chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: dizziness; nausea / feel nauseous; tiredness; sore throat; fever; stiffness of arm; feeling "out of it."; hypersalivation; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced hypersalivation. On 24th July 2021, the patient experienced dizziness, nausea, tiredness, sore throat, fever, limbs stiffness and feeling abnormal. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the dizziness, nausea, tiredness and hypersalivation were not recovered/not resolved and the outcome of the sore throat, fever, limbs stiffness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the dizziness, nausea, tiredness, sore throat, fever, limbs stiffness, feeling abnormal and hypersalivation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient began to experience dizziness, nausea, tiredness, sore throat, fever, stiffness of arm and feeling out of it.  All symptoms had resolved except the dizziness, nausea and tiredness which she was still experiencing. The patient was referred to health care professional. The patient went to an urgent care on 27th July 2021 and was prescribed Zofran.  The patient was experiencing hypersalivation in less than week after vaccination and continued to feel nauseous. The reporter did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Pain, Parasite blood test, Parosmia
Clinical narrative: dizziness; nausea / feel nauseous; tiredness; sore throat; fever; stiffness of arm; feeling "out of it."; hypersalivation; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced hypersalivation. On 24th July 2021, the patient experienced dizziness, nausea, tiredness, sore throat, fever, limbs stiffness and feeling abnormal. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the dizziness, nausea, tiredness and hypersalivation were not recovered/not resolved and the outcome of the sore throat, fever, limbs stiffness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the dizziness, nausea, tiredness, sore throat, fever, limbs stiffness, feeling abnormal and hypersalivation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient began to experience dizziness, nausea, tiredness, sore throat, fever, stiffness of arm and feeling out of it.  All symptoms had resolved except the dizziness, nausea and tiredness which she was still experiencing. The patient was referred to health care professional. The patient went to an urgent care on 27th July 2021 and was prescribed Zofran.  The patient was experiencing hypersalivation in less than week after vaccination and continued to feel nauseous. The reporter did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: SARS-CoV-2 test, Salivary hypersecretion
Clinical narrative: dizziness; nausea / feel nauseous; tiredness; sore throat; fever; stiffness of arm; feeling "out of it."; hypersalivation; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced hypersalivation. On 24th July 2021, the patient experienced dizziness, nausea, tiredness, sore throat, fever, limbs stiffness and feeling abnormal. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the dizziness, nausea, tiredness and hypersalivation were not recovered/not resolved and the outcome of the sore throat, fever, limbs stiffness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the dizziness, nausea, tiredness, sore throat, fever, limbs stiffness, feeling abnormal and hypersalivation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient began to experience dizziness, nausea, tiredness, sore throat, fever, stiffness of arm and feeling out of it.  All symptoms had resolved except the dizziness, nausea and tiredness which she was still experiencing. The patient was referred to health care professional. The patient went to an urgent care on 27th July 2021 and was prescribed Zofran.  The patient was experiencing hypersalivation in less than week after vaccination and continued to feel nauseous. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: he received 2 out of 3 doses / last dose / in 2007; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date) and Twinrix (2nd dose received in 2007).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix 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 are as follows: The case was reported by patient himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. Could not asked any questions regarding adverse event and very limited information was collected as the reporter was getting ready to get off the call.  The reporter refused to provide phone number and zip code due to privacy. The reporter did not consent to follow up.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: has given Boostrix to a 3 year old patient instead of Infanrix; has given Boostrix to a 3 year old patient instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 523X9, expiry date 3rd July 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 26th July 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were 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 reporter stated that, 3 years old patient received Boostrix instead of Infanrix, which led to underdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Pain in extremity, Skin discolouration
Clinical narrative: reaction in the arm / pain/ soreness; reaction in the arm / inflammation; reaction in the arm / pink colored skin; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced inflammation localized and skin discoloration. On 24th July 2021, the patient experienced pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, inflammation localized and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, inflammation localized and skin discoloration to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient was taking anticoagulants. The patient received 1st dose of Shingrix on an unknown arm and less than a day after receiving Shingrix, developed reaction in the arm which included pain, soreness and less than a week after receiving Shingrix, had inflammation and pink colored skin. The reaction was not located in the exact injection site but a few centimeters down. The patient did not presented fever, chills or swelling of the lymph nodes. The patient had been taking Ibuprofen since then. The pain started after the injection, but the rest of the symptoms developed through time and remained till the time of reporting.  Lot number and expiration date of the vaccine were not obtained since the administration of Shingrix was done in an unknown facility. The reporter consented to follow-up.
