chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Chest pain, Computerised tomogram, Computerised tomogram thorax, Differential white blood cell count
Clinical narrative: I was accidentally given 2 boosters at the same time.  The nurse was supposed to give me a booster and flu and I received a booster and booster.   I have been light head, dizzy, short of breath, can't hold a conversation, chest pain,  I was recently diagnosed with Asthma after the injection.   My o2 levels drop to extremely low levels for no reason..  I will be at 77 or 86 or 92 while just watching TV
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Extra dose administered, Fibrin D dimer
Clinical narrative: I was accidentally given 2 boosters at the same time.  The nurse was supposed to give me a booster and flu and I received a booster and booster.   I have been light head, dizzy, short of breath, can't hold a conversation, chest pain,  I was recently diagnosed with Asthma after the injection.   My o2 levels drop to extremely low levels for no reason..  I will be at 77 or 86 or 92 while just watching TV
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Glomerular filtration rate, Laboratory test, Oxygen saturation decreased, Scan with contrast
Clinical narrative: I was accidentally given 2 boosters at the same time.  The nurse was supposed to give me a booster and flu and I received a booster and booster.   I have been light head, dizzy, short of breath, can't hold a conversation, chest pain,  I was recently diagnosed with Asthma after the injection.   My o2 levels drop to extremely low levels for no reason..  I will be at 77 or 86 or 92 while just watching TV
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Speech disorder, White blood cell count
Clinical narrative: I was accidentally given 2 boosters at the same time.  The nurse was supposed to give me a booster and flu and I received a booster and booster.   I have been light head, dizzy, short of breath, can't hold a conversation, chest pain,  I was recently diagnosed with Asthma after the injection.   My o2 levels drop to extremely low levels for no reason..  I will be at 77 or 86 or 92 while just watching TV
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Electroencephalogram abnormal, Encephalopathy, Endotracheal intubation, Hypoxia
Clinical narrative: pt sent from clinic to ED with non-healing wounds, dry gangrene right heel/ankle; pt elected to have amputation; pre-op COVID test was positive; became hypoxic; O2 supplementation; altered mental status; experienced PEA arrest; ACLS x 4 rounds, intubation; ROSC obtained; severe encephalopathy; pt did not make improvements; transitioned to comfort care and he passed away in the hospital
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Leg amputation, Life support, Mental status changes, Myoclonus
Clinical narrative: pt sent from clinic to ED with non-healing wounds, dry gangrene right heel/ankle; pt elected to have amputation; pre-op COVID test was positive; became hypoxic; O2 supplementation; altered mental status; experienced PEA arrest; ACLS x 4 rounds, intubation; ROSC obtained; severe encephalopathy; pt did not make improvements; transitioned to comfort care and he passed away in the hospital
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulseless electrical activity, SARS-CoV-2 test positive
Clinical narrative: pt sent from clinic to ED with non-healing wounds, dry gangrene right heel/ankle; pt elected to have amputation; pre-op COVID test was positive; became hypoxic; O2 supplementation; altered mental status; experienced PEA arrest; ACLS x 4 rounds, intubation; ROSC obtained; severe encephalopathy; pt did not make improvements; transitioned to comfort care and he passed away in the hospital
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amputation, COVID-19, Cardiac arrest, Death, Dry gangrene
Clinical narrative: pt sent from clinic to ED with non-healing wounds, dry gangrene right heel/ankle; pt elected to have amputation; pre-op COVID test was positive; became hypoxic; O2 supplementation; altered mental status; experienced PEA arrest; ACLS x 4 rounds, intubation; ROSC obtained; severe encephalopathy; pt did not make improvements; transitioned to comfort care and he passed away in the hospital
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Encephalopathy, Endotracheal intubation, Hypoxia, Impaired healing, Life support
Clinical narrative: pt sent from clinic to ED with non-healing wounds, dry gangrene right heel/ankle; pt elected to have amputation; pre-op COVID test was positive; became hypoxic; O2 supplementation; altered mental status; experienced PEA arrest; ACLS x 4 rounds, intubation; ROSC obtained; severe encephalopathy; pt did not make improvements; transitioned to comfort care and he passed away in the hospital
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Pulseless electrical activity, SARS-CoV-2 test positive
Clinical narrative: pt sent from clinic to ED with non-healing wounds, dry gangrene right heel/ankle; pt elected to have amputation; pre-op COVID test was positive; became hypoxic; O2 supplementation; altered mental status; experienced PEA arrest; ACLS x 4 rounds, intubation; ROSC obtained; severe encephalopathy; pt did not make improvements; transitioned to comfort care and he passed away in the hospital
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Placental disorder, Stillbirth
Clinical narrative: Mild contractions started around 6:30 am and were steady until 10pm but the baby was not moving. Went to the hospital around 10:30 pm and was provided 2 sonograms. Had seen the baby with a healthy heart beat and adequate amniotic fluid on 8/2/22.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Mild contractions started around 6:30 am and were steady until 10pm but the baby was not moving. Went to the hospital around 10:30 pm and was provided 2 sonograms. Had seen the baby with a healthy heart beat and adequate amniotic fluid on 8/2/22.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amniotic fluid volume, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia
Clinical narrative: Mild contractions started around 6:30 am and were steady until 10pm but the baby was not moving. Went to the hospital around 10:30 pm and was provided 2 sonograms. Had seen the baby with a healthy heart beat and adequate amniotic fluid on 8/2/22.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Stillbirth, Ultrasound foetal abnormal, Uterine contractions during pregnancy
Clinical narrative: Mild contractions started around 6:30 am and were steady until 10pm but the baby was not moving. Went to the hospital around 10:30 pm and was provided 2 sonograms. Had seen the baby with a healthy heart beat and adequate amniotic fluid on 8/2/22.
