chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Inflammation, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient came into the pharmacy today to report that it has been "months" since receiving the shingles vaccine and she still has a small bump where it was administered. This bump was verified by the pharmacist. It was not inflamed, red ,or warm to the touch. At this time, patient expressed that the day after administration, her arm was red, warm and had a raised hard spot where the vaccine was administered. She reports feeling tired and that the area where she had shingles sores in the past felt sore, however she reports that the specific area previously affected by shingles is sore when she is under stress. She reports the inflamed, red, warm area on her arm went away without intervention.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site warmth
Clinical narrative: Patient came into the pharmacy today to report that it has been "months" since receiving the shingles vaccine and she still has a small bump where it was administered. This bump was verified by the pharmacist. It was not inflamed, red ,or warm to the touch. At this time, patient expressed that the day after administration, her arm was red, warm and had a raised hard spot where the vaccine was administered. She reports feeling tired and that the area where she had shingles sores in the past felt sore, however she reports that the specific area previously affected by shingles is sore when she is under stress. She reports the inflamed, red, warm area on her arm went away without intervention.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Immediate (before needle even withdrawn) syncope with short seizure (less than 30 seconds.)  Alert within 60 seconds, completely recovered within 15 minutes.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: Immediate (before needle even withdrawn) syncope with short seizure (less than 30 seconds.)  Alert within 60 seconds, completely recovered within 15 minutes.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Tremor
Clinical narrative: Pt had sudden onset of diffuse shaking/rigors which began about 15 hours after receiving the vaccine; shaking lasted for one hour then fully resolved.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Client reported 2 inch reddened area around injection site. No wheezing, no rash, just local. Patient instructed to ice area, and keep a close eye. Any changes let our office know, unless life threatening, and then ER immediately.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Patient presented with lesions indicating shingles infection on left abdomen 72 hours after injection. Patient seen in clinic by Dr. 05/23/2018 confirming presence of shingles still on abdomen.
Age: 0.58
Sex: F
Vaccine: UNK, UNK
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rashes.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Tendonitis
Clinical narrative: Pain in L deltoid area X 2.5 months that started after the vaccine. Pt declined pain med. Will refer to PT for RC tendonitis.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Pt stated he awoke 5/22/18 morning with symptoms of red, itchy hands and feet along with splotchy, irregular rashes on groin, axilla, upper back and shoulders. Pt stated he took fexofenadine to help with itchiness and it seemed to improve. Pt contacted pharmacy on 5/23 to report reaction. Pt stated the rash was much improved but still very itchy.
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse, who was reporting on himself - a male patient of an unknown age. He had no pertinent medical history, drug reactions or allergies and concomitant therapies. On 08-AUG-1989, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular injection, 1 dose, intramuscularly (exact dose, anatomical localization, lot # and expiration date were not reported). On 08-SEP-1989, he was vaccinated with the second dose of RECOMBIVAX HB intramuscular injection, 1 dose, intramuscularly (exact dose, anatomical localization, lot # and expiration date were not provided). On 25-JAN-1990, the patient was vaccinated with the third dose of RECOMBIVAX HB intramuscular injection, 1 dose, intramuscularly (exact dose, anatomical localization, lot # and expiration date were not reported). On 08-MAY-2018, he had anti-hepatitis B antibodies titers drawn, which demonstrated 9.68 (unit not provided). The patient sought medical attention by seeing an unspecified physician (date not reported). No treatment was given for the event. The outcome of the event was reported as not recovered. The relatedness between the event and RECOMBIVAX HB was not reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Headache, Infectious mononucleosis, Mononucleosis heterophile test, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a 15 year old female non-pregnant patient. The patient had a history of hives with ZITHROMAX in about 2006. The patient had no pertinent medical