chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: administration of Dtap-IPV component of PENTACEL separately from its Hib component with no reported adverse event; Initial information was received on 11-FEB-2022 regarding an unsolicited valid non-serious case received from a pharmacist  via call center.  This case involves a 2 months old male patient who experienced administration of dtap-ipv component of pentacel separately from its hib component with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.     On 03-Feb-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE  via Intramuscular route in thigh (with an unknown strength, batch/Lot number and expiry date) for immunization   On 03-FEB-2022 the patient developed a non-serious event "administration of dtap-ipv component of pentacel separately from its hib component with no reported adverse event" (product preparation issue) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (administration of Dtap-IPV component of PENTACEL separately from its Hib component with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administration of dtap-ipv component of pentacel separately from its hib component with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine Fluzone QIV NP was given during a temperature excursion with no reported adverse event; vaccine Fluzone QIV NP was given during a temperature excursion with no reported adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 38 years old female patient who had experienced an event vaccine  Influenza Quadrival a-b vaccine [Fluzone quadrivalent] was given during a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine at a dose of 0.5 mL (lot UT7383KA; Expiration Date :2022-06-30) (strength, formulation: not reported) via intramuscular route in unknown administration site for immunization.   On an unknown date the patient developed a non-serious vaccine fluzone qiv np was given during a temperature excursion with no reported adverse event (product temperature excursion issue) (product administration error) (unknown latency) following the administration of Influenza quadrival a-b vaccine.  Action taken: not applicable.  At time of reporting, the outcome was unknown for the events product temperature excursion issue , product administration error.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: FLUR4, HEPA, MMRV, PNC13
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: medication error FLUBLOK was administered to two pediatric patients with no adverse event reported; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was administered Flublok with no adverse event reported, while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (unknown dose, formulation, Lot number via unknown route in unknown administration site) as prophylactic vaccination; HEPATITIS A VACCINE INACT (HAVRIX) (unknown dose, formulation, Lot number via unknown route in unknown administration site) as prophylactic vaccination; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) (unknown dose, formulation, Lot number via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation: not reported)(lot QFAA2152 and expiry date: 30-Jun-2022) at a dose of 0.5 ml once via intramuscular route to the left quadriceps as prophylactic vaccination.  On 14-FEB-2022, the patient developed a non-serious event " flublok was administered to two pediatric patients with no adverse event reported" (off label use) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: Patient was administered first dose of menactra in Sep-2021 and was re-administered on 16-Feb-2022 with no reported adverse event; Initial information was received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who was administered first dose of Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] in Sep-2021 and was re-administered on 16-feb-2022 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In September 2021, the patient received a dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site and On 16-Feb-2022, the patient was re administered with the suspect at the dose of 0.5 ml once (batch number: U6951AA and expiry date: 06-Jun-2022) in unknown administration site all for prophylactic vaccination. Information on batch number of first dose administered is requested.  On 16-FEB-2022 the patient developed a non-serious patient was administered first dose of Menactra in sep-2021 and was re-administered on 16-feb-2022 with no reported adverse event (extra dose administered) (latency: approximately: 5 months) following the administration of Meningococcal a-c-y-w135 (d conj) Vaccine.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event extra dose administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Joint stiffness, Musculoskeletal stiffness, Nausea
Clinical narrative: Extremely stiff muscles and joints, pale skin and cold sweats (cold temp), intermittent nausea throbbing headache.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Extremely stiff muscles and joints, pale skin and cold sweats (cold temp), intermittent nausea throbbing headache.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Implantable defibrillator insertion, Road traffic accident, Ventricular tachycardia
Clinical narrative: heart went into ventricular tachycardia causing serious motor vehicle accident giving drugs to slow heart rate and icd installed
