chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had severe pain and swelling at the injection site. It was red and hot to the touch. It later spread to the back of the arm and down the arm. I frequently run a low grade fever. I am now being treated for anemia. At its peak, all I wanted to do was sleep, took frequent naps during The day. As of today 8/28/19, I am beginning to feel better, pain in muscles is lessening. However, now my left leg is swollen from the knee to the foot - no injury involved. Had a DVT Ultrasound, no sign of blood clots. For multiple lab tests and results, contact office of DR.
Pt received 2nd dose of COVID-19 vaccine.  About 8-12 hours later pt develeopd vesicles/pustules  near injection site.  The maculopapular rash was a diameter of approximately 8 inches. Pt further reports other areas on his legs, and in the medial thigh which waxed and waned.  Pt has had a 3 day history of facial swelling, and orbital edema.   Further states nodules on trunk and groin area.  Pt has taken diphenhydramine with minimal relief.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 22-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
Patient came to clinic with severe left arm pain that began the day after her second Pfizer vaccine. Limited motion of arm due to pain. Radiated to left hand and left breast described as burning and constant. Also had diarrhea x2 days and fever of 100.9
Weakness; Dehydration; Fatigue; Rigors; Nausea; Vomiting; Cramping; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DEHYDRATION (Dehydration), MUSCLE SPASMS (Cramping), FATIGUE (Fatigue) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping), VOMITING (Vomiting) and NAUSEA (Nausea). On 13-Jan-2021, the patient experienced ASTHENIA (Weakness), DEHYDRATION (Dehydration), FATIGUE (Fatigue) and CHILLS (Rigors). At the time of the report, ASTHENIA (Weakness), DEHYDRATION (Dehydration), MUSCLE SPASMS (Cramping), FATIGUE (Fatigue), VOMITING (Vomiting), CHILLS (Rigors) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on anti-diarrhea and anti-emetic medications.  Concomitant product use was not provided by the reporter
@ 225PM mom called clinic stating pt recvd shots in AM & now has t103 & trembling, also difficulty breathing-advised to take pt to ER;
Red rash/lesion at injection site. No itching or pain observed within first two days of appearance.
the same side effects as before of mild fever and fatique; the same side effects as before of mild fever and fatique; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "the same side effects as before of mild fever and fatique".  Additional information: It was reported that she just got booster her third. She was asking if this was still ok. She also was asking if she should still expect the same side effects as before of mild fever and fatigue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
immediate syncope causing a fall striking face against floor causing mandible fracture in 2 different areas
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose 1, 0.65 ml, lot no. unknown). On 26-JAN-2015, the patient received a second dose of ZOSTAVAX (subcutaneous, dose 2, 0.65 ml, lot no. unknown. No adverse events were reported. Additional information is not expected, because there is no authorization to contact physician.
I had NO reaction when I got the injection.  I did not even have a sore arm.     Then,   7  DAYS LATER, I woke up with a fever, a large red spot (size of orange), and bad headache. I did NOT call the doctor.  I took Advil, stayed in bed for 4 more hours.  Fever was gone when I got up.  Arm was sore for sever more days, and headache was gone the next day. I thought it was unusual since it happened 7 days later.    I have had no more reactions since this one.
received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 007J21-2A, 016M20 and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.). At the time of the report, ACCIDENTAL OVERDOSE (received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.) outcome was unknown.            No Concomitant product use was reported.  The patient stated that they had received 3 primary series doses, as the patient thought the patient was qualified as immunocompromised due to their advanced age. The patient also stated that the patient had now received the 1st booster dose and till date had received 4 total doses of the Moderna Covid-19 vaccine (3 full doses and 1 booster dose). The patient stated that one of the doctors on a TV program stated that there might be an added advantage to waiting more than 4 months before receiving the 2nd booster dose as it may work better.  The patient had earlier reported that the patient got the 3rd dose more or less as an accident, and the patient thought they only got it because the patient was 86 years old, but the patient didn't had any indications from their doctor.  The treatment medication information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Significant Follow-up was received: The reporter occupation has been changed to patient from consumer. The patient details were updated including date of birth and age. Suspect drug dose details were updated including start dates and lot number of primary series and booster dose. Added event Accidental overdose and the case narrative was updated.