history or concomitant medications. On 12-MAR-2018, the patient was vaccinated with one dose of GARDASIL 9, intramuscular injection, to prevent Human Papilloma Virus (HPV) (lot number and expiration date were not reported). On about 17-APR-2018, the patient developed headache and a sore throat and on 24-APR-2018, she was diagnosed with mononucleosis. The patient sought medical attention and lab diagnostics were performed including blood tests and mono spot, however, the results were not provided. No treatment was given for the adverse event. By the time of the reporting, the patient was recovering from mononucleosis. The reporter did not assess the causal relationship between GARDASIL 9 and the event. This spontaneous report as received from a other health professional refers to a 15 year old female patient with urticaria. On, 1 DF, intramuscular for prophylaxis. On 17-APR-2018, 1 month 6 days after onset of therapy the patient experienced infectious mononucleosis. The outcome of infectious mononucleosis was reported as recovering/resolving. {Additional information has been requested./Additional information is not expected.}
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (0.5 ml, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain at injection site. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fever, general body pain and chills. On an unknown date, the outcome of the influenza-like symptoms, headache, fever, general body pain and chills were recovered/resolved. The reporter considered the influenza-like symptoms, headache, fever, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient noted that she experienced side effects with 1st dose of SHINGRIX vaccine. The patient said that after the SHINGRIX vaccine injection she had flu like symptoms. With the 1st dose, she had chills, fever, headache and body ache. The symptoms started within 48 hours of the injection and then they resolved the next day. This case was linked with US2018GSK085204, reported for 2nd dose of SHINGRIX for same patient.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: First night: site pain, redness, fever, chills, swelling, generalized  joint pain. Current: upper arm redness, swelling, itching, pain, afebrile. Benadryl 50mg and tylenol taken last noc without relief.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pruritus, Pyrexia, Swelling
Clinical narrative: First night: site pain, redness, fever, chills, swelling, generalized  joint pain. Current: upper arm redness, swelling, itching, pain, afebrile. Benadryl 50mg and tylenol taken last noc without relief.
Age: 14.0
Sex: M
Vaccine: HPV9, MMR
Symptoms: Malaise, Nausea, Pyrexia, Rash
Clinical narrative: Client was vaccinated in the afternoon of 5/15/2018. Mom called midday of 5/16/18, stating her child had a fever of 103 degrees, was nauseous, and had a rash around the throat/neck. She stated that the rash began on the morning of 5/16/18. Encouraged mom to give the child TYLENOL or ibuprofen for the fever and if the fever does not reduce go to their primary care provider. Also, encouraged mom to monitor for any signs of anaphylaxis, which she denies. If child has signs of anaphylaxis go to urgent care immediately. Called mom on 5/17/18 to see how the child was doing. Mom stated that the fever was better and the rash did not spread but the child still did not feel well. Encouraged mom to take her child to their primary care provider if the child did not feel any better the following day, as the symptoms could be a result of something else.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash on right thigh were she had the injection.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Syncope
Clinical narrative: PT HAD A SYNCOPE EPISODE WHEN ADMINISTER HPV VACCINE. PT HAD TDAP/ MCV ON RT ARM PT WAS FINE ONLY COMPLAIN WAS (IT HURTS). WHEN NURSE WAS ADMINISTRATING HPV PT HAD THE SYNCOPE EPISODE. NURSE HOLD PT LAY HER DOWN ON EXAM TABLE. MOM CALL DR. RECHECK PT'S VITALS. LAY DOWN PT FOR 15-30 MIN. ON THE EXAM TABLE. PT FEEL BETTER IN 10 MINUTES. DR RECHECK PT EVERY 5 MINUTES TO MAKE SURE PT WAS FINE. PT RECOVERED AND WAS SEND HOME. AS PER MOM PT HAS HAD SYNCOPE EPISODES WHEN SHE GETS SHOTS OR BLOOD DRAWN.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Vaccination error
Clinical narrative: PEDIARIX was given in error.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain
Clinical narrative: Patient mentioned that after dose #1 (administered 3-15-18) he experienced total body soreness and severe lethargy for 2 days post-injection. When I administered his second dose on 5-22-18, he woke up on 5-23-18 with the same extreme symptoms. He described it as soreness like he had mulched or landscaped all day long with no break.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling of body temperature change, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm, decreased mobility, could not sleep, hot and cold flashes with fever 101.6. Patient took  ibuprofen and temp was down to 99.8 in the morning. The next day he stated he still feels bad.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain in arm, decreased mobility, could not sleep, hot and cold flashes with fever 101.6. Patient took  ibuprofen and temp was down to 99.8 in the morning. The next day he stated he still feels bad.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Patient presented with bumps that are itchy similiar chicken pox. She is using lotion stop itching will contact her MD.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Rash vesicular, Varicella
Clinical narrative: Patient presented with bumps that are itchy similiar chicken pox. She is using lotion stop itching will contact her MD.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Hypersensitivity, Urticaria
Clinical narrative: Patient presented with bumps that are itchy similiar chicken pox. She is using lotion stop itching will contact her MD.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient presented with bumps that are itchy similiar chicken pox. She is using lotion stop itching will contact her MD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: She received the shot on 05/10/2018. She reported a stinging sensation that started on 05/13/2018 on her back. She came to the pharmacy on 05/15/2018 and asked me to look at the spots on her back and her stomach. I looked at the areas and it looked like shingles to me. I advised the patient to see her dr, and she did. Her dr agreed with me and said it was shingles. He started her on a steroid dose pack and valacyclovir.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site swelling, Swelling
Clinical narrative: Left side swelling and numbness from left elbow to top of head. Required hospitalization for  3 days.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient describes feeling as if all of her nerves were on fire from 8:30 that morning after breakfast until around dinner time (4-4:30pm).
Sex: U
Vaccine: FLU4
Symptoms: Anti-HLA antibody test positive, Kidney transplant rejection
Clinical narrative: This case was reported in a literature article and described the occurrence of kidney transplant rejection in a child subject who received Flu Seasonal QIV Dresden. The subject's past medical history included kidney transplant. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed kidney transplant rejection. Serious criteria included GSK medically significant. The outcome of kidney transplant rejection was unknown. It was unknown if the investigator considered the kidney transplant rejection to be related to Flu Seasonal QIV Dresden. Relevant Tests: Lab test performed on unspecified date, within 3 month post-vaccination, de novo donor specific anti-HLA antibodies (DSA). The DSA resolved prior to rejection. Additional information was provided. This case was reported in a literature and described the occurrence of kidney transplant rejection in paediatric patient of unspecified gender who was vaccinated with combined unspecified influenza vaccine (manufacturer unknown). The patient was a part of the single-centre retrospective analysis of paediatric kidney recipients to assessed the graft and patient outcomes stratified by whether the patients received the influenza vaccine from 1 January 2006 to 31 December 2015. The patient underwent kidney transplantation. No information on patient's family history or concurrent condition or concomitant vaccination was provided. On an unspecified date between 1 January 2006 and 31 December 2015, within one year post-transplant, the patient received unspecified influenza vaccine (administration site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, within 3 month post-vaccination, de novo donor specific anti-HLA antibodies (DSA). The DSA resolved. Subsequently, the patient had kidney transplant rejection. It was reported that, due to the timing of the vaccine, baseline was defined as one year post-transplant; those with events with in one year of transplant had an event time of zero. Treatment was unknown. The outcome of the event was not reported. The author stated, "In our cohort of paediatric kidney recipients, the influenza vaccine was safe; larger prospective studies are required to confirm that the vaccine is not associated with increased de novo DSA and rejection risk in paediatric kidney recipients."
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unexpected therapeutic effect in a adult patient who received SHINGRIX. Concurrent medical conditions included post herpetic neuralgia. 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 unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that, he heard that, the patient's postherpetic neuralgia (PHN) pain went away after receiving the SHINGRIX vaccine. The healthcare professional heard this from one of his patients, who heard it from their physician about one of the physician's patients. No additional details were available.
