chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, FLU4, TDAP
Symptoms: Mass, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included DPT with an associated reaction of urticaria (received in 2000, see case US2018GSK115151) and Influenza vaccine with an associated reaction of urticaria (received in 2000, see case US2018GSK115151). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and activities of daily living impaired. On an unknown date, the outcome of the injection site pain, injection site swelling and activities of daily living impaired were unknown.  It was unknown if the reporter considered the injection site pain, injection site swelling and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provide date of birth. The age at vaccination was not reported. The patient reported that they experienced a painful area at the injection site, and swelling, further described as a deep arm pain, after receiving SHINGRIX. The patient reported that they could not do a lot for a few days. This case was linked with US2018GSK115151, US2018109095 and US2018109097 reported by the same reporter.
Sex: F
Vaccine: VARZOS, FLU4, TDAP
Symptoms: Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and dTpa vaccine, the patient experienced hives, pruritus and mass. On an unknown date, the outcome of the hives, pruritus and mass were recovered/resolved. It was unknown if the reporter considered the hives, pruritus and mass to be related to Influenza vaccine Quadrivalent unspecified season and dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that in 2000, she experienced itchy hives, and a lump which persisted for months, after having the DPT and flu vaccines. This case was linked with US2018109097, US2018109095 and US2018109093, reported by the same reporter.
Sex: F
Vaccine: VARZOS, FLU4, TDAP
Symptoms: Mass, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and dTpa vaccine, the patient experienced hives, pruritus and mass. On an unknown date, the outcome of the hives, pruritus and mass were recovered/resolved. It was unknown if the reporter considered the hives, pruritus and mass to be related to Influenza vaccine Quadrivalent unspecified season and dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that in 2000, she experienced itchy hives, and a lump which persisted for months, after having the DPT and flu vaccines. This case was linked with US2018109097, US2018109095 and US2018109093, reported by the same reporter.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 82-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020) for prophylaxis. On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, several days after receiving SHINGRIX, the patient experienced rash and ptosis. The patient was treated with acyclovir. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the ptosis was not recovered/not resolved. It was unknown if the reporter considered the rash and ptosis to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on the left arm. The healthcare professional (HCP) reported that, the patient developed a rash on the left side of her head and a droopy left eye in the early April 2018. The reporter stated that this the patient went to her primary care physician and was started on acyclovir cream for the rash, but was diagnosed by her optometrist when she went to see him for her droopy eye. The HCP could not find the lot number or expiry date of the SHINGRIX.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Gianotti-Crosti syndrome, Rash, Rash papular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gianotti-crosti syndrome in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included nebivolol hydrochloride (Bystolic) and mometasone furoate (Nasonex Nasal Spray). In June 2018, the patient received the 1st dose of SHINGRIX. On 11th June 2018, less than a week after receiving SHINGRIX, the patient experienced gianotti-crosti syndrome, papular rash, painful rash and blister. On an unknown date, the outcome of the gianotti-crosti syndrome, papular rash, painful rash and blister were not recovered/not resolved. The reporter considered the gianotti-crosti syndrome to be related to SHINGRIX. It was unknown if the reporter considered the papular rash, painful rash and blister to be related to SHINGRIX. Additional details were provided as follows: Within 3 to 5 days after receiving vaccine, the patient experienced papular painful rash with blisters which was formally diagnosed as a rare skin condition (Gianotti Crosti Syndrome). The patient's symptoms required an office visit to his primary care physician as well as the dermatologist but did not require an emergency room visit. The patient would not be receiving the 2nd dose in the series due to the symptoms. The patient was receiving treatment from both his dermatologist and primary care physician as well as the reporter thought that the symptoms and subsequent syndrome diagnosis due to the SHINGRIX. No further information beyond what was documented above.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prevention. Concurrent medical conditions included hypothyroidism (problem with processing calcium) and hypertension (high blood pressure). Concomitant products included amlodipine besylate, calcium carbonate (Calcium), fluticasone propionate (Fluticasone), calcitriol and hydralazine. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On 3rd April 2018, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm, tingling and numbness. On an unknown date, the outcome of the pain in arm, tingling and numbness were not recovered/not resolved. The reporter considered the pain in arm, tingling and numbness to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received Allergy pill as concomitant medication. At 5:00 hours, the patient received SHINGRIX on the left arm. The patient felt like a deep sharp pain in her arm. The pain was so strong and severe that it would cause her to wake up when it happened if she was not already awake.  The pain initially lasted every day for about 10 days after injection. The patient continued to have pain in her arm but now it comes and goes and was not continuous. The patient said that, there was no swelling or redness of the skin at the injection site. The patient had not spoken to her physician about this, nor did the physician recommend to get the vaccine. The patient decided at her age, she said, that it was probably a good idea to go ahead and get the vaccine. The patient was due to receive the 2nd dose in July 2018. The reported lot number (324KL) for SHINGRIX did not exist and was updated to 3Z4KL, according to sales database.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart racing in a 80-year-old male patient who received SHINGRIX (batch number 4492P, expiry date April 2019) for prophylaxis. Concurrent medical conditions included heartbeats irregular. Concomitant products included acetylsalicylic acid (Aspirin), atorvastatin calcium (Atorvastatin), famotidine, magnesium hydrogen aspartate dihydrate (Magnesium), tamsulosin hydrochloride (Tamsulosin), triamterene, alprazolam, hydrocodone, methocarbamol (Metocarbamol), metoprolol and nicotinamide (Vitamin B3). On 1st May 2018 12:30, the patient received the 1st dose of SHINGRIX. On 1st May 2018 22:00, 9 hrs 30 min after receiving SHINGRIX, the patient experienced heart racing and heartbeats irregular. On 1st May 2018, the outcome of the heart racing and heartbeats irregular were recovered/resolved. It was unknown if the reporter considered the heart racing and heartbeats irregular to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, he received SHINGRIX during daytime. At about 10 pm, the patient's heart started racing and he experienced irregular heartbeats which went away after about 30 to 45 minutes.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain and intramuscular formulation administered by other route. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and intramuscular formulation administered by other route were unknown.  It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, a female the patient inadvertently received a dose of Shingrix vaccine via subcutaneously injection, which led to inappropriate route of vaccination, and as a result, the patient developed arm swelling and pain along with redness at the injection site.  The patient was treated with prednisone taper. No further information was available at the time of reporting. This case has been linked with case US2018110644, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included raloxifene. On 8th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 9th May 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness. On 10th May 2018, the outcome of the tiredness was recovered/resolved. The reporter considered the tiredness to be probably related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient reported that the tiredness resolved after one day. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left arm. The healthcare professional reported that the patient developed fever, chills and shivering later in the evening after receiving SHINGRIX. No further information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Concomitant products included levothyroxine, liothyronine (Armour Thyroid). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced fever, headache and pain. On an unknown date, the outcome of the fever, headache and pain were not recovered/not resolved. The reporter considered the fever, headache and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.  The patient reported that she experienced a low grade fever and a bad headache after receiving the SHINGRIX vaccine in upper left arm. The patient received the shot at 11:30 AM. The patient had denied permission to contact their physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 71-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The onset date or specifics about the rash were not known at time of report.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 79-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th April 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, weakness, nausea, diarrhea and muscle pain. On 22nd April 2018, the outcome of the tiredness, weakness, nausea, diarrhea and muscle pain were recovered/resolved. It was unknown if the reporter considered the tiredness, weakness, nausea, diarrhea and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was tired, weak, experienced severe nausea and muscle ache. No follow up was requested. No further information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of allergic reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, however it could be adult as per package insert. The age at vaccination was not reported.
