chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative:   Patient had an MMR vaccine and had slight erythema around it, was demarcated.  Patient was given Benadryl and ice, and over an hour's time there was no progression and actually shrinkage of the redness.
Age: 51.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Erythema, Myalgia, Pyrexia, Rash
Clinical narrative: Rash across the abdomen, then the following day redness down the left arm, both of which continued to get worse.  Fever around 101, muscle soreness. Treated with oral ibuprofen and oral diphenhydramine. Fever and muscle cleared in 3 days.  Redness still there today.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dry throat, Dyspnoea, Oropharyngeal pain
Clinical narrative: Patient had weakness, SOB, throat pain and dryness approx 15-30 mins after vaccine was given. Went to ED and symptoms subsided.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Acute kidney injury, Blood creatinine increased, Vomiting
Clinical narrative: The morning after patient took the first does he started vomiting.  After vomiting all day we took him to Hospital
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: red erythema around injection site
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Coxsackie virus test positive, Discomfort, Generalised vaccinia, Paraesthesia, Rash vesicular
Clinical narrative: vesicular lesions over body, primarily palmar; tingling in hands; discomfort when making a fist. Patient was seen at the ACC. Cultures taken. Rx: Naproxen, Acetaminophen , and Diphenhydramine
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling and induration about 20 cm X 23 cm, pain, itching, warmth,  developed around 24 hours, pain worsening over next 24 hours, swelling improved slighty over second 24 hours.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Electroencephalogram, Generalised tonic-clonic seizure, Seizure, Tremor
Clinical narrative: Tremors/seizures/tonic clonic  - lasted for 5 months, seem to have stopped at the time of this reporting
Age: 7.0
Sex: F
Vaccine: FLUA3
Symptoms: Wrong product administered
Clinical narrative: Patient was given immunization at a school flu clinic. She received the FLUAD for 65 and older, rather than the Flucelvax or other age appropriate flu vaccine.. No side effects or adverse events were reported to the Pharmacy. Patient's parents have been left message on house phone to call us back so we can give the information to them.
Age: 72.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: IG bottle expired on 8/26/19.  Informed patient. Called manufacturer  and they also did a report. Patient informed she should repeat. She decided not to at this time and stated she will call if she changes her mind.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot given 9-10...experienced flu like symptoms on 9-11.  Beginn 9-12 in the morning injection site became warm, red, and swollen (about 3 inch in diameter).  Patient is putting ice on it.  Patient was referred to contact MD
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECIVED A PEDIATRIC DOSE OF HEPATITIS A VACCINE INSTEAD OF A ADULT DOSE. PROVIDER AND PATIENT NOTIFIED. PATIENT RECIVED CORRECT DOSE (ADULT DOSE) OF HEPATITIS A VACCINE. PATIENT HAS NO SIGNS OR SYMPTOMS CAUSED BY OCCURANCE. NO TREATMENT NEEDED.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Antinuclear antibody negative, Arthralgia, Asthenia, Blood thyroid stimulating hormone normal
Clinical narrative: I had a positive HPV test on 6/18/19 and I decided to get the HPV vaccine based on the recent FDA recommendations. I received my first and only HPV vaccine on 7/23/19. Two days after the vaccination I had flu like symptoms including high temperatures, body aches, headaches, and fatigue. The body aches improved after a few days but high temperature and weakness continued to be a problem intermittently.  I had some labs done to rule out infection including CMP (normal). About one week following vaccination I went to urgent care and was given antibiotics for possible sinusitis. I finished the course of antibiotic with no improvements. The high temperatures were not intermittent anymore and I started having severe joint and bone pain around 8/14/2019. The pain was worst in my hands. My PCP ordered some inflammatory markers (ANA, ARP, RA factor, ESR) to rule out RA, the labs were all negative. It has been about 7 weeks since my vaccination now, bone and joint pain have improved but fatigue continues to be an issue. I sometimes experience the warm feeling (almost like hot flashes) and also miscellaneous body pains (abdominal pain, muscle and joint pain, headache).  I have to point out that prior to this event I was a perfectly healthy individual, I have no history of chronic diseases or reactions to vaccines. I am also a clinical pharmacist and completely pro-vaccine. I understand that current data and research does not support some of the current public concerns about this vaccine but I truly believe that a closer investigation needs to be done regarding these concerns.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Bone pain, Fatigue, Feeling hot, Headache, Inflammatory marker test