Age: 20.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Dizziness, Headache, Muscular weakness, Paraesthesia
Clinical narrative: Headaches, mild dizziness, mild weakness/tingling in both legs.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain in extremity
Clinical narrative: Morning of 5/19/18 (day after administration) patient had very sore arm, thought it was from exercising but it was 10x worse than that. Night of 5/19/18 patient developed chills and was very cold. She woke up morning after that and felt fine, just still had a sore arm. Still felt fine and had sore arm 5/21/18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Gave the SHINGRIX shot subcutaneously in error. Patient has experienced no ill effects thus far. Just wanted to notify of the dosing administration error.
Age: 12.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Alopecia, Alopecia areata, Blood test
Clinical narrative: Shortly after my daughter's last vaccine shots in December, she started losing her hair. It began with a round spot and started growing larger. Doctor diagnosed her with Alopecia Areata and prescribed some drops for her bald spot. It is now May and my daughter has very few strands of hair left.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Borrelia test negative, Computerised tomogram head normal, Computerised tomogram normal, Cystoscopy normal
Clinical narrative: I received a shot of FLUVIRIN TIV on 12/05/2006. Early the next morning I woke up with extreme dizziness. The room was going up and down and I had no balance at all. All I could do was vomit into a pan. This went on for 6 hours and was a very bad experience. During this time my wife called 911 and I was taken to the hospital where I continued vomiting while they took CAT scans of my head. I spent the night in the hospital. 3 weeks later I had the same dizziness and vomiting. This lasted about 4 hours. Following this I went for a number of tests. All tests came back negative. I have taken flu shots for 14 years. Starting now to feel better. Very thankful.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Laboratory test normal, Scan normal, Vomiting
Clinical narrative: I received a shot of FLUVIRIN TIV on 12/05/2006. Early the next morning I woke up with extreme dizziness. The room was going up and down and I had no balance at all. All I could do was vomit into a pan. This went on for 6 hours and was a very bad experience. During this time my wife called 911 and I was taken to the hospital where I continued vomiting while they took CAT scans of my head. I spent the night in the hospital. 3 weeks later I had the same dizziness and vomiting. This lasted about 4 hours. Following this I went for a number of tests. All tests came back negative. I have taken flu shots for 14 years. Starting now to feel better. Very thankful.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager who referred to 50 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as N009798, expiry date 19-FEB-2019 (exact dose and route of administration were not reported) for prophylaxis; and VARIVAX lot# N019840, expiry date 13-JUL-2019, lot# N023960, expiry date 01-SEP-2019, lot# N030407, expiry date 03-OCT-2019 (also reported as 30-OCT-2019) (exact dose and route of administration were not reported). Lot and expiration for properly stored sterile diluent was unknown. The doses of vaccine were stored between 15 degrees Fahrenheit (F) to 46 F (15F) for 2 hours. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. Lot number N009798 is an invalid lot number for PROQUAD. This case is non-valid due to lack of patient's identifiers. Follow up information has been received from a Licensed Practical Nurse on 22-MAY-2018 and confirmed that there were no vaccine adverse experience to report.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Erythema
Clinical narrative: This spontaneous report was received from a 77 year old male patient referring to himself. The patient's pertinent medical history included 8 back surgeries on unspecified dates and shingles when the patient was 36 year old. The patient had not drug reactions/allergies. His concomitant medications included oxycodone. In July 2017, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included sterile diluent(dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as "a couple of months later"), the patient's hands broke out with about 15-20 little pimples (acne) with red nuclei on each hand which were the size of 3 penny nail to pinheads. The patient stated that they lasted for about 2 - 3 weeks. The on an unspecified date, the pimples returned. No treatment was given for the events and no laboratory diagnostic/test was performed. At the time of reporting, the second episode of acne was reported as not recovered. The causality assessment between the events and the suspect therapies was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an officer manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 18-MAY-2018, the patient was vaccinated with a dose of improperly store Oka/Merck VARIVAX lot # N008829, expiration date 16-MAR-2019 for prophylaxis (strength, frequency and route of administration were not provided). Concomitant therapies included MRK STERILE DILUENT. The doses of varicella Oka/Merck VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F during a time frame of 12 minutes and 15°F to 46°F for 3 hours and 30 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Pharmacist, concerning an approximately 22 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2010, the patient was vaccinated with a dose of GARDASIL, for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The pharmacist reported that on an unknown date in 2014, the patient received another dose of GARDASIL. No adverse effects were reported and product quality complaint was involved.
