chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant regarding a male patient of unknown age. The patient's concomitant medications included sterile diluent (manufacturer unknown) (lot number and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of M-M-R II, lot # M045392 with expiration date 17-NOV-2018 for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 15 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect involved.
Red rash face, arms, chest observed; Pt c/o itching, taking BENADRYL , given BENADRYL at Pt on 10/15/08. Pt went to PCP on 10/16/08  and  HYDROCYZINE and METHYLPREDNISOLONE. Dr notified on 10/15 and the other Dr notified 10/17/08
9/19/02 mom called and spoke with PHN states child's L arm swollen, itchy starting this am. PHN-mom to contact phys. 9/20/02 called states she took child to clinic as redness from L elbow to L shoulder area, swollen and defined red edges; warm to touch; child was started on po Keflex po tid. Mom states child c/o extreme itching with soreness of L arm.
Patient experienced redness in arm of injection site that progressed into diffuse joint and body pain, dry cough, fever, elevated inflammatory markers, and elevated LFT.  Symptoms continued to a lesser degree until early May 2020. Reaction has resolved without injury.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 08-MAR-2010 the patient was vaccinated with improperly stored dose of VARIVAX lot # 665413/1128Y dose number 2. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very fatigues and malaise. I had access to a blood pressure cup the reading was 148/92, usually my BP is 100/60. Once they took my BP,  then i went to the ER. As time went on, I got more sleepy and tired. The first ER visit they  did lab work, CBC panel which was normal, thyroid test which was normal, EKG and aniongap which were negative. They gave me no medications to take and was probably there in the ER for about 6 hours.  which was on 01-15-2021.  The second time, it was around 11:45am on 01-21-2021.  While sitting at the edge of my bed, I felt a total sadness and despair and feeling of being alone. I then went to  work  felt normal in the morning  and as i went to type some notes after a minute i felt the same symptoms happening again, my BP 140/88 and went to the ER. I was really tired and could of fallen asleep, felt oriented but took me a while to process things. I also had trouble moving my entire body. They placed an IV, gave me fluids, did an EKG again which was normal. They did a CT  scan, CTA  to my chest and neck and CT perfusion, had to inject contrast, exams were both normal. The doctor came in and told me if I was okay to drive home and I drove home.  On the third episode. 01-25-2021 it occurred around 9am,  the symptoms came back but with less intense. I lied down and rested., could feel my heart racing just like the other two episodes. This symptom lasted for about two hours and kind of lingered all day but i could still function. i felt like I had the flu, moderate malaise with  brain fog.
Tingling, pins and needles on palm  Observed water 183/90 HR 67
After injection  2:01pm - almost passed out. Immediate injection site pain. 4:00pm vaginal bleeding, pain in left and right arm Continuing throughout day- pain in both arms, fatigue,  pain in back, feverish and joint pain. 5/22- headache, fever, fatigue, vaginal bleeding, pain under left rib. (Not persistent pain in left rib) feverish and joint pain. 5/23- pain in both arms, shoulder pain, joint pain,  fatigue vaginal spotting. Took 1 ibuprofen. 5/24- lessening arm and back pain, fatigue and vaginal spotting, shoulder pain. Pain below left rib (not persistent) and joint pain now localized in left hand/fingers and left ankle area. Took 1 ibuprofen.
FAINTED FOR FEW MINUTES UNTIL THE AMBULANCE CAME TO REVIVE HER
103 fever 12-16 hrs later after vaccine lasting 36 hrs; Sore throat; Aches; Chills; This is a spontaneous report from a contactable other hcp. A 36-year-old female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number El9231) into the left arm on 29Jan2021 at 07:00 AM at single dose for COVID-19 immunization. Age at vaccination 36 years old. The patient received first dose of BNT162B2 on an unknown date. The patient did not received other drugs within 2 weeks of vaccination. Medical history was none. On 30Jan2021 the patient reported 103 fever 12-16 hrs after vaccine lasting 36 hrs. Sore throat, aches and chills. No treatment was received. the outcome of the events was recovered.