Clinical narrative: I had a positive HPV test on 6/18/19 and I decided to get the HPV vaccine based on the recent FDA recommendations. I received my first and only HPV vaccine on 7/23/19. Two days after the vaccination I had flu like symptoms including high temperatures, body aches, headaches, and fatigue. The body aches improved after a few days but high temperature and weakness continued to be a problem intermittently.  I had some labs done to rule out infection including CMP (normal). About one week following vaccination I went to urgent care and was given antibiotics for possible sinusitis. I finished the course of antibiotic with no improvements. The high temperatures were not intermittent anymore and I started having severe joint and bone pain around 8/14/2019. The pain was worst in my hands. My PCP ordered some inflammatory markers (ANA, ARP, RA factor, ESR) to rule out RA, the labs were all negative. It has been about 7 weeks since my vaccination now, bone and joint pain have improved but fatigue continues to be an issue. I sometimes experience the warm feeling (almost like hot flashes) and also miscellaneous body pains (abdominal pain, muscle and joint pain, headache).  I have to point out that prior to this event I was a perfectly healthy individual, I have no history of chronic diseases or reactions to vaccines. I am also a clinical pharmacist and completely pro-vaccine. I understand that current data and research does not support some of the current public concerns about this vaccine but I truly believe that a closer investigation needs to be done regarding these concerns.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Metabolic function test normal, Myalgia, Pain, Pain in extremity
Clinical narrative: I had a positive HPV test on 6/18/19 and I decided to get the HPV vaccine based on the recent FDA recommendations. I received my first and only HPV vaccine on 7/23/19. Two days after the vaccination I had flu like symptoms including high temperatures, body aches, headaches, and fatigue. The body aches improved after a few days but high temperature and weakness continued to be a problem intermittently.  I had some labs done to rule out infection including CMP (normal). About one week following vaccination I went to urgent care and was given antibiotics for possible sinusitis. I finished the course of antibiotic with no improvements. The high temperatures were not intermittent anymore and I started having severe joint and bone pain around 8/14/2019. The pain was worst in my hands. My PCP ordered some inflammatory markers (ANA, ARP, RA factor, ESR) to rule out RA, the labs were all negative. It has been about 7 weeks since my vaccination now, bone and joint pain have improved but fatigue continues to be an issue. I sometimes experience the warm feeling (almost like hot flashes) and also miscellaneous body pains (abdominal pain, muscle and joint pain, headache).  I have to point out that prior to this event I was a perfectly healthy individual, I have no history of chronic diseases or reactions to vaccines. I am also a clinical pharmacist and completely pro-vaccine. I understand that current data and research does not support some of the current public concerns about this vaccine but I truly believe that a closer investigation needs to be done regarding these concerns.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: I had a positive HPV test on 6/18/19 and I decided to get the HPV vaccine based on the recent FDA recommendations. I received my first and only HPV vaccine on 7/23/19. Two days after the vaccination I had flu like symptoms including high temperatures, body aches, headaches, and fatigue. The body aches improved after a few days but high temperature and weakness continued to be a problem intermittently.  I had some labs done to rule out infection including CMP (normal). About one week following vaccination I went to urgent care and was given antibiotics for possible sinusitis. I finished the course of antibiotic with no improvements. The high temperatures were not intermittent anymore and I started having severe joint and bone pain around 8/14/2019. The pain was worst in my hands. My PCP ordered some inflammatory markers (ANA, ARP, RA factor, ESR) to rule out RA, the labs were all negative. It has been about 7 weeks since my vaccination now, bone and joint pain have improved but fatigue continues to be an issue. I sometimes experience the warm feeling (almost like hot flashes) and also miscellaneous body pains (abdominal pain, muscle and joint pain, headache).  I have to point out that prior to this event I was a perfectly healthy individual, I have no history of chronic diseases or reactions to vaccines. I am also a clinical pharmacist and completely pro-vaccine. I understand that current data and research does not support some of the current public concerns about this vaccine but I truly believe that a closer investigation needs to be done regarding these concerns.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: weakness for 2 to 3 days no other flu-like symptons
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Induration, Neck pain, Urticaria
