chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: COVID19, FLUA4, COVID19, FLUC3
Symptoms: Urticaria
Clinical narrative: Hives; Flucelvax Quadrivalent and Covid-19 vaccine were both administered on the same date in the same arm; This spontaneous case was retrieved on 13-Nov from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2696328-1) reported by other healthcare professional and concerned a 14-year-old male patient.  The patient's medical history and concomitant medications were not reported.   On 11-oct-2023, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'one', route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was H09835.  It was reported that on the same date, the patient was vaccinated with  Fluad Quadrivalent (influenza vaccine inact sag 4v;route of administration: intramuscular; anatomical location: right arm; dose and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 370659. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product  Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On 12-Oct-2023, one day after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced hives.  The outcome of the event hives was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The event of hives is assessed as possibly related to Flucelvax Quadrivalent, due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.; Sender's Comments: The event of hives is assessed as possibly related to Flucelvax Quadrivalent, due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.
Age: 14.0
Sex: M
Vaccine: COVID19, FLUA4, COVID19, FLUC3
Symptoms: Product administration error, Urticaria
Clinical narrative: Hives; Flucelvax Quadrivalent and Covid-19 vaccine were both administered on the same date in the same arm; This spontaneous case was retrieved on 13-Nov from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2696328-1) reported by other healthcare professional and concerned a 14-year-old male patient.  The patient's medical history and concomitant medications were not reported.   On 11-oct-2023, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'one', route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was H09835.  It was reported that on the same date, the patient was vaccinated with  Fluad Quadrivalent (influenza vaccine inact sag 4v;route of administration: intramuscular; anatomical location: right arm; dose and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 370659. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product  Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On 12-Oct-2023, one day after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced hives.  The outcome of the event hives was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The event of hives is assessed as possibly related to Flucelvax Quadrivalent, due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.; Sender's Comments: The event of hives is assessed as possibly related to Flucelvax Quadrivalent, due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.
Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blister, Contusion, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: caller noticed that the site of the vaccination was now black and necrotic; she had a bruise on the arm where the vaccine was administered; caller noticed that the site of the vaccination was now black and necrotic; she experienced the normal soreness in her arm from the injection needle; she developed a blister and the blister got opened up by her clothing; This serious case was reported by a consumer via call center representative and described the occurrence of injection site necrosis in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-OCT-2023, the patient received Arexvy. On 09-OCT-2023, 4 days after receiving Arexvy, the patient experienced injection site necrosis (Verbatim: caller noticed that the site of the vaccination was now black and necrotic) (serious criteria GSK medically significant), injection site bruising (Verbatim: she had a bruise on the arm where the vaccine was administered), injection site discoloration (Verbatim: caller noticed that the site of the vaccination was now black and necrotic), pain in arm (Verbatim: she experienced the normal soreness in her arm from the injection needle) and blister (Verbatim: she developed a blister and the blister got opened up by her clothing). The outcome of the injection site necrosis, injection site bruising, injection site discoloration, pain in arm and blister were not resolved.   It was unknown if the reporter considered the injection site necrosis, injection site bruising, injection site discoloration and blister to be related to Arexvy. The reporter considered the pain in arm to be related to Arexvy.   It was unknown if the company considered the injection site necrosis, injection site bruising, injection site discoloration and blister to be related to Arexvy. The company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-NOV-2023 and 15-NOV-2023 The reporter stated that after she received the RSV vaccine and she experienced the normal soreness in her arm from the injection needle.  Four days later caller said that she had a bruise on the arm where the vaccine was administered.  After the bruise, she developed a blister and the blister got open up by her clothing. Once the blister was opened, caller noticed that the site of the vaccination was now black and necrotic. The reporter had been to the emergency room twice and was referred by one of the doctors at the emergency room to go see a plastic surgeon.  The pharmacist that administered the vaccine and the caller's husband both had photographs of the caller's arm that was affected.  The reporter was open to being contacted and providing the photographs if necessary. ER (emergency visit) required. The reporter consented to follow up. The case US2023157855 was found to be duplicate of case US2023157864. Hence case US2023157864 would be deleted and all the information of this case would be added in case US2023157855 which was the case of record for this patient.
Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blister, Blister rupture, Injection site pain, Pain in extremity, Vaccination site bruising
Clinical narrative: caller noticed that the site of the vaccination was now black and necrotic; she had a bruise on the arm where the vaccine was administered; caller noticed that the site of the vaccination was now black and necrotic; she experienced the normal soreness in her arm from the injection needle; she developed a blister and the blister got opened up by her clothing; This serious case was reported by a consumer via call center representative and described the occurrence of injection site necrosis in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-OCT-2023, the patient received Arexvy. On 09-OCT-2023, 4 days after receiving Arexvy, the patient experienced injection site necrosis (Verbatim: caller noticed that the site of the vaccination was now black and necrotic) (serious criteria GSK medically significant), injection site bruising (Verbatim: she had a bruise on the arm where the vaccine was administered), injection site discoloration (Verbatim: caller noticed that the site of the vaccination was now black and necrotic), pain in arm (Verbatim: she experienced the normal soreness in her arm from the injection needle) and blister (Verbatim: she developed a blister and the blister got opened up by her clothing). The outcome of the injection site necrosis, injection site bruising, injection site discoloration, pain in arm and blister were not resolved.   It was unknown if the reporter considered the injection site necrosis, injection site bruising, injection site discoloration and blister to be related to Arexvy. The reporter considered the pain in arm to be related to Arexvy.   It was unknown if the company considered the injection site necrosis, injection site bruising, injection site discoloration and blister to be related to Arexvy. The company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-NOV-2023 and 15-NOV-2023 The reporter stated that after she received the RSV vaccine and she experienced the normal soreness in her arm from the injection needle.  Four days later caller said that she had a bruise on the arm where the vaccine was administered.  After the bruise, she developed a blister and the blister got open up by her clothing. Once the blister was opened, caller noticed that the site of the vaccination was now black and necrotic. The reporter had been to the emergency room twice and was referred by one of the doctors at the emergency room to go see a plastic surgeon.  The pharmacist that administered the vaccine and the caller's husband both had photographs of the caller's arm that was affected.  The reporter was open to being contacted and providing the photographs if necessary. ER (emergency visit) required. The reporter consented to follow up. The case US2023157855 was found to be duplicate of case US2023157864. Hence case US2023157864 would be deleted and all the information of this case would be added in case US2023157855 which was the case of record for this patient.
Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Vaccination site discolouration, Vaccination site necrosis
Clinical narrative: caller noticed that the site of the vaccination was now black and necrotic; she had a bruise on the arm where the vaccine was administered; caller noticed that the site of the vaccination was now black and necrotic; she experienced the normal soreness in her arm from the injection needle; she developed a blister and the blister got opened up by her clothing; This serious case was reported by a consumer via call center representative and described the occurrence of injection site necrosis in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-OCT-2023, the patient received Arexvy. On 09-OCT-2023, 4 days after receiving Arexvy, the patient experienced injection site necrosis (Verbatim: caller noticed that the site of the vaccination was now black and necrotic) (serious criteria GSK medically significant), injection site bruising (Verbatim: she had a bruise on the arm where the vaccine was administered), injection site discoloration (Verbatim: caller noticed that the site of the vaccination was now black and necrotic), pain in arm (Verbatim: she experienced the normal soreness in her arm from the injection needle) and blister (Verbatim: she developed a blister and the blister got opened up by her clothing). The outcome of the injection site necrosis, injection site bruising, injection site discoloration, pain in arm and blister were not resolved.   It was unknown if the reporter considered the injection site necrosis, injection site bruising, injection site discoloration and blister to be related to Arexvy. The reporter considered the pain in arm to be related to Arexvy.   It was unknown if the company considered the injection site necrosis, injection site bruising, injection site discoloration and blister to be related to Arexvy. The company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-NOV-2023 and 15-NOV-2023 The reporter stated that after she received the RSV vaccine and she experienced the normal soreness in her arm from the injection needle.  Four days later caller said that she had a bruise on the arm where the vaccine was administered.  After the bruise, she developed a blister and the blister got open up by her clothing. Once the blister was opened, caller noticed that the site of the vaccination was now black and necrotic. The reporter had been to the emergency room twice and was referred by one of the doctors at the emergency room to go see a plastic surgeon.  The pharmacist that administered the vaccine and the caller's husband both had photographs of the caller's arm that was affected.  The reporter was open to being contacted and providing the photographs if necessary. ER (emergency visit) required. The reporter consented to follow up. The case US2023157855 was found to be duplicate of case US2023157864. Hence case US2023157864 would be deleted and all the information of this case would be added in case US2023157855 which was the case of record for this patient.
