chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st vaccine.  She then started feeling very cold, laid down and watched TV.  She then had chills all night and did not sleep well due to that.  When she got up on Tuesday the chills were gone but had a slight headache off and on throughout the day, her temp was 97.2.  Throughout the day she would get warm spurts/hot flashes, as well as fatigue.  She did sleep that night, and when she got up yesterday morning still had the hot flashes and it was 94.2, and took it twice due to it being so low.  She was like that with fatigue and not able to sit up.  She went to bed, took some Tylenol and rested.  The heat feeling it started going away.  Around dinner time she felt more like herself, the headache was gone and her temp was 97.  She was doing pretty good, and the last thing she had was she felt on her cheeks and noticed a rash on her face, like a prickly heat type rash.  Before she went to bed she put Neosporin on it, and when she got up this morning it was almost gone but still has a tiny few bumps.   The arm itself did not hurt at all.    Feels that it is a stressful situation as to where to get the vaccine and having to travel to get it as it's not available in locations closer to their homes.  The people at the pharmacy were great, but had to travel and if it wasn't for her daughter she would probably not have her shot.
This is a spontaneous report from a contactable nurse via a Pfizer representative. A currently 3-year-old male received three dose of PREVNAR 7 and one dose of PREVNAR 13 on unknown dates. The relevant medical history was therapy regimen changed from PREVNAR 7 to PREVNAR 13. Concomitant medications of the patient were unknown. It was reported that the patient was still having pneumococcal meningitis on an unknown date and was hospitalized on an unknown date. The reporter also mentioned that there might be product failure in this case, however serotype was not provided. The relevant lab data were unknown. Therapeutic measures taken in response to the reported event were unknown. The clinical outcome of the reported event was unknown at the time of the report.
This report describes arthritis in a 49 year old female who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. The subject had no relevant medical history and received no medications at the time of immunizations. She mentioned "pulling ticks off her during Lyme season". In approximately12/99, the subject received her second injection of Lymerix. Approximately two weeks later, she began to experience arthritis with joint pain that was "so bad that she could not hold a bag". She also began to experience "frequent headaches that are really bad". The subject was seen by her physician. The arthritis symptoms were treated with rofecoxib (Vioxx) 25 mg as needed. After one year of vioxx therapy, her symptoms have improved and are now experienced "off and on". The Lymerix immunization series was discontinued. On 08/07/02, a Western blot was performed. "It revealed Dalton band 41.the immunoglobulin was 1." the reporter stated that the subject's symptoms were probably related to Lymerix administration.
After 12 days swelling, itching, arm pain.  Called covid reaction line 3 /22/21.    Prescribed Clindamycin and kenalog ointment.  Still problematic.  Currently in ER, triage nurse feels steroid burst will likely be prescribed once seen.
Per FNP  at  6:50 PM patient noted to be clearing throat, face (masked) reddened; hives x 3 on right forehead, 1 hive on upper right arm, patient noted to be rubbing back of neck, upon questioning, patient stated neck and hives on face pruretic, FNP assessed back of neck (unable to assess fully due to body suit under clothes) and back of neck and upper shoulders noted to be reddened with mild hives noted, 7:05 PM patient complained of itching right eyebrow, hive apparent, vital signs B/P 128/80 Pulse 80 Respirations 18, patient continued to be alert and oriented, face, especially cheeks, area around eyes and lips noted to be getting edematous, EpiPen, 0.3mg IM administered in the left upper thigh.  Patient denied difficulty swallowing, continued to down play symptoms, EMS called for transfer to Hospital, recommended that patient call family member, patient placed telephone call to wife, 7:08 PM redness in face noted to be decreasing but patient admitted to feeling swelling in his throat, patient continued to deny difficuty breathing, 7:12 PM B/P 100/70 Pulse 72 Respirations 24, patient complained of feeling "jittery", hands noted to be trembling, explained to patient that these feelings are normal reaction to the Epinephrine, 7:15 PM Heart Rate 84 Respirations 22, reddening of face and neck, resolving, facial swelling with exception of lower lip resolving, EMTs arrived at 7:24 PM; report given to EMTs by EMT present at the vaccine POD.
I received the second dose of Shingrix and had severe flu symptoms beginning 12 hours after the injection, and lasting 24 hours after the injection. I had sweats, chills, a 100 degree fever, body aches, ear ache, skin sensitive to touch, ringing in ears, weakness, nausea, and redness/swelling/pain at the injection site. These symptoms were severe, like I had a bad case of flu. After the first day post-vaccine, I had only itching, redness, swelling and pain at the injection site.
covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-071427 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071427:
Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept for 9 hours. the next day began itching around the middle - stomach and back had to work so did not take anything for it.  by the second day the itching was generalized.  only temporarily relieved by application of cortisone - 10.  the 3rd day I took cetirizine but it didn't seem to help much. the 4th day I took Benadryl  and the itching reduced for the next few days. took another Benadryl on the 7th day.  itching more localized to the stomach and back.  Today, it came back to generalized again. from the scalp to the soles of the feet. I have to work so cannot take Benadryl at this time.  Thought I would not need to see the Dr, hoping it would get better but as it stands today I will need to go see the Dr.
