chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of Vaxelis; Patient was administered Kinrix on 04-JAN-22; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 7-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK receipt date: 4-May-2022 Reporter's comment: Medical assistant reported that the patient was administered Kinrix vaccine instead of the Vaxelis vaccine. The reporter consented to follow-up. Additional Supportive Information: The patient received Kinrix vaccine at an inappropriate age instead of Vaxelis vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administered Pediarix (4th dose) and Rotarix (3rd dose) extra doses to a 12 month old patient; Administered Pediarix (4th dose) and Rotarix (3rd dose) extra doses to a 12 month old patient; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number M4AR7, expiry date 6th July 2023) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th May 2022, the patient received the 4th dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 3rd dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 4th May 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered 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 Information: GSK receipt date: 04-MAY-2022 Reporter's comment: Registered Nurse (RN) enquired, how to proceed and asked for guidance, as on the day of reporting, they inadvertently administered Pediarix (4th dose) in left vastus lateralis and Rotarix (3rd dose) extra doses to a 1 year old patient. RN stated it was not supposed to administer the Pediarix and Rotarix. Consented to follow up. Additional Supportive Information: The 1 year old patient received 4th dose of Pediarix, which led to extra dose administered and 3rd dose of Rotarix, which led to extra dose administered and inappropriate age at vaccine administration.
Age: 59.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chills, Headache, Mobility decreased, Nausea, Spinal pain
Clinical narrative: to limit her mobility; Pain which she described as mid to low spinal pain; Headache; Chils; Nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On 2nd May 2022, the patient received the 1st dose of Shingrix and the 4th dose of COVID-19 VACCINE. On 2nd May 2022, 3 hrs after receiving Shingrix, the patient experienced headache, chills and nausea. On 3rd May 2022, the patient experienced pain in spine. On 4th May 2022, the patient experienced mobility decreased. On 3rd May 2022, the outcome of the headache, chills and nausea were recovered/resolved. On an unknown date, the outcome of the pain in spine and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, nausea, pain in spine and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix along with a 4th COVID booster shot. The patient noted that 3 hours post vaccination she developed headache, chills and nausea which did resolve by the following morning. One day after receiving vaccine, the patient developed a pain which she described as mid to low spinal pain at evening. She stated the pain was severe enough to limit her mobility the following day and has not yet resolved. The patient referred to the healthcare professional and provided medical advice disclaimer. It was unknown if the reporter considered the headache, chills, nausea, pain in spine and mobility decreased to be related to COVID-19 VACCINE . The reporter did not consent to follow-up. Note: The vaccination date and onset dates were discrepant in narrative. As per reported age and the data reported in structured field, we have considered vaccination and onset dates of May 2022. Clarification raised for same.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Gastrostomy
Clinical narrative: G-Tube was placed; This case was reported by a physician via call center representative and described the occurrence of gastrostomy tube insertion in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 7th January 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, less than 4 months after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced gastrostomy tube insertion. On an unknown date, the outcome of the gastrostomy tube insertion was unknown.   The reporter considered the gastrostomy tube insertion to be unrelated to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's comments: The patient received Rotarix orally at 2 months age. The gastrostomy tube was placed a couple of months before the date of reporting. The reporter stated that the placement of the gastrostomy tube was not related to the prior administration of Rotarix. Consented to follow up was given via postal. No lot number or expiry date available. No additional information was available at the time of the call.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Medication error, Product administered at inappropriate site
Clinical narrative: 1st dose on 21-oct-2021 and second dose was given 2nd dose past the 6 month timeframe; reporter was not confirm about 1st dose/possible delayed 2nd dose; 1st dose given it in the back of the arm; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number F5TT2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 21st October 2021, the patient received the 1st dose of Shingrix. On 21st October 2021, not applicable after receiving Shingrix and Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced drug dose administration interval too long and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the drug dose administration interval too long, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's comments: The reporter was administering Shingrix 2nd dose into the deltoid muscle of patient and the patient asked, why you gave it intramuscular, the last time it was given it in the back of the arm. The reporter could not confirm that the first dose was administered into the back of the arm (as it was administered at another facility), but the patient stated that it was (also patient did not stated that it was administered subcutaneously).  It was not verified with reporter when the 2nd dose was administered but possibly the patient received the 2nd dose past the 6 month timeframe. The reporter consented to follow up via postal. Lot number not identifying as a GSK (GlaxoSmithKline) vaccine when entered into the batch identifier and the reporter did not have an expiry date. Additional Supportive Information: The reporter was not sure about 1st dose administration site but as patient mentioned it was given back of arm, it led to vaccine administered to inappropriate site. Also, the 2nd dose was possibly given later than recommended timeframe, which was circumstance of information leading to medication error and if interval is incorrect, it would led to lengthening of vaccination schedule.
