chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced fatigue and diarrhea 2 days after receiving vaccine. Continued to experience diarrhea symptoms for 7 days (intermittently for a month after). Experienced dizziness, shortness of breath and chest pain on April 26, 13 days after receiving vaccine. Went to ER, EKG was clear. Blood work showed elevated D-dimer levels and CT scan of the chest was done with no abnormalities found. Experienced dizziness, shortness of breath and chest pain 3 times after ER visit. Echo and heart monitor was ordered by cardiologist, a month later. Findings showed irregular heartbeat and trace pericardial effusion.
At 8 pm I started to feel chills, I started feel bad, fatigued, achy, kind of like the flu. Then I was just like super tired, and I just lay down, and I took my temperature and it was 102. I was scared because a year ago I had surgery and afterwards I had a super high fever and was super sick and delirious and I went to the ER and they never found out what it was. I felt the same way. I did not want to take any medication, but I started taking Ibuprofen and TYLENOL, alternating. My fever would stay at 104 and then come down, but then stayed at 104. I felt really achy and kind of delirious, I just wanted to sleep. I talked to my doctor and they just told me to take Ibuprofen and TYLENOL and to put on ice packs.
Tremendous leg pain and thighs pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tremendous leg pain and thighs pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C10M20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Tremendous leg pain and thighs pain). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Tremendous leg pain and thighs pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tremendous leg pain and thighs pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C10M20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Tremendous leg pain and thighs pain). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Tremendous leg pain and thighs pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
6 months old patient received Adacel instead of an age appropriate DTap vaccine, no AE; 6 months old patient received Adacel instead of an age appropriate DTap vaccine, no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 6 months male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of an age appropriate DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB).  On 31-Jan-2020, the patient received a 0.5 ml dose (DTP third dose) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5640AA and expiry date: 27-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination instead of an age appropriate DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  It was actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.90.  Concomitant products were not provided.  On 27-Feb-2021, Excursion time was 09 AM,11AM,12 PM,1 PM,2 PM,3 PM,4 PM,5 PM temperature was 33,35,35,35,35,35,34,34,35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Brachial neuritis lt area C7 distribution pain, weakness, paresthesia; referral to neurologist who confirmed dx;
sometimes the pain in her neck affects her ear and swallowing; sometimes the pain in her neck affects her ear and swallowing; it was shooting pain up into her skull and the top of her head; neck pain on the left side; her skin on the left side of her neck is sore to touch; This is a spontaneous report from a contactable nurse (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269, expiration date was not reported) (at 82 years of age), via an unspecified route of administration in the left arm on 06Feb2021 15:40 at a single dose for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. There were no concomitant medications. The patient did not take any other vaccinations within four weeks prior to the first administration date of the vaccine. She had no adverse events prior vaccinations and no illness at time of vaccination. The patient received her 1st dose on Saturday (06Feb2021). On Sunday (07Feb2021), she had neck pain on the left side, which was the same as she got the vaccine, and it was shooting pain up into her skull and the top of her head. She stated that her skin on the left side of her neck was sore to touch on 07Feb2021. Sometimes it affects her ear and swallowing on 09Feb2021. She stated that he looked in her throat and it looked okay. She wanted to know if this was from the vaccine. She stated that the shooting pain was killing her today. She had been using Bengay, heat, and Tylenol which lasts about 8hrs. States that the pain woke her up last night, so she took 2 Tylenol Arthritis. Her 2nd dose of the vaccine is scheduled for 27Feb2021. Her husband kept saying it was from the shot, but she doesn't know. She asked if it was then what is she going to do with the 2nd one? The patient did not go to the emergency room nor visit a physician's office for the events. The outcome of the event neck pain was not recovered while recovering for other events. The events neck pain on the left side, skin on the left side of her neck is sore to touch, and sometimes the pain in her neck affects her ear and swallowing are reported as medically significant events.