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a double dose of liquid portion/not reconstituted with lyophilized portion; received a double dose of liquid portion/not reconstituted with lyophilized portion.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA4398, expiry date 30th August 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMXA4398, expiry date unknown) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Menveo and the 2nd dose of Menveo. On 7th July 2021, unknown after receiving Menveo and 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 provided were as follows: The medical assistant reported that, the patient received double dose of liquid portion of Menveo not reconstituted with lyophilized portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter denied to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the adjuvant component alone; received the adjuvant component alone; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9727R, expiry date 27th January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 provided were as follows: Age at vaccination was not reported Pharmacist called to report that patient received the adjuvant component alone of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further events were reported at the time of the call. Health care professional consented to follow-up by telephone.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: same day / administered /Boostrix; 12 year old patient  received Infanrix; received Infanrix when Boostrix was intended; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 575hc, expiry date 28th February 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. On 28th July 2021, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered were 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: A 12 year old patient received Infanrix when Boostrix was intended to be given, which led to inappropriate age at vaccine administration and wrong vaccine administered. The same day patient was administered the correct vaccine, Boostrix in different arm, which led to overdose. The reporter consented to follow up.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received /on June 30th, 2021/ expired on June 8th, 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 8th June 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Boostrix and Boostrix 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 patient received a dose of Boostrix on 30th June 2021, which was expired on 8th June 2021 and led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 8 to 10 months ago and had not yet received the second dose; This case was reported by a pharmacist via call center representative 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, 8 to 10 months ago of reporting date).   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. The reporter claimed that, the patient had first dose of Shingrix 8 to 10 months ago and had not yet received the second dose, which led to incomplete course of vaccination. The reporter had no information regarding the age or gender of the patient involved nor the exact date of the administration of the first dose. There was no information regarding either the expiration or lot number of the administrated first dose. No further events were reported. The reporter agreed to be contacted for follow-up. This is one of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163653:Same reporter US-GLAXOSMITHKLINE-US2021AMR163652:Same reporter US-GLAXOSMITHKLINE-US2021AMR163653:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose /in 2018 /has not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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 reported as follows: The reporter was patient's wife. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient was referred to healthcare professional and was informed as per content per CDC (Center for disease control). The reporter did not consent to follow up.
Sex: F
Vaccine: HEP, HEP, HEPA
Symptoms: Hepatitis A, Hepatitis A virus test positive, Hepatitis B, Hepatitis B virus test positive, Incomplete course of vaccination
Clinical narrative: Had not received the second / First dose / Engerix-B and Havrix on January 28th 2021; Tested positive for Hepatitis A / on Tuesday 27-jul-2021; Tested positive for Hepatitis A; Tested positive for / Hepatitis B / on Tuesday 27-jul-2021; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 54-year-old female patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number p4dj52156, expiry date 15th December 2022) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th January 2021, the patient received the 1st dose of Havrix, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 27th July 2021, 180 days after receiving Havrix, Engerix B and Engerix B Pre-Filled Syringe Device, not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis a and hepatitis b (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the vaccination failure, hepatitis a, hepatitis b and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the vaccination failure, hepatitis a and hepatitis b to be related to Havrix. It was unknown if the reporter considered the hepatitis a and hepatitis b to be related to Engerix B and Engerix B Pre-Filled Syringe Device.  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 reported as follows: The patient tested positive for Hepatitis A and Hepatitis B on Tuesday, 27th July 2021 after receiving 1st dose of Havrix and Engerix B, but the reporter thought it might be a false positive. Till the time of reporting, the patient did not receive the 2nd dose Engerix B, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEP, HEPA
Symptoms: Vaccination failure