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Ankylosing spondylitis, Road traffic accident
Clinical narrative: This case was reported by a non-health professional via other manufacturer and described the occurrence of allergy to vaccine in a adult female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. Concurrent medical conditions included vitamin d deficiency, anemia, depression, migraine, hypothyroidism and drug allergy (AMOXIL, Tramadol and BENADRYL). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown. It was unknown if the reporter considered the allergy to vaccine to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient was 20 years old at the time of reporting. In December 2017, the patient received COSENTYX (150 mg) subcutaneously once a month for ankylosing spondylitis of unspecified sites in spine. The patient reported not taking COSENTYX for three weeks due possible blood clots after being involved in a car accident. No further information was given. The patient reported in confidence and did not give consent to be contacted. The patient did not give consent for healthcare professional contact.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Induration, Local reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of local reaction in a 4-year-old female patient who received KINRIX for prophylaxis. On 15th June 2018, the patient received KINRIX. On 17th June 2018, 2 days after receiving KINRIX, the patient experienced local reaction. On 18th June 2018, the patient experienced induration. On an unknown date, the outcome of the local reaction and induration were unknown. It was unknown if the reporter considered the local reaction and induration to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient came on the reporting day to the physician since she had  experienced large local reaction approximately 10 cm on right leg which started on  Sunday. On Monday, 18th June 2018, 3 days after receiving vaccination, the patient came in with 8 cm of hardness. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, dizziness and nausea. On an unknown date, the outcome of the injection site pain, fever, chills, dizziness and nausea were unknown. It was unknown if the reporter considered the injection site pain, fever, chills, dizziness and nausea to be related to SHINGRIX. Additional details were reported as follows: This case was reported by an Office Manager. The age at vaccination was not reported. The patient experienced pain at the injection site, followed by fever, chills, dizziness and nausea that evening. The reporter agreed to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Influenza like illness, Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site rash, burning sensation, fatigue and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site rash, burning sensation, fatigue and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site rash, burning sensation, fatigue and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter granted a permission for follow up. The patient had redness, swelling and a rash in the arm at the injection site, went in for an office visit due to this. The patient also had flu like symptoms and fatigue. The arm felt like it was burning.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site rash, burning sensation, fatigue and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site rash, burning sensation, fatigue and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site rash, burning sensation, fatigue and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter granted a permission for follow up. The patient had redness, swelling and a rash in the arm at the injection site, went in for an office visit due to this. The patient also had flu like symptoms and fatigue. The arm felt like it was burning.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash pruritic, Rash vesicular
Clinical narrative: In addition to the sore arm expected for 5 days, I had a shingles-like itchy rash breakout on my abdomen. It is not listed in typical side effects on your website but perhaps should be.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, PPV
Symptoms: Blood test, Diarrhoea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Patient received his routine vaccinations (DTap-IPV  - L thigh and pneumococcal 23 - R thigh) on 6/22. He was initially sore afterwards bilaterally. On the morning of 6/23, he woke up with worsened right lower extremity pain that began where he received his shots but progressed to involve the entire right leg throughout the day on 6/23. He began to progressively limp and refuse to bear weight on his right leg, causing mother to have to carry him around. Mother noted tactile fever that evening. Upon measuring, Tmax 103.3F. Given fever in the setting of prior liver transplant, mother called on call hepatologist for recommendations. It was recommended to come to emergency room for evaluation at Hospital. Associated symptoms include one episode of NBNB emesis, abdominal pain, and looser stools on day of admission. Denied diarrhea, cough, sore throat, cough, rashes. No sick contacts at home.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Full blood count normal, Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Patient presented to ER 3 days after vaccine was administered with superimposed cellulitis and blistering. After the vaccine mother noticed redness in right arm where the vaccine was given. With time the redness spread, worsen, and the arm became indurated, and blistering develop. Patient was treated with clindamycin every 8 hours and IV Benadryl every 8 hours. Patient was discharged home with clindamycin by mouth every 6 hours and Benadryl as needed.  Pt came to the office and right upper arm had mild erythema no induration, not warm to touch and no blisters.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Pruritus, Rash erythematous, Throat irritation
Clinical narrative: Red rash itchy right arm, back, chest, feet. Throat irritation, dyspnea. Patient seen in 3 days after injection. Treatment with prednisone and OTC antihistamines and OTC ranitidine.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Product preparation error
Clinical narrative: It was discovered that on 5/21/18 the ROTARIX was ordered by Dr. The Medical assistant documented that only the ROTARIX diluent was documented as given to the patient. The actual ROTARIX vaccine wasn't given.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Local reddness, swelling, itching and pain at injection site and surrounding areas of arm. Stomach upset and diarrhea.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Local reddness, swelling, itching and pain at injection site and surrounding areas of arm. Stomach upset and diarrhea.