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Since 18 December she has complained of recurrent episodes of localized itching and rashes described as flat and raised, red, itchy ?spots? which can occur on her torso, arms, and legs which worsens where her skin is scraped or scratched. Lesions last less than 24 hours, spare her palms and soles, and resolve without post-inflammatory changes. She denies generalized cutaneous, laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. Possible association with heat. She received her Moderna COVID-19 vaccine booster dose on 8 December, 10 days prior to onset of symptoms. She has used oral antihistamines with only limited benefit. She denies constitutional symptoms. UCT score today is 14 (1, 2, 2, 3, 2, 1, 1, 2). She feels that her symptoms are gradually improving.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: Since 18 December she has complained of recurrent episodes of localized itching and rashes described as flat and raised, red, itchy ?spots? which can occur on her torso, arms, and legs which worsens where her skin is scraped or scratched. Lesions last less than 24 hours, spare her palms and soles, and resolve without post-inflammatory changes. She denies generalized cutaneous, laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. Possible association with heat. She received her Moderna COVID-19 vaccine booster dose on 8 December, 10 days prior to onset of symptoms. She has used oral antihistamines with only limited benefit. She denies constitutional symptoms. UCT score today is 14 (1, 2, 2, 3, 2, 1, 1, 2). She feels that her symptoms are gradually improving.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administrered of vaccines involved in a temperature excursion; This spontaneous report was received from medical assistance and refers to a patient of unreported age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 16-FEB-2022, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally (lot number 1742467, expiration date: 05-OCT-2022, vaccination scheme, and anatomical location of vaccination were not reported) for prophylaxis. Medical assistant reported administration of vaccines was involved in a temperature excursion(Product storage error). The vaccine was stored for the time frame of 1 hours in the temperature of 1.35 C. There was no previous temperature excursion.  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.  This adverse event report is 1 of the 3 adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional information; Expired dose of PROQUAD was administered; This spontaneous report was received from nurse referring to a patient of unknown age. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 18-FEB-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot # T028296 and expiration date reported as 16-FEB-2022), 0.5 milliliter for prophylaxis (expired product administered). Vaccine had not experienced any temperature excursion. No additional information (No adverse event). No product quality complaint reported.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching all over body; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In October 2021, 20 min after receiving Shingrix, the patient experienced pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received his first dose of Shingrix into the muscle of his upper right arm. Twenty minutes after the injection, he reported that he started itching all over his body. After taking Benadryl 50mg every 6 hours for 2-3 days, the itching resolved. The reporter consented to follow up with himself and his healthcare professional but could not provide full demographics.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events (dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death (dose number in series 2). As per reporter, "When I lost my best friend of 6 years die after the booster." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220246041.; Sender's Comments: V0: 20220246293-COVID-19 VACCINE AD26.COV2.S-death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to the touch; swollen all the way around; My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), SWELLING (swollen all the way around) and VACCINATION SITE SWELLING (My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal), Hernia (Patient had hernia between her esophagus & top of her stomach.) and Drug allergy (Augmentin). Concomitant products included POTASSIUM CHLORIDE and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced SWELLING (swollen all the way around) and VACCINATION SITE SWELLING (My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow). On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), SWELLING (swollen all the way around) and VACCINATION SITE SWELLING (My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The  patient was wondering what she can take for the pain.  No Treatment medications reported.   This case was linked to MOD-2022-489376 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Formication, Inflammation, Pain, Paraesthesia, Pruritus
Clinical narrative: a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared; It is like tingling; Throughout the whole day he feelslike it is pain but it is not agony; It is slight pain, like an itch as if something is crawling on him; Itching/irritation all over his body/unbearable itching and irration; becomes inflamed and then goes back down; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared), PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony), FORMICATION (It is slight pain, like an itch as if something is crawling on him) and PRURITUS (Itching/irritation all over his body/unbearable itching and irration) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 009C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy and G6PD deficiency (Patient Got diagnosed when they did tests for the  either in 2017 or 2018).   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-Feb-2022, the patient experienced URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared), PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony), FORMICATION (It is slight pain, like an itch as if something is crawling on him), PRURITUS (Itching/irritation all over his body/unbearable itching and irration) and INFLAMMATION (becomes inflamed and then goes back down). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared) had not resolved, PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony) and FORMICATION (It is slight pain, like an itch as if something is crawling on him) outcome was unknown, PRURITUS (Itching/irritation all over his body/unbearable itching and irration) was resolving and INFLAMMATION (becomes inflamed and then goes back down) had resolved.            Concomitant medications included Medications through the  but no mention of the names.