Age: 22.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 22 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 22-MAY-2018, the patient was inadvertently vaccinated with one dose of Oka-Merck) PROQUAD for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 85-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was received via chat. The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced arm pain which limited activity for approximately 3 weeks following administration of the dose of SHINGRIX. The HCP did not have access to the lot number or expiration date of SHINGRIX or further patient details at the time of reporting.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site stinging in a 78-year-old male patient who received SHINGRIX. Concomitant products included Baby Aspirin, finasteride, naproxen, Tamsulosin and fish oil. On May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site stinging, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site stinging was unknown and the outcome of the injection site swelling and injection site erythema were not recovered/not resolved. The reporter considered the injection site stinging, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was wife of the patient. The patient received SHINGRIX in left arm. The patient experienced stinging at time of injection and then developed redness and swelling at injection site later that evening. The caller reported that the patient had red and swollen area that was approximately 3 inches in diameter around injection site. The reporter was unable to provided full demographics of prescriber or vaccine administration facility.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood uric acid normal, Chondrocalcinosis pyrophosphate, Condition aggravated, Gout
Clinical narrative: Pt received first dose of SHINGRIX vaccine 2/8/18, unclear how pt tolerated that dose. Second SHINGRIX shingles vaccine on May 2. He reports that following the administration of that vaccine, he developed joint pains that spread to all my joints. He states that the pain was mild at first, then increased over the following two days to the point where it was 10/10 at times. He reports most pain in shoulders and knees, though reports pain in hands, elbows, and ankles as well. He states that pain was so bad overnight that he could not sleep, prompting him to call 911. Pt diagnosed with gout and pseudogout flare, evidenced by warm, tender swollen knee. (L) knee was tapped and synovial fluid noted few intracellular CPPD crystals. Rare intra and extracellular monosodium urate crystals. Patient given prednisone 40mg x1, with improvement in symptoms the next morning. Acetaminophen 650 mg prn.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Joint swelling, Joint warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt received first dose of SHINGRIX vaccine 2/8/18, unclear how pt tolerated that dose. Second SHINGRIX shingles vaccine on May 2. He reports that following the administration of that vaccine, he developed joint pains that spread to all my joints. He states that the pain was mild at first, then increased over the following two days to the point where it was 10/10 at times. He reports most pain in shoulders and knees, though reports pain in hands, elbows, and ankles as well. He states that pain was so bad overnight that he could not sleep, prompting him to call 911. Pt diagnosed with gout and pseudogout flare, evidenced by warm, tender swollen knee. (L) knee was tapped and synovial fluid noted few intracellular CPPD crystals. Rare intra and extracellular monosodium urate crystals. Patient given prednisone 40mg x1, with improvement in symptoms the next morning. Acetaminophen 650 mg prn.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Synovial fluid crystal present
Clinical narrative: Pt received first dose of SHINGRIX vaccine 2/8/18, unclear how pt tolerated that dose. Second SHINGRIX shingles vaccine on May 2. He reports that following the administration of that vaccine, he developed joint pains that spread to all my joints. He states that the pain was mild at first, then increased over the following two days to the point where it was 10/10 at times. He reports most pain in shoulders and knees, though reports pain in hands, elbows, and ankles as well. He states that pain was so bad overnight that he could not sleep, prompting him to call 911. Pt diagnosed with gout and pseudogout flare, evidenced by warm, tender swollen knee. (L) knee was tapped and synovial fluid noted few intracellular CPPD crystals. Rare intra and extracellular monosodium urate crystals. Patient given prednisone 40mg x1, with improvement in symptoms the next morning. Acetaminophen 650 mg prn.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Throat irritation