Pt reported severe pain upon injection. said the shot felt "like being slugged in the arm by her big brother" and the pain expanded through the area immediately after it started. she appeared distraught about the pain and was unwilling to receive her 2nd shot
Coworker of patient called the pharmacy on 10/15/13 in the afternoon to say patients left arm was a little red, hurt and was he was having chest pains and nausea. Patient was told to go to ER, he did not.  Patient came to pharmacy 10/16/13 at 10:15 am. Patient's left arm was warm, red, and extremely swollen all the way down his arm. Complained that he could not lift it because it hurt. Phoned patient's physician right away to get him in to see Dr. At 10:20am went to doctors office. Doctor sent patient to ER at 12:15 pm the same day. Have not heard from patient or family.
MEMBER RECIEVED ANTHRAX VACCINE ON 7 MAR 09. SWELLING AND DISCOLORATION A THE SITE OF THE INJECTION. MEMBER STATES THAT SWELLING IS SIZE OF QUARTER. SWELLING STARTED DAY AFTER VACCINATION.
p/vax pt serum varicella zoster virus antibodies test revealed vaccine failure (0.73);
Child is 12 yr old. DAPTACEL given instead of ADACEL.
Within 4 days I was having trouble walking w/ severe pain in my hips and legs; I went into work late 10/11/16 due to these perplexing painful symptoms. Over the course of the day/week I also developed diffuse myalgias, joint pain, malaise/weakness, hoarseness, red irritated eyes, and headaches/migraine. I was extremely fatigued, could not sleep and was emotional from the progressive symptoms. On the morning of 10/11/18 I could not walk downstairs in my home without holding on to the banister railing with both hands. My physician drew labs on 10/19 as my symptoms worsened and my CRP was 135 and my ANA was positive. My hip X-rays were negative. At that point she put me on a high dose steroid pack. This improved my symptoms minimally and by 10/23 I was worsening with all the inflammation. I went to the ER on 10/26/18 and was admitted with a PE felt to be due to the excessive inflammatory response. No source of clot was found (no DVT, normal ECHO, normal coag labs). Despite 2 days of rest and treatment, I continued to have excessive inflammation and sought the care of a rheumatologist. I saw him on 11/7/16. Severe flare of symptoms again on 11/14/16 - got repeat chest CT, bilateral diagnostic mammograms, labs and more prednisone. Saw rheum again 12/12/16 and diagnosed w/ UCTD. Started on PLAQUENIL - took about 2wks to see some improvement. All of 2017 and into 2018 I have continued to seek medical care  for my chronic joint pain, muscle pain, extreme fatigue, neuropathic pain, numbness, dry eyes/mouth, Raynaud's and sensitivity to light/noise.
COVID-19; With each vaccine they only had a little sore arm for a few days; swelling on injection site for a few days; would get tired/very tired/very exhausted; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), PAIN IN EXTREMITY (With each vaccine they only had a little sore arm for a few days), INJECTION SITE SWELLING (swelling on injection site for a few days) and FATIGUE (would get tired/very tired/very exhausted) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced FATIGUE (would get tired/very tired/very exhausted). On an unknown date, the patient experienced COVID-19 (COVID-19), PAIN IN EXTREMITY (With each vaccine they only had a little sore arm for a few days) and INJECTION SITE SWELLING (swelling on injection site for a few days). At the time of the report, COVID-19 (COVID-19) and FATIGUE (would get tired/very tired/very exhausted) outcome was unknown and PAIN IN EXTREMITY (With each vaccine they only had a little sore arm for a few days) and INJECTION SITE SWELLING (swelling on injection site for a few days) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient thought he had a he had strep. Patient was prescribed with all kinds of antibiotics but nothing worked.   This case was linked to US-MODERNATX, INC.-MOD-2023-729751, US-MODERNATX, INC.-MOD-2023-729758, US-MODERNATX, INC.-MOD-2023-729747, US-MODERNATX, INC.-MOD-2023-729726 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729751:Monovalent Product of Wife US-MODERNATX, INC.-MOD-2023-729758:Monovalent Product of Husband US-MODERNATX, INC.-MOD-2023-729747:Wife Bivalent product case US-MODERNATX, INC.-MOD-2023-729726:Other patient case
Coughing, wheezing, hoarseness, very difficult to breathe.  Took antihistamines and a inhaler my wife had on hand.