Clinical narrative: Welting  and induration 4-6 cm, hives on forearm and chest,  pain in back and neck for approximately 24 hours
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: hive like reaction to arm around the site of the 2 injections.  area is itchy -started several hours after receiving vaccines
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized Swelling/Redness around injection site & leg.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site bruise, Administration site swelling, Injection site pain
Clinical narrative: Administration site had a large, raised area about 2-3 inch in diameter. It was bruised and painful to the touch and when pressure was applied for approximately one month.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: LEFT UUPER ARM WITH MODERATE -LARGE DEGREE OF SWELLING . MULTIPLE URTICARIAL PATCHES ON UPPER ARM ; ARM WARM TO TOUCH . MILD PAIN WITH TOUCH   This reaction has happened with the 2018 and 2019 flu vaccine, but not previous to those years.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: fever, chills, upset stomach x 6 hrs followed by fatigue x 6 hrs (unable to carry out normal activities)
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Monoplegia, Musculoskeletal stiffness
Clinical narrative: From start of left shoulder to elbow, arm became swollen and red after 1 day of receiving both vaccines. Patient taken Aleve and used ice to decrease swelling and pain. Left arm became stiff and unable to move properly. Patient described to the left arm to be in a paralyzed with the arm flexed. Patient received new prescriptions for a arm brace and prednisone after 4 days of receiving the vaccines.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Orthosis user
Clinical narrative: From start of left shoulder to elbow, arm became swollen and red after 1 day of receiving both vaccines. Patient taken Aleve and used ice to decrease swelling and pain. Left arm became stiff and unable to move properly. Patient described to the left arm to be in a paralyzed with the arm flexed. Patient received new prescriptions for a arm brace and prednisone after 4 days of receiving the vaccines.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Redness in arm from shoulder to elbow. Was taking Benadryl but didn?t seem to help much. She then called pharmacy to seek advice. Was notified to seek medical assistance for possible steroid to reduce inflammation.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site haemorrhage, Injection site pain, Injection site vesicles
Clinical narrative: the injection sites were painful for a few days then resulted into a blister.  The blister is about as big as a grain of rice, with clear fluid and some red clotted blood inside
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Acute respiratory distress syndrome, Aspiration pleural cavity, Bilevel positive airway pressure, Bronchoscopy, Chest X-ray
Clinical narrative: Presented to clinic on 08/20 for difficulty breathing and shortness of breath. States he received anthrax vaccine three days prior. Went to Hospital on 08/23 for worsening shortness of breath, mild productive cough, intermittent fever and chills was treated with azithromycin, vantin, albuterol PRN. Admitted with multifocal pneumonia, non-severe sepsis, bilateral pleural effusion, superimposed pulmonary edema, SEPSIS, ARDS, Acute hypoxic respiratory failure, and suspicion of hypersensitivity pneumonia. Treated with antibiotics and empirical steroids. Started on BIPAP in ICU
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Computerised tomogram thorax, Dyspnoea, Intensive care, Laboratory test
Clinical narrative: Presented to clinic on 08/20 for difficulty breathing and shortness of breath. States he received anthrax vaccine three days prior. Went to Hospital on 08/23 for worsening shortness of breath, mild productive cough, intermittent fever and chills was treated with azithromycin, vantin, albuterol PRN. Admitted with multifocal pneumonia, non-severe sepsis, bilateral pleural effusion, superimposed pulmonary edema, SEPSIS, ARDS, Acute hypoxic respiratory failure, and suspicion of hypersensitivity pneumonia. Treated with antibiotics and empirical steroids. Started on BIPAP in ICU
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Pleural effusion, Pneumonia, Productive cough, Pulmonary oedema, Pyrexia
Clinical narrative: Presented to clinic on 08/20 for difficulty breathing and shortness of breath. States he received anthrax vaccine three days prior. Went to Hospital on 08/23 for worsening shortness of breath, mild productive cough, intermittent fever and chills was treated with azithromycin, vantin, albuterol PRN. Admitted with multifocal pneumonia, non-severe sepsis, bilateral pleural effusion, superimposed pulmonary edema, SEPSIS, ARDS, Acute hypoxic respiratory failure, and suspicion of hypersensitivity pneumonia. Treated with antibiotics and empirical steroids. Started on BIPAP in ICU
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Respiratory failure, Sepsis
