chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Blood pressure increased, Dry mouth, Eye pain, Headache, Injection site pain
Clinical narrative: Site pain which was usual for me ever year taking a flu shot; but then headache behind the eyes and left side of the head and nausea not usual. Continued for the day of the injection then sleep. Woke in the middle of the night with higher than usual blood pressure for me: 155/79 with a 92 pulse. No fever.  Called nurse line at insurance and took Tylenol which helped.  The next day when Tylenol wore off headache returned with nausea, dry mouth some body aches. Contacted my PCP who said the symptoms may last into tomorrow and I will report back to him. I am reporting because this is the first time a vaccine has disrupted my routine at all, and not my first time taking  the over 65 dose. I hope my reporting may be helpful even though it did not cause an emergency.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Middle insomnia, Nausea, Pain
Clinical narrative: Site pain which was usual for me ever year taking a flu shot; but then headache behind the eyes and left side of the head and nausea not usual. Continued for the day of the injection then sleep. Woke in the middle of the night with higher than usual blood pressure for me: 155/79 with a 92 pulse. No fever.  Called nurse line at insurance and took Tylenol which helped.  The next day when Tylenol wore off headache returned with nausea, dry mouth some body aches. Contacted my PCP who said the symptoms may last into tomorrow and I will report back to him. I am reporting because this is the first time a vaccine has disrupted my routine at all, and not my first time taking  the over 65 dose. I hope my reporting may be helpful even though it did not cause an emergency.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pt developed redness/soreness/swelling to left deltoid on 9/5/20.  Pt c/o hard lump at injection sites.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injected limb mobility decreased, Injection site bruising, Injection site erythema
Clinical narrative: Close to twenty four hours post vaccination, I began to have severe swelling, redness and heat at the injection site. Fever and body aches. I felt as though I actively had the flu. Very weak and sore. This lasted for 3 days and got so severe I was unable to even move my arm. I began to have relief Sunday 9/6/2020. Today ( 9/8/2020) it is bruised still and has a small mass right at the injection site. I feel back to normal today. I felt i should report this for the purpose I don't think the vaccination was studied in people who have actually had shingles and at my age as well. I have had shingles 11 times from the age if 18-30.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Close to twenty four hours post vaccination, I began to have severe swelling, redness and heat at the injection site. Fever and body aches. I felt as though I actively had the flu. Very weak and sore. This lasted for 3 days and got so severe I was unable to even move my arm. I began to have relief Sunday 9/6/2020. Today ( 9/8/2020) it is bruised still and has a small mass right at the injection site. I feel back to normal today. I felt i should report this for the purpose I don't think the vaccination was studied in people who have actually had shingles and at my age as well. I have had shingles 11 times from the age if 18-30.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Swelling/redness to the left thigh and right arm s/p vaccines. Area of redness on left thigh approx. size of tennis ball. Pt started vomiting 1 day after vaccines.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Crying, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Can't bring arm away from her body / can't get dressed; Arm was painful / Crying in pain / Pounding pain; Crying in pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and crying. On 31st August 2020, the patient experienced mobility decreased. The patient was treated with ibuprofen (Advil) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the pain in arm, crying and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, crying and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and arm was painful and after a few hours she was crying in pain.  It remained painful throughout the day and when she went to sleep then there was pounding pain.  The patient took Asprin and Advil but had a horrible night.  The patient arm was very painful, but she slept better.  The patient can lift arm, but she cannot bring arm away from her body and cannot get dressed. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Immunoglobulin therapy, Non-Hodgkin's lymphoma
Clinical narrative: Non-Hodkin Lymphoma; This case was reported by a other health professional via call center representative and described the occurrence of non-hodgkin's lymphoma in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced non-hodgkin's lymphoma (serious criteria GSK medically significant). The patient was treated with infliximab (Remicade), immunoglobulins nos (Ivig) and prednisone. On an unknown date, the outcome of the non-hodgkin's lymphoma was not recovered/not resolved.   It was unknown if the reporter considered the non-hodgkin's lymphoma to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix with non hodkin lymphoma had received several treatments (among those, Remicade, IVIG, prednisone). The primary care physician recommended the patient to avoid getting the second dose of Shingrix.  The other health professional could not provide date for first dose given and first line agent did not clarify if the diagnose was before or after the first dose this cannot be discarded. The reporter did not consent to follow-up.