Age: 73.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: I never had chicken pox - verified by negative January 6, 2022 Varicella Zoster Antibody, IGG, Serum test; therefore I was at zero risk for shingles and was not a candidate for a shingles vaccine.  Having done extensive research on this, I went to the pharmacy web site and scheduled a Varicella vaccination (also a COVID-19 Moderna dose three) for February 9, 2022) and received an email confirmation showing I would received the MM&R vaccine.  On February 9. O went to the Pharmacy desk , presented my printout of the confirmation and stated I was there to received the varicella and Moderna COVID vaccinations.  I was told it would take a while to get them ready, so have a seat.  After at least a 15-minute wait, a woman ushered me into a room, had me sit down, and administered two shots, one in each arm.  To get my arms into the "right" positions, she yanked my arms so hard that even a couple days later, one shoulder still hurt, at which time I contacted Pharmacy and discussed my bad experience with him ; we had a good conversation - and that I thought was the end of it. Last week, I discovered the pharmacy is closing, and since I was told to return in two to six months for a second dose, I returned on Monday April 4th (my "adverse event") to obtain a written printout of my dose one vaccination record that would enable me to go elsewhere for the second shot.  To my astonishment, the printout said the vaccine Pharmacy put into my body was not the varicella vaccine but "Inactive Herpes Zoster" "Shingrix Vial Kit."  That was not the vaccine I ordered - and I was not told nor did I give informed consent for that change. On February 8, never having had chicken pox, I had  zero risk for shingles.  On February 9, Pharmacy injected me  with a substance that contained some form of shingles (even if it wasn't the live vaccine), and  so far, no one can tell me if that now puts me at risk for shingles or not.  I have spoken with the doctors' information line at Glaxo and the CDC information line, and received links to recent scientific updates from both.  Updates dated 2022 do say that Shingrix is NOT indicated for immunocompromised individuals who have never had chicken pox and also that there is no protection afforded against chicken pox.  So now I have no idea where I stand and what to do:  do I get dose two, do I get the varicella vaccine, what do I do?  And who holds the pharmacy responsible?
Age: 73.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Injection site pain, Wrong product administered
Clinical narrative: I never had chicken pox - verified by negative January 6, 2022 Varicella Zoster Antibody, IGG, Serum test; therefore I was at zero risk for shingles and was not a candidate for a shingles vaccine.  Having done extensive research on this, I went to the pharmacy web site and scheduled a Varicella vaccination (also a COVID-19 Moderna dose three) for February 9, 2022) and received an email confirmation showing I would received the MM&R vaccine.  On February 9. O went to the Pharmacy desk , presented my printout of the confirmation and stated I was there to received the varicella and Moderna COVID vaccinations.  I was told it would take a while to get them ready, so have a seat.  After at least a 15-minute wait, a woman ushered me into a room, had me sit down, and administered two shots, one in each arm.  To get my arms into the "right" positions, she yanked my arms so hard that even a couple days later, one shoulder still hurt, at which time I contacted Pharmacy and discussed my bad experience with him ; we had a good conversation - and that I thought was the end of it. Last week, I discovered the pharmacy is closing, and since I was told to return in two to six months for a second dose, I returned on Monday April 4th (my "adverse event") to obtain a written printout of my dose one vaccination record that would enable me to go elsewhere for the second shot.  To my astonishment, the printout said the vaccine Pharmacy put into my body was not the varicella vaccine but "Inactive Herpes Zoster" "Shingrix Vial Kit."  That was not the vaccine I ordered - and I was not told nor did I give informed consent for that change. On February 8, never having had chicken pox, I had  zero risk for shingles.  On February 9, Pharmacy injected me  with a substance that contained some form of shingles (even if it wasn't the live vaccine), and  so far, no one can tell me if that now puts me at risk for shingles or not.  I have spoken with the doctors' information line at Glaxo and the CDC information line, and received links to recent scientific updates from both.  Updates dated 2022 do say that Shingrix is NOT indicated for immunocompromised individuals who have never had chicken pox and also that there is no protection afforded against chicken pox.  So now I have no idea where I stand and what to do:  do I get dose two, do I get the varicella vaccine, what do I do?  And who holds the pharmacy responsible?