Clinical narrative: Presented to clinic on 08/20 for difficulty breathing and shortness of breath. States he received anthrax vaccine three days prior. Went to Hospital on 08/23 for worsening shortness of breath, mild productive cough, intermittent fever and chills was treated with azithromycin, vantin, albuterol PRN. Admitted with multifocal pneumonia, non-severe sepsis, bilateral pleural effusion, superimposed pulmonary edema, SEPSIS, ARDS, Acute hypoxic respiratory failure, and suspicion of hypersensitivity pneumonia. Treated with antibiotics and empirical steroids. Started on BIPAP in ICU
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: The patient reported having significant pain, redness, and swelling at injection site within a day after administration. She stated that a large hard nodule about the size of her fist developed below the site of injection and traveled down her arm toward her elbow. She also developed severe mouth sores, similar to canker sores that are very painful. She states that her doctor told her it is related to the herpes zoster virus, and treated her with valacyclovir.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pain, Stomatitis
Clinical narrative: The patient reported having significant pain, redness, and swelling at injection site within a day after administration. She stated that a large hard nodule about the size of her fist developed below the site of injection and traveled down her arm toward her elbow. She also developed severe mouth sores, similar to canker sores that are very painful. She states that her doctor told her it is related to the herpes zoster virus, and treated her with valacyclovir.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphthous ulcer, Erythema, Fatigue, Glossodynia, Induration
Clinical narrative: The patient reported having significant pain, redness, and swelling at injection site within a day after administration. She stated that a large hard nodule about the size of her fist developed below the site of injection and traveled down her arm toward her elbow. She also developed severe mouth sores, similar to canker sores that are very painful. She states that her doctor told her it is related to the herpes zoster virus, and treated her with valacyclovir.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: The patient reported having significant pain, redness, and swelling at injection site within a day after administration. She stated that a large hard nodule about the size of her fist developed below the site of injection and traveled down her arm toward her elbow. She also developed severe mouth sores, similar to canker sores that are very painful. She states that her doctor told her it is related to the herpes zoster virus, and treated her with valacyclovir.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pain in extremity, Pruritus, Rash, Somnolence
Clinical narrative: The patient reported having significant pain, redness, and swelling at injection site within a day after administration. She stated that a large hard nodule about the size of her fist developed below the site of injection and traveled down her arm toward her elbow. She also developed severe mouth sores, similar to canker sores that are very painful. She states that her doctor told her it is related to the herpes zoster virus, and treated her with valacyclovir.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: The patient reported having significant pain, redness, and swelling at injection site within a day after administration. She stated that a large hard nodule about the size of her fist developed below the site of injection and traveled down her arm toward her elbow. She also developed severe mouth sores, similar to canker sores that are very painful. She states that her doctor told her it is related to the herpes zoster virus, and treated her with valacyclovir.
Age: 31.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Patient was vaccinated in left deltoid muscle with prevnar vaccine and afluria.  Prevnar had to be done twice  since pt moved arm (flinched) with 1st prevnar and full dose wasnt injected. therefore another dose was given 1 inch apart.  patients arm hurt 2 days later and continued for more than a week. On 09-09-19 RPH told patient to go to urgent care. Dr referred patient to neurologist since there were no physical findings. we are now awaiting the patient contacting us after she sees neurologist
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema
Clinical narrative: Patient presented with redness around the injection site diameter of 3 inches to 4 inches. Patient noticed it around 7 am this morning. As per patient there was no pain just the redness. Advised patient to apply cold compress and to take an antihistamine (Benadryl) as patient has taken it prior. Advised patient if worsens or spreads to immediately call her Physician and seek medical attention.  Called Patient at 4:30pm. Patient has been applying cold compress and as per patient it has gotten better.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Pain
Clinical narrative: patient complained of severe joint aches, whole body hurt, believed he had a fever, malaise for several days
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling and very sore gland in armpit of vaccination site.