Pain in injection site on day given & aprox 5 day later R. arm hurting  spoke w/ HCP and told to use ice pack first then heating pad for comfort. And then 4 day on 11/25 became "useless" unable to raise above waist still using heating pad at night for comfort & due to pain so she can sleep. Started physical therapy 12-29-14.
pt recvd vax 14SEP93 & 15SEP93 devel diarrhea; formula was changed w/no improvement in diarrhea; @ the time of report sx persisted; No further details were provided;
vision problems/Had problems in both eyes after the second vaccine shot.; This is a spontaneous report from a contactable consumer (patient). A male patient unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Lot number not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced vision problems/had problems in both eyes after the second vaccine shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MMR given on 4/8/2009. Pt noted symptoms. Flu like achy onset 4/18/09. Stopped 4/21/09. Rash onset 4/21/09 - ongoing. Rash on side of face, neck & trunk.
A non-serious spontaneous report of inadvertently administered second dose of H1N1 LAIV and cranky was received from a mother/consumer concerning her 11-year-old son, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medication was reported for this patient. On 05-Dec-2009, the patient received first dose of H1N1, Intranasal for unspecified indication. On 16-Dec-2009, the patient was inadvertently administered a second dose of H1N1, Intranasal for unspecified indication. The patient had been cranky after receiving both doses of the vaccine. The patient continued to be cranky sporadically at the time of reporting. The outcome of the event of inadvertently administered second dose of H1N1 LAIV was resolved and that of cranky was not resolved.
Seven minutes after vaccine (10:07 AM) lighheadedness, Tacharida, hives, shortness of breath. Went to ER, given Prednisone, Benadryl, Pepcid at 11:00 AM. Discharged at at 12:30 after symptoms subsided. Fatigue present 2/24 and 25. Today is 2/26.
At about 15 minutes after injection, heart rate rose to about 180bpm. I was laid onto a cot by paramedics. They tried to take me to the emergency room but I refused. They measured my blood pressure, but I don't remember what it was. I lied there for about 15 minutes with legs raised while we waited for my heart rate to lower. They let me go when my heart rate reached around 90-100bpm, where it stayed for several hours. I had difficulty walking for a few days -- it was like I had a bad POTS (Postural Orthostatic Tachycardia Syndrome) flare-up. Every time I would stand or sit up, my heart rate would suddenly increase by a notable amount, causing temporary vision loss, light-headedness, and loss of balance, and sometimes difficulty breathing.
Temps 101-102.5, headache, body aches, lasted 18-20h, treated w ibuprofen and rest
Patient felt like her body had been invaded and did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Patient felt like her body had been invaded and did not feel good) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Patient felt like her body had been invaded and did not feel good). On 10-Mar-2021, FEELING ABNORMAL (Patient felt like her body had been invaded and did not feel good) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-238556 (Patient Link).
Developed shortness of breath, tachycardia, dizziness, inability to regulate body temperature, brain fog, fatigue, and headaches.  Was diagnosed with POTS (Postural Tachycardia Syndrome) which she is still suffering from and may be chronic.