Clinical narrative: While waiting in room patient began to report that she was having some itching to her throat and her body. BENADRYL provided with positive effect patient stayed in clinic and V/S rechecked 97.2 B/P 126/76 HR 70 RR 16 Spo2 100% on RA patient denied any more itching at this time. Patient instructed to seek medical attention if any further issues arise, patient verbalized understanding.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a male patient who received SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site discoloration. On an unknown date, the outcome of the injection site swelling and injection site discoloration were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling and injection discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The vaccination date was unknown. It was given at a pharmacy. The patient received SHINGRIX vaccine in upper arm but which arm was not specified. The physician reported that the patient experienced the symptoms shortly after receiving the 2nd dose and they were still present after 6 weeks. There was swelling with a brown undertone at the injection site. The healthcare professional told the representative that she had more information to provided in follow up but did not have the information with her at the reporting time.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. 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 pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist had made a comment in general that a lot of people complained about pain when they were getting vaccinated with SHINGRIX. The reporter had just made a general comment and did not have any specific patient information, just that most patients complained about pain at injection site after administration of SHINGRIX. The health care professional did not wish to be contacted for any follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site bruising, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2019). 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 extensive swelling of vaccinated limb, injection site bruising, injection site rash and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site bruising, injection site rash and injection site pain were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site bruising, injection site rash and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received a dose of SHINGRIX in the left deltoid. After receiving the vaccine, the patient experienced rash, bruising, pain and swelling about the size of her palm a couple inches below the injection site. These symptoms resolved after 3 days.
Age: 78.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Eye irritation, Lacrimation increased, Pruritus generalised
Clinical narrative: Pt's representative came by the pharmacy and claimed pt started itching all over, eyes irritated and runny after they received the two vaccines. Informed them to take Benadryl if they're planning to sleep and/or a non-drowsy antihistamine such as Claritin, Allegra or Zyrtec now and then Benadryl prior to sleep. Also informed them about possibility of allergy getting worse such as trouble breathing, etc to go to ER right away because they may need an epipen. Also informed them to speak to MD and annotated allergy on profile.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Nausea
Clinical narrative: Severe pain at injection site. Severe chills. Fatigue. Mild nausea.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site bruising
Clinical narrative: Patient presented to the clinic for a routine establish care appt. on 5/18/18. Patient was given VIS and signed consent for PNEUMOVAX vaccination. Location mapped out with two finger widths below left shoulder. Vaccination given without complaint from patient. Patient called on call provider approximately 4 hours later and stated that she could not move her left arm. Was informed to see PCP. Was seen on 5/21/18 and noted to have slight bruise at injection site and inability to freely move should region of arm. Patient informed that this was a reaction and to allow time. Patient presented to clinic for no relief of symptoms on 5/23/18. Patient continues to complain of pain and inability to freely move shoulder region of left arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Foster parent reported rash beginning in AM 5/23/18 to face, neck and knee area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Vomiting, chills, fever for ~24 hours.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Bacterial test positive, Pain, Pyrexia, Urinary tract infection
Clinical narrative: Fever and body aches. Treated in the ER at a different hospital. Diagnosed with "Adverse effect of vaccine, initial encounter" and "Urinary tract infection without hematuria". Was prescribed BACTRIM 800-160mg directions: take 1 tablet by mouth BID for 10 days.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody negative, Balance disorder, Body temperature increased, Borrelia test negative, C-reactive protein normal