Age: 49.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Abdominal pain, Computerised tomogram, Diarrhoea haemorrhagic, Impaired work ability, Laboratory test
Clinical narrative: Exactly twelve hours following injections acute, excruciating, debilitating abdominal pain progressing to loss of consciousness and transport to ER via 911.  Ten hours in ER with severe pain , nausea, and bloody diarrhea.  Loss of work two days.  Recovery lasting ten days.
Age: 49.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Loss of consciousness, Nausea, Pain, Urine analysis
Clinical narrative: Exactly twelve hours following injections acute, excruciating, debilitating abdominal pain progressing to loss of consciousness and transport to ER via 911.  Ten hours in ER with severe pain , nausea, and bloody diarrhea.  Loss of work two days.  Recovery lasting ten days.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Influenza, Myalgia
Clinical narrative: pt claimed has bad muscle aches and had flu symptoms
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: HIVES---FROM HEAD TO TOE, TREATMENT: BENADRYL 25MG Q4H , ZANTAC 150 Q12
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: -Slight HA occurring minuted after injection -Woke @ 0430 8/28 to extreme HA pain (9/10) to base of head/occipital area -Within half hour has emesis X 2 with slight nausea & diarrhea -Took Advil (no relief) Took APAP (no relief) -Unable to hold down food or water -Emesis after each dosing of OTC pain medications -HA pain lasted at 7-9/10 pain through the rest of the day, until approx 1600 -3 more episodes of emesis with continued diarrhea throughout the day -Upon waking 8/29 I experienced right arm pain to elbow, on the top side of my upper arm, below the deltoid with calor, no redness, with limited ROM (not just site pain)  -8/29 All day experienced generalized fatigue and body aches -8/30 All sx resolved -
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: -Slight HA occurring minuted after injection -Woke @ 0430 8/28 to extreme HA pain (9/10) to base of head/occipital area -Within half hour has emesis X 2 with slight nausea & diarrhea -Took Advil (no relief) Took APAP (no relief) -Unable to hold down food or water -Emesis after each dosing of OTC pain medications -HA pain lasted at 7-9/10 pain through the rest of the day, until approx 1600 -3 more episodes of emesis with continued diarrhea throughout the day -Upon waking 8/29 I experienced right arm pain to elbow, on the top side of my upper arm, below the deltoid with calor, no redness, with limited ROM (not just site pain)  -8/29 All day experienced generalized fatigue and body aches -8/30 All sx resolved -
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: patient's wife claimed that after he received the shot, he developed a bad fever (105 F) later night and ends up in ER. Doctors cannot figure out the reason why. There is no other unusual things he did on that day. So the wife is thinking the flu shot gave him the fever.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Pneumonia
Clinical narrative: Developed pneumonia roughly three weeks after injection requiring heavy, broad spectrum antibiotics and  albuterol treatments.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Urticaria
Clinical narrative: Fever for 24 hours, welts, hives in various places and red spots on abdomen for 2 weeks.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported to the pharmacy to receive a flu shot and reported swelling at the injection site, pain, and redness. She said the symptoms were really extreme and persisted for multiple days. She said she used NSAIDs to treat the symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Head discomfort, Headache, Nausea
Clinical narrative: By 11:30pm started with severe chills, maybe had fever, severe headache that lasted for several hours, severe nausea but did never threw up; did not sleep all night or next morning. The headache was so severe that even eyes hurtfelt like her head was going to explode.  Patient considered calling ambulance but knew that it was not an anaphylactic reaction. Did not want to scare mom that was in the other room so at 8am called her to bring some aspirin.  Symptoms improved 3-4 hours after taking medicine; slept from 12pm to 7pm.   After headache was gone could walk but weakness lasted for the next 2-3 days. Patient did not take any other medication. Spoke to pharmacist about the adverse event and was encouraged to call VAERS; pharmacist mentioned that had another patient reporting similar symptoms.  Mother and brother-in-law had no symptoms and sister had severe headache but nothing like patient's. Patient had severe chickenpox in childhood and shingles episode at 42 years
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: By 11:30pm started with severe chills, maybe had fever, severe headache that lasted for several hours, severe nausea but did never threw up; did not sleep all night or next morning. The headache was so severe that even eyes hurtfelt like her head was going to explode.  Patient considered calling ambulance but knew that it was not an anaphylactic reaction. Did not want to scare mom that was in the other room so at 8am called her to bring some aspirin.  Symptoms improved 3-4 hours after taking medicine; slept from 12pm to 7pm.   After headache was gone could walk but weakness lasted for the next 2-3 days. Patient did not take any other medication. Spoke to pharmacist about the adverse event and was encouraged to call VAERS; pharmacist mentioned that had another patient reporting similar symptoms.  Mother and brother-in-law had no symptoms and sister had severe headache but nothing like patient's. Patient had severe chickenpox in childhood and shingles episode at 42 years