Age: 1.17
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Patient less than 7 yo, and received Td vaccine instead of DT.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Feeling of body temperature change, Loss of consciousness, Pain, Pain in extremity
Clinical narrative: Patient experienced hot and cold flashes, stabbing chest pain, arm pain, body aches and passed out on his bedroom floor
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness, Fatigue, Feeling hot, Heart rate increased
Clinical narrative: First, I was given the high-dose flu vaccine (they said it was for over age 50) at the same time as the SHINGRIX vaccine, so I'm not sure if my side effects were due to an interaction, etc. That said, my Sx were extreme fatigue (starting about 10:30 am and  lasting 3-4 days), but the worst AEs started about 2:00 pm that day, and included dizziness (couldn't sit up), tingling/numbness and shakiness in hands, sweating/hot feeling (but no fever), heavy chest, fast/hard heartbeat - all of which lasted about 3 hours.. I was never warned that I could experience these (or any) side effects, and so I called the nurse, and she said these were all expected side effects and that I should only worry if I got a rash around the injection site. I feel like these were pretty severe, not to mention scary, and worth reporting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia, Palpitations, Paraesthesia, Product administered to patient of inappropriate age
Clinical narrative: First, I was given the high-dose flu vaccine (they said it was for over age 50) at the same time as the SHINGRIX vaccine, so I'm not sure if my side effects were due to an interaction, etc. That said, my Sx were extreme fatigue (starting about 10:30 am and  lasting 3-4 days), but the worst AEs started about 2:00 pm that day, and included dizziness (couldn't sit up), tingling/numbness and shakiness in hands, sweating/hot feeling (but no fever), heavy chest, fast/hard heartbeat - all of which lasted about 3 hours.. I was never warned that I could experience these (or any) side effects, and so I called the nurse, and she said these were all expected side effects and that I should only worry if I got a rash around the injection site. I feel like these were pretty severe, not to mention scary, and worth reporting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: First, I was given the high-dose flu vaccine (they said it was for over age 50) at the same time as the SHINGRIX vaccine, so I'm not sure if my side effects were due to an interaction, etc. That said, my Sx were extreme fatigue (starting about 10:30 am and  lasting 3-4 days), but the worst AEs started about 2:00 pm that day, and included dizziness (couldn't sit up), tingling/numbness and shakiness in hands, sweating/hot feeling (but no fever), heavy chest, fast/hard heartbeat - all of which lasted about 3 hours.. I was never warned that I could experience these (or any) side effects, and so I called the nurse, and she said these were all expected side effects and that I should only worry if I got a rash around the injection site. I feel like these were pretty severe, not to mention scary, and worth reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Swelling
Clinical narrative: Joint pain; swelling; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 weeks after receiving Shingrix, the patient experienced joint pain and swelling. On an unknown date, the outcome of the joint pain and swelling were unknown.   It was unknown if the reporter considered the joint pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient experienced joint pain and swelling.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Influenza, Influenza virus test positive, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Not been able to get her second vaccine due to Covid 19; Influenza A/flu; fever; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of influenza a virus infection in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 5th March 2020, between 3 and 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza a virus infection, fever and diarrhea. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the influenza a virus infection, fever, diarrhea and social problem were unknown.   It was unknown if the reporter considered the influenza a virus infection, fever and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient came down with Influenza A. The patient experienced fever and diarrhea and tested positive for the flu but was negative for Covid 19. The patient had not been able to get her 2nd vaccine due to Covid 19.  The patient was now scheduled to receive her second shingrix vaccine day after the date of reporting. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Social problem
Clinical narrative: Not been able to get her second vaccine due to Covid 19; Influenza A/flu; fever; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of influenza a virus infection in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 5th March 2020, between 3 and 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza a virus infection, fever and diarrhea. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the influenza a virus infection, fever, diarrhea and social problem were unknown.   It was unknown if the reporter considered the influenza a virus infection, fever and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient came down with Influenza A. The patient experienced fever and diarrhea and tested positive for the flu but was negative for Covid 19. The patient had not been able to get her 2nd vaccine due to Covid 19.  The patient was now scheduled to receive her second shingrix vaccine day after the date of reporting. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: blisters on the face; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient experienced blisters on the face. The reporter was not sure yet if it was related or not to the vaccination. No other information was provided. The reporter consented to follow up.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram head normal, Hypoaesthesia
Clinical narrative: Patient stated she received the flu vaccine one week prior to ED visit.  Unknown which vaccine and the location of administration. Patient presented to the ED with left arm numbness which is the same arm she received the flu vaccine in.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site mass, Local reaction, Pain
Clinical narrative: Lump that looks like a local reaction at the site of injection. Numbness and pain for 3 days and just pain thereafter.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: SEVERE REACTION - SWELLING OF ARM AND CHEST/BREAST AREA. DR SUGGESTED TO ICE IT AND NOT TO RECEIVE THE SECOND DOSE
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received both Proquad and MMR on the same day. No adverse event/signs or symptoms presented in the baby. Today we are on the 6th day from the date of the vaccines.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Bicep became swollen 3-4 " away from injection site and red. Swelling into forearm.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Pain, Pruritus, Swelling
Clinical narrative: 7x11 cm swelling induration. itching  some pain
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a nurse and refers to a 9-week-old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 04-AUG-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular, lot # S036823, expiration date: 31-MAR-2022 (dose not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 33 minutes in the temperature above 47 degrees Fahrenheit / 9 degrees Celsius (8.9 C). There was no previous temperature excursion. Digital Data Logger was involved.  The outcome of medication error was unknown.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 09-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2003USA007542: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot# T002848, expiry date 23-JAN-2022 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  The vaccine underwent the following temperature excursions: -14 to -10 degree Celsius (C) (-12.1C) for 3 hours (multiple excursions) and -9 to 8 C (-7.5C) for 8 hours and 30 minutes (multiple excursions). The call was because of digital data logger.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event, Product confusion, Wrong product administered
Clinical narrative: The patient came back in the office at a later date and did not report having any side effects; The patient was in the office to receive the Meningitis Vaccine, Manectra, but the MMR II was administered instead; She states the patient had already received all his childhood MMR II doses; This spontaneous report has been received from an office manager concerning a 17 year old male patient. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.      On 17-AUG-2020, the patient was inadvertently  vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (dosage regimen was not provided)  Lot # S032036, expiration date 10-OCT-2021 for prophylaxis.        The patient was in the office to receive the meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA), but the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  was administered instead. The reporter stated this error was due to product confusion because the meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) vaccine and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) were next to each other in the fridge. The fridge was organized in alphabetical order.  Further details about the product confusion were not reported.  On an unknown date (reported as ¨at a later date¨), the patient came back in the office  and did not report having any side effects. The reporter confirmed,  the patient had already received all his childhood measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, 2 days after receiving Shingrix, the patient experienced rash. On 31st August 2020, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 51 or 52 years. The patient received dose 1 of Shingrix one week ago. She states that two days after the patient received the dose they developed a rash that lasted for two days and resolved. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Erythema, Full blood count normal, Injection site pain
Clinical narrative: The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; she could not lift the arm; it's red and extends down arm; red marks going through her biceps and can see red areas; it's red and extends down arm; red marks going through her biceps and can see red areas; Had received Prevnar 13 already when in (city name) more than 2 years ago before moving here/received a shot of Prevnar 13, the second dose this Sat, 29; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the second dose of  pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration to left arm on 29Aug2020 at single dose for routine vaccination, influenza vaccine (FLU), via an unspecified route of administration to left arm on 29Aug2020 at unknown dose for routine vaccination. Medical history included hypothyroidism from Feb1999 and ongoing. The patient's concomitant medications were not reported. The patient previously received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization more than 2 years ago. The patient reported that she received a shot of Prevnar 13, the second dose this Saturday, 29Aug2020. The pain was significant, but not only that she could not lift the arm on 29Aug2020. It stung and it's red and that had extended down to her arm and when touched it hurts on 29Aug2020. That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but received that at the Pfizer infirmary. The arm had gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentioned again it hurts when touched. In addition to getting the Prevnar 13 she had the flu shot as well that day and never experienced this with the flu shot. She had received Prevnar 13 already when in (city name) more than 2 years ago before moving here. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC with differential, urine, TSH, free T4, lipids,  and vitamin D; all on 28Aug2020 with result of normal. The outcome of event "she could not lift the arm" was resolving, outcome of other events was not resolved.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Lipids normal, Metabolic function test normal, Mobility decreased, Pain, Tenderness
Clinical narrative: The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; she could not lift the arm; it's red and extends down arm; red marks going through her biceps and can see red areas; it's red and extends down arm; red marks going through her biceps and can see red areas; Had received Prevnar 13 already when in (city name) more than 2 years ago before moving here/received a shot of Prevnar 13, the second dose this Sat, 29; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the second dose of  pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration to left arm on 29Aug2020 at single dose for routine vaccination, influenza vaccine (FLU), via an unspecified route of administration to left arm on 29Aug2020 at unknown dose for routine vaccination. Medical history included hypothyroidism from Feb1999 and ongoing. The patient's concomitant medications were not reported. The patient previously received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization more than 2 years ago. The patient reported that she received a shot of Prevnar 13, the second dose this Saturday, 29Aug2020. The pain was significant, but not only that she could not lift the arm on 29Aug2020. It stung and it's red and that had extended down to her arm and when touched it hurts on 29Aug2020. That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but received that at the Pfizer infirmary. The arm had gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentioned again it hurts when touched. In addition to getting the Prevnar 13 she had the flu shot as well that day and never experienced this with the flu shot. She had received Prevnar 13 already when in (city name) more than 2 years ago before moving here. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC with differential, urine, TSH, free T4, lipids,  and vitamin D; all on 28Aug2020 with result of normal. The outcome of event "she could not lift the arm" was resolving, outcome of other events was not resolved.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Thyroxine free normal, Urine analysis normal, Vitamin D
Clinical narrative: The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; she could not lift the arm; it's red and extends down arm; red marks going through her biceps and can see red areas; it's red and extends down arm; red marks going through her biceps and can see red areas; Had received Prevnar 13 already when in (city name) more than 2 years ago before moving here/received a shot of Prevnar 13, the second dose this Sat, 29; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the second dose of  pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration to left arm on 29Aug2020 at single dose for routine vaccination, influenza vaccine (FLU), via an unspecified route of administration to left arm on 29Aug2020 at unknown dose for routine vaccination. Medical history included hypothyroidism from Feb1999 and ongoing. The patient's concomitant medications were not reported. The patient previously received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization more than 2 years ago. The patient reported that she received a shot of Prevnar 13, the second dose this Saturday, 29Aug2020. The pain was significant, but not only that she could not lift the arm on 29Aug2020. It stung and it's red and that had extended down to her arm and when touched it hurts on 29Aug2020. That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but received that at the Pfizer infirmary. The arm had gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentioned again it hurts when touched. In addition to getting the Prevnar 13 she had the flu shot as well that day and never experienced this with the flu shot. She had received Prevnar 13 already when in (city name) more than 2 years ago before moving here. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC with differential, urine, TSH, free T4, lipids,  and vitamin D; all on 28Aug2020 with result of normal. The outcome of event "she could not lift the arm" was resolving, outcome of other events was not resolved.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count, Erythema, Full blood count, Injection site pain