Age: 35.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Client described swelling and blistering developing at injection site, a day later the blisters popped.  Went to Urgent care and was treated with antibiotics and steroid. Site is improving, no further swelling.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Autopsy, Death, Sudden infant death syndrome
Clinical narrative: Death, ruled SIDS.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Product substitution error
Clinical narrative: A state supplied vaccine was administered to an adult of age 19 years old.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Pain, swelling, redness, and itching at injection site left arm. Also, been getting a fever.
Age: 17.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Blood glucose normal, Dizziness postural, Electrocardiogram normal, Loss of consciousness, Seizure
Clinical narrative: Patient was given vaccines then allowed to leave right after. She felt dizzy upon standing. She sat down in a chair, said she could not see, then passed out. She looked like she was having a mild seizure. Paramedics were called to transport to hospital because she took longer to come to consciousness than expected. Hospital did EKG, blood sugar testing, blood pressure, and determined it was Vasovagal Syncope. Advised her to be hydrated and eat a good breakfast before shots and to sit or lie down for 15 minutes after a shot.
Age: 17.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Syncope, Visual impairment
Clinical narrative: Patient was given vaccines then allowed to leave right after. She felt dizzy upon standing. She sat down in a chair, said she could not see, then passed out. She looked like she was having a mild seizure. Paramedics were called to transport to hospital because she took longer to come to consciousness than expected. Hospital did EKG, blood sugar testing, blood pressure, and determined it was Vasovagal Syncope. Advised her to be hydrated and eat a good breakfast before shots and to sit or lie down for 15 minutes after a shot.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient stated swelling, pain, heat to area where vaccine placed. Patient was seen on 6/27/18 where provider diagnosed with Cellulitis and patient was given Rx of Keflex 500mg.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient came into pharmacy 48 hours after receiving the SHINGRIX vaccine in her left deltoid muscle. The area where she was vaccinated was bright red and swollen. She said the reaction did not happen until 24 hours after the vaccination. She said it is sore and the soreness has persisted since yesterday afternoon. She described the soreness as feeling like she 'got punched in the arm.'  She said she has been taking ibuprofen 800mg tablets for the pain and it is not helping it.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site irritation, Injection site warmth, Nausea
Clinical narrative: Redness, warmth and skin irritation around injection site along with chills and nausea.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Redness, warmth and skin irritation around injection site along with chills and nausea.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Malaise
Clinical narrative: Headache; weakness; overall feeling of malaise. All effects lasted 1 day.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Patient showed a red swollen arm. Patient reports that on 06 27 took some ADVIL to relieve pain but arm was very stiff and sore.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bradyphrenia, Disorientation, Fatigue, Headache
Clinical narrative: About 16 hours after the injection, I had muscle pain and swelling at the injection site - I had a headache and upset stomach and my entire body was tired. About 20 hours after the injection, I felt disorientated. I looked at my watch 4 different times before it actually registered in my brain what time it was. I could walk and talk but my thinking was not registering correctly - it was very slow. The next morning I was still tired, but the other side effects were gone.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: About 16 hours after the injection, I had muscle pain and swelling at the injection site - I had a headache and upset stomach and my entire body was tired. About 20 hours after the injection, I felt disorientated. I looked at my watch 4 different times before it actually registered in my brain what time it was. I could walk and talk but my thinking was not registering correctly - it was very slow. The next morning I was still tired, but the other side effects were gone.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist, referring to a 26 year old female patient. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. No prenatal tests or results were reported. Neither the pregnancy outcome nor the fetal outcomes were known at the time of the report. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown dates, the patient was vaccinated with first and second dose of GARDASIL 9 for prophylaxis(dose, route of administration, lot number and expiration date were not reported). Now, on 14-JUN-2018, an email was received in Merck National Service Center (MNSC), with a pharmacist inquiry "Pharmacist was asking if the patient has received her first two doses of GARDASIL 9 and is now pregnant, what would be the recommendation for the third dose?". It was unclear whether the therapy was taken during or before pregnancy.The pregnancy outcome and the gestational age were not reported. No additional information was provided.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a lab technician referring to a 12 month old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were reported as unknown. On 27-MAY-2018, the patient was vaccinated with a dose of VARIVAX injection (strength, lot # and expiry date were not reported) for prophylaxis whose route of administration was reported as unknown. On an unknown date in 2018, after the vaccine administration the patient developed cutaneous lesions also reported as rash on an unspecified location of the body (varicella) for which the patient sought medical attention and was hospitalized on an unspecified date in 2018. On 16-JUN-2018, a lesion sample was collected, tested in the hospital laboratory and the result revealed as positive for varicella zoster virus (VZV+). It was also reported that on an unspecified date, the rash was swabbed and tested positive for varicella and patient was being treated with antiviral Acyclovir (manufacturer unknown). The reporter confirmed that the patient was currently hospitalized. It was reported that patient had no new vesicles to obtain a sample for testing. The outcome of event was not reported. The causality assessment between the event and VARIVAX was not reported. There was no product quality complaint (PQC) reported. The patient was enrolled in the Varicella Zoster Virus Identification Program (VZVIP) to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. The patients concurrent conditions, medical history, drug reactions and allergies were not reported. The patients concomitant medication included Diluent MRK Inj used to reconstitute M-M-R II, which did not undergo a temperature excursion. On an unknown date, patients were vaccinated with improperly stored GARDASIL 9 (dose, units, frequency, route, lot# and expiration date not reported) and M-M-R II (dose, units, frequency, route, lot# and expiration date not reported). The administered vaccines had temperature excursion from 0 degree Celsius (C) to 1 C (1.23 C) and from 9 C to 25 C (9.63 C) for an unknown time frame as recorded by digital data logger (Incorrect product storage). The administered vaccines had no previous temperature excursion. No adverse effects reported in any patients. No product quality complaint involved. This is a non-valid report due to lack of patient identifiers. Follow-up information has been received on 25-JUN-2018 from a physician. This report refers to a 4 year old female patient. On 24-MAR-2018, the patient was vaccinated with improperly stored second dose of M-M-R II (Lot # M045394, Expiration date: 14-NOV-2018, Route: Subcutaneous, Site: Right thigh), second dose of VARIVAX (Lot # N017699, Expiration date: 09-JUN-2019, Route: Subcutaneous, Route: Right thigh) and KINRIX (Lot # 75747, Expiration date unknown, Route: Intramuscular, Route: Left thigh) for prophylaxis. The temperature excursion occurred as a result of a reading from a digital data logger.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Lip swelling
Clinical narrative: Lip swelling inside mouth - lower lip within 20 minutes after injection resolved within 24 hrs. No treatment needed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme swelling and pain on left arm, numbness in left arm - in physical therapy.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: 6:50 Pt became light headed, nurse assisted pt down to floor. Lower extremities raised opened eyes when name called. BP 64/42 H.R 70 A&Ox4 56 BP 98-60 HR 74. Recovered within 20 min and discharged with Mom & Dad.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site erythema, Pain