Pt states that on 23OCT22 he received his flu shot. He noticed that a few days later he was having extreme leg pain and worsening muscle pain and soreness. On Saturday, 5NOV22 he woke up and was unable to move.  He could not sit up, roll over, or stand. He was able to call his mates. He was transported to hospital with ascending bilateral LE paresis and was admitted to NICU with working diagnosis of GBS.   He inadvertently received the entire 5-day course of IVIG 2g/kg over the span of every 8 hours. However, he was able to start moving his arms again almost immediately.  He also had a failed lumbar puncture. He subsequently developed a severe headache that finally resolved.  He was released on 10NOV22 and returned home.
Flu like symptoms; This is a spontaneous report from a contactable consumer via company representative. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu like symptoms post first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
I was very sick; pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was very sick"; PAIN (non-serious), outcome "unknown", described as "pain". Additional information: Patient called in because she took her Covid vaccination and did not stop medication. Patient stated that medication does not appear to be working as well and she has to take Tylenol to help with the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
He had a seizure 2 days later, had to call 911 and see ER
Upon conclusion of the 15-minute observation period, when asked how he was doing, he said he felt fine but that he noticed a "tingling sensation" of his left (injection) arm and left leg. He was offered the option to stay for further observation, but repeated that he otherwise felt fine. He was contacted on 121820, and he reported resolution of symptoms without intervention.
Patient was seen in the emergency room by myself.  Vital signs are noted.  Patient is afebrile, nontoxic in no acute distress.  Patient came in for shortness of breath and hypoxia.  He was 88% per EMS when they arrived on room air.  They put him on 10 L and we have decrease that down to 6 L and he is satting at 98%.  Patient complains of some rapid breathing after he had a fainting spell while on the toilet.  He denies any difficulty breathing currently or any chest pain.  He states he does get dizzy spells similar to this.  He denies any falls or recent injury.  He does have a history of PE and is on Xarelto
My body became so very weak that I could not roll over or walk on my own.  I experienced a lot of joint pain.  I was so worried that my MS was becoming active.   This conditioned lasted about 24 hours , but the weakness and fatigue lasted for several days. It has been 4 days since my  vaccine and am feeling myself again. This was my second vaccine.  The first vaccine, I experienced weakness and difficulty walking, but it was no where as bad as the second vaccine.
Lack of drug effect; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4380396-00.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Batch/Lot number: unknown) and on 01Jun2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Lack of drug effect"; COVID-19 (medically significant), outcome "not recovered".  The reporter's assessment of the causal relationship of "lack of drug effect" and "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Triggered acute manic episode.  I have not been really able to sleep or eat for a week, yet I feel fatigued.  I don't feel well at all.  I feel like I am losing my mind.   The mania seems to be getting a little better but I still feel so tired.
Pain at injection site, shoulder pain, lasting 4 days. Fever w/transient tachycardia to 108 bpm (self-report), for one-two days. Alternated application of ice and warm pack, ibuprofen and tylenol. Employee had reported having sore throat day of injection and prior to injection, and that daughter had been ill with flu sxs during week prior.
Pt reports no adverse events.  Pt received vaccine that was kept in freezer for 3 days longer than Pfizer's recommended time.
Pain started at the injection site about eighthours after vaccination was applied.  The next morning the pain areas were injection site(left arm), shoulder and neck.  Two days later pain in the arm went away but neck pain remained.  As of today 04/20/2021 neck pain is still present.  It hurts when I turn my head to the left and when I tilt my head forward or backwards.
Shoulder injury related to vaccine administration; associated symptoms include stiffness, soreness, severe pain. Pain started immediately after injection in January. Treated with naproxen, and tramadol. Received X-rays and MRI and started Celebrex and Myoflex cream. MRI resulted in diagnosis of bursitis.
I woke in the am with extreme fatigue and generalized muscle aches and a cold sore.  This progressed through the day to the evening with severe muscle aches and joint pain and stiffness in all joints except my hands and feet.  I also am experiencing a sore throat and a slightly productive cough that continues today.  I took Tylenol and Benedryl at bedtime.
15 weeks pregnant, estimated delivery July 30, 2021. Severe headaches periodically for 8 days. Firm, warm, itchy rash just below injection site on 2-11.
