chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels tired; muscle ache; joint ache; fever (up to 100F).; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 61-years, at single dose on 22Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received first dose of pfizer covid vaccine yesterday (on 22Mar2021). Today (on 23Mar2021), she felt tired, muscle ache, joint ache and fever (up to 100F). The patient underwent lab tests and procedures which included body temperature was up to 100F on 23Mar2021. Events outcome was unknown.  Information on the lot/ batch number has been requested.
I was feeling unusual and feeling really tired on 06/16/2022. The next morning I was feeling congested and extremely tired. I had  diarrhea as well, it lasted for about 3 days.  I had chills and started spiking a fever up to 101 two days later.  I have had a long time breaking fever, it took 24hours. I am still congested and feeling fatigued it has taken forever to start having energy again.  I contacted a telehealth doctor and prescribed Paxlovid and instructed that I stop taking and decongestion medicines.
Lower Body Temperature; Fatigue; A spontaneous report was received from a consumer concerning a 53 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  Low body temperature/ Hypothermi and fatigue.  The patient's medical history was not provided.  concomitant product use was not provided  by the reporter.     On 17 Feb 2021 The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) . On 10 Mar 2021  prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the Left arm for prophylaxis of COVID-19 infection.    On 10 Mar 2021, after Second  dose of vaccination, patient experienced the events Lower Body temperature and chills and the  Lower Body Temperature  is Medically significant. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events  therefore, action taken with the drug in response to the events  is not applicable.  The outcome of events, Lower Body temperature and fatigue were Unknown.; 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, a causal relationship cannot be excluded.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional (unspecified). On an unspecified date in 2016, the patient experienced shingles (herpes zoster) and was treated by a healthcare provider (unspecified). The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
Uncontrolled sneezing, swollen eyes tingling itching extremities, SOB, "fullness" in throat, increased P, "fluttery" feeling-lasted approx. 12-18 hours. Called advice nurse on 7/15-took antihistamine and symptoms resolved.
The patient requested the high dose vaccine several times and FLD QUAD was administered; Very upset; This spontaneous case from was received on 10-Nov-2020 from other non-health professional (consumer) via The Agency (reference number: SEQW20-04960) and concerned a 72-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On 26-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid) for flu prophylaxis. The batch number was not reported. The patient requested the high dose vaccine, and in the pharmacy, they confirmed that Fluad Quadrivalent was a high dose vaccine. Later the patient was advised that Fluad Quadrivalent was a standard dose vaccine (explicitly coded as 'Wrong vaccine administered').  On an unspecified date in 2020, after receiving Fluad Quadrivalent, the patient was very upset that Fluad Quadrivalent was being marketed by the pharmacy as a high dose vaccine.  The outcome of the event was not reported.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The patient experienced emotional distress on an unspecified date after administration of Fluad Quadrivalent. Reportedly, the patient requested the high dose vaccine several times and FLD QUAD. Wrong product administered is assessed as unrelated per company conventions and emotional distress is also assessed as unrelated. There is no suggestion that the product produced this event. Temporal association is unclarified and there is no biological background for this association.; Sender's Comments: The patient experienced emotional distress on an unspecified date after administration of Fluad Quadrivalent. Reportedly, the patient requested the high dose vaccine several times and FLD QUAD. Wrong product administered is assessed as unrelated per company conventions and emotional distress is also assessed as unrelated. There is no suggestion that the product produced this event. Temporal association is unclarified and there is no biological background for this association.
Headaches, Weakness, Blood pressure changes, occasional tingling in extremities, blurred vision with head movement.
Patient called the pharmacy 3 days after receiving the vaccine to inform us that he was experiencing an adverse reaction to his flu shot.  He was experiencing chills/fever of 102 and other flu like symptoms but tested negative for covid.  He asked that we report his adverse reaction and he would contact his provider.
Swelling in hands in feet with lot of pain; Swelling in hands in feet with lot of pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 15:30 (Lot number: EW1072) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN (non-serious) all with onset 21Aug2021 20:30, outcome "not recovered" and all described as "Swelling in hands in feet with lot of pain". The event "swelling in hands in feet with lot of pain" and "swelling in hands in feet with lot of pain" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of peripheral swelling, pain.  Additional information: No prolonged hospitalization required. The patient did not receive any other vaccines within four weeks prior to the vaccination. Swelling in hands in feet with lot of pain. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 25Aug2021. The patient did not provide information regarding the reported adverse event(s) with the use of the product. Pfizer/Biontech Covid-19 Vaccine details for 1st dose, Date 09Aug2021, Intramuscular, Lot: EW1074  and 2nd dose, Date 31Aug2021, Intramuscular, Lot: FC3183  No follow-up attempts are possible. No further information is expected.