Age: 1.75
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 21 months old patient received a 4th dose; 21 months old patient received a 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 21-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date 17th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2022, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered 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 Information: GSK Receipt Date: 6-May-2022 Reporter's comments: The reporter consented to follow up. Additional Supportive Information: The patient received 4th dose of Pediarix at 21 month of age, which led to extra dose and inappropriate age at vaccine administration
Age: 69.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Vaccine had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old male patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) 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.   On 6th May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th May 2022, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 9-May-2022 Reporter's comments: The patient administered with Twinrix and the then noticed the vaccine had expired. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Twinrix beyond it's expiry, which led to expired vaccine used.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Ended up going to the hospital due to tachycardia; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tachycardia (serious criteria hospitalization). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.     Additional Information: GSK receipt date: 09-MAY-2022 Reporter's comment: The patient received the Shingrix vaccine in his left arm and ended up going to the hospital (no duration given for hospital stay) due to tachycardia.  The patient reported that the hospital had him take Benadryl and the tachycardia resolved after 2 weeks. The patient did add that he waited to report the adverse event until he received the hospital bill. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B virus test, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: Patient has non-immunity after 2 series; 2nd series, 3rd dose was given on 9th May 2022; 1st series: 1st 8/9/02, 2nd 2/14/03, 3rd 5/21/03; 1st series: 1st 8/9/02, 2nd 2/14/03, 3rd 5/21/03; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 6-month-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis, HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B PEDIATRIC) and HEPATITIS B VACCINE (ENGERIX B PEDIATRIC).   On 9th August 2002, the patient received the 1st dose of Engerix B pediatric. On 14th February 2003, the patient received the 2nd dose of Engerix B pediatric. On 21st May 2003, the patient received the 3rd dose of Engerix B pediatric. On 9th May 2022, the patient received the 6th dose of Engerix B pediatric. On 14th February 2003, not applicable after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, unknown after receiving Engerix B pediatric and not applicable after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, the patient experienced drug dose administration interval too long. On 21st May 2003, the patient experienced drug dose administration interval too long. On 9th May 2022, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long, drug dose administration interval too long and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: After 1st completed series, the immunity test was carried out and it showed, the patient had no-immunity. The 2nd series was started on 22nd December 2021, 2nd dose was given on 21st January 2022 and 3rd dose was administered on the reporting day. This was all of the reported information by the healthcare provider at this time. The patient's immunity was tested for higher education. The reporter consented to follow up. Additional Supportive Information: The patient had no  immunity for Hepatitis after complete primary series, which led to therapy non-responder. Also, the 2nd and 3rd doses of primary series were received late than the recommended interval, which led to lengthening of vaccination schedule. The patient started second series but the 3rd dose was received too early, which led to shortening of vaccination schedule.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 19-feb-2018, in the left arm, not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th February 2018, intramuscular in left arm).   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 Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The reporter was patient and reported he received his first Shingrix vaccine in pharmacy and he did not receive his second Shingrix vaccine. The patient was never told he needed to come back and get the second Shingrix vaccine in 2 to 6 months by the pharmacy. The patient did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received which led to incomplete course of vaccination. The case was linked with case US2022076281 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076281:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2018 not received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of the Shingrix vaccine in 2018 in an unknown arm intramuscularly ).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). 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 Information: Add GSK Receipt Date: 10-May-2022 Reporter's Comments: The reporter was patient's husband. The reporter reported that his wife received his first Shingrix vaccine and she did not receive his second Shingrix vaccine. The patient did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received which led to incomplete course of vaccination. The case has been linked with the case US2022076274 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076274:Same Reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient was accidently given expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number ag7m9, expiry date 6th May 2022) for prophylaxis.   On 10th May 2022, the patient received Shingrix (intramuscular) .5 ml. On 10th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The patient was accidently given expired SHINGRIX vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received expired SHINGRIX vaccine which led to expired vaccine used.
Age: 49.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bexsero in patient over 25 y/o; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The pharmacist reported that a patient received the Bexsero vaccine over the age of 25 year old. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Bexsero at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant component; received only the adjuvant component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 95B23, expiry date 6th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th December 2021).   On 10th May 2022, the patient received the 2nd dose of Shingrix. On 10th May 2022, 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 Information: Reporter's Comments: The nurse reported that a patient inadvertently received only the adjuvant component of Shingrix vaccine for her second dose. The invalid dose which was administered on the day of reporting reportedly had a lot number of 95B23 and an expiration of 06th July 2023. However, this did not match anything in salesforce, and the call was not recorded. The nurse declined to provide additional information due to time constraints. Additional information was not available. The reporter did not consent to follow up. Additional Supportive Information: The patient inadvertently received only the adjuvant component of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received vaccine IV; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2022, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On 11th May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comments: The pharmacist reported that patient received a dose of Boostrix vaccine intravenously instead of intramuscularly. The reporter consented to follow up. Additional Supportive Information: The use of Boostrix vaccine intravenously instead of intramuscularly, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received only one dose on 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2018).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comments: The pharmacist reported that patient only received first dose of Shingrix vaccine. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix below recommended temperature, subsequently administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 31st March 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Medical Assistant reported that, Boostrix went below recommended temperature range on 21st March 2022.  The lowest temperature was 30.2F.  The readings were then ranging from 32.9F to 41.8F.  The duration was 7 hr. 45 min.  A dose was subsequently administered on 31sr March 2022.  The reporter did not have lot number, expiration date, or patient information aside from initials.  Till the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error. This is one of five cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077006:Same reporter US-GLAXOSMITHKLINE-US2022077007:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter US-GLAXOSMITHKLINE-US2022077009:Same reporter
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 68 year female. Initial information was processed with the additional information received on 10-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild occasional asthma, and allergy. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 06-MAR-2021 for prophylactic vaccination.  Age at time of vaccination 67 years old. No concomitant medications were reported.  The patient additionally received Pfizer Biontech covid-19 vaccine (tozinameran, dose number in series 2) (form of administration, route of administration, batch number were not reported), dose was not reported, received on left arm on AUG-2021 for prophylactic vaccination. No adverse events reported after Pfizer Biontech covid-19 vaccine (dose number in series 2). Non-company suspect vaccine included Moderna covid-19 vaccine (elasomeran, dose number in series 3) (form of administration and route of administration were not reported, batch number LGH022887060) dose was not reported, received on left arm on 08-JAN-2022 for prophylactic vaccination.  On an unspecified date in 2022, the patient experienced COVID-19. It was reported as, five days after completing a five days treatment (from 17-APR-2022 to 21-APR-2022) with Paxlovid (nirmatrelvir and ritonavir) all symptoms disappeared and patient was tested negative. On 25-APR-2022, the symptoms reappeared and patient was tested positive ((confirmed covid-19 infection, dose number in series 3) and (confirmed clinical vaccination failure, dose number in series 1)).  The patient continued to test positive over four days and finally tested negative on 30-APR-2022 (5th day).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with elasomeran was not reported. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000230235.; Sender's Comments: V0: 20220517622-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Surgery, Thrombosis
Clinical narrative: BLEEDING; MULTIPLE SURGERIES; BLOOD CLOT IN THE LEFT LEG; This spontaneous report received from a patient concerned a 63 year female. The patient's height, and weight were not reported. The patient's past medical history included: surgery, and concurrent conditions included:  drug allergy (erythromycin, Ultram), non-alcohol user, and non-smoker, and patient did not use illicit drug or drug abuse. Patient took a lot of medications but nothing for the blood clot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAY-2021 on right arm for prophylactic vaccination. Age at time of vaccination 63 years old. No concomitant medications were reported.  Two days after vaccination on 21-MAY-2021, patient had surgery on left leg and then had the blood clot. Patient ended up on Heparin for a long time. Patient was in hospital for long time and had 4 surgeries and was at high risk and in wheelchair. Patient had the surgery started bleeding and had to do another surgery and rehab , and was on heparin for long time and went to the hospital for many times, after she left the hospital on 27-JUL-2021 started weening down on Heparin and went home. Patient had initial surgery on 7-MAY-2021 and another on 21-MAY-2021 then on 16-JUN-2021 and 15-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in the left leg, and the outcome of multiple surgeries and bleeding was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220520075-Covid-19 vaccine ad26.cov2.s-Blood clot in the left leg, Multiple surgeries. The event(s) 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(s). Therefore, this event(s) is considered unassessable. V0:20220520075-Covid-19 vaccine ad26.cov2.s Bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS(HEPARIN). Therefore, this event(s) is considered not related.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 5 decade old male of unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was was 44 years old at the time of his primary vaccination. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 04-FEB-2022) dose was not reported, 1 total, administered on 12-MAR-2021 for an prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received additionally  booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, 1 total administered on 08-NOV-2021 for prophylactic vaccination. Age at time of vaccination 45 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid symptoms which include slight nasal congestion with an occasional cough (suspected covid-19 infection) (dose number in series 2). On 10-MAY-2022, the patient tested positive through COVID-19 antigen test (Binax) which led to suspected clinical vaccination failure (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220523971-covid-19 vaccine ad26. cov2.s-suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: LIGHTHEADEDNESS/DIZZY; This spontaneous report received from a patient concerned an adult female with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received two doses of non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 1) (form of admin unknown, intramuscular, batch number was not reported), dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse reaction following vaccination with primary vaccination (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number and expiration date were unknown) dose was not reported,1 total administered on unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced lightheadedness/dizzy (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tozinameran, and adalimumab was not reported. The patient had not recovered from lightheadedness/dizzy. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Rhinorrhoea, SARS-CoV-2 test, Urine analysis
Clinical narrative: Started to lose hair after getting first dose of the vaccine.; Runny nose after getting the first dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H271A) for COVID-19 vaccination.     Patient was never diagnosed or tested positive for COVID-19. Patient does not have any acute illness at the time of vaccination or one month before.  The patient's past medical history included Carpal tunnel syndrome in January 2022, Dizziness (no recent changes) in 2017 and Surgery in January 2022. Concurrent medical conditions included Penicillin allergy (Patient was allergic since she was a kid.), Allergy to NSAIDs (Patient was allergic since she was a kid.), Heartbeats irregular (Since patient was a kid.), Allergy to NSAIDs (Ibuprofen), Cervical disc degeneration (no recent changes) since 2015, Cardiac murmur (no recent changes) since 2018, Vitamin D deficiency, Hypertension and Neck pain. Concomitant products included METOPROLOL for Hypertension, GABAPENTIN, OXYCODONE and TRAMADOL for Neck pain, VITAMIN D NOS for Vitamin D deficiency.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2021, the patient experienced ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.). On 23-Dec-2021, RHINORRHOEA (Runny nose after getting the first dose of vaccine.) had resolved. At the time of the report, ALOPECIA (Started to lose hair after getting first dose of the vaccine.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood test: normal (normal) Normal. In January 2022, SARS-CoV-2 test: negative (Negative) Negative. In January 2022, Urine analysis: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No vaccine received 1 month prior to Moderna Covid-19 Vaccine. Patient did not experienced similar events in the past. Patient mentioned that they do not have any family history of hair loss. No treatment information was provided.   This case was linked to MOD-2022-553114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow up received reporter added, medical history, concomitant medications and vaccine route of administration added. Indication of concomitant drugs also updated
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022; patient received an expired dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow up received contain significant information. Patient demographics added and narrative updated. On 11-May-2022: Follow-up received contain no significant information. On 11-May-2022: Significant follow-up appended- Date on which vial was removed from refrigeration updated.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of administered expired product (received dose post-punctured for over 12 hours) and product storage error (dose punctured for over 12 hours) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (received dose post-punctured for over 12 hours) and product storage error (dose post-punctured for over 12 hours). At the time of the report, administered expired product (received dose post punctured for over 12 hours) and product storage error (dose punctured for over 12 hours) outcome: unknown.  No concomitant medication or treatment information provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022; Patients received an expired dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose of the Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was confirmed that the product had not undergone any temperature excursion issue.  Vial was stored in the refrigerator less than a month.  No treatment medication was reported.   This case was linked to MOD-2022-560455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow up received, contains patient details, dose number and current condition were added. On 11-May-2022: Follow up received, contains no new information. On 11-May-2022: Follow up received contains, I-narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: Brain injury, Magnetic resonance imaging
Clinical narrative: Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN INJURY (Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced BRAIN INJURY (Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory) (seriousness criterion medically significant). At the time of the report, BRAIN INJURY (Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: have brain damage shown in several mri have brain damage shown in several MRI.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Brain injury (Have brain damage shown in several MRI), that occurred on an unknown date after receiving a dose of mRNA-1273 vaccine (latency between vaccine and event cannot be established).  Patient developed memory impairment for which several magnetic resonance imaging done reportedly showed brain damage with no identifiable cause. The event was resolving at the time of report.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Brain injury (Have brain damage shown in several MRI), that occurred on an unknown date after receiving a dose of mRNA-1273 vaccine (latency between vaccine and event cannot be established).  Patient developed memory impairment for which several magnetic resonance imaging done reportedly showed brain damage with no identifiable cause. The event was resolving at the time of report.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.