Clinical narrative: Redness at injection site (~4" by 6" stripe on her upper arm around injection site) - flu-like symptoms: fatigue, headache, body aches.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: Large red inflamed area, itchy, hot to touch. Received Cephalexin 500mg every 8 hours for 7 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Patient just came in today stating he had "hard lymph nodes starting on 6/20/18 but never called our pharmacy to inform us and just informed us today 6/28/18. But, he did call his DR. as soon as it happened and Dr. states he told him this is rare but can happen with the injection. Dr. advised pt to take Ibuprofen and not to get second vaccination until 5 to 6 months after first vaccination. Patient states he only called physician on phone and Dr. stated he did not need to see patient in office regarding this. I called Dr. today and spoke with office that states Dr. did tell patient it is from the vaccination and he is not concerned about it at this time and will subside with time. Dr. does want pt to still get 2nd vaccination but not for 5 to 6 months after first vaccination.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: Pt experienced soreness and somre erythema for TRUMENBA which began a few hours after it was administered, the symptoms for Menactra began next day. Minimal erythema and edema over both deltoid areas where immunizations were applied. Minimal tenderness to palpation. Pt to take ibuprofen prn for pain and inflammation and to apply cool/warm compresses. Symptoms have improved since symptoms initially appeared, pt has been afebrile.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: Sore Arm at injection site and an area of redness on outside of arm surrounding the area of injections,  Patient also reports area of redness on inside of left leg.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Autonomic nervous system imbalance, Blood test, Condition aggravated, Dizziness
Clinical narrative: Started getting light headed. Passed out at school twice. Started getting migraines, severe nausea. Lost a lot of weight. Chronically tired, all over body pain. Has severe sensitivity to sounds so much so that she stays in her room to avoid people. Had to do school online for three years to graduate. Anxiety increased because of fear of passing out. Diagnosed with dysautonomia which means her blood pressure is no longer regulated by her body. Doctor threatened to put in a feeding tube because of weight loss. This is ongoing. Has not resolved three years later. Doctors kept prescribing meds that had severe side effects that made her feel worse.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram, Fatigue, Hyperacusis, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: Started getting light headed. Passed out at school twice. Started getting migraines, severe nausea. Lost a lot of weight. Chronically tired, all over body pain. Has severe sensitivity to sounds so much so that she stays in her room to avoid people. Had to do school online for three years to graduate. Anxiety increased because of fear of passing out. Diagnosed with dysautonomia which means her blood pressure is no longer regulated by her body. Doctor threatened to put in a feeding tube because of weight loss. This is ongoing. Has not resolved three years later. Doctors kept prescribing meds that had severe side effects that made her feel worse.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Migraine, Nausea, Pain, Weight decreased
Clinical narrative: Started getting light headed. Passed out at school twice. Started getting migraines, severe nausea. Lost a lot of weight. Chronically tired, all over body pain. Has severe sensitivity to sounds so much so that she stays in her room to avoid people. Had to do school online for three years to graduate. Anxiety increased because of fear of passing out. Diagnosed with dysautonomia which means her blood pressure is no longer regulated by her body. Doctor threatened to put in a feeding tube because of weight loss. This is ongoing. Has not resolved three years later. Doctors kept prescribing meds that had severe side effects that made her feel worse.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Approx. 10 min. after receiving vaccines, the patient states she felt dizzy and she fainted. She responded within less then a minute. We elevated her feet, placed a cool cloth on her forehead. Her pulse was strong at 70 BPM. She was given water and a candy to suck on. After a few minutes she was up to a chair feeling "fine" although she was quite pale, her color returned to her lips, her pulse was 76 BPM. After waiting approx. 10 min. in the waiting room, she left our clinic with her mom.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: Patient reported theses side effects in her following visit in 6/28/18. She stated that shortly after she had the shot, her left arm swollen, red. It was swollen for few days before swelling started to subside. Also patient reported bad headache lasted for one day and resolved with over the counter NSAID.   Patient about 6 weeks earlier received 1st dose MenB (TRUMENBA) and Flu vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash erythematous, Skin induration
