chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, HEP, HEPA
Symptoms: Circumstance or information capable of leading to medication error, Product storage error
Clinical narrative: influenza, hep a, and hep b vaccines were exposed to a low temperature; possible vaccines were administered after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine, Hepatitis A vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis A vaccine and Influenza vaccine, the patient experienced incorrect storage of drug (Verbatim: influenza, hep a, and hep b vaccines were exposed to a low temperature) and circumstance or information capable of leading to medication error (Verbatim: possible vaccines were administered after temperature excursion).  The outcome of the incorrect storage of drug and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The pharmacist reported that the vaccines were exposed to a low temperature of minus 0.7 C on the day of reporting at 10:40 am.  The reporter stated that these were GlaxoSmithKline vaccines but was not able to confirm brand name at time of call.  The reporter stated that it was possible these vaccines were administered after the temperature excursion in an employee health setting, but she did not know this for certain.  She did not have any patient information or further details available at time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. Influenza, Hepatitis A and Hepatitis B vaccines were possibly administered after temperature excursion, which led to incorrect storage of drug and circumstance or information capable of leading to medication error.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose if it was administered before the 2 month period to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 28-JUL-2023, the patient received the 2nd dose of Shingrix. On 28-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: second dose if it was administered before the 2 month period to a patient).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 A pharmacist called in to request information about the validity of a second dose if it was administered before the 2-month period to a patient. The patient received 2nd dose before recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: couple of patients who are past the 2-6 month window for the 2nd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: couple of patients who are past the 2-6 month window for the 2nd dose of Shingrix).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The pharmacist stated that there were a couple of patients who were past the 2 to 6 month window for the 2nd dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter did not have any patient or additional details at this time.  The reporter consented to follow-up via postal. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received only diluent component of Shingrix, without the powder; received only diluent component of Shingrix, without the powder; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number NJ75B, expiry date 21-AUG-2024) for prophylaxis.   On 03-OCT-2023, the patient received Shingrix. On 03-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only diluent component of Shingrix, without the powder) and inappropriate dose of vaccine administered (Verbatim: received only diluent component of Shingrix, without the powder).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 3-Oct-2023 The case was received from the medical assistant. The reporter consented to follow-up via email. The patient only received diluent component of shingrix without powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose of Shingrix was administered today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14-SEP-2023) for prophylaxis.   On 03-OCT-2023, the patient received the 1st dose of Shingrix. On 03-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of Shingrix was administered today).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 3-Oct-2023 The case was received from the medical assistant. Initials were not provided during call. The reporter consented to follow-up via email. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain, Product administered at inappropriate site
Clinical narrative: developed pain after the administration; dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint; dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 922yf, expiry date 07-MAY-2025) for prophylaxis.   On 29-SEP-2023, the patient received the 2nd dose of Shingrix. On 29-SEP-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint) and vaccine administered at inappropriate site (Verbatim: dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint). On an unknown date, the patient experienced pain (Verbatim: developed pain after the administration).  The outcome of the pain was not reported and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK receipt date: 3-Oct-2023 Pharmacist reported that the patient developed pain after the administration. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up. The patient received a dose of Shingrix and the dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missing 2nd dose by 1 year; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missing 2nd dose by 1 year).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 3-Oct-2023 The case was reported by the physician. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Choking, Hypotonia, Immediate post-injection reaction, Oral administration complication, Wrong technique in product usage process
Clinical narrative: Choked on vaccine during administration; limp; Wrong technique in drug usage process; This serious case was reported by a nurse via call center representative and described the occurrence of choking in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   On 02-OCT-2023, the patient received Rotarix lyophilized formulation (oral). On 02-OCT-2023, immediately after receiving Rotarix lyophilized formulation, the patient experienced choking (Verbatim: Choked on vaccine during administration) (serious criteria GSK medically significant), limping (Verbatim: limp) and wrong technique in drug usage process (Verbatim: Wrong technique in drug usage process). On 02-OCT-2023, the outcome of the choking and limping were resolved.The outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the choking and limping to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the choking and limping to be related 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: 03-OCT-2023 and 04-OCT-2023 The reporter reported that baby choked during administration of Rotarix.  Prior to administration baby was not crying and during the last bit of Rotarix started choking, went completely limp and the baby recovered after 1-2 minutes, mom fed baby and CNA was able to give rest of vaccine, which led to wrong technique in drug usage process. The reporter grabbed baby and ran to the provider to determine if baby was holding breath and the baby was not.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2023136408, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023136408:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Arthralgia, Discomfort, Myalgia, Sleep disorder
Clinical narrative: Muscle and joint pain; Muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (had covid earlier this year in July and it wasn't as bad as what is experiencing with the shot. Covid was longer lasting then the vaccine symptoms.).    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain). At the time of the report, ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain) outcome was unknown.            Concomitant medications were not reported. Treatment medication for muscle and joint pain was not reported.  Patient had Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) (Pfizer's latest covid 19 vaccine), it's the XBB 1.5 Pfizer's newest one, Lot no. HG 4432 vaccination card states received it on October 2nd, but actually received it on October 1st, 2023.  Patient had severe muscle and joint pain that night when received the vaccine. Monday morning patient started having the reaction and at 4 o'clock in the morning it woke patient up, and it was so bad. Patient had similar reactions to Moderna as well, but this was more severe. Patient stated that the side effect of the vaccine, it was very mild now. Patient took Tylenol to keep it under control, it was a lot less than it was yesterday. Patient does not feel comfortable, and it wakes patient up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hyposmia
Clinical narrative: Approximately 48 hours after vaccination, I began to experience a substantial reduction in my ability to smell. In particular, my ability to smell retronasally (i.e. to detect aromas while eating and drinking) is diminished. 12 days later, I'm still experiencing this form of hyposmia.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Gait inability, Head discomfort, Muscle strength abnormal, Pain in extremity
Clinical narrative: Extreme blurry vision, no strength in muscles to where need to crawl, head pressure, chills, pain down entire arm but no redness or soreness at injection site
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Extreme blurry vision, no strength in muscles to where need to crawl, head pressure, chills, pain down entire arm but no redness or soreness at injection site
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Woke up with dizziness in the morning, felt like the room was spinning along with nausea. Subsided after a few hours
Age: 17.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Abdominal pain upper, Burning sensation, Dysphagia, Dyspnoea, Headache
Clinical narrative: Patient called at 2-3 PM day of stating she was having burning and pain in her Left arm, stomach pain, headache, shortness of breath and trouble swallowing. She states these symptoms started 30 min to an hour after vaccines. She was able to talk on the phone, able to eat and drink, no N/V, I encouraged motrin and rest. Go to ER if intractable vomiting, unable to keep anything down, severe pain, or increased work of breathing
Age: 17.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Pain in extremity
Clinical narrative: Patient called at 2-3 PM day of stating she was having burning and pain in her Left arm, stomach pain, headache, shortness of breath and trouble swallowing. She states these symptoms started 30 min to an hour after vaccines. She was able to talk on the phone, able to eat and drink, no N/V, I encouraged motrin and rest. Go to ER if intractable vomiting, unable to keep anything down, severe pain, or increased work of breathing
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site scab, Injection site vesicles, Myalgia
Clinical narrative: Blister at injection site.  Still scabbed over 1 month later.  Soreness in arm muscle.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Arthralgia, Headache, Joint stiffness, Lethargy, Myalgia
Clinical narrative: Acute sharp joint pain & stiffness, muscled aching, headache & lethargy.  Started this morning (~12hrs after Vaccine & has persisted all day). Sharp shooting pains in joints & aching muscles while at rest & with movement. Intermittent
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: Patient states soreness,  limit in range of motion, numbness and tingling.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Pyrexia, Rash
Clinical narrative: gave Spikevax to pt on 10/9/23 at around 9:45am. Pt said reaction started about 4 hours later around 2pm with fever of 101F, chills, and rash on both arms and body trunk. Today 10/10/23 she called pharmacy at 4:55pm to informed pharmacy of reaction. She said the rash is now only on her right arm and trunk. She took a benadryl last the night on 10/9/23 for the itch to help her go to sleep.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Tachycardia
Clinical narrative: Tachycardia 110-130 while resting. intermittent lightheadedness on standing. bone pain in hips and lower back
Age: 73.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Back pain, Dyspnoea, Pain
Clinical narrative: Patient was seated in front of the pharmacy after her vaccines were administered. A few minutes after receiving the vaccine, I heard some heavy breathing noises and checked on her.  She said she was having a hard time breathing and she was experiencing shooting pains.  I stepped outside of the pharmacy to examine her more closely and she was shouting about pain that kept throbbing in her lower right back area. She was breathing very heavily and was in severe pain.  She remained seated but her condition worsened and her breathing was more forced/labored and she was in significant pain.  It was at that time we initiated calling 911 and to administer diphenhydramine liquid. She continued shouting and jolting her body due to the severe pain she was experiencing in her lower back (on the right side). There was no swelling or redness at the injection sites.  The paramedics arrived and brought her to the ambulance for further observation.
Age: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd flu vaccine dose was give one week too early (given at 3 weeks past the first dose). No reported reactions
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Confusional state, Disorientation, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: field of vision narrowed, episodic syncope over 45 minute period, confusion, diaphoresis, disorientation, exhaustion, prolonged light-headedness.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Syncope, Visual field defect
Clinical narrative: field of vision narrowed, episodic syncope over 45 minute period, confusion, diaphoresis, disorientation, exhaustion, prolonged light-headedness.
Age: 80.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Flushing, Hypoaesthesia, Injection site pain
Clinical narrative: Pt tolerated COVID vaccine fine. RSV burned a little but during injection. Pt went out to lobby to sit in chair for 15". Noticed she was still there at 20" and she looked like she was sleeping. She was not but she said her arms and face felt "like balloons and like they had Novocain in them". SHe did not have SOB, her tongue was not swollen she did appear a little flushed but was coherent and able to walk back into the clinic. Got a set of vitals, 148/69 and HR 52--which is baseline. She said she felt numb but it was resolving. Ate a full breakfast. Declined juice and crackers. ARNP came to assess patient. She told us a bit about a syncopal/ vasovagal episode in 2018. She has a diagnosis of paroxsymal hemicrania after an MVA in her 20s. We went over any symptoms of a TIA or CVA and she agreed she felt better and would go to urgent care or call EMS if any symptoms or episodes of numbness.  We monitored her for about 40" total and she only left when she felt 100% fine and she agreed to take it easy today.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Skin induration, Skin warm
Clinical narrative: Hard knot under the skin 1 inch in diameter, warm to touch 6 days post administration day.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: sore left arm; body aches; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A, 001C21A, 039C21A and 033K21-2A) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Dysequilibrium, Autoimmune disorder (Autoimmune disorder after being bitten by a Deer tick in 2005.) since 2005, Lyme disease (Lyme Disease with MS symptoms) and Blood pressure abnormal (on Blood Pressure Medication).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore left arm), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore left arm) and MYALGIA (body aches) outcome was unknown and HEADACHE (headache) and FATIGUE (fatigue) was resolving.            Patient was on unspecified blood pressure medication. Patient had a sore left arm, body aches, headache, and fatigue after first, second, third and fourth doses of the Moderna vaccine. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744170 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744170:PFS case
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Contusion
Clinical narrative: bruising
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore injection site arm) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Sore injection site arm). At the time of the report, INJECTION SITE PAIN (Sore injection site arm) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient reported two adverse events in her discussion. Patient had a sore injection site arm and said that she had heard horror stories of patients who have received the primary series of the Moderna Covid-19 vaccine. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2023: Live Follow-up received and had no new information.