Age: 36.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: Exposure to AREXVY during pregnancy; 36 years old patient received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X723B, expiry date 08-DEC-2024) for prophylaxis.   On 29-SEP-2023, the patient received Arexvy (left arm). On 29-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 36 years old patient received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Exposure to AREXVY during pregnancy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 13-Nov-2023 The reporter reported that the pregnant woman patient received Arexvy vaccine, which led to vaccine exposure during pregnancy. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did consent to follow up.
Age: 36.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Exposure to AREXVY during pregnancy; 36 years old patient received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X723B, expiry date 08-DEC-2024) for prophylaxis.   On 29-SEP-2023, the patient received Arexvy (left arm). On 29-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 36 years old patient received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Exposure to AREXVY during pregnancy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 13-Nov-2023 The reporter reported that the pregnant woman patient received Arexvy vaccine, which led to vaccine exposure during pregnancy. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did consent to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Joint swelling, Muscle spasms, Urticaria
Clinical narrative: Welts the same day as vaccine.  1 week after the vaccine she developed leg weakness. She also had knee tightness with trouble bending and hips locked up. She also complains of muscle cramping.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Inflammatory marker test, Joint lock, Joint stiffness, Muscle spasms, Muscular weakness
Clinical narrative: Welts the same day as vaccine.  1 week after the vaccine she developed leg weakness. She also had knee tightness with trouble bending and hips locked up. She also complains of muscle cramping.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Ultrasound Doppler, Urticaria
Clinical narrative: Welts the same day as vaccine.  1 week after the vaccine she developed leg weakness. She also had knee tightness with trouble bending and hips locked up. She also complains of muscle cramping.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Pt was waiting in the exam room for the after vaccine period of observation. Pt reported at 1:20 pm (APPROXIMATELY six minutes after sitting in the room), that he had some numbness in his tongue and swelling of his lips. There was no prior history of this happening before. Pt was brought into the exam room and had a set of vitals taken with a quick examination. The mother of the patient expressed concern for the swelling in his lips. Patient was evaluated and given 50 mg of diphenhydramine.  Vitals were taken every 5-10 minutes.  Symptoms resolved about 20 minutes after the antihistamine was given. Patient obsrved for an hour.  No vital signs concerns.  No other symptoms.  Discharge instructions provided. No questions. Has remaining diphenydramine at release. Normal vitals. No problem breathing, swallowing and had resolution of his lip edema and tongue sensation concern resolved. Follow up if ANY concerns. HA are aware and will check with the patient later. D/C to home.