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: The patient's doctor called the pharmacy to report the adverse events the patient was experiencing. Per physician, patient showed up to the office with hives and rashes all over the body.  Physician reported that the hives were raised, red, and itchy.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site haematoma
Clinical narrative: Chills, fatigue, headache, nausea lasting 5-6 hours. Localized reaction circular, well demarcated erythematous, puritic hematoma 2.5 inches in diameter at injection site
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Local reaction, Nausea
Clinical narrative: Chills, fatigue, headache, nausea lasting 5-6 hours. Localized reaction circular, well demarcated erythematous, puritic hematoma 2.5 inches in diameter at injection site
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Blister, Blister rupture, Faeces discoloured, Local reaction
Clinical narrative: Patient reports sore arm and local reaction. A day or two after he noticed a knot, which may have been a blister that ruptured when he rubbed it. It now healed up and had a scab over it. He said it was getting better and healing. Patient also said he had nausea and stomach issues and had green colored stools.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Nodule, Pain in extremity, Scab
Clinical narrative: Patient reports sore arm and local reaction. A day or two after he noticed a knot, which may have been a blister that ruptured when he rubbed it. It now healed up and had a scab over it. He said it was getting better and healing. Patient also said he had nausea and stomach issues and had green colored stools.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: day after receiving vaccine pt woke up with very large red rash covering her arm where she received the injection as well as her neck and her chest. she went to the md office and md stated it was a cellulitis and prescribed cephalexin to treat it. md told her it was due to the injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient was administered first dose of shingrix on 9/9/19 and reported an adverse event on 9/12/19.  Patient sought medical treatment and was diagnosed as having cellulitis. Patient was treated with antibiotics.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pt had severe body pain 20 hr post injection
Age: 64.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient experienced pain, swolleness, and rash, including itchiness on left arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site swelling, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient says had sore arm and was really hard around the shot area it was swollen .Pt stated couldn't move arm and was unable to do routine work and exercise
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Patient received Pneumovax in left arm and high dose fluzone in right arm on 9/11.  That evening the left arm became swollen and sensitive/painful to touch.  on the evening of 9/12 she presented to pharmacy with bruising at the injection site of the left arm (pneumovax) and redness/swelling going down the arm around the elbow.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: pt called pharmacy stating that he noticed redness approximately 3 inches below shot area, no swelling burning or pain, wouldnt have noticed really except when he went to remove bandaid
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient visited local ER after shoulder pain resulting from flu immunization did not resolve in 1-2 days. MRI was performed at ER, patient was prescribed tramadol for pain on 9/4. I followed up with the patient on 9/7 and she stated the shoulder pain had resolved.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Chills, Coordination abnormal, Fatigue, Migraine
Clinical narrative: Major migraine headache, stomach aches, fatigue, chills, coordination is off
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Patient said her arm became red and puffy 2 hours after vaccine was given on 9/10/19. She waited until the morning of 9/12/19 to go to an Urgent Care. She said she took Benadryl on her own at home in the meantime and it did not help. It was determined that she had a reaction and they prescribed a steroid taper and an antibiotic (she said she had a tooth or gum problem x 1 week prior and was told to f/u with dentist). They sent her home and she came to the pharmacy and told me about the reaction and showed me. Red and puffy from her shoulder to her elbow on the left arm. Said it was not painful unless touched. Said she felt fine otherwise. The area has not changed since she first noticed it. She has appointment with PCP on 9/18 and I told her to mark the area on her arm so she can see if it gets better. Told her to call us with any concerns in the meantime and that I would follow up with her over the next few days.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swellin in L lateral thigh area .