Clinical narrative: Had not received the second / First dose / Engerix-B and Havrix on January 28th 2021; Tested positive for Hepatitis A / on Tuesday 27-jul-2021; Tested positive for Hepatitis A; Tested positive for / Hepatitis B / on Tuesday 27-jul-2021; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 54-year-old female patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number p4dj52156, expiry date 15th December 2022) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th January 2021, the patient received the 1st dose of Havrix, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 27th July 2021, 180 days after receiving Havrix, Engerix B and Engerix B Pre-Filled Syringe Device, not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis a and hepatitis b (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the vaccination failure, hepatitis a, hepatitis b and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the vaccination failure, hepatitis a and hepatitis b to be related to Havrix. It was unknown if the reporter considered the hepatitis a and hepatitis b to be related to Engerix B and Engerix B Pre-Filled Syringe Device.  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 reported as follows: The patient tested positive for Hepatitis A and Hepatitis B on Tuesday, 27th July 2021 after receiving 1st dose of Havrix and Engerix B, but the reporter thought it might be a false positive. Till the time of reporting, the patient did not receive the 2nd dose Engerix B, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: received the Menveo vaccine / in her thigh; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 15-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA466A, expiry date 21st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Menveo vaccine in thigh,which led to vaccine administered at inappropriate site. No further events were reported at the time of the call. The reporter consented to follow up. The HCP consented to follow-up by email.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: BURNING PAIN IN THE CHEST AREA; HEADACHE; This spontaneous report received from a patient 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: unk) dose was not reported, administered on 28-JUL-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 burning pain in the chest area, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning pain in the chest area and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED VACCINE VIAL THAT OPENED MORE THAN 6 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a male 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: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced incorrect product storage. On 29-JUL-2021, the subject experienced administered vaccine vial that opened more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine vial that opened more than 6 hours and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER MORE THAN 12 HOURS OUTSIDE OF RECOMMENDED STORAGE AREA; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a male 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: Unknown) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-JUL-2021, the subject experienced vaccine administered after more than 12 hours outside of recommended storage area. On 30-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine administered after more than 12 hours outside of recommended storage area was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills
Clinical narrative: DEEP BONE PAIN IN LEGS; CHILLS; This spontaneous report received from a consumer concerned a 20 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 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUL-2021, the subject experienced deep bone pain in legs. On 30-JUL-2021, the subject experienced chills. Treatment medications (dates unspecified) included paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from deep bone pain in legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: SWEATING PROFUSELY; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the subject experienced sweating profusely. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sweating profusely. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE NOT STORED PROPERLY (LEFT AT ROOM TEMPERATURE FOR UNKNOWN AMOUNT OF TIME); PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned an adult 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: 1820096, expiry: 03-SEP-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced administration of vaccine not stored properly (left at room temperature for unknown amount of time). On 29-JUL-2021, the subject experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine not stored properly (left at room temperature for unknown amount of time) and product storage error was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Underdose
Clinical narrative: UNDER DOSE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 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, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced under dose. On 30-JUL-2021, the subject experienced product administered to subject of inappropriate age. On 30-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, off label use and under dose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Skin burning sensation
Clinical narrative: ACCIDENTAL EXPOSURE WHILE ADMINISTERING DRUG/ A SMALL AMOUNT OF VACCINE CAME IN CONTACT WITH FINGER; PERSISTENT BURNING SENSATION DUE TO VACCINE ACCIDENTAL EXPOSURE; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported 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 accidental exposure while administering drug/ a small amount of vaccine came in contact with finger, and persistent burning sensation due to vaccine accidental exposure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent burning sensation due to vaccine accidental exposure, and the outcome of accidental exposure while administering drug/ a small amount of vaccine came in contact with finger was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A BIT RUN DOWN BUT DID NOT LAST LONG; This spontaneous report received from a patient concerned a male 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced a bit run down but did not last long. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a bit run down but did not last long. This report was non-serious. This case, from the same reporter is linked to 20210801289.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Diplopia, Dizziness, Headache, Herpes zoster