Clinical narrative: The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; she could not lift the arm; it's red and extends down arm; red marks going through her biceps and can see red areas; it's red and extends down arm; red marks going through her biceps and can see red areas; Had received Prevnar 13 already when in (city name) more than 2 years ago before moving here/received a shot of Prevnar 13, the second dose this Sat, 29; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the second dose of  pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration to left arm on 29Aug2020 at single dose for routine vaccination, influenza vaccine (FLU), via an unspecified route of administration to left arm on 29Aug2020 at unknown dose for routine vaccination. Medical history included hypothyroidism from Feb1999 and ongoing. The patient's concomitant medications were not reported. The patient previously received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization more than 2 years ago. The patient reported that she received a shot of Prevnar 13, the second dose this Saturday, 29Aug2020. The pain was significant, but not only that she could not lift the arm on 29Aug2020. It stung and it's red and that had extended down to her arm and when touched it hurts on 29Aug2020. That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but received that at the Pfizer infirmary. The arm had gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentioned again it hurts when touched. In addition to getting the Prevnar 13 she had the flu shot as well that day and never experienced this with the flu shot. She had received Prevnar 13 already when in (city name) more than 2 years ago before moving here. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC with differential, urine, TSH, free T4, lipids,  and vitamin D; all on 28Aug2020 with result of normal. The outcome of event "she could not lift the arm" was resolving, outcome of other events was not resolved.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Metabolic function test normal, Mobility decreased, Pain in extremity
Clinical narrative: The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; The pain was significant, but not only that she could not lift the arm/It stung /when touched it hurts/it still hurts where shot was placed; she could not lift the arm; it's red and extends down arm; red marks going through her biceps and can see red areas; it's red and extends down arm; red marks going through her biceps and can see red areas; Had received Prevnar 13 already when in (city name) more than 2 years ago before moving here/received a shot of Prevnar 13, the second dose this Sat, 29; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the second dose of  pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration to left arm on 29Aug2020 at single dose for routine vaccination, influenza vaccine (FLU), via an unspecified route of administration to left arm on 29Aug2020 at unknown dose for routine vaccination. Medical history included hypothyroidism from Feb1999 and ongoing. The patient's concomitant medications were not reported. The patient previously received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization more than 2 years ago. The patient reported that she received a shot of Prevnar 13, the second dose this Saturday, 29Aug2020. The pain was significant, but not only that she could not lift the arm on 29Aug2020. It stung and it's red and that had extended down to her arm and when touched it hurts on 29Aug2020. That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but received that at the Pfizer infirmary. The arm had gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentioned again it hurts when touched. In addition to getting the Prevnar 13 she had the flu shot as well that day and never experienced this with the flu shot. She had received Prevnar 13 already when in (city name) more than 2 years ago before moving here. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC with differential, urine, TSH, free T4, lipids,  and vitamin D; all on 28Aug2020 with result of normal. The outcome of event "she could not lift the arm" was resolving, outcome of other events was not resolved.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Blood test, Fatigue, Limb discomfort, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Peripheral neuropathy, nerve pain, fatigue, heaviness of arms and legs. Spinal tap. Bloodwork, MRI
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Nerve conduction studies, Neuralgia, Neuropathy peripheral
Clinical narrative: Peripheral neuropathy, nerve pain, fatigue, heaviness of arms and legs. Spinal tap. Bloodwork, MRI
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Vaccination site pain
Clinical narrative: Post vaccination, her left arm where she got the pneumonia vaccination became very painful to her and complains of loss of motion. She can't raise her arm beyond heart level and when she does, her pain level becomes 7-8 out of 10. She reports her arm is not numb, it feels normal. No redness or swelling at the area of vaccination. She reported event 3 days post vaccination and that symptoms have not gotten worse since onset, but not improved either. Taking ibuprofen helps her some.
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Abdominal pain upper, Dizziness, Dyschezia, Dyskinesia, Immediate post-injection reaction
Clinical narrative: 9/5/20 - immediate slight involuntary muscle reaction in left upper arm; momentary feeling of slight light headedness.  resolved in 1-2 minutes.  no other symptoms on this date.  treatment: 500 mg ibuprofen taking within first hour of the 2 vaccine injections.  9/6/20 - on waking - the whole body aches that one might feel with the flu. within one hour of waking - severe stomach pain, painful bowel movements (multiple). thought i had ruptured stomach, had hernia, something.  pain lessened, but still noticeable, throughout day.  treatment: ibuprofen  500 mg morning, afternoon, and evening.  probiotics morning, afternoon, and evening.  by evening I was starting to feel 'normal' again.  otherwise rested all day.   9/7/20 - no symptoms at this time.
