chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: a bruise on his left arm / of the bruise and she described it as pretty large; This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   On 31st July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced bruising of arm. On an unknown date, the outcome of the bruising of arm was not recovered/not resolved.   It was unknown if the reporter considered the bruising of arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had bruise on his left arm where he received the Shingrix vaccination.   The patient could not lift his shirt for the pharmacist to see the entire bruise, however, she saw the bottom half of the bruise and she described it as pretty large in size. The reporter consented to follow up. The reporter could follow up with the Pharmacist directly.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Facial Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced facial swelling (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with Shingrix, the patient had  facial swelling and even required admission to in Hospital. The patient had to administered steroid at the hospital. At the time of reporting, the patient came in wanting a second dose and they had it drawn up. No difficulty breathing reported. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: fever as high as 102.2F; rash on the cheeks; This case was reported by a nurse via call center representative and described the occurrence of fever in a 18-month-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date).   On 3rd August 2020, the patient received Havrix. In August 2020, 48 hrs after receiving Havrix, the patient experienced fever and rash. On an unknown date, the outcome of the fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the fever and rash to be related to Havrix.  Additional details were provided as follows: After receiving booster dose Havrix, the patient experienced fever as high as 102.2 degree F and it continued. The patient also had rash on the cheeks. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Immediate post-injection reaction, Rash, Sepsis
Clinical narrative: Cellulitis; Sepsis; Rash / Severe Rash at the Collarbone; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number, expiry date unknown) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On 26th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant) and sepsis (serious criteria hospitalization and GSK medically significant). On 26th July 2020, the patient experienced rash. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, sepsis and rash were unknown.   It was unknown if the reporter considered the cellulitis, sepsis and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's daughter. The patient was immunocompromised with lupus. The patient immediately developed rash. The rash improved over the days but this Monday it get worse again, more severe along the collarbone area.  On day of reporting, the patient was diagnosed with cellulitis and sepsis and she was hospitalized. The patient was administered with antibiotics by intravenous route. The reporter did not have the lot number and expiration date of the vaccine. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Dizziness, Hip fracture, Hip surgery, Hypotension
Clinical narrative: Had broken Hip on 4/24/20 - SurgERy to REpair. FiRst symptom occuRed on 5/4/20; Left side of tongue swells. Called MD - advised to take Benadryl 50 mg. Relief in 24 hRs. Second tongue swelling a week LAter. Again Benadryl taken. All this time extReme feeling of hot inside mouth, Like Hot Sauce. Using mouth wash - No help - Lips start to have "blisteRs" on inside of mouth - See MD - Blood work shows nothing. Another episode go to ER - told might hAve allergy to BP Medication (LOSARtoN) unconfirmed after stopping this Med. As of this date still experience some Heat - tongue And Lips doing Much better. QuestioN: Will this go away in a timely FashioN? Is there An Antidote? HAve there been other people Reporting this condition? Conclusion: After exam by primary physician, allergist, dentist, + ER doctor. Lab results - etc all negative! I researched side effects and found "SEVER" side effects: This is what happened to me - low blood pressure, hives (in mouth), lightheadedness, swelling of face, lips, tongue +, among others (weight loss)  I hope this report is of help in finding cause in my cause.  Condition has been ongoing for over 3 months now. Some progress is being made as frequency of events have lessened greatly with burning in mouth not as severe. Using pharmacy prepared mouth wash when needed.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Oral discomfort, Oral mucosal blistering, Swelling face, Swollen tongue