Left upper arm pain, severe, 8/10 pain. No redness, heat, or swelling in arm.
2 minutes into observation, the patient experienced a syncopal episode lasting 10 seconds. The patient regained consciousness quickly and was oriented x 4. The patient had symptoms of clammy skin, diaphoretic, and lightheadedness. Legs elevated, water, icepacks, and lollipops provided. Vital signs within normal range. The patient stated he has a history of passing out with blood draws.  observation extended to additional 30 minutes. Pt stated symptoms fully resolved and left the site ambulatory and in stable condition.
Following booster, patient reports that she developed psoriasis for the first time in her life; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19, Previous dose Brand: Pfizer , Previous dose Brand unknown: False , Previous dose Lot number: Unknown, Previous dose Lot unknown: False, Previous dose number: 1), for COVID-19 immunization; Bnt162b2 (Previous dose details:, Previous dose product: COVID 19, Previous dose Brand: Pfizer , Previous dose Brand unknown: False , Previous dose Lot number: Unknown, Previous dose Lot unknown: False, Previous dose number: 2), for COVID-19 immunization.  The following information was reported: PSORIASIS (non-serious), outcome "not recovered", described as "Following booster, patient reports that she developed psoriasis for the first time in her life". The event "following booster, patient reports that she developed psoriasis for the first time in her life" required physician office visit. Therapeutic measures were taken as a result of psoriasis.  Additional Information: Following booster, patient reports that she developed psoriasis for the first time in her life. This happened about 3-4 weeks following the booster. It was unknown if she had any known allergies and other medical history. It was unknown if she had other vaccine in four weeks and other medications in two weeks. It was unknown if she had COVID-19 prior to vaccination and was tested for COVID-19 post the vaccination. She received Methotrexate as a treatment medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided.
This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 16-OCT-2014, the patient was vaccinated with MMR II (lot number, dose, route and site of administration was not reported) who was inadvertently administered with (Merck) VARIVAX vial 1350 U (lot number, dose, route and site of administration was not reported) on 30-OCT-2014 (inappropriate schedule of drug administration). No concomitant medications were reported. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information is not expected, because there was no consent for further contact.
Describe Event, Problem, or Product Use Error: Bivalent COVID vaccine use for COVID-19 under Emergency Use Authorization (EUA): packaging between original and bivalent vaccine are exceptionally similar leading to potential errors.
F-ever:temperature is 101. -O2saturation 93%. -Right upper extremity hemiplegia due to acute cerebrovascular accident at 9/24. Plan: isolation. DVT prophylaxis. cefepime
Had gotten the flu shot at pharmacy. Right after my arm swelled up like a baseball, got very hot, and turned red. This has never happened to me before and I get my flu shot every year.
Information has been received from a Registered Nurse concerning an 84 year old female patient with breast cancer and no drug reactions or allergies who on 28-JAN-2011 was vaccinated with PNEUMOVAX 23 0.5 mL intramuscularly. On 28-JAN-2011 the patient developed "swelling and redness on the upper arm where the injection was administered." The patient was given KEFLEX 500 mg 1 capsule four times daily for 10 days. "The patient was also given ADVIL and BENADRYL." Lab diagnostics included complete blood cell count "CBC test" (result not reported). The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
A 21 year old black female with urinary tract infections, a history of possible migraines and a history of 2 pregnancies and 2 live births who in 08/00, was vaccinated with varicella virus vaccine live. Subsequently, the patient learned she was pregnant with a last menstrual period of 06/23/00, and an estimated delivery date of 03/13/01. On 12/15/00, an ultrasound revealed an anatomy within normal limits. Subsequently, the patient experienced complex partial seizures, vaginal candidiasis, trichomoniasis, bacterial vaginosis and possible migraines. On 03/16/01, the patient delivered a normal male baby weighing 3656 grams. Upon internal review, complex partial seizures was determined to be an Other Medical Event.  F/U states: Subsequently, the pt learned she was pregnant with a last menstrual period of 6/23/00 and an estimated delivery date of 3/14/01. It was noted that the pt conceived while on oral contraceptives. It was noted that the pt saw neurology during pregnancy and was dx'd with complex partial seizures with secondary generalization. It was also noted that during pregnancy, the pt was dx'd with trichomoniasis, bacterial vaginosis and vaginal candidiasis. Treatment for these dx's included metronidazole (500mg PO on 12/14/01 for trichomoniasis), metronidazole (500mg 1 PO for 7 days starting 2/6/01 for bacterial vaginosis) and metronidazole (12/14/01 for 7 days for vaginal candidiasis). As of 12/14/01, the pt was taking prenatal vitamins. On 3/16/01, the pt delivered a normal, healthy male baby weighing 3656 grams, measuring 47.5cm long and having a head circumference of 37cm. He was delivered using vacuum extraction and had Apgars of 8 and 9 at 1 and 5 minutes respectively. It was noted that the child had macrocephaly. A head ultrasound was done and was normal. There were no observed abnormalities at the newborn exam or at discharge. Circumcision was done with no complications. Screening tests were all done and were normal except a hemoglobinopathy showed "FA + Hemoglobin Barts (trait)". Upon internal review, complex partial seizures with secondary generalization was determined to be an "Other Important Medical Event".