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared; It is like tingling; Throughout the whole day he feelslike it is pain but it is not agony; It is slight pain, like an itch as if something is crawling on him; Itching/irritation all over his body/unbearable itching and irration; becomes inflamed and then goes back down; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared), PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony), FORMICATION (It is slight pain, like an itch as if something is crawling on him) and PRURITUS (Itching/irritation all over his body/unbearable itching and irration) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 009C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy and G6PD deficiency (Patient Got diagnosed when they did tests for the  either in 2017 or 2018).   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-Feb-2022, the patient experienced URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared), PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony), FORMICATION (It is slight pain, like an itch as if something is crawling on him), PRURITUS (Itching/irritation all over his body/unbearable itching and irration) and INFLAMMATION (becomes inflamed and then goes back down). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared) had not resolved, PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony) and FORMICATION (It is slight pain, like an itch as if something is crawling on him) outcome was unknown, PRURITUS (Itching/irritation all over his body/unbearable itching and irration) was resolving and INFLAMMATION (becomes inflamed and then goes back down) had resolved.            Concomitant medications included Medications through the  but no mention of the names.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  The vial was initially stored in the refrigerator on 17-Sep-2021.The vial did not undergo any temperature excursions. The patient did not report any other adverse events.  The reporter reported about the expired Moderna Covid-19 vaccines that was administered to 17 patients.  No treatment medication was provided by reporter.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Antinuclear antibody positive, Breast pain, C-reactive protein increased, Coagulation test
Clinical narrative: I received the first and second vaccine early in my pregnancy, I didnt know I was pregnant at time. July 1st 2021 I first went to the ER with leg pain/cramps. As the weeks progressed I started to feel a sharp poking and tingly feeling in my legs that traveled up to my arms, breast, abdomen and fingers. During this time I also started to feel a burning sensation in my breasts and abdomen. Once all the symptoms kicked in I was about 13 weeks pregnant. I had multiple labs done and my CRP and sedimentation rate were elevated. I had multiple autoimmune and hemotological labs done and the work up was negative. I was in and out of the ER with extreme pain and numbness and tingling, but they couldnt do anything for me because I was pregnant. I was sent to a Physiatrist that placed me on Tramadol during my whole pregnancy. I was told all my symptoms were probably from pregnancy and theybwould probably go away once I had the baby. I had the baby and the symptoms came back with a worse intensity. I was placed on gabapentin and had a upper and lower bilateral EMG done that was unremarkable. I am now on waiting  list to see neurology and rheumatology. They did do another ANA test last week that came back positive. All in all this has changed my life. If I miss a fose of Gabapentin the numbness, tingling, pain and while body coldness comes on as a cascade of symptoms that always start the same way, numbness, pain and tingling starts in my feet and goes up to my legs, then arms and fingers, then the whole body coldness kicks in. The worst of all the symptoms is the coldness.. no matter what i do It will not go away, my while body starts to sweat.... but im freezing, then i take my gabapentin and sometimes tramadol for the pain and everything slightly goes away. No one can tell me whats wrong. I am desperate for an answer.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Delivery, Electromyogram normal, Exposure during pregnancy, Feeling cold, Full blood count
Clinical narrative: I received the first and second vaccine early in my pregnancy, I didnt know I was pregnant at time. July 1st 2021 I first went to the ER with leg pain/cramps. As the weeks progressed I started to feel a sharp poking and tingly feeling in my legs that traveled up to my arms, breast, abdomen and fingers. During this time I also started to feel a burning sensation in my breasts and abdomen. Once all the symptoms kicked in I was about 13 weeks pregnant. I had multiple labs done and my CRP and sedimentation rate were elevated. I had multiple autoimmune and hemotological labs done and the work up was negative. I was in and out of the ER with extreme pain and numbness and tingling, but they couldnt do anything for me because I was pregnant. I was sent to a Physiatrist that placed me on Tramadol during my whole pregnancy. I was told all my symptoms were probably from pregnancy and theybwould probably go away once I had the baby. I had the baby and the symptoms came back with a worse intensity. I was placed on gabapentin and had a upper and lower bilateral EMG done that was unremarkable. I am now on waiting  list to see neurology and rheumatology. They did do another ANA test last week that came back positive. All in all this has changed my life. If I miss a fose of Gabapentin the numbness, tingling, pain and while body coldness comes on as a cascade of symptoms that always start the same way, numbness, pain and tingling starts in my feet and goes up to my legs, then arms and fingers, then the whole body coldness kicks in. The worst of all the symptoms is the coldness.. no matter what i do It will not go away, my while body starts to sweat.... but im freezing, then i take my gabapentin and sometimes tramadol for the pain and everything slightly goes away. No one can tell me whats wrong. I am desperate for an answer.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematology test normal, Hyperhidrosis, Hypoaesthesia, Immunology test normal, Laboratory test abnormal
Clinical narrative: I received the first and second vaccine early in my pregnancy, I didnt know I was pregnant at time. July 1st 2021 I first went to the ER with leg pain/cramps. As the weeks progressed I started to feel a sharp poking and tingly feeling in my legs that traveled up to my arms, breast, abdomen and fingers. During this time I also started to feel a burning sensation in my breasts and abdomen. Once all the symptoms kicked in I was about 13 weeks pregnant. I had multiple labs done and my CRP and sedimentation rate were elevated. I had multiple autoimmune and hemotological labs done and the work up was negative. I was in and out of the ER with extreme pain and numbness and tingling, but they couldnt do anything for me because I was pregnant. I was sent to a Physiatrist that placed me on Tramadol during my whole pregnancy. I was told all my symptoms were probably from pregnancy and theybwould probably go away once I had the baby. I had the baby and the symptoms came back with a worse intensity. I was placed on gabapentin and had a upper and lower bilateral EMG done that was unremarkable. I am now on waiting  list to see neurology and rheumatology. They did do another ANA test last week that came back positive. All in all this has changed my life. If I miss a fose of Gabapentin the numbness, tingling, pain and while body coldness comes on as a cascade of symptoms that always start the same way, numbness, pain and tingling starts in my feet and goes up to my legs, then arms and fingers, then the whole body coldness kicks in. The worst of all the symptoms is the coldness.. no matter what i do It will not go away, my while body starts to sweat.... but im freezing, then i take my gabapentin and sometimes tramadol for the pain and everything slightly goes away. No one can tell me whats wrong. I am desperate for an answer.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate increased
Clinical narrative: I received the first and second vaccine early in my pregnancy, I didnt know I was pregnant at time. July 1st 2021 I first went to the ER with leg pain/cramps. As the weeks progressed I started to feel a sharp poking and tingly feeling in my legs that traveled up to my arms, breast, abdomen and fingers. During this time I also started to feel a burning sensation in my breasts and abdomen. Once all the symptoms kicked in I was about 13 weeks pregnant. I had multiple labs done and my CRP and sedimentation rate were elevated. I had multiple autoimmune and hemotological labs done and the work up was negative. I was in and out of the ER with extreme pain and numbness and tingling, but they couldnt do anything for me because I was pregnant. I was sent to a Physiatrist that placed me on Tramadol during my whole pregnancy. I was told all my symptoms were probably from pregnancy and theybwould probably go away once I had the baby. I had the baby and the symptoms came back with a worse intensity. I was placed on gabapentin and had a upper and lower bilateral EMG done that was unremarkable. I am now on waiting  list to see neurology and rheumatology. They did do another ANA test last week that came back positive. All in all this has changed my life. If I miss a fose of Gabapentin the numbness, tingling, pain and while body coldness comes on as a cascade of symptoms that always start the same way, numbness, pain and tingling starts in my feet and goes up to my legs, then arms and fingers, then the whole body coldness kicks in. The worst of all the symptoms is the coldness.. no matter what i do It will not go away, my while body starts to sweat.... but im freezing, then i take my gabapentin and sometimes tramadol for the pain and everything slightly goes away. No one can tell me whats wrong. I am desperate for an answer.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test, Vitamin B12, Vitamin D
Clinical narrative: I received the first and second vaccine early in my pregnancy, I didnt know I was pregnant at time. July 1st 2021 I first went to the ER with leg pain/cramps. As the weeks progressed I started to feel a sharp poking and tingly feeling in my legs that traveled up to my arms, breast, abdomen and fingers. During this time I also started to feel a burning sensation in my breasts and abdomen. Once all the symptoms kicked in I was about 13 weeks pregnant. I had multiple labs done and my CRP and sedimentation rate were elevated. I had multiple autoimmune and hemotological labs done and the work up was negative. I was in and out of the ER with extreme pain and numbness and tingling, but they couldnt do anything for me because I was pregnant. I was sent to a Physiatrist that placed me on Tramadol during my whole pregnancy. I was told all my symptoms were probably from pregnancy and theybwould probably go away once I had the baby. I had the baby and the symptoms came back with a worse intensity. I was placed on gabapentin and had a upper and lower bilateral EMG done that was unremarkable. I am now on waiting  list to see neurology and rheumatology. They did do another ANA test last week that came back positive. All in all this has changed my life. If I miss a fose of Gabapentin the numbness, tingling, pain and while body coldness comes on as a cascade of symptoms that always start the same way, numbness, pain and tingling starts in my feet and goes up to my legs, then arms and fingers, then the whole body coldness kicks in. The worst of all the symptoms is the coldness.. no matter what i do It will not go away, my while body starts to sweat.... but im freezing, then i take my gabapentin and sometimes tramadol for the pain and everything slightly goes away. No one can tell me whats wrong. I am desperate for an answer.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Sleep disorder
Clinical narrative: I woke up at 4am from the chest pain. I just got my booster around 4pm yesterday.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Hypoaesthesia, Neuropathy peripheral, Pain, Paraesthesia
Clinical narrative: Shortly after vaccination #1 within a week or so, I began experiencing pain; numbness/tingling in my legs, feet, arms and hands. It was excruciating and would wake me up during the night. I got neuropathy with each shot, and every time it hit worse (including back). I was beginning to get arthritis in my back and knee. Also after booster shot, within 2 days couldn't move my right thumb. I saw a doctor and told this was the beginning of trigger finger, which I find funny because I never had any health issues at all before. Now I have neuropathy; back pain etc. My experience with these vaccines has been awful. It has caused me a lot of health issues.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Spondylitis, Trigger finger
Clinical narrative: Shortly after vaccination #1 within a week or so, I began experiencing pain; numbness/tingling in my legs, feet, arms and hands. It was excruciating and would wake me up during the night. I got neuropathy with each shot, and every time it hit worse (including back). I was beginning to get arthritis in my back and knee. Also after booster shot, within 2 days couldn't move my right thumb. I saw a doctor and told this was the beginning of trigger finger, which I find funny because I never had any health issues at all before. Now I have neuropathy; back pain etc. My experience with these vaccines has been awful. It has caused me a lot of health issues.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Irregularities in menstrual cycle.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose years ago, not received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years before reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not received the second dose until the time of reporting, which led incomplete course of vaccination. The patient did not have information on the lot/expiration date, date/route of administration, dose and left/right arm. The reporter consented to follow-up herself and with her health care professional.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a patient via a company representative via Social Media concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "I know people that had every jab and booster and still died!" On an unspecified date, the patient died from unknown cause of death (dose number in series 1). It was unspecified if an autopsy was performed . The patient received additional covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on an unspecified date. This report was serious (Death).; Sender's Comments: V0:20220231899-Covid-19 vaccine ad26.cov2.s-Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: PRETTY BAD SHAPE; This spontaneous report received from a patient via a company representative concerned  9 decades of unspecified sex. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pretty bad shape. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pretty bad shape was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthritis, Mouth ulceration, Muscle twitching, Myalgia
Clinical narrative: ARTHRITIS; MOUTH ULCERS (SORES); MUSCLE TWITCHING; MUSCLE PAIN; PAIN IN STOMACH; SWOLLEN TONGUE WITHIN 15MINUTES OF ADMINISTRATION; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B221A, and expiry: UNKNOWN) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-SEP-2021, the patient experienced swollen tongue within 15 minutes of administration. On 05-OCT-2021, the patient experienced pain in stomach, arthritis, mouth ulcers (sores), muscle twitching, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in stomach, swollen tongue within 15minutes of administration, arthritis, mouth ulcers (sores), muscle twitching, and muscle pain. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: ARTHRITIS; MOUTH ULCERS (SORES); MUSCLE TWITCHING; MUSCLE PAIN; PAIN IN STOMACH; SWOLLEN TONGUE WITHIN 15MINUTES OF ADMINISTRATION; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B221A, and expiry: UNKNOWN) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-SEP-2021, the patient experienced swollen tongue within 15 minutes of administration. On 05-OCT-2021, the patient experienced pain in stomach, arthritis, mouth ulcers (sores), muscle twitching, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in stomach, swollen tongue within 15minutes of administration, arthritis, mouth ulcers (sores), muscle twitching, and muscle pain. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURE; This spontaneous report received from a consumer via media via a company representative concerned a 27 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date it was reported that, "No vac for me. Medical freedom. My girlfriend's son got the J and J. 27/diabetic and had a seizure the next day." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220245766-covid-19 vaccine ad26.cov2.s-seizure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced death. The reporter stated that, "Johnson & Johnson Vaccine killed my sister". On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220245790 -COVID-19 VACCINE AD26.COV2.S - Death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Hot flush, Irritable bowel syndrome
Clinical narrative: IRRITABLE BOWEL SYNDROME SYMPTOMS; LOWER BACK PAIN; SHORTNESS OF BREATH; HOT FLASHES; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 205 pounds, and height was 74 inches. The patient's concurrent conditions included: essential tremor, non alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient did not ingest caffeine or other drugs. Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, administered on 09-FEB-2022 for prophylactic vaccination. Concomitant medications included propranolol for essential tremor. On 11-FEB-2022, the patient experienced irritable bowel syndrome symptoms, lower back pain, shortness of breath, and hot flashes. Treatment medications (dates unspecified) included: buspirone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritable bowel syndrome symptoms, lower back pain, shortness of breath, and hot flashes. This report was non-serious.