Clinical narrative: Had broken Hip on 4/24/20 - SurgERy to REpair. FiRst symptom occuRed on 5/4/20; Left side of tongue swells. Called MD - advised to take Benadryl 50 mg. Relief in 24 hRs. Second tongue swelling a week LAter. Again Benadryl taken. All this time extReme feeling of hot inside mouth, Like Hot Sauce. Using mouth wash - No help - Lips start to have "blisteRs" on inside of mouth - See MD - Blood work shows nothing. Another episode go to ER - told might hAve allergy to BP Medication (LOSARtoN) unconfirmed after stopping this Med. As of this date still experience some Heat - tongue And Lips doing Much better. QuestioN: Will this go away in a timely FashioN? Is there An Antidote? HAve there been other people Reporting this condition? Conclusion: After exam by primary physician, allergist, dentist, + ER doctor. Lab results - etc all negative! I researched side effects and found "SEVER" side effects: This is what happened to me - low blood pressure, hives (in mouth), lightheadedness, swelling of face, lips, tongue +, among others (weight loss)  I hope this report is of help in finding cause in my cause.  Condition has been ongoing for over 3 months now. Some progress is being made as frequency of events have lessened greatly with burning in mouth not as severe. Using pharmacy prepared mouth wash when needed.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Weight decreased
Clinical narrative: Had broken Hip on 4/24/20 - SurgERy to REpair. FiRst symptom occuRed on 5/4/20; Left side of tongue swells. Called MD - advised to take Benadryl 50 mg. Relief in 24 hRs. Second tongue swelling a week LAter. Again Benadryl taken. All this time extReme feeling of hot inside mouth, Like Hot Sauce. Using mouth wash - No help - Lips start to have "blisteRs" on inside of mouth - See MD - Blood work shows nothing. Another episode go to ER - told might hAve allergy to BP Medication (LOSARtoN) unconfirmed after stopping this Med. As of this date still experience some Heat - tongue And Lips doing Much better. QuestioN: Will this go away in a timely FashioN? Is there An Antidote? HAve there been other people Reporting this condition? Conclusion: After exam by primary physician, allergist, dentist, + ER doctor. Lab results - etc all negative! I researched side effects and found "SEVER" side effects: This is what happened to me - low blood pressure, hives (in mouth), lightheadedness, swelling of face, lips, tongue +, among others (weight loss)  I hope this report is of help in finding cause in my cause.  Condition has been ongoing for over 3 months now. Some progress is being made as frequency of events have lessened greatly with burning in mouth not as severe. Using pharmacy prepared mouth wash when needed.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient is an 82-year-old male who came to clinic on 1/9/20 for Shingrix vaccine. Vaccine given at approximately 1030. Later that day, patient returned to clinic c/o left arm and deltoid pain after Shingrix shot starting at approximately 1400. Patient unable to elevate arm and rated pain 9/10. MD prescribed ibuprofen 600 mg BID with food and hydrocodone/APAP 7.5/325 mg PO TID PRN for pain. clinic called patient on 1/10/20 to f/u; wife stated that pain had improved with increased movement of left arm. F/u'd again on 1/13/20; wife stated that patient able to drive. Final f/u 1/21/20; wife stated that patient is back to baseline before receiving Shingrix vaccine.  Myalgia IBUPROFEN 1 TAB BID WITH FOOD ,ACETAMINOPHEN/HYDROCODONE 1 TAB TID PRN FOR PAIN
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Lymph node pain
Clinical narrative: Patient has rash from injection site down to elbow and lymph node on that side is tender.
Age: 37.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient was to receive Pneumovax-23. Received PCV-13 in error
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Feeling hot
Clinical narrative: I woke in the middle of the night to pain all over my body, from the top of my head to the bottom of my feet. My joints and muscles hurt. Severe pain in back, neck and hips. Major headache. Then I started having chills and took some ibuprofen at around 6:45 am then I broke out in a sweat and felt like I was in fire. I?m very tired and fluctuating between hot and cold. Also have pain at site of shot, but no worse than with flu shot. I also seemed to be having a little bit of rapid heartbeat earlier.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Headache, Heart rate increased, Hyperhidrosis, Injection site pain
Clinical narrative: I woke in the middle of the night to pain all over my body, from the top of my head to the bottom of my feet. My joints and muscles hurt. Severe pain in back, neck and hips. Major headache. Then I started having chills and took some ibuprofen at around 6:45 am then I broke out in a sweat and felt like I was in fire. I?m very tired and fluctuating between hot and cold. Also have pain at site of shot, but no worse than with flu shot. I also seemed to be having a little bit of rapid heartbeat earlier.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Neck pain, Pain
Clinical narrative: I woke in the middle of the night to pain all over my body, from the top of my head to the bottom of my feet. My joints and muscles hurt. Severe pain in back, neck and hips. Major headache. Then I started having chills and took some ibuprofen at around 6:45 am then I broke out in a sweat and felt like I was in fire. I?m very tired and fluctuating between hot and cold. Also have pain at site of shot, but no worse than with flu shot. I also seemed to be having a little bit of rapid heartbeat earlier.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling hot, Headache, Insomnia