Clinical narrative: 2-3 hours after vaccine, dizziness, stiff neck, tingling in face/upper lip, racing heart, nausea, off-balance, later (over the next 2-3 days), tingling in hands, dizziness/nausea, itchy rash on neck/chest, "brain fog" with difficulty concentrating, temp to 100F, motion sickness. The neck stiffness and hand tingling lasted 5 weeks. The dizziness/motion sickness and feeling nausea/dizzy when looking at phone/computer has continued longer but seems to be improving. She remains unable to work.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Differential white blood cell count normal, Disturbance in attention, Dizziness, Feeling abnormal, Full blood count normal
Clinical narrative: 2-3 hours after vaccine, dizziness, stiff neck, tingling in face/upper lip, racing heart, nausea, off-balance, later (over the next 2-3 days), tingling in hands, dizziness/nausea, itchy rash on neck/chest, "brain fog" with difficulty concentrating, temp to 100F, motion sickness. The neck stiffness and hand tingling lasted 5 weeks. The dizziness/motion sickness and feeling nausea/dizzy when looking at phone/computer has continued longer but seems to be improving. She remains unable to work.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Laboratory test normal, Motion sickness, Musculoskeletal stiffness, Nausea
Clinical narrative: 2-3 hours after vaccine, dizziness, stiff neck, tingling in face/upper lip, racing heart, nausea, off-balance, later (over the next 2-3 days), tingling in hands, dizziness/nausea, itchy rash on neck/chest, "brain fog" with difficulty concentrating, temp to 100F, motion sickness. The neck stiffness and hand tingling lasted 5 weeks. The dizziness/motion sickness and feeling nausea/dizzy when looking at phone/computer has continued longer but seems to be improving. She remains unable to work.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Palpitations, Paraesthesia, Paraesthesia oral, Rash
Clinical narrative: 2-3 hours after vaccine, dizziness, stiff neck, tingling in face/upper lip, racing heart, nausea, off-balance, later (over the next 2-3 days), tingling in hands, dizziness/nausea, itchy rash on neck/chest, "brain fog" with difficulty concentrating, temp to 100F, motion sickness. The neck stiffness and hand tingling lasted 5 weeks. The dizziness/motion sickness and feeling nausea/dizzy when looking at phone/computer has continued longer but seems to be improving. She remains unable to work.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic, Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: 2-3 hours after vaccine, dizziness, stiff neck, tingling in face/upper lip, racing heart, nausea, off-balance, later (over the next 2-3 days), tingling in hands, dizziness/nausea, itchy rash on neck/chest, "brain fog" with difficulty concentrating, temp to 100F, motion sickness. The neck stiffness and hand tingling lasted 5 weeks. The dizziness/motion sickness and feeling nausea/dizzy when looking at phone/computer has continued longer but seems to be improving. She remains unable to work.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 21-MAY-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 intramuscularly, lot # N014946 with expiration date: 01-FEB-2019 (strength, dose and anatomical location were not reported) for prophylaxis. No known adverse effects. No further information provided. The temperature excursion occurred between 47°F to 77°F with a time frame of 63 hours. The was not given by a data logger and no previous temperature excursion occurred.
Age: 14.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 15 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 16-MAR-2018, the patient was vaccinated with a dose of VARIVAX (lot # N014631, expiry date: 11-MAY-2019), and a dose of M-M-R II (lot # M015930, expiry date:29-MAR-2018) for prophylaxis. Then, on 17-APR-2018, the patient was vaccinated with a dose of PROQUAD (lot # N025718, expiry date: N025718), as well for prophylaxis (dose # and route of administration were unknown for all vaccines). Details regarding sterile diluent used for reconstitution were not provided. No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, patient was given adult dose of Hep A after already completing Pediatric Series.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Rash pruritic