Clinical narrative: SHINGLES ON STOMACH; DIZZY; DOUBLE VISION; VERY WEAK; MILD HEADACHE; PAINFUL SHOT; This spontaneous report received from a patient concerned a 79 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced painful shot. On 29-JUL-2021, the subject experienced shingles on stomach. On 29-JUL-2021, the subject experienced dizzy. On 29-JUL-2021, the subject experienced double vision. On 29-JUL-2021, the subject experienced very weak. On 29-JUL-2021, the subject experienced mild headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles on stomach, very weak, dizzy, double vision, mild headache and painful shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SHINGLES ON STOMACH; DIZZY; DOUBLE VISION; VERY WEAK; MILD HEADACHE; PAINFUL SHOT; This spontaneous report received from a patient concerned a 79 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced painful shot. On 29-JUL-2021, the subject experienced shingles on stomach. On 29-JUL-2021, the subject experienced dizzy. On 29-JUL-2021, the subject experienced double vision. On 29-JUL-2021, the subject experienced very weak. On 29-JUL-2021, the subject experienced mild headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles on stomach, very weak, dizzy, double vision, mild headache and painful shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: LIGHT FEVER; HEADACHE; LITTLE TIREDNESS; 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 was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 22-MAY-2021, the subject experienced light fever. On 22-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced little tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light fever, and headache on 22-MAY-2021, and little tiredness on 23-MAY-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: BAD SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a male 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bad side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad side effects was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hypokinesia, Myalgia, Tremor
Clinical narrative: BREATHING ISSUES; UNCONTROLLABLE SHAKING; CAN NOT MOVE ARMS; CHILLS; MUSCLES HURT; This spontaneous report received from a consumer concerned a 22 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, route of admin not reported, batch number: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced breathing issues. On 30-JUL-2021, the subject experienced uncontrollable shaking. On 30-JUL-2021, the subject experienced can not move arms. On 30-JUL-2021, the subject experienced chills. On 30-JUL-2021, the subject experienced muscles hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breathing issues, chills, uncontrollable shaking, can not move arms, and muscles hurt. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POTENTIALLY EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a male 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: not reported) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced potentially expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potentially expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Feeling abnormal, Injection site pain, Pain
Clinical narrative: SOME BODY ACHES; BRAIN FOG (ESSENTIALLY FELT LIKE YOU DO WHEN YOU'RE STARTING TO COME DOWN WITH SOMETHING); FELT A LITTLE COOL/CLAMMY; LITTLE SORENESS AT INJECTION SITE (LIKE REALLY MINISCULE); 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some body aches, brain fog (essentially felt like you do when you're starting to come down with something), felt a little cool/clammy, and little soreness at injection site (like really miniscule). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some body aches, brain fog (essentially felt like you do when you're starting to come down with something), little soreness at injection site (like really miniscule) and felt a little cool/clammy was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: ARM PAIN; HEADACHE; POSSIBLE FEVER THAT FELT HOT; PAIN IN BACK OF CALF AREA OF BOTH LEGS; This spontaneous report received from a patient concerned a 20 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, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced pain in back of calf area of both legs. On 30-JUL-2021, the subject experienced arm pain. On 30-JUL-2021, the subject experienced headache. On 30-JUL-2021, the subject experienced possible fever that felt hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and possible fever that felt hot on 30-JUL-2021, and had not recovered from pain in back of calf area of both legs, and arm pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED A DOSE OF VACCINE THAT WAS OPENED FOR 18 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced administered a dose of vaccine that was opened for 18 hours. On 29-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered a dose of vaccine that was opened for 18 hours and incorrect product storage was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: NUMBNESS AND TINGLING IN HANDS AND FEET WHICH WAS GETTING WORSE; This spontaneous report received from a pharmacist concerned a 64 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 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced numbness and tingling in hands and feet which was getting worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness and tingling in hands and feet which was getting worse. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hunger, Hyperhidrosis, Somnolence
Clinical narrative: SWEATS; EXTREMELY SLEEPY; HUNGRY; CHILLS; This spontaneous report received from a patient 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sweats, extremely sleepy, hungry, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweats, chills, extremely sleepy and hungry was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: MILD ACHINESS IN SHOULDERS; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 135 pounds, and height was 62 inches. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient is allergic to certain antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced mild achiness in shoulders. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild achiness in shoulders on 27-JUL-2021. This report was non-serious.