Clinical narrative: I received shingles shot at 9:30 am on August 6 ,2020. At 9:00 pm I experienced blurryness and dizzyness and the chills. I went to bed at 9:30 pm. I had a headache and a neckache. about 12:30 am I got thirsty and needed to go to the bathroom. When I got up I was dizzy and had to hold on to things to get to the bathroom and the kitchen for a drink. As I laid back down on the bed, it felt like the bed was on fire. My fingers got stiff and I could hardly move for a while. I didn't sleep much and was concidering calling 911 or my family , as I live alone. I got awake at 3 am to go to the bathroom again. I was still somewhat dizzy and still had headache and neckache. I fell asleep and was awake at 6:30. to go to the bathroom again. I went back to bed and was up at 7:30. It was a horrible night.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Thirst, Vision blurred
Clinical narrative: I received shingles shot at 9:30 am on August 6 ,2020. At 9:00 pm I experienced blurryness and dizzyness and the chills. I went to bed at 9:30 pm. I had a headache and a neckache. about 12:30 am I got thirsty and needed to go to the bathroom. When I got up I was dizzy and had to hold on to things to get to the bathroom and the kitchen for a drink. As I laid back down on the bed, it felt like the bed was on fire. My fingers got stiff and I could hardly move for a while. I didn't sleep much and was concidering calling 911 or my family , as I live alone. I got awake at 3 am to go to the bathroom again. I was still somewhat dizzy and still had headache and neckache. I fell asleep and was awake at 6:30. to go to the bathroom again. I went back to bed and was up at 7:30. It was a horrible night.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Eye pain, Malaise, Movement disorder, Tremor
Clinical narrative: 7/7/20 mom called questioning a possible vaccine reaction  She reports patient up around 535am complaining of not feeling well. Took motrin, showered. While in shower yelled to mom  "I can't move" was on shower seat with legs straightout then eyes open & unresponsive x 3 seconds per mom. Mom noted slight tremor in patient hand. She assisted  patient back to bed. Patient felt chilled.  Mom says no seizure history. Did faint once years ago.  At noon patient reported eye pain. By 1pm no symptoms &  patient was out with friends. Mom declined in office/virtual/telephone visit after encouragement from triage nurse.  (see patient chart phone notes 7/7/20 & 8/16/2020)
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Unresponsive to stimuli
Clinical narrative: 7/7/20 mom called questioning a possible vaccine reaction  She reports patient up around 535am complaining of not feeling well. Took motrin, showered. While in shower yelled to mom  "I can't move" was on shower seat with legs straightout then eyes open & unresponsive x 3 seconds per mom. Mom noted slight tremor in patient hand. She assisted  patient back to bed. Patient felt chilled.  Mom says no seizure history. Did faint once years ago.  At noon patient reported eye pain. By 1pm no symptoms &  patient was out with friends. Mom declined in office/virtual/telephone visit after encouragement from triage nurse.  (see patient chart phone notes 7/7/20 & 8/16/2020)
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever - 102, vomiting, nausea, loss of appetite
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Oral mucosal eruption, Pyrexia, Rash, Rash pruritic
Clinical narrative: fever, rash on abdomen, back around mouth, including hands and feet. Rash is pruritic, watery stool
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms or additional adverse effects; patient recevied unspecifed dose in Gardasil 9 immunization series was administered after being improperly stored; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 02-JUN-2020, the patient was vaccinated with a improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1614898, expiration date reported as 14-NOV-2021, but upon internal validation established as 15-NOV-2021 for prophylaxis (exact dose, dose #, route of administration and anatomical location were not provided). The temperature excursion was 28.8 degrees Fahrenheit (F) for 5 minutes. There were no previous excursions reported. The digital data logger was involved. No symptoms or additional adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported; patient received a second dose of GARDASIL9 earlier than the dosing regimen indicated in PI; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 01-JUL-2020, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly (dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 30-JUL-2020 (reported as earlier than the dosing regimen indicated in package insert (PI)), the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot # S028737 and expiration date 03-APR-2022 (dose and anatomical location were not reported) for prophylaxis. No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: did not feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell. In August 2020, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details: Age at vaccination was not reported but patient could be 57 or 58 years of age at the time of vaccination. The patient received the second dose of Shingrix and she did not feel well for 24 hours and then the side effect resolved. The reporter consented to follow up. This case was linked with case US2020156565 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156565:same reporter