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Blood glucose abnormal, Blood lactic acid, Body temperature, Condition aggravated
Clinical narrative: she came down with Covid in Jan2022; she came down with Covid in Jan2022; 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 46-year-old female patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single, administration date 20Apr2021 (Lot number: EW0169) as dose 2, single and administration date 30Mar2021 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing), notes: Trigeminal neuralgia; "Bell's palsy" (unspecified if ongoing), notes: Bell's palsy; "Covid-19", start date: Sep2020 (unspecified if ongoing), notes: she was diagnosed but was asymptomatic. Concomitant medication(s) included: LYRICA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she came down with Covid in Jan2022". The patient underwent the following laboratory tests and procedures: blood culture: negative; blood lactic acid: not provided; investigation: not provided.  Additional information: She is glad that she had it because she came down with Covid in Jan2022, she had Covid twice. Once before she was vaccinated in Sep2020, she was diagnosed but was asymptomatic. That scared her she didn't have any symptoms other than little bit of a fever. she was living with her brother and his girlfriend and babysitting full time for them. Then got Covid again, states the boyfriend refuses to get vaccinated. Her symptoms were mild only lasted 24 hours, could not say had covid because it did not feel like it only had a fever for 24 hours. Bounced back to herself, she was scared because she has a compromised autoimmune system multiple and takes injection that lowers immune system to fight things. Description of Product Complaint: Description of complaint: Hydrochlorothiazide: there is a diuretic in the hydrochlorothiazide too as she does retain water, she doesn't think it helps with her blood pressure too much to be honest. Adds she is glad that she had it because she came down with Covid in Jan2022. Patient did not administer any other vaccines on same day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Glycosylated haemoglobin, Headache, Pain, Pyrexia
Clinical narrative: she came down with Covid in Jan2022; she came down with Covid in Jan2022; 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 46-year-old female patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single, administration date 20Apr2021 (Lot number: EW0169) as dose 2, single and administration date 30Mar2021 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing), notes: Trigeminal neuralgia; "Bell's palsy" (unspecified if ongoing), notes: Bell's palsy; "Covid-19", start date: Sep2020 (unspecified if ongoing), notes: she was diagnosed but was asymptomatic. Concomitant medication(s) included: LYRICA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she came down with Covid in Jan2022". The patient underwent the following laboratory tests and procedures: blood culture: negative; blood lactic acid: not provided; investigation: not provided.  Additional information: She is glad that she had it because she came down with Covid in Jan2022, she had Covid twice. Once before she was vaccinated in Sep2020, she was diagnosed but was asymptomatic. That scared her she didn't have any symptoms other than little bit of a fever. she was living with her brother and his girlfriend and babysitting full time for them. Then got Covid again, states the boyfriend refuses to get vaccinated. Her symptoms were mild only lasted 24 hours, could not say had covid because it did not feel like it only had a fever for 24 hours. Bounced back to herself, she was scared because she has a compromised autoimmune system multiple and takes injection that lowers immune system to fight things. Description of Product Complaint: Description of complaint: Hydrochlorothiazide: there is a diuretic in the hydrochlorothiazide too as she does retain water, she doesn't think it helps with her blood pressure too much to be honest. Adds she is glad that she had it because she came down with Covid in Jan2022. Patient did not administer any other vaccines on same day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Blood lactic acid, Drug ineffective, Investigation, Suspected COVID-19
Clinical narrative: she came down with Covid in Jan2022; she came down with Covid in Jan2022; 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 46-year-old female patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single, administration date 20Apr2021 (Lot number: EW0169) as dose 2, single and administration date 30Mar2021 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing), notes: Trigeminal neuralgia; "Bell's palsy" (unspecified if ongoing), notes: Bell's palsy; "Covid-19", start date: Sep2020 (unspecified if ongoing), notes: she was diagnosed but was asymptomatic. Concomitant medication(s) included: LYRICA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she came down with Covid in Jan2022". The patient underwent the following laboratory tests and procedures: blood culture: negative; blood lactic acid: not provided; investigation: not provided.  Additional information: She is glad that she had it because she came down with Covid in Jan2022, she had Covid twice. Once before she was vaccinated in Sep2020, she was diagnosed but was asymptomatic. That scared her she didn't have any symptoms other than little bit of a fever. she was living with her brother and his girlfriend and babysitting full time for them. Then got Covid again, states the boyfriend refuses to get vaccinated. Her symptoms were mild only lasted 24 hours, could not say had covid because it did not feel like it only had a fever for 24 hours. Bounced back to herself, she was scared because she has a compromised autoimmune system multiple and takes injection that lowers immune system to fight things. Description of Product Complaint: Description of complaint: Hydrochlorothiazide: there is a diuretic in the hydrochlorothiazide too as she does retain water, she doesn't think it helps with her blood pressure too much to be honest. Adds she is glad that she had it because she came down with Covid in Jan2022. Patient did not administer any other vaccines on same day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Disorientation, Fear, Hallucination, Pyrexia