Sex: F
Vaccine: PPV
Symptoms: Cough, Dizziness, Pain, Pyrexia
Clinical narrative: Fever Body ache Dizziness  Cough
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (R) ARM Swelling and Red
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, swollen, red area warm & Hot to touch, tenderness in Arm, chills, fever.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Rash, swollen, red area warm & Hot to touch, tenderness in Arm, chills, fever.
Age: 13.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arm was red; Rash in arm; Dispensing error; Inappropriate age at vaccine administration; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 13-year-old male patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.  On 22nd July 2019, the patient received Shingrix. On 22nd July 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The nurse called to report that Shingrix was inadvertently adminstered to a 13 year old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.   Follow up information received from nurse on 5th September 2019: The patient's mother reported that the patient's arm was red and had a rash for couple of days. The patient participated in normal daily activities. The reporter said that the error was in dispensing, which led to drug dispensing error. The nurse prepared the incorrect vaccine and administered it. It was administered with correct process but it was the incorrect vaccine, which led to wrong vaccine administered. It was unknown if the reporter considered the erythema of extremities and rash to be related to Shingrix. The VAERS details were updated.
Age: 13.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Product administered to patient of inappropriate age, Rash, Wrong product administered
Clinical narrative: Arm was red; Rash in arm; Dispensing error; Inappropriate age at vaccine administration; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 13-year-old male patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.  On 22nd July 2019, the patient received Shingrix. On 22nd July 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The nurse called to report that Shingrix was inadvertently adminstered to a 13 year old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.   Follow up information received from nurse on 5th September 2019: The patient's mother reported that the patient's arm was red and had a rash for couple of days. The patient participated in normal daily activities. The reporter said that the error was in dispensing, which led to drug dispensing error. The nurse prepared the incorrect vaccine and administered it. It was administered with correct process but it was the incorrect vaccine, which led to wrong vaccine administered. It was unknown if the reporter considered the erythema of extremities and rash to be related to Shingrix. The VAERS details were updated.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Myalgia, Neuralgia, Nodule, Pain
Clinical narrative: nerve pain; pain that shot up behind left ear; pain; pain limited to the area in which he received the injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 2 days after receiving Shingrix, the patient experienced pain in arm and injection site pain. On an unknown date, the patient experienced nerve pain and ear pain. The patient was treated with lidocaine hydrochloride (Lidocaine), paracetamol (Tylenol), steroids nos (Steroid Shot (Nos)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the pain in arm, nerve pain and ear pain were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the injection site pain, nerve pain and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. Within a day or two days, the patient started to have really bad pain in his arm which he received the injection. It caused him a problem for about 4 months. He first saw a doctor at the urgent care who provided Tylenol and Lidocaine patches but this did not relieve his pain. He was then referred to a sports doctor who gave him a steroid injection and within 48 hours, the pain started to reduce and continued to get better with physical therapy.   The patient mentioned that, the nerve pain was gone including the pain that shot up behind his left ear. The patient still had some pain but it was limited to the area in which he received the injection. The patient indicated he filled out a form for the CDC (Center for Disease Control) as requested by his pharmacist to report his experience.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: nerve pain; pain that shot up behind left ear; pain; pain limited to the area in which he received the injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 2 days after receiving Shingrix, the patient experienced pain in arm and injection site pain. On an unknown date, the patient experienced nerve pain and ear pain. The patient was treated with lidocaine hydrochloride (Lidocaine), paracetamol (Tylenol), steroids nos (Steroid Shot (Nos)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the pain in arm, nerve pain and ear pain were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the injection site pain, nerve pain and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. Within a day or two days, the patient started to have really bad pain in his arm which he received the injection. It caused him a problem for about 4 months. He first saw a doctor at the urgent care who provided Tylenol and Lidocaine patches but this did not relieve his pain. He was then referred to a sports doctor who gave him a steroid injection and within 48 hours, the pain started to reduce and continued to get better with physical therapy.   The patient mentioned that, the nerve pain was gone including the pain that shot up behind his left ear. The patient still had some pain but it was limited to the area in which he received the injection. The patient indicated he filled out a form for the CDC (Center for Disease Control) as requested by his pharmacist to report his experience.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: nerve pain; pain that shot up behind left ear; pain; pain limited to the area in which he received the injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 2 days after receiving Shingrix, the patient experienced pain in arm and injection site pain. On an unknown date, the patient experienced nerve pain and ear pain. The patient was treated with lidocaine hydrochloride (Lidocaine), paracetamol (Tylenol), steroids nos (Steroid Shot (Nos)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the pain in arm, nerve pain and ear pain were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the injection site pain, nerve pain and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. Within a day or two days, the patient started to have really bad pain in his arm which he received the injection. It caused him a problem for about 4 months. He first saw a doctor at the urgent care who provided Tylenol and Lidocaine patches but this did not relieve his pain. He was then referred to a sports doctor who gave him a steroid injection and within 48 hours, the pain started to reduce and continued to get better with physical therapy.   The patient mentioned that, the nerve pain was gone including the pain that shot up behind his left ear. The patient still had some pain but it was limited to the area in which he received the injection. The patient indicated he filled out a form for the CDC (Center for Disease Control) as requested by his pharmacist to report his experience.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Rash erythematous
Clinical narrative: The patient told me that her arm was red and very swollen. She went to the doctor's office and they though it was due to the Shingrix shot. The patient notified me a week after she started having the symptoms and she said that her arm was not swollen anymore but she still had red spots on it.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Rash
Clinical narrative: He continues having fevers and rashes. i don't know where to take him . i don't trust doctors now
Age: 4.0
Sex: M
Vaccine: MMRV, UNK, UNK
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm from injection site (below shoulder area) to elbow swelling, warmth, redness. Hives under left eye, followed by swelling in both eyes the morning after initial hive symptom appeared. Ongoing treatment with Claritin and Benadryl. Still with swelling to R upper arm, and reduced swelling to eyes.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC13
Symptoms: Generalised tonic-clonic seizure, Haemoglobin normal, Neutrophil percentage decreased, Platelet count normal, Postictal state
Clinical narrative: At 4:30 PM patient had a generalized tonic -clonic seizure and fever of 103. Seizure lasted 3-4 minutes and was postictal for 45-50 mins. Was transferred by EMS to ER. In ER  temp was 100.2. her physical exam waas normal. Labs: WBC8.63k; Hgb 12.2; Plts 374.2k ; neut 60 %; Urinanalysis  was negative; procalcitonin .10
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC13
Symptoms: Procalcitonin increased, Pyrexia, Urine analysis normal, White blood cell count normal
Clinical narrative: At 4:30 PM patient had a generalized tonic -clonic seizure and fever of 103. Seizure lasted 3-4 minutes and was postictal for 45-50 mins. Was transferred by EMS to ER. In ER  temp was 100.2. her physical exam waas normal. Labs: WBC8.63k; Hgb 12.2; Plts 374.2k ; neut 60 %; Urinanalysis  was negative; procalcitonin .10
Age: 1.0
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; 12 month old patient was administered a dose of GARDASIL 9; This spontaneous report has been received from a nurse referring to a 12 month old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 28-DEC-2012, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided) (inappropriate age at vaccine administration). No adverse effects. The outcome of the events was unknown. No product quality complaint (PQC) involved.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered via intramusclar route; no adverse  event; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported. The patient's concomitant medication included sterile diluent. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R029517, expiry date: 14-OCT-2020) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R031636, expiry date: 01-NOV-2020) (dose details unknown) for prophylaxis. Both the vaccines were administered via intramuscular route instead of subcutaneous route (incorrect route of product administration). No adverse event reported. measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type of rHA involved.