Age: 26.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Axillary mass, Injection site erythema, Injection site swelling
Clinical narrative: Enlarged red mark and swelling at injection site. Lump in armpit on the same arm
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Flank pain, Gait disturbance, Headache
Clinical narrative: Severe vomiting began on 11/17 approximately every six hours and continued on 11/18 and less severe on 11/19.  Initially vomit was food, digested food, then bile then the last day clear liquid.  Headache from 11/17 - 11/20.   Weak and bedridden.  Of course no appetite.  Felt awful.  Some diarrhea starting 11/18-11/21  as well.  Pain in the left flank.   Tried to make myself sip water every now and then.   Tried to go out for a walk on 11/19 and I could barely get around.  Finally improved the evening of 11/21 began to get better.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vomiting
Clinical narrative: Severe vomiting began on 11/17 approximately every six hours and continued on 11/18 and less severe on 11/19.  Initially vomit was food, digested food, then bile then the last day clear liquid.  Headache from 11/17 - 11/20.   Weak and bedridden.  Of course no appetite.  Felt awful.  Some diarrhea starting 11/18-11/21  as well.  Pain in the left flank.   Tried to make myself sip water every now and then.   Tried to go out for a walk on 11/19 and I could barely get around.  Finally improved the evening of 11/21 began to get better.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Chest X-ray, Chills, Dyspnoea, Erythema
Clinical narrative: Had initial red arm, fever,HA, chills day one.  Then resolved.  Then 11 days later developed full body urticaria and SOB/fatigue that is ongoing.  Severe symptoms with poor response thus far to treatment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Headache, Metabolic function test, Pyrexia
Clinical narrative: Had initial red arm, fever,HA, chills day one.  Then resolved.  Then 11 days later developed full body urticaria and SOB/fatigue that is ongoing.  Severe symptoms with poor response thus far to treatment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test, Troponin, Urticaria
Clinical narrative: Had initial red arm, fever,HA, chills day one.  Then resolved.  Then 11 days later developed full body urticaria and SOB/fatigue that is ongoing.  Severe symptoms with poor response thus far to treatment.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE; HCP calling to report an AE regarding PNEUMOVAX 23. HCP reported that a patient was administered an expired dose of the PNEUMOVAX 23 vaccine. HCP provided limited pertinent information and had no further clarifications. Permission was provided to con; Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-OCT-2023, the patient was vaccinated with and expire dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W021636, expiration date: 01-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The reporter provided limited pertinent information and had no further clarifications.
Age: 0.33
Sex: F
Vaccine: MMR, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately approximately 4-month-old (also repotred as 5-month-old) female patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 22-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event). On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours.       This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002927: US-009507513-2311USA002932: US-009507513-2311USA002931: US-009507513-2311USA002929: US-009507513-2311USA002930:
Age: 0.17
Sex: M
Vaccine: MMR, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for  ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for GARDASIL 9, ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately 2-month-old (also reported as 3-month-old) male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours. On this date, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002927: US-009507513-2311USA002928: US-009507513-2311USA002932: US-009507513-2311USA002931: US-009507513-2311USA002930:
Age: 1.08
Sex: F
Vaccine: MMR, RV5
Symptoms: Product storage error
Clinical narrative: HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to a 13-month-old female patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours. On 11-OCT-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided), (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA002931: US-009507513-2311USA002932: US-009507513-2311USA002927: US-009507513-2311USA002928: US-009507513-2311USA002929: US-009507513-2311USA002930:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report that a dose of VARIVAX was given on 11/16/2023, to a 2-month and 7-day old male patient. HCP reports no signs or symptoms are present in the patient, and that the patient is no longer in the office. HCP gives permission to contac; HCP called to report that a dose of VARIVAX was given on 11/16/2023, to a 2-month and 7-day old male patient. HCP reports no signs or symptoms are present in the patient, and that the patient is no longer in the office. HCP gives permission to contac; This spontaneous report was received from a nurse referring to a 2-month-old male patient.   The patient's medical history and current conditions were not reported.   On 16-NOV-2023, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/once, lot #X017487 (lot verified), expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). On the same date, pneumococcal vaccine conj 7v (CRM197) (PREVNAR) (formulation, strength, dose, lot #, expiry date, and route of administration were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (formulation, strength, dose, lot #, expiry date, and route of administration were not reported) were also given to the patient. No signs or symptoms were reported in the patient at the moment of the visit at the office (No adverse event).   At the time of reporting, the outcome of the events was unknown.
Age: 0.5
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The caller confirmed no adverse effects were noted; The HCP reported that a 6month old patient inadvertently received a dose of VARIVAX; This spontaneous report was received from a other health professional (nurse) referring to an 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapy were not reported.   On 16-NOV-2023, the 6-month-old patient was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection administered 0.5 mL once for prophylaxis (strength, route of administration, lot#, expiration date and anatomical location was not reported) (product administered to patient of inappropriate age). No adverse effects were noted after the adverse event occurred (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Musculoskeletal stiffness, Tenderness
Clinical narrative: Pain in joint involving hand; joints are swelling; my husband has to rub my hands because they are so sore; my husband has to rub my hands because they are so stiff; This non-serious case was reported by a consumer and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced joint pain (Verbatim: Pain in joint involving hand), swollen joints (Verbatim: joints are swelling), pain in hand (Verbatim: my husband has to rub my hands because they are so sore) and limbs stiffness (Verbatim: my husband has to rub my hands because they are so stiff). The outcome of the joint pain and swollen joints were not resolved and the outcome of the pain in hand and limbs stiffness were not reported.   It was unknown if the reporter considered the joint pain, swollen joints, pain in hand and limbs stiffness to be related to Shingles vaccine.     It was unknown if the company considered the joint pain, swollen joints, pain in hand and limbs stiffness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-NOV-2023 The reporter reported that she received the Shingles vaccine, and she had severe pain in all of the joints of both of her hands. At the reporting time the patient's joints were swelling and her physician told her it must be related to her receiving the vaccine. Patient woke up in the morning and her husband had to rub her hands because they were so sore and stiff. Reporter asked question what was going on, she was very concerned, and she requested to call her.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hot flush, Nasopharyngitis
Clinical narrative: pain at previous surgery sites (2 shoulder surgeries for torn bicep); cold; hot flashes; joint pain; headache; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), HOT FLUSH (hot flashes), ARTHRALGIA (joint pain), HEADACHE (headache) and ARTHRALGIA (pain at previous surgery sites (2 shoulder surgeries for torn bicep)) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 209F232A) for COVID-19 prophylaxis.     The patient's past medical history included Torn muscle (torn bicep) and Surgery (2 shoulder surgeries for torn bicep).    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Nov-2023, the patient experienced NASOPHARYNGITIS (cold), HOT FLUSH (hot flashes), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced ARTHRALGIA (pain at previous surgery sites (2 shoulder surgeries for torn bicep)). On 12-Nov-2023, NASOPHARYNGITIS (cold), HOT FLUSH (hot flashes), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, ARTHRALGIA (pain at previous surgery sites (2 shoulder surgeries for torn bicep)) outcome was unknown.      Concomitant and treatment medications were not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Dizziness, Headache
Clinical narrative: stomach pain; weakness; dizziness; chills; headache; slight fever; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 208523-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (Lot number 1808609) on 23-Mar-2021 and Moderna (Lot number 213021A) on 19-Nov-2021; for Product used for unknown indication: RSV and Flu. Past adverse reactions to the above products included No adverse event with Flu, Moderna, Moderna and RSV.    On 12-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023 at 2:30 AM, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and PYREXIA (slight fever). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Stomach pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and PYREXIA (slight fever) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The symptoms was lasted 12 hours.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stomach pain; weakness; dizziness; chills; headache; slight fever; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 208523-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (Lot number 1808609) on 23-Mar-2021 and Moderna (Lot number 213021A) on 19-Nov-2021; for Product used for unknown indication: RSV and Flu. Past adverse reactions to the above products included No adverse event with Flu, Moderna, Moderna and RSV.    On 12-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023 at 2:30 AM, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and PYREXIA (slight fever). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Stomach pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and PYREXIA (slight fever) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The symptoms was lasted 12 hours.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hip fracture, Pneumonia
Clinical narrative: broke a hip; pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Lot number: FD0809) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: on COPD medication; "anxiety" (ongoing), notes: on anti anxiety medication; "blood pressure" (ongoing), notes: on blood pressure medication. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single. Vaccination history included: bnt162b2 (DOSE 2, SINGLE), administration date: 06Apr2021, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE, Expiry date: 31Jul2021), for COVID-19 immunisation. The following information was reported: HIP FRACTURE (hospitalization, medically significant) with onset 2023, outcome "unknown", described as "broke a hip"; PNEUMONIA (hospitalization) with onset 2023, outcome "unknown". The patient was hospitalized for hip fracture, pneumonia (start date: 10Nov2023). Therapeutic measures were taken as a result of hip fracture. Clinical course: Caller asked if being in the hospital should he take the fourth dose of the vaccine. Caller said he has COPD, he has been in the hospital twice and broke a hip a month a half ago. Caller currently in hospital for pneumonia, that he had about a week before being admitted to hospital, the symptoms were not as bad. Carries oximeter, his numbers just crashed, went way down. Clarified, he was admitted to hospital 10Nov2023. Had hip surgery about a month and a half ago, they put his hip back together. Patient was currently on COPD medication, anti anxiety medication, blood pressure medication. Prior vaccination included flu shot and pneumonia shot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300372632 same reporter/patient, different dose/event;
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "Lupus nephritis" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL SULFATE, start date: Mar2008; IMURAN [AZATHIOPRINE], start date: Feb2016; METOPROLOL, start date: May2017; BENLYSTA, start date: May2021. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Dilaudid, reaction(s): "Known allergies: Dilaudid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Oct2023 to 04Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370240 same patient, different drug;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arachnoid cyst, Blood test, Magnetic resonance imaging, Migraine, Primary stabbing headache
Clinical narrative: Arachnoid cyst/Brain cysts have now developed; migraines; "ice pick" headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: 6J3275) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EM9810, Anatomical location: Left arm), administration date: 26May2021, for Covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EM9810, Anatomical location: Left arm), administration date: 16Jun2021, for Covid-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FD7218, Anatomical location: Left arm), administration date: 06Jan2022, for Covid-19 immunisation. The following information was reported: ARACHNOID CYST (disability, medically significant), outcome "not recovered", described as "Arachnoid cyst/Brain cysts have now developed"; MIGRAINE (disability, medically significant), outcome "not recovered", described as "migraines"; PRIMARY STABBING HEADACHE (disability, medically significant), outcome "not recovered", described as ""ice pick" headaches". The events "arachnoid cyst/brain cysts have now developed", "migraines" and ""ice pick" headaches" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Negative; Magnetic resonance imaging: Cleared; SARS-CoV-2 test: Negative. It was unknown if therapeutic measures were taken as a result of arachnoid cyst, migraine, primary stabbing headache. Clinical course: Brain cysts had now developed to the patient. She had migraines and had have clear MRI scans prior to vaxxing. She kept a journal "after vaxxing" and She complained of headaches. lasting a week or two after vaxxing. Now she had been diagnosed with "ice pick" headaches in addition to migraines after vaxxing also brain cysts. Patient had no covid prior to vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Arachnoid cyst/Brain cysts have now developed; migraines; "ice pick" headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: 6J3275) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EM9810, Anatomical location: Left arm), administration date: 26May2021, for Covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EM9810, Anatomical location: Left arm), administration date: 16Jun2021, for Covid-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FD7218, Anatomical location: Left arm), administration date: 06Jan2022, for Covid-19 immunisation. The following information was reported: ARACHNOID CYST (disability, medically significant), outcome "not recovered", described as "Arachnoid cyst/Brain cysts have now developed"; MIGRAINE (disability, medically significant), outcome "not recovered", described as "migraines"; PRIMARY STABBING HEADACHE (disability, medically significant), outcome "not recovered", described as ""ice pick" headaches". The events "arachnoid cyst/brain cysts have now developed", "migraines" and ""ice pick" headaches" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Negative; Magnetic resonance imaging: Cleared; SARS-CoV-2 test: Negative. It was unknown if therapeutic measures were taken as a result of arachnoid cyst, migraine, primary stabbing headache. Clinical course: Brain cysts had now developed to the patient. She had migraines and had have clear MRI scans prior to vaxxing. She kept a journal "after vaxxing" and She complained of headaches. lasting a week or two after vaxxing. Now she had been diagnosed with "ice pick" headaches in addition to migraines after vaxxing also brain cysts. Patient had no covid prior to vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She had two initial shots of Pfizer vaccine and no issues. Had first booster in Jan2022. All have been Pfizer; She had two initial shots of Pfizer vaccine and no issues. Had first booster in Jan2022. All have been Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She had two initial shots of Pfizer vaccine and no issues. Had first booster in Jan2022. All have been Pfizer". Clinical course: She had two initial shots of Pfizer vaccine and no issues. Had first booster in Jan2022. All had been Pfizer. Not had any boosters after that. Not had Covid at all until a couple of months ago and she got Covid. She never had any problem with that or trouble breathing.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370259 same patient, different dose/AE.;