Sex: U
Vaccine: UNK
Symptoms: Chills
Clinical narrative: Experienced very bad chills but was not sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (Experienced very bad chills but was not sick) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Experienced very bad chills but was not sick). At the time of the report, CHILLS (Experienced very bad chills but was not sick) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain, Malaise, Pyrexia, Vomiting
Clinical narrative: vomiting; fever; malaise; abdominal pain; This spontaneous case was reported by a physician and describes the occurrence of VOMITING (vomiting), PYREXIA (fever), MALAISE (malaise) and ABDOMINAL PAIN (abdominal pain) in a 6-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 06-Oct-2023, the patient experienced VOMITING (vomiting), PYREXIA (fever), MALAISE (malaise) and ABDOMINAL PAIN (abdominal pain). At the time of the report, VOMITING (vomiting), PYREXIA (fever), MALAISE (malaise) and ABDOMINAL PAIN (abdominal pain) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not reported.
Sex: U
Vaccine: RSV
Symptoms: Product leakage, Syringe issue
Clinical narrative: the syringe broke and the diluent leaked out; the syringe broke and the diluent leaked out; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), PRODUCT LEAKAGE (non-serious), outcome "unknown" and all described as "the syringe broke and the diluent leaked out". Additional information: when they twisted the cap off the diluent, the syringe broke and the diluent leaked out.  Causality for "the syringe broke and the diluent leaked out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Secretion discharge, Toothache
Clinical narrative: Mucus coming up; Teeth hurting; Feeling achy all over; Not feeling good; Head hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Moderna covid-19 vaccines in the past" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation, reaction(s): "Not having any problems". The following information was reported: PAIN (non-serious) with onset 05Oct2023, outcome "unknown", described as "Feeling achy all over"; HEADACHE (non-serious) with onset 05Oct2023, outcome "unknown", described as "Head hurting"; SECRETION DISCHARGE (non-serious) with onset 05Oct2023, outcome "unknown", described as "Mucus coming up"; MALAISE (non-serious) with onset 05Oct2023, outcome "unknown", described as "Not feeling good"; TOOTHACHE (non-serious) with onset 05Oct2023, outcome "unknown", described as "Teeth hurting".  Additional information: Patient reported getting an injection of the new Pfizer covid-19 vaccine yesterday. Patient reported experiencing not feeling good, mucus coming up, teeth hurting, head hurting, and feeling achy all over. Patient reported receiving Moderna covid-19 vaccines in the past and not having any problems.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Dizziness, Hypersensitivity, Rash, Rash pruritic, Rash vesicular
Clinical narrative: allergic reaction to Prevnar 20; very itchy rash with blisters from shoulder to elbow and rash; very itchy rash with blisters from shoulder to elbow and rash; dizzy spells; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to Prevnar 20"; BLISTER (non-serious), RASH PRURITIC (non-serious), outcome "unknown" and all described as "very itchy rash with blisters from shoulder to elbow and rash"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy spells". Therapeutic measures were taken as a result of rash pruritic. Additional information: the patient reported that she had an allergic reaction to pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein), and described it as a breakout, very itchy rash with blisters from shoulder to elbow and rash on the face accompanied with dizzy spells. The events happened two days after the shot. The patient went to an urgent care and was given two medications for rash.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash
Clinical narrative: heart palpitations; skin rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: PALPITATIONS (hospitalization), outcome "unknown", described as "heart palpitations"; RASH (hospitalization), outcome "unknown", described as "skin rash".  Additional information: Reporter was not the only one that has had these types of effects, in her same age group. Reporter heard other people had reactions to it, in her age group, the heart palpitations. One woman went into hospital for a week or 2. Reporter clarified that, other people in her age group had same reactions, including woman who was hospitalized. Does not have any further details to provide for the report.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid as treatment from 06Sep2023 to 02Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itchiness and redness at the injection site; itchiness and redness at the injection site; This is a spontaneous report received from a contactable reporter (Other HCP) from the Medical Information Team.  A patient (no qualifiers provided) received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (batch/lot number: unknown) for immunization; for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovering" and all described as "itchiness and redness at the injection site." Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site erythema.  Additional information: The caller reported an adverse reaction experienced by a patient from Abrysvo Respiratory Syncytial Virus Vaccine which was itchiness and redness at the injection site which was intense for the 1st 24 hours and became less intense after Benadryl. Caller asked if there are any available educational material that can be sent to them for patients to see.  The information on the batch/lot number for respiratory syncytial virus vaccine prot.subunit pref 2v, respiratory syncytial virus vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Spinal fracture
Clinical narrative: I am laying here with three breaks in my back, where we can get Pfizer injection for Covid.; 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 77-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: SPINAL FRACTURE (medically significant), outcome "unknown", described as "I am laying here with three breaks in my back, where we can get Pfizer injection for Covid.".  Clinical course: Patient asked for help locating Pfizer covid 19 vaccine 2023-2024 formula in privacy area. Caller stated that they always had Pfizer (Covid 19 vaccine and they don't want Moderna) Can not find in Privacy area heard that is not certified yet, where they can get it. Patient stated she was laying here with three breaks in her back, where they can get Pfizer injection for Covid she asked. husband will be 84 in couple of months. Patient was asking for the availability of the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on 21Sep using home antigen test (2 tests).; Tested positive for COVID on 21Sep using home antigen test (2 tests).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 1, single (Lot number: GH9703) at the age of 75 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2023, outcome "unknown" and all described as "Tested positive for COVID on 21Sep using home antigen test (2 tests).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2023) Positive, notes: Tested positive for COVID on 21Sep using home antigen test (2 tests); (21Sep2023) Positive, notes: Tested positive for COVID on 21Sep using home antigen test (2 tests). Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient Tested positive for COVID on 21Sep using home antigen test (2 tests). First noticed symptoms 20Sep. Began the 5 doses of Paxlovid evening of 21Sep. Took a home antigen test 28Sep (negative). Waited 48 hours and took another, also negative. Felt okay and that I was probably recovered, but a day or two later started to notice a dry cough and feeling a little congested in chest; also tired, like maybe still recovering. Then started to feel like I was getting worse instead of better; so on 05Oct (five days after second negative test), decided to take another home antigen test which came out positive.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Parotitis
Clinical narrative: I started getting left sided parotitis swelling and pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUAD QUADRIVALENT taken for immunisation, in Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAROTITIS (non-serious) with onset 05Oct2023 at 10:30, outcome "recovering", described as "I started getting left sided parotitis swelling and pain". Therapeutic measures were taken as a result of parotitis.  Additional information: Reported as, Consumer (Physician) stated, he was a Physician and he got his Pfizer Booster (Captured as Unspecified Booster Vaccine) yesterday at Withheld and today about 10:30 he started getting left sided parotitis swelling and pain. The parotitis was acute was not too bad, there was excessive swelling but and that was coming under control. He had taken Flu vaccine (Fluad Quadrivalent Vaccine) 10 days prior. There is no Investigations. He had taken Ibuprofen 800 milligram and it was helping the swelling and pain was going down. Causality: patient mentioned the unspecified Booster vaccine caused the event (parotitis), (Further not clarified).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 03:15 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: G57524, Location of injection: Arm Left), administration date: 30Sep2022, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FJ9943, Location of injection: Arm Right), administration date: 01Apr2022, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2588, Location of injection: Arm Left), administration date: 17Sep2021, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 19Feb2021, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9261), administration date: 29Jan2021, for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was given PAXLOVID.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 75 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 14Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: FE2588), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FJ441), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "allergies Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 23Sep2023 to 28Sep2023 as Treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300319576 same patient, different drug/event;
Age: 50.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 4 (booster), single (Lot number: 050D22A) at the age of 50 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: Yes; "ADPKD" (unspecified if ongoing); "hashimoto's" (unspecified if ongoing); "RA" (unspecified if ongoing); "CVA" (unspecified if ongoing); "CKD2" (unspecified if ongoing); "cerebral aneurysms" (unspecified if ongoing); "adrenal insufficiency" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient took concomitant medications (immunosuppressants). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started on 25Sep2023.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 69 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Lot number: FP7139) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's Disease" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: Oct2012; CARBIDOPA/LEVODOPA, start date: Oct2016; PRAMIPEXOLE, start date: Oct2014; RASAGILINE, start date: Oct2014. Past drug history included: Amantidine base, reaction(s): "Known allergies: Amantidine base". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes paxlovid.