Started as a Fibromyalgia event with feeling aggravating pain throughout body, unable to sit or stand.  Which then sends me to bed.  But the pain increased to more intense than I would normally feel.  I felt this pain from head to toes.  Especially, upper back and neck with migraine-type headache, my lower back and hips, my knees radiated to ankles, felt the pain on top of my feet, also my rib cage, arms, hands and fingers.  Needed to take a full  Hydrochodone 7.5-325  but pain persisted on and off throughout night and next day. Still feeling increased amount of fatigue.   Also experienced pain in left arm pit and found several enlarged lymphnodes.
Pain in arm; drowsiness and could not put head together; anxiety; Rash on his palm/Rash on his hand/Rash looks like eczema; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (drowsiness and could not put head together), ANXIETY (anxiety) and RASH (Rash on his palm/Rash on his hand/Rash looks like eczema) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (drowsiness and could not put head together), ANXIETY (anxiety) and RASH (Rash on his palm/Rash on his hand/Rash looks like eczema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) at a dose of 25 mg and MUPIROCIN at a dose of 2 %. At the time of the report, PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (drowsiness and could not put head together), ANXIETY (anxiety) and RASH (Rash on his palm/Rash on his hand/Rash looks like eczema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.    This case was linked to MOD-2021-114485, MOD-2021-114485 (Patient Link).
Caller's wife had a fever of 101F after getting the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Reporter's wife).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced caller's wife had a fever of 101f after getting the 1st dose on an unspecified date. The patient underwent lab tests and procedures which included body temperature was 101 Fahrenheit (fever). The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old female (Non-pregnant) patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 27Feb2021 11:00 as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that the patient had no allergies. The patient did not receive any other vaccine in four weeks. No other medications in two weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that on 6Feb2021 had my first Pfizer vaccine and within 24 hours developed diarrhoea - it lasted about 4 days - received my second vaccine on 27Feb2021 -Again, within 24 hours developed diarrhoea again on 28Feb2021 08:15 once again taking Pepto-Bismol. It has been 48 hours since my second vaccine. The outcome of event not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
By about end of August/early September, I started to notice the skin on the front of my calves getting oddly bumpy. The bumps traveled up my legs to my buttocks. I then started to notice bumps on my arms. I called a dermatologist for an appt. By the time I could see the Dr(took about 2 weeks), the bumps had multiplied and enlarged. The Dr looked at me and wanted to put me into the hospital. Instead, he decided to put me onto prednisonewhich I was on for a month. It made a little difference. I've seen about 7 dermatologists and 2 allergists and no one can really figure out what is wrong with me. I've had 3 biopsies with 3 different diagnosis. Nothing had really helped. I'm now receiving ozone therapy and IV chelation
red dots all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red dots all over body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Exposure to poison ivy on 13-Mar-2021.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced RASH (red dots all over body). The patient was treated with PREDNISONE for Adverse event, at a dose of 5 day regimen. At the time of the report, RASH (red dots all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient was reported to be exposed to poison ivy on 13-MAR-2021 (2 days prior to the first dose of vaccine) and developed small patches of red blisters on their hand.  Then on 17-MAR-2021 after the first dose of vaccination, the patient developed red dots all over their body and was treated in urgent care with a steroid injection and prescribed a 5 day regimen of prednisone.
The vial was open for 48 hours in refrigerated condition, administered to patient; A spontaneous report was received from a pharmacist concerning a 32-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and that the vial was open for 48 hours in refrigerated condition and vaccine was administered to patient.   The patient's medical history was not provided. No concomitant medications were reported.   On 24 Jan 2021 at approximately 12:01pm, the patient received first dose of mRNA-1273 (Lot number: 062G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Jan 2021, a dose of the vaccine was administered after the vial had been in refrigerated conditions for 48 hours. The pharmacist wants to know what the efficacy of a vial that was administered to a patient after 6 hours and is inquiring if the dose should be repeated.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event "the vial was open for 48 hours in refrigerated condition, administered to patient' was not provided.; Reporter's Comments: This case concerns a 32 year old female who received first dose of mRNA-1273 (Lot number: 062G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and the vial was open for 48 hours in refrigerated condition and vaccine was administered to patient. There were no reported adverse events after the vaccine was administered in this case of product storage error.