Clinical narrative: 24 hours after the vaccination on 05/19 the patients back started itching. She went home and her husband looked at it and she had rash. The following day on 05/20 her rash spread to her abdomen and continued itching. She then went to urgent care where she was diagnosed with shingles and given prescriptions for shingles treatment.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Soreness in arm of vaccination,  nausea, aches, severe headache.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: 5/21/18 in the morning patient began to notice redness and a lump at injection site. The redness had spread on 5/22/18 so patient circled red area. On 5/23 the redness had definitely spread beyond previously noted area, patient had a slight fever and felt fatigued. Patient went to Urgent Care and was subsequently prescribed Cephalexin 500mg for a 7 day course.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raised red spot at injection site. Area is tender and warm to the touch.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Fatigue, Headache, Hypersomnia, Loss of consciousness
Clinical narrative: Patient stated that evening she felt fatigued and went to bed early. She said she slept much longer than she usually does ("slept for an entire day"). The next day she still felt malaise, nausea, and complained of a headache. Later that day, she tried to go out to eat, hoping that would make her feel better. The nausea continued with dry heaves. She even passed out at the restaurant and they had to call her a squad to transport her to the local ER. When there, the told her she was dehydrated and most likely experiencing adverse effects from the SHINGRIX vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Retching, Vaccination complication
Clinical narrative: Patient stated that evening she felt fatigued and went to bed early. She said she slept much longer than she usually does ("slept for an entire day"). The next day she still felt malaise, nausea, and complained of a headache. Later that day, she tried to go out to eat, hoping that would make her feel better. The nausea continued with dry heaves. She even passed out at the restaurant and they had to call her a squad to transport her to the local ER. When there, the told her she was dehydrated and most likely experiencing adverse effects from the SHINGRIX vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Influenza like illness, Nausea, Pain
Clinical narrative: Entire arm swollen up to neck, hurt to move, tingling and sensitive to touch, headache, nausea and flu like symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Entire arm swollen up to neck, hurt to move, tingling and sensitive to touch, headache, nausea and flu like symptoms.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on arms, legs, buttocks and one breast that was present for 4 days and is now clearing.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Ear pain, Myalgia, Pyrexia
Clinical narrative: Extreme weakness; painful earache; chills, fever, muscle pain?? never been so sick in all my life.
Age: 1.5
Sex: F
Vaccine: HIBV, MMR, VARZOS
Symptoms: Product preparation error
Clinical narrative: Sterile diluent used for sub q vaccine and conjugate compound 135 liquid men cyw used for sub q vaccine. not sure which diluent was used with what sub q vaccine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site pain, Paraesthesia, Wrong technique in product usage process
Clinical narrative: ON 5/14/2018, MONDAY, PATIENT RECEIVED AT PREVNAR 13 INOCULATION FROM PHARMACIST IN THE UPPER LEFT ARM IM.  PATIENT EXPRESS SOME "TINGLING" DOWN THAT ARM AS SHOT WAS BEING GIVEN. PHARMACIST WITHDREW THE NEEDLE AND GAVE REMAINDER OF THE VACCINE IN A DIFFERENT SITE ON THE SAME ARM.  PATIENT HAD NO ACKNOWLEDGED DISCOMFORT AT THAT SITE, BUT DID EXPRESS SORENESS AT THE FIRST SITE. PHARMACIST SAW NO INJURY, HAD PATIENT ROTATE ARM, AND ASK THAT SHE REMAIN AT THE STORE, SEATED, FOR A FEW MINUTES TO BE SURE THERE WERE TO FURTHER DEVELOPMENTS. PATIENT DID SIT DOWN, BUT LEFT BEFORE THE PHARMACIST COULD CHECK HER ARM AGAIN, ABOUT 5 MINUTES. PATIENT CAME INTO DRUG STORE AGAIN ON 5/23/2018 COMPLAINING OF DISCOMFORT, SORENESS, AND SOME PAIN IN THE SHOULDER WHERE THE SHOT WAS GIVEN.  NO LESIONS, SWELLING, OR BUMPS WERE PRESENT UNPON PHARMACIST VIEWING. PHARMACIST SENT HER TO HER FAMILY PROACTIVE PROVIDER AT ONCE.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness
Clinical narrative: Flu-like symptoms within 24 hours lasting 4 days and numbness starting 48 hours post immunization last 8 days.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: She said she had redness, swelling and itching. Site of injection spread to half dollar size.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She said she had redness, swelling and itching. Site of injection spread to half dollar size.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness
Clinical narrative: Flu-like symptoms starting same day last 4 days or so, numbness also starting same day and lasting up to 8 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Patient stated she got a rash. She did seek medical attention and the thought was chicken pox. She is following up with other Drs. to get more information and for treatment.