Patient was supposed to be getting primary Moderna bivalent vaccine but instead was given booster vaccine at 0.2mls
Pt given flu immunization approximately 10 mins after giving-she stated she was having some tightness in her throat like a lump. Also some difficulty breathing. States has asthma at 305pm she was given Benadryl .25mg IM LD and was taken to EHS for observation. She also gave herself 2 puffs of inhalers.
constantly dropping things; Pain in eyes; motor function was slightly impaired; Extremely tired/extremely exhausted; Pain in his body; Weak and brain fog; Weak and brain fog; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm left on 16Aug2021 at 16:00 (Lot Number: FC3181) as dose 2, single (at the age of 35 years old) for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 26Jul2021 at 04:00 PM (Lot number: FA7484) via intramuscular administered in left arm as dose 1 (at the age of 35 years old) for COVID-19 immunization. No other vaccine in two weeks and four weeks. No COVID prior vaccination and was not tested post vaccination. No known allergies. The patient experienced extremely tired still, pain in his body, weak, and brain fog on 16Aug2021 at 16:30. It was reported that after second (2nd) shot a month later (as reported), patient still wake up extremely exhausted. On 16Aug2021 at 18:00, reported that she constantly dropping things now which never happened before. Further reported that patient experienced pain in eyes, motor function was slightly impaired, stated playing basketball now his precision accuracy were way off on 16Aug2021 at 18:00. Asked on how much longer will that last. No treatment was provided. The outcome of the events was not recovered  No follow-up attempts are needed. No further information is expected.
PATIENT WAS GIVEN .5ML OF VACCINE (IN TWO .25 SHOTS) AND SHOULD HAVE RECEIVED .25ML.
Rash and redness and swelling; cellulitis. Doxycycline 100 mg BID.
lightheaded then came the headache and nausea.   The next afternoon I had achiness all over, low grade fever (99.2), headache and nausea.  It lasted until about 5pm on the 2nd of May.
Covid-19; Covid-19; This is a spontaneous report from a contactable consumer (patient), from a sponsored program.  A 71-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and dose 2 via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced covid-19 on an unspecified date with outcome of unknown. Caller is asking for recommendations on the booster vaccine. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pretty sick /felt ill; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 19Mar2021, outcome "recovering", described as "Pretty sick /felt ill"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovering", described as "Flu like symptoms".  Additional information: Consumer stated, he and his wife both had the second vaccine (Unspecified vaccine) on Thursday, and they came down pretty sick flu like symptoms and stuff like that. Patient felt ill Friday. Today he felt little bit better still following plans. He just wanted to know would they contagious to other people, as they wanted to go to church around old people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021320612 same reporter/Vaccine, different patient
fever of 102 R 1 wk following vax listed below; 225AUG93 pt broke out in a rash described by mom as welts occuring only on legs; rash was confirmed to thighs & ankles;
36 hours Following Flu vaccine developed raised red 1" diameter swollen area just below site of injection; Slightly more red and inflamed in past 24 hours. Referred to own Primary Care MD. Pt agrees to call - today.
No immediate results until roughly 6 hours after the shot. Was not able to go to sleep after the 6 hour mark. Shortly began to get cold sweats/chills alternating through the night.  Became extremely weak and was no longer able to walk or use my arms from ~midnight until 8 AM the next day. I also was experiencing huge migraines that entire time. The migraines occurred from the 6 hour mark until ~48 hours later.  Became slightly difficult to breath and it felt slightly weird when breathing(somewhat like a tickle in throat/feeling when you breath air that is too cold and it doesn't feel like its working). This was from approximately that 6 hour mark until the ~48 hour mark.  My already high (~100 bpm typically despite being 22) heart rate increased significantly as well. This was from the same 6 hour mark till the 48 hour mark  Overall I had a significantly worse reaction to the shot than I did to my case of Covid itself.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 08-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Couple of months later after my 2nd dose vaccination I experienced severe palpitation - I went to the ER and they did an EKG. Up to this date I am still experiencing on and off heart palpitations and this did not happen before I had my COVID 19 vaccine.
