chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in the left arm; pain always down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm) and ARTHRALGIA (pain always down to the elbow) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm) and ARTHRALGIA (pain always down to the elbow). The patient was treated with PREDNISONE at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (pain in the left arm) and ARTHRALGIA (pain always down to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
rash/cellulitis to bilateral hands and wrists; rash/cellulitis to bilateral hands and wrists; This is a spontaneous report from a contactable physician. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 56 years of age), dose 1 via an unspecified route of administration, administered in arm left on 31Mar2021 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), acetylsalicylic acid (ASPIRIN 81); vitamin d3; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ubidecarenone (COQ10 [UBIDECARENONE]), trazodone, lisinopril and ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously took lortab [loratadine], Lincocin [clindamycin], Wellbutrin and Chantix and experienced drug hypersensitivity with these. The patient experienced rash/cellulitis to bilateral hands and wrists on 01Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of the events with Decadron Shot. The events resulted in Doctor or other healthcare professional office/clinic visit.
6/30/22 @ 1243 patient had stroke 7/6/22 @ 0938 patient expired
pt recv vax & exp migraine h/a, n/v evening p/vax;pt then exp muscle aches/soreness;24OCT98 pt exp migraine again & was hosp;spinal tap revealed inc WBC;pt still in hosp @ time of reporting & has been dx w/viral encephalitis;
Pt tells PHN on 3-19-02 that he had increased heart rate and required hospital visit that evening same day he got Hepatitis b vaccine. States he was laying on couch watching TV when his heart started beating fast and he felt funny. Seen in ER 11-14-01. Treated for "panic attack". Never had this before and none since this episode.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 14-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS-LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 32F (0 Celsius) for 104 hours; also there were reported temperatures of 48F (8.8 C) and 34F (1.1 C). The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    No concomitant and treatment medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case
Flu like. Cold, chills, low fever, cold sweats, headaches and body aches.
On day 7 (1/9/21) developed right axilla pain. Felt like there was swelling and aching in my armpit. Eventually the pain spread down my arm. On day 20 (1/22/21), I was instructed by my employee health to go to urgent care for my right arm and axilla pain.   I also had a red rash and swelling on Day 12, as is more common.
On 8/1/23, pt was due to receive the Dtap and Hib vaccines. However, he received two doses of Dtap in the forms of Daptacel and Pentacel. He did have the normal side-effect of fever, but did not suffer any adverse reactions to receiving the double dose of Dtap. We continued to follow-up with the family in the following days and next week and he continued to be free from any other reaction.
This spontaneous report was received from a pharmacist referring to an unspecified number of patients unknown ages and genders. The patients' concurrent conditions and medical histories were not provided. On unknown dates (also reported as "over several years"), the patients were vaccinated with ZOSTAVAX (Lot numbers and expiration dates were not provided) no doses, strengths, anatomical locations were provided. There was not concomitant medication reported. The reporter stated that she heard of patients who have received ZOSTAVAX and were then later diagnosed with the shingles. At the time of the report, the outcome of herpes zoster was unknown. The reporter did not assess the casual relationship between the adverse event and the ZOSTAVAX. Additional information has been requested.
no additional AE reported; the vaccine expired on 06-FEB-2021 and was administered on 08-FEB-2021; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 08-FEB-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # 1660942, expiration date 06-FEB-2021 for prophylaxis. No adverse events were reported.
Pain and bright red at site 24 hours post vax. Mother also palpated hard 'mass' at site. Otherwise afebrile, active, health-appearing.
Swelling and redness at injection site on (R) thigh. Patient c/o itching but no pain.
After vaccine was given within the first 2 minutes began to feel light headiness, short of breath and heart palpitations.  After 15 minutes symptoms persist and noted to become more short of breath and my heart continue to have feels of unease. I was given Benadryl 50 mg p.o. with water. The symptoms did not resolve and I was taken to the emergency room. My vital signs were obtained and I was noted to be hypertensive and bradycardic. My heart rate was 30 beats per minute and systolic blood pressure noted in 170's.  A EKG was obtained and troponin was completed which results revealed sinus bradycardia and troponin 0.00. Please ask for records as I was in distress and not able to recall each occurrence.
Patient was inadvertently given extra vaccines. She did not require the PCV or HIB. This was our mistake.
Right after I felt fine.. I felt nauseas . Later that night , I was really dizzy, Fainted, nauseas, I felt feverish
Eleven hours after the vaccination I experienced extreme muscle and joint pain. I could feel every bone I could barely walk and had to hold onto the walls to walk to the bathroom. I also had fever and chills that went on for two days. I had intense brain fog that cause me to stay out of work for three days because of the symptoms. I took ibuprofen and Tylenol to help alleviate my symptoms.
anaphylactic reaction; tingling; itching; throat tightening; problems breathing; generalized allergic reaction; A spontaneous report was received from a consumer concerning a 67 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) for prophylaxis of COVID-19 infection. After that she had numbness, tingling and itching in left side of her face, which has stayed. Then, almost immediately after shot she had an anaphylactic reaction: throat tightening and problems breathing. In the ER, they gave her Benadryl and that was enough to stop it. Now, she says the numbness is similar to being numb from going to the dentist.  On 16 Mar 2021, immediately after the shot, the patient experienced the event(s) anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea. The event anaphylactic reaction is medially significant. So, this is a serious case.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea was unknown.; Reporter's Comments: This case concerns a 67 Y/O M had a serious expected event of anaphylactic reaction and nonserious unexpected hypersensitivity, pruritus, dyspnea, throat tightness, and paresthesia.  Event onset immediately after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This subject is a ten month old who died due to child abuse/homicide while enrolled in a Comparative post-marketing study of DAPTACEL administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received one dose of the study vaccine on 12/30/02. The subject received a DAPTACEL vaccination, lot number C0812AA (route and site not reported) on 12/30/02. On 9/7/03, the subject suffered acute neurologic deterioration association with occipital skull fracture, cerebral edema and subarachnoid hemorrhage. On 1/26/04, the patient died from injuries secondary to child abuse. Per the coroner's office the cause of death was blunt force trauma. This case is considered a homicide and is still under investigation. An autopsy was performed but not obtained. The death was reported by the investigator as unrelated to the study vaccine.
Muscle aching, cramping in legs, hands, Etc. Serious shaking, shivering, fever, stiffness, headache, fatigue, started about nine hours after vaccine was administered, is continued soreness, stiffness, fatigue a day after. Recovering 11/08/05. 11/12/2005 symptoms completely resolved approx 5 days.
strong reaction; very uncomfortable to sleep; past her due date for their second dose; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced strong reaction (Vaccination complication) and very uncomfortable to sleep (insomnia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: G12M20A) intramuscularly for prophylaxis of COVID-19 infection.    After receiving the vaccine, on an unspecified date, the patient experienced a strong reaction to it. The patient did not have to go to the doctor, but it was very uncomfortable to sleep. The patient was past her due date for her second dose (inappropriate schedule of vaccine administered). Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, strong reaction, very uncomfortable to sleep and past her due date for their second dose were unknown.
Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 34-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the adult was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       The parent experienced symptoms such as coughing, chest condition, loss of smell, runny nose and diarrhea and received treatment with ibuprofen for the fever and some sinus medicine for the coughing and congestion.   This case was linked to MOD-2021-299764 (Parent-Child Link).   See case MOD-2021-299764 for details regarding the Parent case.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, SORE THROAT, FATIGUE Narrative;
Sore arm; very mild muscle aches; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 07:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, premenstrual dysphoric disorder and seasonal allergy. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC) and loratadine (CLARITIN) all for unknown indications and from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 11Mar2021 at 08:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 11:00, the patient experienced sore arm, very mild muscle aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm, muscle ache and headache were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
feeling bad, mainly dizziness, nausea, chills, malaise, unable to eat;treated in ER for dehydration & released;will not get last dose in series;
sore arm; slight flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 at 09:30 as dose 1, single (Lot number: EN6208) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 1978 (unspecified if ongoing); "Depression" (unspecified if ongoing); "B/P" (unspecified if ongoing); "Hormones" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE oral taken for blood pressure measurement, start date: 2012 (ongoing); CITALOPRAM oral taken for depression, start date: 2019 (ongoing); ESTRADIOL oral taken for hormone therapy, start date: 1999 (ongoing); WELLBUTRIN oral taken for depression, start date: 2012 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "slight flu like symptoms".
This spontaneous report as received from a 51 year old female patient with a degenerative spine condition, reporting on herself. There were no pertinent medical history and no drug reactions or allergies. On an unspecified date in December 2013 the patient was vaccinated with ZOSTAVAX injection, dose 1 (strength, lot#, expiration date and route not reported). Concomitant therapies included unspecified anesthetics for a degenerative spine condition. On an unspecified date in January 2014, the patient experienced chickenpox and on an unspecified date in May 2014 the patient experienced shingles. No treatment was given. No laboratories diagnostic test were performed. At the moment of the report, the outcome of shingles and chickenpox was unknown. The patient did not seek medical attention. No further relevant medical data were provided. Additional information is not expected.
Arm soreness from vaccine site to elbow started 5/5 around 6pm and is persistent as of 5/7 3am.  Very severe headache, fever, and chills 5/5 6pm until 5/6 10am. Moderate headache persisted and is unresolved as of 5/7 3am.
I received the 2nd SHINGRIX shot yesterday 6/4/2018. I have severe pain in the muscle where the shot was administered. Over night I started with an upset stomach and chills and sweats. I felt like I was going the throw up. It became more severe early in the morning lasting for approximately 10 hours. My stomach has remained uncomfortable but I don't feel like I have to throw up as the 12 - 14 hour after the onset of symptoms.
Dizziness; the pt started to experience that her brain is swelling; arm was sore; A spontaneous report was received from a consumer concerning a 61 years old female patient who experienced dizziness/dizziness, brain is swelling/adverse reaction following immunization and sore in the arm/Vaccination site pain.  The patient's medical history was not provided. The relevant concomitant medications were also not provided by the reporter.  On 12-Jan-2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (batch number:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After receiving the shot the patient felt dizziness and sore in her arm and three days after (15- jan-2021) the patient started to experience brain fog.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event dizziness and brain swelling was unknown. The event sore in the arm was recovered on 15-Jan-2021.  Additional information received on 19 Jan 2021 include patients date of birth, gender and also the events such as brain fog and sore in the arms.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of dizziness and vaccination site pain, a causal relationship cannot be excluded.  Very limited information has been provided for the event of adverse reaction after immunization. Further information has been requested.