women are having reactions with vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (women are having reactions with vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced ADVERSE REACTION (women are having reactions with vaccine). At the time of the report, ADVERSE REACTION (women are having reactions with vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication use was provided by the reporter. No treatment of events was reported.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number was not reported). The physician stated, that on an unknown date, had something happened to the patient, after the patient was administered a dose of PNEUMOVAX 23. The outcome of event was not reported. The relatedness between event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine). At the time of the report, VACCINATION SITE PRURITUS (Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Convulsion type chills at night  Skin and organs hurt Eyes hurt Headache  Tires
Belching; heartburn; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (Belching), DYSPEPSIA (heartburn) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced ERUCTATION (Belching), DYSPEPSIA (heartburn) and DIARRHOEA (Diarrhea). At the time of the report, ERUCTATION (Belching), DYSPEPSIA (heartburn) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided
Information has been received from a physician concerning a 6 month old male with no known allergies or pertinent medical history who on 02-FEB-2008 was vaccinated orally with a second dose of Rotateq (lot # 659682/1733U).  There was no concomitant medication.  The patient received the first dose of Rotateq (lot # 657673/0904U) on 15-DEC-2007.  On 30-MAR-2008 the patient developed intussusception.  The patient was hospitalized on 30-MAR-2008 and was successfully treated by pneumatic reduction.  The patient was discharged on 31-MAR-2008.  The patient was considered recovered.  There was no product quality complaint involved.  Additional information has been requested.  The reporter considered the patient's intussusception to be serious as an other important medical event, disabling and life threatening.  06/09/2008 MR received for DOS 3/30-31/2008 with D/C DX: Ileocolic Intussusception. Pt presented to ER with 1 day hx of vomiting everything immediately after eating. ? blood in emesis.  Has had diarrhea x several days prior to start of vomiting. (+) rhinorrhea and cough. PE WNL. IS noted on US and reduced by pneumatic floroscopy. D/C next day.
I have had a great deal of increasing pain in my left elbow the has radiated up into my shoulder and down into my fingers ever since having had my vaccination. Nothing I take Tylenol, Ibuprofen, Excedrin, ASA, Aleve seem to work to help the pain. I can't even hardly lift up my glass to drink.
This spontaneous report was received from an administrator and refers to five unspecified patients (gender and age unknown). No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unspecified dates, five injectable doses of M-M-R II, that were exposed to light varying from 1 to 6 hours (Incorrect product storage) (strength, dose, frequency, route of administration, anatomical location,  lot # and expiration date were not reported), were administrated to five unspecified patients for prophylaxis. No adverse symptoms were reported. Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 12/28/20 Lot# 01L20A;  Moderna 12/27/21 Lot# 028K21A
Fever, nausea, dizziness, muscle pain, joint pain, headaches, vomiting
Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash.  Treatment - bed rest.  Outcomes - OK after 4 days.
Covid (Coronavirus disease); Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown age) female patient who experienced covid (coronavirus disease) (covid-19) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On september 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious covid (coronavirus disease) (covid-19) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "So did my niece last week, now this week she got Covid...I'm sure it is just a coincidence"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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.  There will be no information available on the batch number for this case.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 83-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma and RA. Concomitant products included CRESTOR, Folate, MgO, Vitamin C, vitamin d, valsartan, Omega-3, RESTASIS, ORENCIA, AZOPT, latanoprost, MINIVELLE, SYNTHROID, trazodone, Coq10 and selegiline. On 23rd January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced erythema, influenza like illness, dry skin, skin irritation and rash. On an unknown date, the outcome of the erythema, dry skin, skin irritation and rash were not recovered/not resolved and the outcome of the influenza like illness was recovered/resolved. The reporter considered the erythema, influenza like illness, dry skin, skin irritation and rash to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Less than a month after receiving vaccination, the patient had some mild flu-like symptoms initially, but they resolved after a few days. Several weeks later the patient noticed red streaks on her face going down in two lines from her nostrils towards her mouth and extending out towards her cheeks. At first the patient thought her skin was dry and irritated, but it had not improved in the past 3 to 4 weeks that she had been experiencing this. The patient described it as rash, but it was not raised or bumpy, and does not itch or peel. It was just like a bad sunburn, but it does not hurt. She thought it was spreading in area, going more toward nostrils and her cheeks, but had not changed in color.
For 2 days following 2nd covid Pfizer vaccine, had dark/brown urine color, no pain or problem, just color change.; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Mar2021 at 14:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), heart disorder and hypothyroidism. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included pantoprazole sodium sesquihydrate (PANTOPROZOLE); ranolazine (RANEXA), apixaban (ELIQUIS); atorvastatin calcium (LIPITOR) and unspecified medications; all from unknown indication from an unknown dates and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 left arm on 29Jan2021 at 12:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. On 03Mar2021, at 00:00, the patient experienced for 2 days following 2nd covid Pfizer vaccine, dark/brown urine color, no pain or problem, just color change. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event brown urine was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
when home from MD fussy, temp; cont to fuss, not eat, not sleep, not walk, couldn't find a comfortable spot; would not be comforted; temp ranged 101 to 103; very listless seen by MD 29OCT;
vial was stored at room temperature post puncture for more than 24 hrs; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs) 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 (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs).    Patient did not report being immunocompromised.  Patient did not have any medication record. No concomitant medications information was reported. It was reported that 1 vial was involved. 1st vaccine was administered on 02-AUG-2022 at 10 am and the remaining were administered every 15 minutes after 10 am until 11 am. The vial was initially stored in the refrigerator on 01-AUG-2022 at 09:30 am. The vial was stored in room temperature post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degrees to 25 degree Celsius) was just over 24 hours about 24 hours and 30 minutes. Patient did not report having side effects.
That night I vomited For at least 2 weeks I had: -tenderness, swelling, muscle twitching on site -pain radiated from shoulder to elbow -extreme weakness in arm -extreme lethargy and ill feeling