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: local redness after injection, pain, and swelling; local redness after injection, pain, and swelling; local redness after injection, pain, and swelling; area was hot to touch; This is a spontaneous report from a contactable nurse.  An elderly (reported as over 65-years-old) female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date after the vaccination, the patient experienced local redness after injection, pain, and swelling, and area was hot to touch.  The clinical outcomes of local redness after injection, pain, and swelling, and area was hot to touch were unknown.    No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Feeling hot, Headache, Hypersomnia
Clinical narrative: Headache; Chills; Lethargic; Almost sleeping for 24 hours because he was so tired; Almost sleeping for 24 hours because he was so tired; He was warm; Rash in the chest area; This is a spontaneous report from contactable healthcare professional via a Pfizer Vaccine Sales Representative. A 17-year-old male patient received first dose of meningococcal group b rlp2086 (TRUMENBA), intramuscular on 04Aug2020 at 0.5 mL for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received Flu and tDap vaccines and the patient did develop other reactions to the Flu and tDap vaccines that they have documented, it was noted in his file from when he was 11 years old. It was reported that patient got the meningococcal group b rlp2086 vaccine on 04Aug2020 and he developed side effects within the hour, patient had a headache, chills, was lethargic, he was almost sleeping for 24 hours because he was so tired, he was warm, but had no fever. They just talked the mom who was going ballistic. A lot of the side effects have gone down, but he has since developed a rash in the chest area in Aug2020. He is coming back to the office to follow up on the side effects and the rash he developed. The patient's mother was going ballistic and did not hear the fact that they were trying to rule out Covid because the family just got back from a state. The reporter said that had they known that, they would not have given the patient the vaccine and would have waited 14 days before allowing him to come back to the office. The patient is stable, but except for the side effect of the rash. The outcome of the event rash in the chest area was not recovered while the outcome of the other events was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Lethargy, Rash
Clinical narrative: Headache; Chills; Lethargic; Almost sleeping for 24 hours because he was so tired; Almost sleeping for 24 hours because he was so tired; He was warm; Rash in the chest area; This is a spontaneous report from contactable healthcare professional via a Pfizer Vaccine Sales Representative. A 17-year-old male patient received first dose of meningococcal group b rlp2086 (TRUMENBA), intramuscular on 04Aug2020 at 0.5 mL for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received Flu and tDap vaccines and the patient did develop other reactions to the Flu and tDap vaccines that they have documented, it was noted in his file from when he was 11 years old. It was reported that patient got the meningococcal group b rlp2086 vaccine on 04Aug2020 and he developed side effects within the hour, patient had a headache, chills, was lethargic, he was almost sleeping for 24 hours because he was so tired, he was warm, but had no fever. They just talked the mom who was going ballistic. A lot of the side effects have gone down, but he has since developed a rash in the chest area in Aug2020. He is coming back to the office to follow up on the side effects and the rash he developed. The patient's mother was going ballistic and did not hear the fact that they were trying to rule out Covid because the family just got back from a state. The reporter said that had they known that, they would not have given the patient the vaccine and would have waited 14 days before allowing him to come back to the office. The patient is stable, but except for the side effect of the rash. The outcome of the event rash in the chest area was not recovered while the outcome of the other events was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 0.17
Sex: M
Vaccine: DTAP, PNC13, UNK, UNK, UNK
Symptoms: Blood test, Pyrexia, Transfusion, Ultrasound abdomen, Vomiting
Clinical narrative: Vomiting; Fever; This is spontaneous report from a contactable consumer. A 11-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on 15Nov2019 at single dose, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid (DTAP) on 15Nov2019 at unknown dose, hepatitis b vaccine on 30Aug2019 at unknown dose, hib vaccine on 15Nov2019 at unknown dose, polio vaccine inact (IPV VACCINE) on 15Nov2019 at unknown dose, rotavirus vaccine (ROTAVIRUS PENTAVALENT) on 15Nov2019 at unknown dose; all via an unspecified route of administration for immunization. Medical history included having feeding tube. Concomitant medications were none. The patient had vomiting. Due to the vaccines he had fever. He did not had any conditions before the vaccines, he was healthy. The patient underwent lab tests and procedures which included X rays, blood transfusions, abdominal ultrasounds, blood test. They had extracted his blood and ran for normal test and the reporter was still trying to receive the medical reports for the blood test. Outcome of the events was unknown. The lot number has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, PNC13, UNK, UNK, UNK
Symptoms: X-ray
Clinical narrative: Vomiting; Fever; This is spontaneous report from a contactable consumer. A 11-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on 15Nov2019 at single dose, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid (DTAP) on 15Nov2019 at unknown dose, hepatitis b vaccine on 30Aug2019 at unknown dose, hib vaccine on 15Nov2019 at unknown dose, polio vaccine inact (IPV VACCINE) on 15Nov2019 at unknown dose, rotavirus vaccine (ROTAVIRUS PENTAVALENT) on 15Nov2019 at unknown dose; all via an unspecified route of administration for immunization. Medical history included having feeding tube. Concomitant medications were none. The patient had vomiting. Due to the vaccines he had fever. He did not had any conditions before the vaccines, he was healthy. The patient underwent lab tests and procedures which included X rays, blood transfusions, abdominal ultrasounds, blood test. They had extracted his blood and ran for normal test and the reporter was still trying to receive the medical reports for the blood test. Outcome of the events was unknown. The lot number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Impaired work ability
Clinical narrative: unable to work due to health issues; This is a spontaneous report from a Pfizer-sponsored program from a contactable other HCP.  A 79-years-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot#: 4908000), on 07Aug2020 at single dose for immunisation.  The patient medical history and the concomitant medications were not reported. The patient was unable to work due to health issues. The outcome was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: had a swollen, red reaction at injection site; had a swollen, red reaction at injection site; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. This Physician reported for similar events for three patients. This is 1st of three reports. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. Patient had a swollen, red reaction at injection site on an unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020307304 Same reporter/drug, different patient;US-PFIZER INC-2020307303 Same reporter/drug, different patient
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: had a swollen, red reaction at injection site; had a swollen, red reaction at injection site; This is a spontaneous report from a contactable Physician via Pfizer Sales Representative. This Physician reported similar events for 3 patients. This is 2nd of 3 reports.   An unknown age and gender patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecific date at single dose for immunization. Medical history and concomitant drug were not reported. it was reported that patient experienced swollen, red reaction at injection site. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020307227 Same reporter/drug, different patient;US-PFIZER INC-2020307304 Same reporter/drug, different patient
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: had a swollen, red reaction at injection site; had a swollen, red reaction at injection site; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. This physician reported same events for 3 patients. This is 3rd of 3 reports. A patient of an unknown age and gender received meningococcal group b rlp2086 (TRUMENBA) at single dose via an unknown route for immunisation. Medical history and concomitant drug were not provided.  The 3 patients had a swollen, red reaction at injection site. The events took place after use of product. Outcome of the events was unknown.   No follow-up attempts needed, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020307303 Same reporter/drug, different patient;US-PFIZER INC-2020307227 Same reporter/drug, different patient
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Mother stated 5 hours after vaccines were given pt was fussy along with swelling and redness (L) thigh where injection was given. Mother used cool compresses & Tylenol with symptoms resolving
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site rash, Irritability
Clinical narrative: Mom saw rash at site of vaccine inj. in morning after given. Dad saw rash spread in afternoon and baby cranky. No other S or S.  Dad advised by provider to give Benadryl & to watch for signs of further allergic rxn.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Discomfort, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: 8/9/2020 - Severe pain in right neck, shoulder and upper back area to the point where I could barely turn my head to the left. Pain awakened me at 6:00am and severe discomfort lasted all day. Took both Tylenol 500mg and naproxen 8/10/20 - Less severe pain in left neck, shoulder and upper back area; improved ability to turn my head to the left       8/11/20 - increased mobility, but still have residual pain
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reports pain, swelling and redness at the injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: swelling, red streak, pain at injection site and surrounding area.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site erythema, Nausea
Clinical narrative: a sore L arm with moderate pain after, started 11pm on day of vaccine and is still occuring.  Took ibuprofen at 11:30pm on 8/11.  redness and swelling at the site of vaccination, , started 11pm on day of vaccine and is still occuring.  Took ibuprofen at 11:30pm on 8/11. Starting 8/12 at 7:30 am:   headache, nausua, shivering, fever, stomach pain  and is still occuring.,  Took two tums.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: a sore L arm with moderate pain after, started 11pm on day of vaccine and is still occuring.  Took ibuprofen at 11:30pm on 8/11.  redness and swelling at the site of vaccination, , started 11pm on day of vaccine and is still occuring.  Took ibuprofen at 11:30pm on 8/11. Starting 8/12 at 7:30 am:   headache, nausua, shivering, fever, stomach pain  and is still occuring.,  Took two tums.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash vesicular
Clinical narrative: On 5/18/2020 developed small red spots around injection site. On 5/19/2020 developed varicella like rash per MD. MD at time did not feel it needed to be reported. Today mom requests.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory, Hypoacusis
Clinical narrative: Bilateral sensorineural hearin loss; Decreased hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 30-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered acute hearing loss bilaterally. Pt was diagnosed with bilateral sensorineural hearing loss (deafness neurosensory) and decreased hearing (hypoacusis). It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, deafness neurosensory was considered medically significant.
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: nurse reporting that patient had vomited after administration of ROTATEQ; This spontaneous report was received from a registered nurse, referring to an infant male patient of unknown age. The nurse was unaware of any patient's medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications.   On 04-AUG-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered (dosage, vaccination scheme, frequency, lot number and expiration date were unknown by the reporter) as prevention of rotavirus gastroenteritis. Immediately after the administration of the vaccine the patient vomited 4 times. In addition, the nurse reported that the infant had been drinking formula prior the vaccination and that, this was a "well child checkup" for an infant. There were no laboratory diagnostic studies performed. No other adverse events were reported in the patient.   The outcome of the event vomiting was reported as recovered. The causal relationship between the aforementioned event and therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date, on or before 07-FEB-2013 and on or before 25-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 18-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Temperature excursion due to Adacel left out side and exposed to 70 Fahrenheit for 6 hours/No AE; Temperature excursion due to Adacel left out side and exposed to 70 Fahrenheit for 6 hours. Stability data not reported in source document and there is no vaccine administered hence case considered as non case.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccine was given IM instead of Subcutaneously. No other adverse reactions noted.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given IM instead of SQ
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: very sore arm (much worse than flu shot) body aches very tired mild fever (99 degrees F)
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Injection site pain, Injection site reaction
Clinical narrative: Painful left arm at site of injection at depth muscle and bone for 4+ months.  I?m concerned about bone infection because injection might have been too deep.
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not have any reactions noted in the clinic. I administered a Tdap and a Quadracel (DTAP&IPV), because his sibling was getting 4 yr old vaccines today as well and I just grabbed the wrong immunization to give him. resulting in an extra dose of Dtap
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain of skin, Peripheral swelling, Skin warm
Clinical narrative: a few hours after shot, arm startd to swell, warm to touch, tender. continues to spread downwards toward elbow
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Vaccines were given at a different facility. Pt mother noted rash on her arms.
Age: 1.42
Sex: M
Vaccine: PNC13
Symptoms: Crying, Decreased activity, Fatigue, Gait disturbance, Injection site swelling
Clinical narrative: Mom reports yesterday after shot at home patient was tired and was not active like before and did not want to walk. Mom tried to move him while he was laying in bed last night and he cried out in pain. Patient was also "hot." Mom gave Motrin at 12am and temp went away. Patient is walking now and is limping and not running. Mom reports the right leg is affected, it is a little swollen, no redness, no bruising.  RN advised mom to use cool compress on area and watch for fevers or any worsening signs and symptoms.
Age: 1.42
Sex: M
Vaccine: PNC13
Symptoms: Pain, Skin warm
Clinical narrative: Mom reports yesterday after shot at home patient was tired and was not active like before and did not want to walk. Mom tried to move him while he was laying in bed last night and he cried out in pain. Patient was also "hot." Mom gave Motrin at 12am and temp went away. Patient is walking now and is limping and not running. Mom reports the right leg is affected, it is a little swollen, no redness, no bruising.  RN advised mom to use cool compress on area and watch for fevers or any worsening signs and symptoms.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Face injury, Fall, Syncope, Traumatic tooth displacement
Clinical narrative: Syncope, fell face first, displaced 4 front teeth and possibly jaw
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Disorientation, Dizziness, Fall, Fundoscopy normal, Head injury
Clinical narrative: VASOVAGAL SYNCOPE:  After receiving HPV9 vaccine, family was advised to wait 15-20 min.  Patient and his Gfa did NOT wait and proceded to check out.  At that time, patient became dizzy and fainted.  Gfather could not catch him and he hit his head on the wall at check out.  Per staff who witnessed his fall, he was immediately conscious tho sl disoriented.  After about 10 min he was able to stand and was assisted to room#2 where he was placed supine on the exam table.  Examined by NP.  HR 80, RR 28, BP 112/68, SaO2 98%.  Lungs clear.  HR steady. Abrasion to left forehead--c/o pain with palpation.  Mild swelling.  Ice pack applied.  Abrasion to left lower outer orbit.  Fundascopic bilat WNL.  Palpation to left orbit - denied pain.  EOM equal.  PEARLA.  Patient  reported nothing to eat since about 7a this morning (poptart).  No lunch.  After resting about 10 minutes, was able to sit up without dizziness.  Given 2 oz coke.  Tol well.  Denies HA with exception of where abrasions are.  Tylenol 15 ml given po.  Was able to stand without dizziness.  Gfa instructed to monitor for next 6 hours, rousing every 1-2 hours if he naps.  Incr pain, vomiting, change in LOC, or concerns--to call on-call number or go to ER for eval.  Gfa agreed.  Was able to walk unassisted to vehicle and denied ongoing dizziness
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Skin abrasion, Swelling, Syncope, Tenderness
Clinical narrative: VASOVAGAL SYNCOPE:  After receiving HPV9 vaccine, family was advised to wait 15-20 min.  Patient and his Gfa did NOT wait and proceded to check out.  At that time, patient became dizzy and fainted.  Gfather could not catch him and he hit his head on the wall at check out.  Per staff who witnessed his fall, he was immediately conscious tho sl disoriented.  After about 10 min he was able to stand and was assisted to room#2 where he was placed supine on the exam table.  Examined by NP.  HR 80, RR 28, BP 112/68, SaO2 98%.  Lungs clear.  HR steady. Abrasion to left forehead--c/o pain with palpation.  Mild swelling.  Ice pack applied.  Abrasion to left lower outer orbit.  Fundascopic bilat WNL.  Palpation to left orbit - denied pain.  EOM equal.  PEARLA.  Patient  reported nothing to eat since about 7a this morning (poptart).  No lunch.  After resting about 10 minutes, was able to sit up without dizziness.  Given 2 oz coke.  Tol well.  Denies HA with exception of where abrasions are.  Tylenol 15 ml given po.  Was able to stand without dizziness.  Gfa instructed to monitor for next 6 hours, rousing every 1-2 hours if he naps.  Incr pain, vomiting, change in LOC, or concerns--to call on-call number or go to ER for eval.  Gfa agreed.  Was able to walk unassisted to vehicle and denied ongoing dizziness
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt states he received first shingrix vaccine last fall without incident. Upon returning for his second vaccine on June 8th he immediately/next day had a 'nasty' case of the shingles. He was informed by his doctor that the pharmacy had given him a live vaccine causing a severe case of shingles and that the pharmacy and/or manufacturer should be help responsible for him developing a severe 2month shingles outbreak.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient reported nausea, vomiting, and diarrhea after receiving viccination.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Began to have a rash on his chest on 07/29/20.  Now, 2 week , mother states the rash is on his face, shoulders, chest, and back.  No pain or redness @ either vaccination injection sites.  DH asked mother to refer to primary provider for evaluation of the rash.