Clinical narrative: first COVID vaccine with modest side effects for the first one; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included MS.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one). At the time of the report, VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that patient had a dilemma. No concomitant medication was provided. No treatment information was given.   This case was linked to MOD-2022-530858, MOD-2022-530872 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: first COVID vaccine with modest side effects for the first one; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included MS.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one). At the time of the report, VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that patient had a dilemma. No concomitant medication was provided. No treatment information was given.   This case was linked to MOD-2022-530858, MOD-2022-530872 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: first COVID vaccine with modest side effects for the first one; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included MS.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one). At the time of the report, VACCINATION COMPLICATION (first COVID vaccine with modest side effects for the first one) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that patient had a dilemma. No concomitant medication was provided. No treatment information was given.   This case was linked to MOD-2022-530858, MOD-2022-530872 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Disorientation, Fear, Hallucination, Pyrexia
Clinical narrative: had a fever; adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) and PYREXIA (had a fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included MS (Patient has MS(Multiple sclerosis)). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SERTRALINE and VIT D [VITAMIN D NOS] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2021, the patient experienced VACCINATION COMPLICATION (adverse reaction). On an unknown date, the patient experienced PYREXIA (had a fever). At the time of the report, VACCINATION COMPLICATION (adverse reaction) and PYREXIA (had a fever) outcome was unknown.            No treatment medications were reported. After 2nd dose within 24 hours patient experienced adverse reaction.   This case was linked to MOD-2022-530872, MOD-2022-532467 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains Significant information - New event fever, patient information, reporter information and Concurrent condition were added.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: had a fever; adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) and PYREXIA (had a fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included MS (Patient has MS(Multiple sclerosis)). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SERTRALINE and VIT D [VITAMIN D NOS] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2021, the patient experienced VACCINATION COMPLICATION (adverse reaction). On an unknown date, the patient experienced PYREXIA (had a fever). At the time of the report, VACCINATION COMPLICATION (adverse reaction) and PYREXIA (had a fever) outcome was unknown.            No treatment medications were reported. After 2nd dose within 24 hours patient experienced adverse reaction.   This case was linked to MOD-2022-530872, MOD-2022-532467 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains Significant information - New event fever, patient information, reporter information and Concurrent condition were added.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: had a fever; adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) and PYREXIA (had a fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included MS (Patient has MS(Multiple sclerosis)). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SERTRALINE and VIT D [VITAMIN D NOS] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2021, the patient experienced VACCINATION COMPLICATION (adverse reaction). On an unknown date, the patient experienced PYREXIA (had a fever). At the time of the report, VACCINATION COMPLICATION (adverse reaction) and PYREXIA (had a fever) outcome was unknown.            No treatment medications were reported. After 2nd dose within 24 hours patient experienced adverse reaction.   This case was linked to MOD-2022-530872, MOD-2022-532467 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains Significant information - New event fever, patient information, reporter information and Concurrent condition were added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Very swollen lymph nodes both arm pits, left worse. Lymph nodes in breasts, throat and pelvic area swollen.  Slight headache.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Cough, Headache, Malaise
Clinical narrative: Breakthrough COVID + Traveling for work - Woke early morning 28Mar2022 ~ 1am feeling quite ill, cough, headache, joint/body pain, nasal and chest congestion Found a 24 hour pharmacy for a home COVID test. Went back to hotel test returned positive.  Tested again 31Mar2022 still postitive Tested again 03Apr2022
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID + Traveling for work - Woke early morning 28Mar2022 ~ 1am feeling quite ill, cough, headache, joint/body pain, nasal and chest congestion Found a 24 hour pharmacy for a home COVID test. Went back to hotel test returned positive.  Tested again 31Mar2022 still postitive Tested again 03Apr2022
Age: 72.0
Sex: F
Vaccine: DT
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 45.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injected limb mobility decreased, Laboratory test, Magnetic resonance imaging, Skin reaction, Skin warm
Clinical narrative: Her arm was red and hot at first 2 days after the reaction and  she was  happy that it was going away until she woke up the next day (3rd day) and she was not able to lift her arm.
