasil first and then Menactra. Shortly after the Menactra was administered, he fainted and lost consciousness for about one minute. Then, he started to seize for less than fifteen seconds and became conscious again. Shortly after, he became nauseous and threw up and reported that he felt better after he threw up. We monitored him for 15 minutes and gave him water and had him sit down and rest until he was fully recovered and alert again. We did call his prescribing doctor, Dr., to report the incident and the doctor's office stated that if the patient is feeling fine, he is free to go. I called to check on him 4 hours later and spoke to his mother, and his mother stated he is feeling tired and is resting in bed. I told them to give the doctor a call if the patient feels any adverse symptoms and to take Tylenol if he has fever or pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient reports joint pain starting day of injection and persisting through this report day 6/30/20
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given MMRV and a separate Varicella Vaccine. No adverse reactions noted.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash vesicular, Scab, Secretion discharge
Clinical narrative: A couple hundred EXTREMELY itchy hive or chicken pox-like lesions on extremities and ears.  At first looked like about 8 mosquito bites, and when I got up in the morning I had them all over.  They were red with small blister-like centers that the next day or so drained a clear light yellow sticky substance.  I have pictures on my cell phone.  After a few days they got a little scab in the middle and stopped itching.  I had about 3 distinct waves of these, as one batch was healing another very itchy round began.  A month later now, the larger one, about 20 are still red with a larger scab in the center, many have faded out, but there is still about 50 that are light brown in color on their way to fading.  I took nor applied anything during this time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: A couple hundred EXTREMELY itchy hive or chicken pox-like lesions on extremities and ears.  At first looked like about 8 mosquito bites, and when I got up in the morning I had them all over.  They were red with small blister-like centers that the next day or so drained a clear light yellow sticky substance.  I have pictures on my cell phone.  After a few days they got a little scab in the middle and stopped itching.  I had about 3 distinct waves of these, as one batch was healing another very itchy round began.  A month later now, the larger one, about 20 are still red with a larger scab in the center, many have faded out, but there is still about 50 that are light brown in color on their way to fading.  I took nor applied anything during this time.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram head, Computerised tomogram thorax, Electroencephalogram, Facial pain
Clinical narrative: Started having muscle pain and weakness and feeling lethargic same day of the vaccine. Started having migraine type headaches 4 days after the flu vaccine (extreme sensitivity to light and sound). Ended up in the Hospital ER Nov. 2, 2019 from intense headache.Two weeks later started having tension type headaches.  Dec. 3, 2019 headaches continued then started having respiratory disturbances and tremors all over and ended up being hospitalized. Afterward, I started having facial muscle pain and facial tightness.  I ended back in the ER a  3rd time for facial pain/headache. Even today, 8 months later, my head and forehead stiffens with touch, and I am still having extreme sensitivity to sound.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hyperacusis, Lethargy, Lumbar puncture, Magnetic resonance imaging brain
Clinical narrative: Started having muscle pain and weakness and feeling lethargic same day of the vaccine. Started having migraine type headaches 4 days after the flu vaccine (extreme sensitivity to light and sound). Ended up in the Hospital ER Nov. 2, 2019 from intense headache.Two weeks later started having tension type headaches.  Dec. 3, 2019 headaches continued then started having respiratory disturbances and tremors all over and ended up being hospitalized. Afterward, I started having facial muscle pain and facial tightness.  I ended back in the ER a  3rd time for facial pain/headache. Even today, 8 months later, my head and forehead stiffens with touch, and I am still having extreme sensitivity to sound.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Muscular weakness, Musculoskeletal stiffness, Myalgia, Photophobia
Clinical narrative: Started having muscle pain and weakness and feeling lethargic same day of the vaccine. Started having migraine type headaches 4 days after the flu vaccine (extreme sensitivity to light and sound). Ended up in the Hospital ER Nov. 2, 2019 from intense headache.Two weeks later started having tension type headaches.  Dec. 3, 2019 headaches continued then started having respiratory disturbances and tremors all over and ended up being hospitalized. Afterward, I started having facial muscle pain and facial tightness.  I ended back in the ER a  3rd time for facial pain/headache. Even today, 8 months later, my head and forehead stiffens with touch, and I am still having extreme sensitivity to sound.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory disorder, Skin tightness, Tension headache, Tremor
Clinical narrative: Started having muscle pain and weakness and feeling lethargic same day of the vaccine. Started having migraine type headaches 4 days after the flu vaccine (extreme sensitivity to light and sound). Ended up in the Hospital ER Nov. 2, 2019 from intense headache.Two weeks later started having tension type headaches.  Dec. 3, 2019 headaches continued then started having respiratory disturbances and tremors all over and ended up being hospitalized. Afterward, I started having facial muscle pain and facial tightness.  I ended back in the ER a  3rd time for facial pain/headache. Even today, 8 months later, my head and forehead stiffens with touch, and I am still having extreme sensitivity to sound.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Anal incontinence, Dysstasia, Erythema, Pain in extremity, Tremor
Clinical narrative: 3 episodes of fecal incontinence, legs were so shaky that she couldn't get out of chair well, arm was red and sore for a few days. Symptoms resolved after 24 days
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Induration, Pyrexia, Rash macular, Skin warm
Clinical narrative: Patient came back to the pharmacy on 6/25  with a large red blotch on his arm; area was hard and hot to the touch.  He stated he had a 101 degree fever starting on 6/20 that progressively improved over the next several days.  He also he called the COVID hotline that day.  He left the pharmacy and proceeded to the emergency room.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient came back to the pharmacy on 6/25  with a large red blotch on his arm; area was hard and hot to the touch.  He stated he had a 101 degree fever starting on 6/20 that progressively improved over the next several days.  He also he called the COVID hotline that day.  He left the pharmacy and proceeded to the emergency room.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Lymphadenopathy
Clinical narrative: First Shangrix Shot/Dose given on 4/15/2020. No immediate side affects. Beginning on May, 2020 started experiencing all body neuropathy, pain, burning feet. Went away on it's own in 6 weeks. Received second dose on 6/20/2020. Woke the next day with a high fever, body aches, chills, and swollen glands. Lasted two days, then went into cold symptoms. By Saturday 6/27/2020, started experiencing all body neuropathy. On Monday, 6/29/2020, the neuropathy became worse and by night time, my legs were achy and fatigued, along with knee joint pain. During my sleep, I awoke with burning feet and a tremendous amount of pain. on Tuesday, 6/30/2020, I called my pharmacist to report and he told me it is a very low percentage but that gout and neuropathy were two adverse side affects of the vaccine. He advised me to call my doctor. I went to see a Nurse Practitioner, because my doctor was unavailable. She indicated she didn't know much about the vaccine and wasn't sure how to treat, other than to wait it out and see if it goes away. In the meantime, I am in excruciating pain. I never thought this vaccine would do this to me and I sure hope I don't have any long term issues with neuropathy because of this shingles vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Neuropathy peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: First Shangrix Shot/Dose given on 4/15/2020. No immediate side affects. Beginning on May, 2020 started experiencing all body neuropathy, pain, burning feet. Went away on it's own in 6 weeks. Received second dose on 6/20/2020. Woke the next day with a high fever, body aches, chills, and swollen glands. Lasted two days, then went into cold symptoms. By Saturday 6/27/2020, started experiencing all body neuropathy. On Monday, 6/29/2020, the neuropathy became worse and by night time, my legs were achy and fatigued, along with knee joint pain. During my sleep, I awoke with burning feet and a tremendous amount of pain. on Tuesday, 6/30/2020, I called my pharmacist to report and he told me it is a very low percentage but that gout and neuropathy were two adverse side affects of the vaccine. He advised me to call my doctor. I went to see a Nurse Practitioner, because my doctor was unavailable. She indicated she didn't know much about the vaccine and wasn't sure how to treat, other than to wait it out and see if it goes away. In the meantime, I am in excruciating pain. I never thought this vaccine would do this to me and I sure hope I don't have any long term issues with neuropathy because of this shingles vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever (101.1), chills, headache, body aches, soreness at injection sight
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Malaise, Pain in extremity, Tenderness
Clinical narrative: Severe headache, malaise, arm tenderness, new joint pain in right middle finger, right second toe, right lateral ankle, with increased pain in left hip.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Facial pain, Inflammation, Rash
Clinical narrative: red, painful, inflamed face. Started 6/11/20 afternoon. Pt states he was in a house working 6/10/20-6/11/20 and out of the sun. Patient states rash got progressively worse. Patient is still experiencing symptoms. He wakes up due to pain, showers, exfoliates face and has not been using lotion. Pain has not improved.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, arm and body soreness, redness at injection site about the size of a saucer, warmth at injection site
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Became unresponsive with legs extended and shaking x one minute
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Vertigo
Clinical narrative: vertigo, resolved without intervention
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swelled, red, warm to touch
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Product administered at inappropriate site
Clinical narrative: The varicella vaccine caused no problems but the Tdap felt like it had been injected into my shoulder joint. The nurse placed the injection very high on my shoulder and I could tell when it went in that something wasn't right. I did not experience any kind of allergic reaction, however, over the next few days, the stiffness and muscle weakness in that shoulder intensified until I woke up on 6/21/20 in extreme pain and unable to move or use my arm. I went back into the Health Department where I had received the shot the next day and they evaluated my shoulder and told me to take the week off of work and rest it. My range of motion was seriously reduced and I could not lift anything with that hand. They prescribed me 800mg Ibuprofens and that seemed to help until it wore off. I went back the following week on 6/29/20 to be re-evaluated. They called me off of work for an additional week. They recommended that I get an MRI to see if the shot could have damaged some muscle or soft tissue but I don't have health insurance or a way to pay for an MRI so I have decided to see if it continues to heal. I have had some improvement in my mobility and it seems to be getting better on its own. However, I still experience sharp pains when I move it certain ways, like across to the right side of my body or when I try to raise my arm straight up or out to the side.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint range of motion decreased
Clinical narrative: The varicella vaccine caused no problems but the Tdap felt like it had been injected into my shoulder joint. The nurse placed the injection very high on my shoulder and I could tell when it went in that something wasn't right. I did not experience any kind of allergic reaction, however, over the next few days, the stiffness and muscle weakness in that shoulder intensified until I woke up on 6/21/20 in extreme pain and unable to move or use my arm. I went back into the Health Department where I had received the shot the next day and they evaluated my shoulder and told me to take the week off of work and rest it. My range of motion was seriously reduced and I could not lift anything with that hand. They prescribed me 800mg Ibuprofens and that seemed to help until it wore off. I went back the following week on 6/29/20 to be re-evaluated. They called me off of work for an additional week. They recommended that I get an MRI to see if the shot could have damaged some muscle or soft tissue but I don't have health insurance or a way to pay for an MRI so I have decided to see if it continues to heal. I have had some improvement in my mobility and it seems to be getting better on its own. However, I still experience sharp pains when I move it certain ways, like across to the right side of my body or when I try to raise my arm straight up or out to the side.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain, Product administered at inappropriate site
Clinical narrative: The varicella vaccine caused no problems but the Tdap felt like it had been injected into my shoulder joint. The nurse placed the injection very high on my shoulder and I could tell when it went in that something wasn't right. I did not experience any kind of allergic reaction, however, over the next few days, the stiffness and muscle weakness in that shoulder intensified until I woke up on 6/21/20 in extreme pain and unable to move or use my arm. I went back into the Health Department where I had received the shot the next day and they evaluated my shoulder and told me to take the week off of work and rest it. My range of motion was seriously reduced and I could not lift anything with that hand. They prescribed me 800mg Ibuprofens and that seemed to help until it wore off. I went back the following week on 6/29/20 to be re-evaluated. They called me off of work for an additional week. They recommended that I get an MRI to see if the shot could have damaged some muscle or soft tissue but I don't have health insurance or a way to pay for an MRI so I have decided to see if it continues to heal. I have had some improvement in my mobility and it seems to be getting better on its own. However, I still experience sharp pains when I move it certain ways, like across to the right side of my body or when I try to raise my arm straight up or out to the side.
Sex: U
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: vasovagal syncope around 5 minutes after vaccines were injected
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-APR-2016 unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 07-AUG-2016 , the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse effect reported; patient was administered a dose both PROQUAD and VARIVAX on the same day; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not provided.     On 01-JUN-2017, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in the left arm (dose, frequency, lot/batch # and expiration date not reported) as prophylaxis.   On 19-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the left arm (dose and frequency not reported; lot # S017239, expiration date 01-DEC-2020). On the same date, she was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) in the right arm (dose and frequency not reported; lot # S002874, expiration date 29-JAN-2021). Both vaccines were administered subcutaneously as prophylaxis. No additional adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Patient was administered a dose of PROQUAD which was improperly stored; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   On 24-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose number, route and anatomical location were not reported) (Lot # S027463 with expiry date: 02-MAR-2021) for prophylaxis (product storage error). The vaccine was exposed to a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit: 9 degrees Fahrenheit for 40 minutes.  Previously the vaccine exposed to 6 degrees Fahrenheit to 14 degrees Fahrenheit: 9 degrees Fahrenheit for 40 minutes. It was reported that the call was because of digital data logger. No additional adverse effects reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed/administered by a healthcare provider (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient received Ipol vaccine at 2 month, 4 month, 6 to 9 months and fourth dose at one year of age too early and should have been at age 4 to 6 years, No AE; Initial information received on 23-Jun-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 12 months old female patient who received a fourth dose of IPV (VERO) [IPOL] (batch number and expiry date not reported), via intramuscular route and in an unknown site of administration for prophylactic vaccination on 19-Jun-2020. The patient also received IPOL, at the age of two months, four months and six to nine month batch number and expiry date not reported), via an unknown route and site of administration for prophylactic vaccination  on an unknown date.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HIB VACCINE (HIB VACCINE) for prophylactic vaccination.  It was a case of an actual medication error case due to Inappropriate drug dose administration interval too short.  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 holder's compliance with the requirements set out in Directive and Module VI of the 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.  There will be no information available on batch number for this case.