Diarrhoea; Headache; Sore throat; Cough; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9264), dose 1 via an unspecified route of administration, administered in Arm Right on 23Feb2021 as a single dose for covid-19 immunization (at the age of 56-years-old). Medical history included Cancer (2 year's ago), Known allergies Penicillin, Codeine, ceph drugs, and Tamiflu. The patient's concomitant medications were not reported. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: El9264), dose 1 via an unspecified route of administration, administered in Right Arm on 02Feb2021 at 02:30 PM as a single dose for COVID-19 immunization (at the age of 56-years-old). Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Patient visited to Physician Office. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient did not receive other vaccine within 4 weeks and 2 weeks prior to the COVID vaccine. The patient previously took codeine for drug hypersensitivity, tamiflu for drug hypersensitivity. Patient told to take Imodium and drink pedialite. On 03Feb2021 (at 10:00 PM), the patient experienced diarrhoea, headache, and sore throat, and cough. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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 concomitant information was provided by the reporter. It was reported that the vial was to expire on 30-JUL-2021 because it was removed from the freezer to store in the fridge. No treatment information was reported.
dizziness and balance issues, nausea, cloudy/muted hearing on side of vaccine (left ear), pain, fever, sweating, chest pain, elevated blood pressure
Last night (4/17/21) I noticed swelling, redness, and itching below my injection site.  The symptoms persist today (4/18/21); however, they are  relatively mild.
Pt experienced a rash to face, chest and shoulders after being in the sun. Pt taken to ER and treated with Zyrtec and Prednisone.
Vertigo when I awoke on 2.12.21. The smell of roasting chicken prompted GI symptoms like food poisoning: intense gastrointestinal cramps, soft stools, then vomiting. I slept for many hours, ate a little so I could take my antibiotic, slept, ate and took my second antibiotic, slept, awoke at 1 am with an intense headache, so ate 1/2 banana, took 2 Advil, then slept for 8 hours. I awoke feeling spent, but healthy again! Still experiencing vertigo from time to time.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy, influenza like illness and product supply issue. SHINGRIX was discontinued. On an unknown date, the outcome of the sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy and product supply issue were unknown and the outcome of the influenza like illness was recovered/resolved. It was unknown if the reporter considered the sickness, injection site swelling, injection site erythema, injection site pain, headache, nausea, fever, lethargy and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient could be 54 or 55 years old. The patient was trying to locate the vaccine for her booster and was worried on how to get the booster in time. The patient had called at her physician's location. The locator showed it was available but there was no availability at any of the locations.  The patient kept calling but was hoping for an updated list. The reporter had no specific information as to which locations currently the vaccine would be available. The locator only listed the locations that offered the vaccine. The shipment had just released the week from the date of reporting and had one scheduled for the next week. The patient got really sick and did not want to start over. The patient experienced bad side effects such as swelling, red and painful at site, plus headache, nausea, fever, felt lethargic and flu like for 3 day. It was reported that as per FDA dosing schedule for SHINGRIX, the vaccine must be received as the 1st dose at month zero, followed by 2nd dose 2 to 6 months after the 1st dose. It had been 6 months since the patient had received the 1st dose and was advised to receive the 2nd dose as soon as possible and need not to restart the vaccine series.
4 days after vaccination, I was awakened in the night by new tinnitus symptoms.  I have had tinnitus for many years, but this was much louder and included a new, different sound (pitch) that was unlike any of the tones I had previously experienced.  This increased intensity still persists.  I had the 2nd dose of the vaccine on May 10, and was awakened 36 hours later by a loud and different sound. This one resolved after 2 days, but the original still remains.
Sweating; Pain at the injection site left arm; Mild fever; Tiredness; I have a severe throbbing headache that has lasted for 10 days,; I received my booster dose on 20AUG2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever), FATIGUE (Tiredness) and HEADACHE (I have a severe throbbing headache that has lasted for 10 days,) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever), FATIGUE (Tiredness) and HEADACHE (I have a severe throbbing headache that has lasted for 10 days,). 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster dose on 20AUG2021). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster dose on 20AUG2021) had resolved. On 30-Aug-2021, HEADACHE (I have a severe throbbing headache that has lasted for 10 days,) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.   This case was linked to MOD-2021-302375, MOD-2021-028030.