At 11:45 AM the day following my Vaccination, I began having chills. Then I had 102 degree fever. This last for roughly 24 hours. I has have heat and redness at the injection site.
Pins and needles sensation and numb feeling in bilateral hands and feet starting 2 hours after administration and has continued for 24+.  Awaiting employer instructions for treatment.
Patient states  that his skin is clammy and he feel flushed. Patient  was transported to ER by ambulance.
Headache started on the 10th. I was exhausted. Monday, I started having abdominal pain and the pain throughout my left side of my body. I still had  a slight headache. The abdominal pain comes and goes - I still get it to this day. I called my Dr and he referred me to go to ER on Tuesday, 13th. No treatment, they told me to follow up with dr if I had pain continue.  I just went today to a follow up with my doctor. She increased my medication for pain so I can get to work as I've been out for the last 5 days since I have not been able to. She told me to do the Naproxen twice  a day now and also gave me Gabapentin and Tramadol.
SORENESS; PAIN IN ARM FROM SHOULDER TO HAND; CHILLS; FEVER; NAUSEA; DIARRHEA; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: chocolate allergy, seasonal allergies, non alcohol user, non-smoker, and sulfa drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On 12-APR-2021, the patient experienced soreness. On 12-APR-2021, the patient experienced pain in arm from shoulder to hand. On 12-APR-2021, the patient experienced chills. On 12-APR-2021, the patient experienced fever. On 12-APR-2021, the patient experienced nausea. On 12-APR-2021, the patient experienced diarrhea. On 12-APR-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm from shoulder to hand on 12-MAY-2021, and chills, fever, nausea, and diarrhea on 15-APR-2021, and the outcome of headaches and soreness was not reported. This report was non-serious.
On 1/18/2022, I developed red/pink rashes and itching on my neck, legs, stomach and arms. The rashes continued and appeared in different places. On 1/20/2022, I woke up feeling pressure in both of my forearms. Later in the day, my right forearm was so painful, I felt like it was going to explode. The doctor said I had an allergic reaction and tendonitis.
1 of 2 pts vaxed on 18OCT94 w/Tetramune/OPV/Hep B;pt exp noisy breathing, was pale & unresponsive w/rt side face twitching, 4 hrs post vax temp 101; seen in ER sxs not present in ER: tx w/Motrin;no anticonvulsant prescribed;pt saw MD
pt recv vax 9APR96 & pt passed out & turned white for about 1min;pt hands then cupped sl for a few seconds & pt stiffened up for about 30min;
Besides a sore arm there were no immediate symptoms however a month later I observed hair loss and most recently actual bald spots.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-AUG-2009, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 30-SEP-2015, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA PNEUMOCOCCAL, EAR INFECTION (medically significant), outcome "unknown" and all described as "Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series"; SINUSITIS (medically significant), outcome "unknown", described as "recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series". The patient underwent the following laboratory tests and procedures: Antibody test: Negative, notes: Antibody titers negative after completed series.  Clinical course details: Recurring infection (ear sinus, and s pneumo). Antibody titers negative after completed series.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300086882 same reporter/drug/event, different patient;
fever to 102, headache, vomiting, redness and swelling at injection site.  No  warmth or induration at injection site to indicate cellulitis.  Symptoms self resolved within 24 hours with supportive care. Patient had negative Covid testing and strep testing in our office to rule out other causes for fever, headache, and vomiting.
Tested positive with COVID-19; felt rotten; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive with COVID-19) and FEELING ABNORMAL (felt rotten) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive with COVID-19) and FEELING ABNORMAL (felt rotten). At the time of the report, COVID-19 (Tested positive with COVID-19) and FEELING ABNORMAL (felt rotten) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, Before vaccination and positive (Positive) Positive, after vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-069665 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-Significant follow up appended to AER: contact information On 29-Jul-2021: Significant Follow up received and age of the patient, and one event updated.; Sender's Comments:  MOD21-069665:Patient case
1: He had his second Moderna vaccine shot at noon May 12,2021. Within one hour, he consistently had hiccups, then followed vomiting. It last for 24 hours without any food and sleeping. 2: 5/13/2021, he was sent to Urgent care, had infusion, and Ondansetron. But he constantly had hiccups and vomiting. He could not fall asleep due to the illness.3: 5/17/2021, his vomited dark brown color material, and his defection had black color. He was sent to urgent care second time, but transferred to ER at hospital.4: 5/24/21, he started hiccups and vomiting again. His 5/25 blood tests had significant problems in liver, kidney and pancreas ( details in blood test reports). These test results make us very anxious.
Child developed hives 1 day post vaccination on left arm at injection site. Also developed hives on ankle area. Benadryl given and much improved by the following day.