Age: 45.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Erythema, Muscle disorder, Muscular weakness, Peripheral swelling, Skin discolouration
Clinical narrative: Her arm was red and hot at first 2 days after the reaction and  she was  happy that it was going away until she woke up the next day (3rd day) and she was not able to lift her arm.
Age: 45.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Her arm was red and hot at first 2 days after the reaction and  she was  happy that it was going away until she woke up the next day (3rd day) and she was not able to lift her arm.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Pain
Clinical narrative: Nausea and dizziness leading to momentary loss of consciousness for  approx 5-10 seconds; Extreme generalized body pain everywhere
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Rash
Clinical narrative: I present rashes all over the skin red colors, every day it got worse it lasted almost two weeks.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye irritation, Ocular discomfort, Photophobia
Clinical narrative: I never had eye issues before and I used to spend a lot of time on screens.  Rather quickly after the first 2 shoots I had eye sensitivity, burning sensation in the eye, sensitivity to light, feeling of pressure in the eye, pain but I thought it might just be a sign of aging.  My eyes would be burning to the point I couldnt open them after I would spend time on screen, outside when sunny or after crying. When they would start hurting, it would slowly get worst. If I stopped everything and closed my eyes for few hours, it would help. Otherwise it would be bad all day and even the following day. I want to insist that I had few episode where it was so bad I could not keep my eyes open while driving.  After my first 2 shoots the symptoms lasted for about a year, slowly getting better overtime. After about a year I could cry and not have the burning sensation that would last all day.  After my booster the symptoms came back, this is how I associated with the vaccine, they came back 4 days after my booster shoot. My doctor gave me steroid drops, which helped a lot so he concluded it was an inflammation.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Carditis, Chest X-ray abnormal, Computerised tomogram head, Computerised tomogram thorax abnormal
Clinical narrative: High blood pressure heart swelling collapsed lunch headache nausea fluid on heart short of breath fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hypertension, Nausea
Clinical narrative: High blood pressure heart swelling collapsed lunch headache nausea fluid on heart short of breath fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Pneumothorax
Clinical narrative: High blood pressure heart swelling collapsed lunch headache nausea fluid on heart short of breath fatigue
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster infection within 24 hours of vaccination
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives rash reoccurring
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: transient reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (transient reactions) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION COMPLICATION (transient reactions). At the time of the report, VACCINATION COMPLICATION (transient reactions) outcome was unknown.            No concomitant medication reported.   Reporter stated she received the Moderna primary two dose series approximately one month part. Patient received the third dose about 4 to 6 months after the 2nd dose and was given 0.5 ml because of her immune problems. On 01-Apr-2022 she received the 4th Moderna dose (a booster) 6 months and 3 weeks after receiving the 3rd dose. She reported she received 0.25 ml for the booster dose. Patient has never gotten COVID-19 infection.  No treatment medication reported.   This case was linked to MOD-2022-531820, MOD-2022-531830 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was exposed to room temperature for 26 hours; The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 26 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 016B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 26 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.  On 18Mar2022, the vial was initially stored in the refrigerator.  The vial was taken out day before and HCP forgot to discard it at the end of the day but the following day, the vial was not checked prior to administering the vaccine dose. The vial was exposed to room temperature for 26 hours as 1 dose was administered to a patient from it.   This case was linked to MOD-2022-532408, MOD-2022-532364 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: two booster doses were administered to two patients after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two booster doses were administered to two patients after the published expiration date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (two booster doses were administered to two patients after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (two booster doses were administered to two patients after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   On 28 Mar 2022 vial was initially stored in refrigerator.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; expired dose of VARlVAX administered; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 28-JAN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 mg, lot # T002846, expiration date 23-JAN-2022; strength and anatomical location were not reported) subcutaneously (SQ) for prophylaxis (expired product administered). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2022, the patient was administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #T039467, expiration date: 20-MAY-2023 (strength, and route of administration were not provided) for prophylaxis. The vaccine experienced temperature excursion of 33.4 degrees Fahrenheit for 2595 hours (product storage error). There was no previous temperature excursions. No other adverse events reported (no adverse event).  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007825: US-009507513-2203USA007812: US-009507513-2203USA007997: US-009507513-2203USA008063: US-009507513-2203USA008097: US-009507513-2203USA007915:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Medical assistant calling to report expired PROQUAD administered to patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 18-MAR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliters once, lot number T030760 (rHA) and expiration date 08-MAR-2022 (route of administration were not provided) as prophylaxis (expired vaccine used).  No adverse symptoms or temperature excursion was reported.