Dead arm, small bumps below injection site, stiffness of muscle at injection site, tired, headache
I started getting tired and experienced pain in the middle of my chest . When I would kneel over the pressure in my chest would get worse it was also hard to take a deep breath in but it wasn?t my lungs it seem like my heart was having trouble keeping up.. It got worse each day until I called the on call doctor on Sunday 3 days post Vaccine. They said most times people have side effects up up to five days so I didn?t go in.     I was also exhausted at the time so badly that I could hardly keep my eyes open.
Two hrs after receipt began to feel achy, and had a headache.  As the night progressed she felt worse.  C/O chills nausea, diarrhea and back and hip pains.  Went away after 48 hrs.  Night of 3/14/21 state itchy, blotchy rash appeared on left arm below site of vaccine administration.  Some swelling.  Has taken a benadryl and applied topical corticosteroids.
Physician reprted 51yr white male was vacc w/ 1st,2nd,3rd dose of hep B vacc (recomb.) in Mar,apr, &sept, 1988.  In Dec 1989 patient developed GBS and was hosp.  Discharged the week of 09jan90.No further details provided.
The patient described that he experienced a severe neuropathy from his head to toes, that caused tingling pain and numbness. He stated that he was seen by a specialist and the symptoms are just now starting to resolve.
Raspy throat and very runny nose, and sneezing, slight sinus pressure. I tested at home for COVID19 and then I did an online test to treat program and was prescribed PAXLOVID. I started PAXLOVID on 3/31 and ended on 4/6. My symptoms subsided but started coming back on 4/8 and I tested positive again. I still have symptoms.
Patient had a syncopal episode around 5 minutes after vaccines and fell to the ground, striking his head on the floor.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOTENSION  9/30/2022 --  RECURRENCE OF SAME SYMPTOMS
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2023, outcome "not recovered". Additional information: Patient stated that he was wondering, he had Comirnaty 12 plus Covid 23-24 SDV two weeks ago. Has been two weeks and they still experience fatigue. Wanted to know is that normal. Was curious as to whether it is normal to be tired after two weeks for him. Wondering if other people were reporting fatigue after two weeks.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316111 similar report from same reporter, different patients;
Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
I got shot in the arm and got swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, No events reported), for Covid-19 Immunization.The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "I got shot in the arm and got swelling".  Additional information: consumer stated, "Yes, you know my arm react to the (second) shot and it begun like have little small swelling, so I put ice on it." if patient got a shot in the arm is like got a little swelling and put ice on it. Is that the correct thing to do (treatment)."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experienced Vertigo with naseau and dry heaves after second vaccine shot, probably for at least a month. Gradually went away.  I did contact my doctor and had my hearing checked etc.  I never thought of it  tied to the vaccine.  However now I am home with Covid ( 1/14/22) and experiencing same symptoms fo vertigo that I had after vacccine.
Temperature 98.1 Pulse 93 Respiration 20 B/P 105/71. Redness and swelling both upper arms. Left arm - 15 cm x 11 cm red, warm, blanching. Right arm - 9.5 cm x 8 cm red, warm, blanching.
Fever 102 for two days, LGF on the third day (today). Severe  body aches (joints, skin, eyes, mucosa, bones ovary/flank area, sacroiliac joint and soft tissue) requiring 24 hr alternating ibuprofen/acetaminophen. Uncontrollable intermittent  crying for 3 days. Significant visible and tender lymphadenopathy from injection site deltoid area inferno lateral arm progressing medically through left axilla and on to left lateral thorax. Fatigue and dizziness requiring missed work for the last three days. I?m calling in tomorrow as well. Headache.
MUSCLES IN BONES WAS SORE FROM WAIST DOWN; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (MUSCLES IN BONES WAS SORE FROM WAIST DOWN) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced MYALGIA (MUSCLES IN BONES WAS SORE FROM WAIST DOWN). At the time of the report, MYALGIA (MUSCLES IN BONES WAS SORE FROM WAIST DOWN) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter.  No concomitant medications were provided by the reporter.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient felt faint and lightheaded, never completely lost consciousness. Was fine 5 minutes after. Paramedics were called and had examined the patient, but he was fine.