Clinical narrative: Chills, fever, redness /rash, hot skin, hardness of skin, pain/soreness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Chills, fever, redness /rash, hot skin, hardness of skin, pain/soreness.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: Patient stated she had redness and swelling at the injection site and very mild itching. She also had headache and just didn't feel very well.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizzy, very tired for 24 hours. Felt better by 9:30 a.m. on Sunday, May 27, 2018.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, chills, patient is being treated with TYLENOL and monitored by husband.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Tenderness
Clinical narrative: Patient had the regularly reported pain and tenderness but on day 3 developed a red area she describes as roughly 6 inches X 8 inches in size and warm to the touch. Patient went in to see immediate care at her primary care physician's office and was diagnosed with cellulitis. She was placed on 7 days of an antibiotic. Returned to clinic on 6/27 and was prescribed an additional 3 days of same said antibiotic then on advice of physician's office, contacted us with all this information.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Two days after having the shot in my left arm I woke up and was unable to lift my arm without a great amount of pain. It gradually got better but took about 5-6 days before I could lift my arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Nocturia, Pain, Pain in extremity
Clinical narrative: Right arm sore and could not be raised without considerable pain, temperature at 100F overall soreness at other joints. 2 TYLENOL tablets taken at 4 pm but did not have much effect. Worst pain and soreness occurred about 10 to 11 pm. 2 more TYLENOL tablets taken without much effect. Fitful sleep during the night with frequent urination about once per hour. Gradual recovery the next day and no fever.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Poor quality sleep
Clinical narrative: Right arm sore and could not be raised without considerable pain, temperature at 100F overall soreness at other joints. 2 TYLENOL tablets taken at 4 pm but did not have much effect. Worst pain and soreness occurred about 10 to 11 pm. 2 more TYLENOL tablets taken without much effect. Fitful sleep during the night with frequent urination about once per hour. Gradual recovery the next day and no fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, mild pain and mild swelling to injection site. Applied ice to site with relief of symptoms.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Arthralgia, Asthenia, Blood test, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Both vaccinations were mixed together and given at the same time in the same left arm. It was immediately red, and hot at the injection site, which became very sore  and remained red and hot for nearly 7 days. Then, later that fall, after three phlebotomies related to treatment for life-long hemochromatosis, I developed "Frozen Shoulder" which persisted with pain and limited use of the left arm. This was diagnosed by an orthopedic specialist nearly six months later. A steroid shot was given by that doctor to provide pain relief and aid in mobility recovery.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal disorder, Pain
Clinical narrative: Both vaccinations were mixed together and given at the same time in the same left arm. It was immediately red, and hot at the injection site, which became very sore  and remained red and hot for nearly 7 days. Then, later that fall, after three phlebotomies related to treatment for life-long hemochromatosis, I developed "Frozen Shoulder" which persisted with pain and limited use of the left arm. This was diagnosed by an orthopedic specialist nearly six months later. A steroid shot was given by that doctor to provide pain relief and aid in mobility recovery.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Pain in extremity, Periarthritis, Product preparation error, X-ray limb
Clinical narrative: Both vaccinations were mixed together and given at the same time in the same left arm. It was immediately red, and hot at the injection site, which became very sore  and remained red and hot for nearly 7 days. Then, later that fall, after three phlebotomies related to treatment for life-long hemochromatosis, I developed "Frozen Shoulder" which persisted with pain and limited use of the left arm. This was diagnosed by an orthopedic specialist nearly six months later. A steroid shot was given by that doctor to provide pain relief and aid in mobility recovery.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Patient's Shoulder aches badly and when he lifts his arm forward a shooting pain shoots down his forearm. No fever, no injection site redness or swelling.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Body temperature, Chills, Nausea, Peripheral swelling
Clinical narrative: Swollen arm/temperature/chills/nausea.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Raised bump at injection site, itchy and red. Lasted 1 week.