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: 9/5/20 - immediate slight involuntary muscle reaction in left upper arm; momentary feeling of slight light headedness.  resolved in 1-2 minutes.  no other symptoms on this date.  treatment: 500 mg ibuprofen taking within first hour of the 2 vaccine injections.  9/6/20 - on waking - the whole body aches that one might feel with the flu. within one hour of waking - severe stomach pain, painful bowel movements (multiple). thought i had ruptured stomach, had hernia, something.  pain lessened, but still noticeable, throughout day.  treatment: ibuprofen  500 mg morning, afternoon, and evening.  probiotics morning, afternoon, and evening.  by evening I was starting to feel 'normal' again.  otherwise rested all day.   9/7/20 - no symptoms at this time.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT DESCRIBED SIGNIFICANT SWELLING BEGINNING 2 DAYS AFTER RECEIVING VACCINE.  THE SWELLING OCCURRED AT SITE OF INJECTION, WAS RED, WARM, AND PAINFUL TO THE TOUCH.  PATIENT DESCRIBED SWELLING TO BE BASEBALL SIZE IN DIAMETER.  PATIENT DID NOT TAKE ANYTHING OR USE ANYTHING TO RELIEVE ANY REACTION.  THE SWELLING LASTED ABOUT 3 DAYS AFTER IT STARTED.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Myositis, Pain in extremity
Clinical narrative: Myositis in left lower extremity (calf muscle pain)
Age: 67.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Chills, Diarrhoea, Dysgeusia, Movement disorder, Pain
Clinical narrative: Vommiting, diarrhea, body ache, chills, no temperature. Right arm movement issues for 2 days. Bitter taste in mouth still ongoing.
Age: 67.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Vomiting
Clinical narrative: Vommiting, diarrhea, body ache, chills, no temperature. Right arm movement issues for 2 days. Bitter taste in mouth still ongoing.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 29-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2003USA007542: US-009507513-2008USA013488: US-009507513-2008USA013490:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 28-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2003USA007542: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Caller reporting an expired dose of VARIVAX was administered to a patient; This spontaneous report has been received from an office manager  concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.       On 04-AUG-2020,  the patient was vaccinated with an expired dose of  varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection,  0.5 ml,  Lot # R018142, expiration date 26-JUN-2020 for prophylaxis (frequency and patient route of administration were not reported).  No additional adverse event details were available.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site rash, Rash
Clinical narrative: Rash across upper stomach, rash at injection site roughly size of egg, rash across entire upper right arm, orange size rash on upper right leg, and egg size rash on lower left leg.  All rashes are in the exact same location as one experienced after the two shot Shingles vaccine.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Mild chickenpox symptoms occurred on trunk , legs and feet started 3 to 4 days after the first dose.  Symptoms are mild but prevalent after 10 days.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Rash, Rash papular
Clinical narrative: Diffuse papular rash beginning on abdomen, then over the next 24 hours spreading to groin, back, proximal extremities, posterior head, and face.  No fevers.  Irritability and decreased appetite.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Full blood count, Henoch-Schonlein purpura, Metabolic function test, Urine analysis
Clinical narrative: Henoch Schonlein Purpura
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: fever, injection site pain, chills
Age: 70.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not state he had any reaction. I will check in again on Thursday 9/10/20. This is per pharmacy protocol to file VAERS in the event of administering a vaccine out side of standing order and CDC guidelines.
Age: 70.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Decreased appetite, Full blood count normal, Lymphadenopathy, Malaise
Clinical narrative: 4 days following injection sore throat began. 6 days later fever began and continued for 10 days. 2 days into fever and 8 days from vaccination, fever spiked to 103.8.  Malaise, bilateral neck lymphadenopathy, shaking chills, loss of appetite and weight loss throughout the time of illness.
Age: 70.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Metabolic function test normal, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, Weight decreased
Clinical narrative: 4 days following injection sore throat began. 6 days later fever began and continued for 10 days. 2 days into fever and 8 days from vaccination, fever spiked to 103.8.  Malaise, bilateral neck lymphadenopathy, shaking chills, loss of appetite and weight loss throughout the time of illness.
Age: 70.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Fatigue, Full blood count normal, Headache, Lymphadenopathy
Clinical narrative: 4 days following injection sore throat began. 6 days later fever began and continued for 10 days. 2 days into fever and 8 days from vaccination, fever spiked to 103.8.  Malaise, bilateral neck lymphadenopathy, shaking chills, loss of appetite and weight loss throughout the time of illness.