Age: 13.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional AE reported; HCP reported that patient was accidently administered the wrong vaccine; This spontaneous report was received from a medical assistant and refers to a 13-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 21-MAR-2022, the patient was accidentally vaccinated with the wrong vaccine (wrong product administered), the patient received haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number U014992 with expiration date 29-OCT-2023 (dose, route and anatomical location were not reported), but it was supposed to received meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: An expired dose of ROTATEQ was administered to the patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 22-MAR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (ml) (strength, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot #1707460 that was verified to be a valid lot number with an expiration date reported and established as 14-MAR-2022) for prophylaxis (expired product administered). It was stated that the administered vaccine had not been involved in any temperature excursions. No additional information provided.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA008972: US-009507513-2203USA008826:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other adverse events reported; patient received their second dose of GARDASIL 9 too early.; This spontaneous report was received from medical assistant and concerns the patient of unknown gender, who would be 14-year-old at the time of report. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-FEB-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #: T030746, expiration date 16-MAR-2023 (concentration, dose, route of administration and anatomical location were not reported) for prophylaxis.  On 25-MAR-2022, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #: T030746, expiration date 16-MAR-2023 (concentration, dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of product administration).   No other adverse events were reported.
Age: 0.92
Sex: M
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE; patient received the vaccine six days before his first birthday; This spontaneous report was received from Physician and refers to an 11-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUL-2013, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection,  dose: 0.5 milliliter as prophylaxis (strength, lot #, expiry date, dose number, and route of administration), six days before his first birthday (Product administered to patient of inappropriate age).
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on Feb. 23, 2022, second dose on March 25, 2022; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 25th March 2022, the patient received the 2nd dose of Shingrix. On 25th March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient was approximately 66 years old. The patient received second dose of Shingrix less than 2 months after first dose. The patient got her second dose at a pharmacy, but her first dose from reporter address. The patient denied having any problems or reactions with the second dose, she wanted GlaxoSmithKline to knew she had gotten both doses. The reporter did not consent to follow-up. Connected with medical information via to address nurse question. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to drug dose administration interval too short.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Fall, Hyponatraemia, Product administered at inappropriate site, Renal disorder, Tremor
Clinical narrative: tremor; tremors that caused her to fall to the ground and flop around like a fish; hyponatremic; kidney issues; administered the vaccine into her stomach; This case was reported by a consumer via other manufacturer and described the occurrence of tremor in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included furosemide (Lasix) for product used for unknown indication.   On 16th April 2021, the patient received Shingrix. On an unknown date, the patient started Lasix at an unknown dose and frequency. On 16th April 2021, unknown after receiving Shingrix and not applicable after starting Lasix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced tremor (serious criteria hospitalization), fall (serious criteria hospitalization), hyponatremia (serious criteria hospitalization) and renal disorder (serious criteria hospitalization). The action taken with Lasix was unknown. On an unknown date, the outcome of the tremor, fall, hyponatremia, renal disorder and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the tremor, fall, hyponatremia and renal disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments:  The patient's past medical history, medical treatment, vaccination and family history were not provided. The patient experienced hospitalized 5 times, tremors, tremors that cause her to fall to the ground and flop around like a fish, hyponatremic, kidney issues and physician administered the vaccine into her stomach while being treated with Furosemide and Shingrix.  Additional Supportive Information: The patient received Shingrix vaccine into her stomach, which led to vaccine administered at inappropriate site. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively.