chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles even though I had them 2 years ago/ suspected Vaccination failure; Shingles; Pain; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient had shingles even though the patient received shingles vaccine 2 years before the date of reporting. The patient had pain which was not gone. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: arm was useless for a week / pain in each arm; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, reference case US2021AMR122050).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself.  The age at vaccination was not reported. The reporter mentioned that, he/she was not expected the amount of pain he/she experienced after getting each shot. The patient's arm was useless for a week. The reporter mentioned that, Shingles vaccine did not make him/her sick but he/she was not expected the pain in each arm, but he/she did not regret it at all. The reporter mentioned that, he/she would do it over a hundred times plus before getting shingles. The follow-up would not be possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR122050:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received my first vaccine in 2019 but have not received my 2nd vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. The patient received his or her first vaccine in 2019 but did not receive 2nd vaccine till the time of reporting, which led to incomplete course of vaccination. The reporter enquired did he or she need to get the 2nd vaccine or would have to start over again. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: has been 7 months since 1st dose of shingles/Due to the 2 doses if Covid; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date approximately 7 months before day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. The reporter mentioned that he or she missed the dosing schedules of Shingrix. The reporter enquired what happened if approximately 7 months had been past since first dose due to COVID shots being administered. The reporter asked could he or she get the 2nd dose. The follow up was not required.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Liquid product physical issue, Syringe issue, Underdose
Clinical narrative: resistance when withdrawing the medication/"sticky" at the beginning/ could not get the medication to come out/  difficulty to push the plunger; was not able to administer the full dose due to difficulty to push the plunger; get the medication to come out of the barrel of the syringe.; Product consitency issue; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9335X, expiry date 29th January 2023) for prophylaxis. This case was associated with a product complaint.   In May 2021, the patient received Boostrix. In May 2021, unknown after receiving Boostrix, the patient experienced underdose, syringe issue and product physical consistency issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the underdose, syringe issue, product physical consistency issue and pharmaceutical product complaint were unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The pharmacist was the reporter. The pharmacist reports that he began to administer the vaccine but was not able to administer the full dose due to difficulty to push the plunger which led to syringe issue and pharmaceutical product complaint. The pharmacist stated that he could not get the medication to come out of the barrel of the syringe, which led to syringe issue. The pharmacist reports that he immediately met a lot of resistance when withdrawing the medication and was sticky at the beginning, which led to product physical consistency issue. The pharmacist reports that this complaint occurred over the weekend. The pharmacist does still have the device in question and states he will try to return it without the needle. The pharmacist did not take any pictures of the product. The following PQC questions were asked did the plunger eventually push or was it unusable and replied it was not impossible but too difficult to administer completely, are any blockages visible in the syringe body or barrel and replied no, are any abnormal particles observed in the vaccine and replied no and was luer lok needle used or different kind used and replied luer lock. The reporter consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red; Injection site / "heated"; Can still feel a small bump at injection site; Tired; Chills; Vaccine stung when going in / soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7GA9, expiry date 11th November 2022) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and chills. On 2nd June 2021, the patient experienced injection site erythema, injection site warmth and injection site swelling. In June 2021, the outcome of the injection site erythema, injection site warmth, fatigue and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, fatigue and chills to be related to Shingrix.  Additional details were provided as follows: The case reported by patient herself. The patient received 1st dose of Shingrix in right arm muscle and on the same day experienced soreness at injection site, tired and chills. The next day, patient also experienced injection site small bump, injection site redness and injection site heat. The reporter mentioned that, the vaccine stung while going in. The Pharmacist told to patient, some of the newly trained staff was giving one vial (adjuvant) instead of reconstituting. The patient was inquiring if Shingrix dose equal to two vials, also inquiring if Shingrix needs to be 2 doses only or if she may need another dose in the future. The patient was concerned but with further questioning, she feels she did get both because she saw the pharmacy reconstituting two vials with different colored caps.  Educated on when to receive second dose.  The consent with Healthcare professional was given. The case has been linked with the case US2021AMR121361, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR121361:Same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Product preparation issue
Clinical narrative: Injection site red; Injection site / "heated"; Can still feel a small bump at injection site; Tired; Chills; Vaccine stung when going in / soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7GA9, expiry date 11th November 2022) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and chills. On 2nd June 2021, the patient experienced injection site erythema, injection site warmth and injection site swelling. In June 2021, the outcome of the injection site erythema, injection site warmth, fatigue and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, fatigue and chills to be related to Shingrix.  Additional details were provided as follows: The case reported by patient herself. The patient received 1st dose of Shingrix in right arm muscle and on the same day experienced soreness at injection site, tired and chills. The next day, patient also experienced injection site small bump, injection site redness and injection site heat. The reporter mentioned that, the vaccine stung while going in. The Pharmacist told to patient, some of the newly trained staff was giving one vial (adjuvant) instead of reconstituting. The patient was inquiring if Shingrix dose equal to two vials, also inquiring if Shingrix needs to be 2 doses only or if she may need another dose in the future. The patient was concerned but with further questioning, she feels she did get both because she saw the pharmacy reconstituting two vials with different colored caps.  Educated on when to receive second dose.  The consent with Healthcare professional was given. The case has been linked with the case US2021AMR121361, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR121361:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Dose 1 shingrix on 08/01/2019. ok to give second dose or revaccinate?; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st August 2018, batch number- M77B4 and expiration date- 1st August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was asking if it was ok to give the 2nd dose or the patient should be revaccinated. The reporter consented to follow up.  Note: Query was sent for the confimation of vaccination date (1st dose of Shingrix) and no reply was received yet, hence vaccine date and expiry date for 1st dose was captured as reported in the structured field.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received / the liquid component / without / the powder portion; Patient received /  the liquid component / without / the powder portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 21-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA397A, expiry date 31st August 2022) for prophylaxis.   On 4th June 2021, the patient received Menveo (intramuscular). On 4th June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received a dose of the liquid component of Menveo without being reconstituted with the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported batch number of AMXA397A was not found in sales data sheet, hence updated to AMVA397A. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Fist dose  was / 2018 / second dose administrated March 18 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2018).   On 18th March 2021, the patient received the 2nd dose of Shingrix. On 18th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follow:  No vaccination date provided for the first dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient had no known side effects. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; fever; fatigue; chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 1st June 2021, the patient received the 2nd dose of Shingrix. On 2nd June 2021, 1 days after receiving Shingrix, the patient experienced headache, fever, fatigue and chills. In June 2021, the outcome of the headache, fever, fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the headache, fever, fatigue and chills to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine and experienced fatigue, headache, fever, chills the next day but they resolved. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: patient was administered Shingrix vaccine/ stored out of range for more than 72 hours; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received the Shingrix vaccine which was stored out of range for more than 72 hours, which led to incorrect storage of drug. No further events and information were reported at the time of the call. The reporter consented to follow up by email.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Infanrix/ expired on May31st, 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old patient who received DTPa (Infanrix) (batch number unknown, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the patient received an expired dose of Infanrix, which led to expired vaccine used. The HCP declined provide patient's information The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on 10/16/2019 / second dose has not been received yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 16th October 2021, batch number K9L3M and expiration date-29th October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on 06Nov2019 / has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on 6th November 2019, no adverse reaction was reported).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Havrix, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dysgeusia, Fatigue
Clinical narrative: Bitter taste in her mouth which is not resolved; weakness; Felt tired/ fatigue; This case was reported by a consumer via call center representative and described the occurrence of taste bitter in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID19 Vaccine (received in February 2021).   On 2nd June 2021, the patient received the 1st dose of Shingrix. On 3rd June 2021, 1 days after receiving Shingrix, the patient experienced weakness and fatigue. On 4th June 2021, the patient experienced taste bitter. On an unknown date, the outcome of the taste bitter was not recovered/not resolved and the outcome of the weakness and fatigue were recovered/resolved.   It was unknown if the reporter considered the taste bitter, weakness and fatigue to be related to Shingrix.  Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported. The patient had her first dose of the Shingrix vaccine and the next day she felt tired and weakness. On the morning of day of reporting (Friday), she felt better but had a bitter taste (latency 2 day) in her mouth which was not resolved. The reporter declined to provide demographic information and declined follow up with physician. The reporter did not consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was administrated with the powder component of Menveo with sterile water; was administrated with the powder component of Menveo with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo with sterile water, which led to wrong solution used for drug reconstitution and inappropriate dose of vaccine administered. No adverse event was reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile water instead of the provided diluent portion; Administration of the Shingrix vaccine reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 13th September 2022) for prophylaxis.   On 4th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th June 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient was administered with the Shingrix 2nd dose reconstituted with sterile water instead of the provided diluent portion, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported.  The HCP consented to follow up.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: My heart rate has been elevated since getting the vaccine. Prior to the vaccine my heart rate was in the range of 65-100 during normal daily activities. After the vaccine my heart rate is in the range of 95-130 during normal daily activities.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Condition aggravated, Dermatitis allergic, Neuropathy peripheral
Clinical narrative: Starting approx 5 days after 1st shot - joint pain in knees, hands and feet.  Peripheral neuropathy consisting of tingling, burning in lower arms, legs and feet, a sensation of wearing tight socks up to my knees when no socks are being worn.   Hypersensitivity in my skin all over making my skin hypersensitive to touch and even my clothes "hurt" on my skin.  In addition I have had mild tinnitus in my left ear for a couple of years that has now gotten louder since receiving the vaccine.  These symptoms started out mild for the first few days and gradually got worse.  They are now significant and ongoing.  It has been almost two months since these problems started after the vaccine and no improvement whatsoever.  I went to my primary physician on 5-17-21.  He referred me to a rheumatologist who I went to on 5-27-21.  The rheumatologist prescribed a Medrol pack which did not help at all.  He then prescribed Sulfasalazine 500m 1x in the morning and 1x in the evening.  I just started taking it so no improvement yet.  My rheumatogist has advised me NOT to get the second Pfizer shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased, Tinnitus
Clinical narrative: Starting approx 5 days after 1st shot - joint pain in knees, hands and feet.  Peripheral neuropathy consisting of tingling, burning in lower arms, legs and feet, a sensation of wearing tight socks up to my knees when no socks are being worn.   Hypersensitivity in my skin all over making my skin hypersensitive to touch and even my clothes "hurt" on my skin.  In addition I have had mild tinnitus in my left ear for a couple of years that has now gotten louder since receiving the vaccine.  These symptoms started out mild for the first few days and gradually got worse.  They are now significant and ongoing.  It has been almost two months since these problems started after the vaccine and no improvement whatsoever.  I went to my primary physician on 5-17-21.  He referred me to a rheumatologist who I went to on 5-27-21.  The rheumatologist prescribed a Medrol pack which did not help at all.  He then prescribed Sulfasalazine 500m 1x in the morning and 1x in the evening.  I just started taking it so no improvement yet.  My rheumatogist has advised me NOT to get the second Pfizer shot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Blood cholesterol increased, Blood creatine phosphokinase increased, Blood triglycerides increased, Low density lipoprotein increased
Clinical narrative: May 28, 2021: post 2nd vaccine: muscle pain, stiffness, swelling.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Rhabdomyolysis, Swelling
Clinical narrative: May 28, 2021: post 2nd vaccine: muscle pain, stiffness, swelling.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Musculoskeletal stiffness, Myalgia, Swelling
Clinical narrative: May 28, 2021: post 2nd vaccine: muscle pain, stiffness, swelling.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Memory impairment, Somnolence
Clinical narrative: This spontaneous report received from a patient concerned a 65-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, controlled high blood pressure, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced became slower at work. On 2021, the subject experienced felt really weird. On MAR-2021, the subject experienced constantly sleepy. On 13-MAR-2021, the subject experienced very tired. On 15-MAR-2021, the subject experienced fog/not remembering conversations, directions, not as conscious about her work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constantly sleepy, became slower at work, and felt really weird on MAY-2021, and fog/not remembering conversations, directions, not as conscious about her work, and very tired on 08-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Headache, Pruritus, Rash macular
Clinical narrative: BLOOD DOTS ON BOTH ARMS; HEADACHE; ITCHING; BIG RED BLOTCH ON SKIN/ BIG BLOOD BLOTCH ON SKIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 112 pounds, and height was 63 inches. The patient's past medical history included smoker, and concurrent conditions included chronic obstructive pulmonary disease, reflex sympathetic dystrophy, arthritis, gastrooesophageal reflux disease, fibromyalgia, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with pethidine hydrochloride, ibuprofen, lansoprazole, loratadine, pregabalin, naproxen, and aluminium hydroxide/magnesium hydroxide/simeticone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced itching. On 2021, the subject experienced big red blotch on skin/ big blood blotch on skin. On 29-MAY-2021, the subject experienced blood dots on both arms. On 29-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 29-MAY-2021, and the outcome of blood dots on both arms, big red blotch on skin/ big blood blotch on skin and itching was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Incorrect route of product administration, Off label use
Clinical narrative: SEVERE BAD ADVERSE REACTION AFTER THE INJECTION; WRONG ROUTE OF ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and anxiety.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown, expiry: Unknown) (Incorrect route of product administration and off label use) dose was not reported, 1 total, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUN-2021, post vaccination the patient experienced severe bad adverse reactions (unspecified) and was admitted to the hospital. The patient was kept overnight (one day) at the hospital and discharged on 03-JUN-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from off label use, wrong route of administration, and severe bad adverse reaction after the injection. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;20210607696-COVID-19 VACCINE AD26.COV2.S-severe bad adverse reactions . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event . V0 20210607696-COVID-19 VACCINE AD26.COV2.S-Wrong route of administration , off label use. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: UNEVALUABLE EVENT (SIDE EFFECT OR COVID VACCINE WAS LITTLE ROUGH); This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab.  On 20-MAY-2021, the subject experienced unevaluable event (side effect or covid vaccine was little rough). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unevaluable event (side effect or covid vaccine was little rough) was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Discomfort, Dry throat, Feeling cold
Clinical narrative: FEELING HEAVY; NECK IS STIFF; SLIGHT DRAINAGE; FEELING WEAK; FEVER OF 100.4; HEADACHE; SPREADING COLD THEN TURNS TO SPREADING HOT OVER WHOLE BODY; SINUS PRESSURE; THROAT IS DRY AND THROBBING; VERY COLD; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and antibody infusion, and concurrent conditions included sulfa allergy, and myosin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced spreading cold then turns to spreading hot over whole body. On 03-JUN-2021, the subject experienced sinus pressure. On 03-JUN-2021, the subject experienced throat is dry and throbbing. On 03-JUN-2021, the subject experienced very cold. On 03-JUN-2021, the subject experienced fever of 100.4. On 03-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4. On 04-JUN-2021, the subject experienced feeling heavy. On 04-JUN-2021, the subject experienced neck is stiff. On 04-JUN-2021, the subject experienced slight drainage. On 04-JUN-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very cold, spreading cold then turns to spreading hot over whole body, sinus pressure, feeling heavy, neck is stiff, slight drainage, headache, and feeling weak, and the outcome of throat is dry and throbbing and fever of 100.4 was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Musculoskeletal stiffness, Ophthalmic fluid drainage, Paranasal sinus discomfort
Clinical narrative: FEELING HEAVY; NECK IS STIFF; SLIGHT DRAINAGE; FEELING WEAK; FEVER OF 100.4; HEADACHE; SPREADING COLD THEN TURNS TO SPREADING HOT OVER WHOLE BODY; SINUS PRESSURE; THROAT IS DRY AND THROBBING; VERY COLD; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and antibody infusion, and concurrent conditions included sulfa allergy, and myosin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced spreading cold then turns to spreading hot over whole body. On 03-JUN-2021, the subject experienced sinus pressure. On 03-JUN-2021, the subject experienced throat is dry and throbbing. On 03-JUN-2021, the subject experienced very cold. On 03-JUN-2021, the subject experienced fever of 100.4. On 03-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4. On 04-JUN-2021, the subject experienced feeling heavy. On 04-JUN-2021, the subject experienced neck is stiff. On 04-JUN-2021, the subject experienced slight drainage. On 04-JUN-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very cold, spreading cold then turns to spreading hot over whole body, sinus pressure, feeling heavy, neck is stiff, slight drainage, headache, and feeling weak, and the outcome of throat is dry and throbbing and fever of 100.4 was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEELING HEAVY; NECK IS STIFF; SLIGHT DRAINAGE; FEELING WEAK; FEVER OF 100.4; HEADACHE; SPREADING COLD THEN TURNS TO SPREADING HOT OVER WHOLE BODY; SINUS PRESSURE; THROAT IS DRY AND THROBBING; VERY COLD; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and antibody infusion, and concurrent conditions included sulfa allergy, and myosin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced spreading cold then turns to spreading hot over whole body. On 03-JUN-2021, the subject experienced sinus pressure. On 03-JUN-2021, the subject experienced throat is dry and throbbing. On 03-JUN-2021, the subject experienced very cold. On 03-JUN-2021, the subject experienced fever of 100.4. On 03-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4. On 04-JUN-2021, the subject experienced feeling heavy. On 04-JUN-2021, the subject experienced neck is stiff. On 04-JUN-2021, the subject experienced slight drainage. On 04-JUN-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very cold, spreading cold then turns to spreading hot over whole body, sinus pressure, feeling heavy, neck is stiff, slight drainage, headache, and feeling weak, and the outcome of throat is dry and throbbing and fever of 100.4 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: MIGRAINE; BODY ACHES; RUNNING A FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, body aches, and running a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the running a fever, migraine and body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hot flush, Insomnia, Myalgia, Nausea
Clinical narrative: VOMITING; KEPT ME UP ALL NIGHT; HEAT FLASHES; CHILLS; MUSCLE PAIN ALL OVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The company was unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, kept me up all night, heat flashes, chills, muscle pain all over, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, kept me up all night, heat flashes, chills, muscle pain all over and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; KEPT ME UP ALL NIGHT; HEAT FLASHES; CHILLS; MUSCLE PAIN ALL OVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The company was unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, kept me up all night, heat flashes, chills, muscle pain all over, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, kept me up all night, heat flashes, chills, muscle pain all over and nausea was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a pharmacist concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discharge, Injection site discolouration
Clinical narrative: YELLOW SKIN AT INJECTION SITE; OOZING AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On an unspecified date, the subject experienced yellow skin at injection site, and oozing at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the yellow skin at injection site and oozing at the site of injection was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT USED; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203 21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced expired product used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product used was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN IN THE LEFT ARM / SHOULDER AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAY-2021, the subject experienced pain in the left arm / shoulder at the injection site. Treatment medications (dates unspecified) included: camphor/menthol/methyl salicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the left arm / shoulder at the injection site. This report was non-serious.