chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient said the rash was warm and tender to touch; the patient said the rash was warm and tender to touch; one female patient had a rash developed on her left arm leading to her lymph nodes; This spontaneous report was received from a pharmacist referring to a 61 year old, non-pregnant female patient. The patient's medical history included a previous breast cancer and her current conditions included diabetes. The patient was also allergic to nitrofurantoin (MACROBID).  On 11-AUG-2019, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, with lot number reported as S0045647 and expiration date on 12-AUG-2020, for prophylaxis (dose number and anatomical injection site were not reported). On the same date, after the administration of the vaccine, the patient had a rash developed on her left arm and in her armpit leading to her lymph nodes. The patient stated that the rash was warm and tender to touch (skin warm and tenderness). The patient went back to the pharmacy, but she did not received any treatment. No diagnostic laboratories or studies were performed.  At the time of the report, the patient had not recovered from the events. The causality assessment between rash, skin warm and tenderness with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Lot number S0045647 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).
Pt devel hives on the rt upper arm, lasting 4 days, several hrs p/receiving Influenza vax; In addition, pt exp severe h/a, sore throat, & fever, all persisting for 5 days; The day following inject nausea & vomiting occurred & persisted 3d;
Patient was given Pfizer 5-11 vaccine inadvertently rather than the Pfizer 6 month to 4 year vaccine. Disclosed to mother that incorrect dose was given and advised to contact clinic for any adverse reactions. No adverse reaction noted at the time of vaccination.
C/O swelling of arm and fingers and S.O.B. Went to private MD on Tuesday 12/15/2009 & was diagnosed with a severe localized reaction & prescribed Prednisone X6 days. States MD says S.O.B. may have been over the anxiety over the shot & the arm swelling. TC to client 12/23/2009 and feeling well without any complaints.
Pain for 3 weeks after injection limited active range of motion of shoulder and elbow. Ibuprofen using sling and ice.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented a small bump at administration site that has otherwise resolved
Experienced fatigue, headache, body chills, body sweats, muscle pain (back and neck), some nausea from 8PM day of administration-current (9:30 AM 1/14/2021); Sore arm at injection site.
hit by cytokine storm worse than initial event; productive cough; Labored breathing; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) 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 (Dose: 2), for Covid-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 07Jun2022, outcome "unknown", described as "Labored breathing"; NASAL CONGESTION (non-serious) with onset 07Jun2022, outcome "unknown", described as "congestion"; CYTOKINE STORM (non-serious), outcome "unknown", described as "hit by cytokine storm worse than initial event"; PRODUCTIVE COUGH (non-serious), outcome "unknown".  Clinical course: 2-vaccines. 1-booster, no COVID until 03Jun2022. Labored breathing, congestion clearing thru 07Jun, productive cough. Exposed to cordyceps dust (insecticide) on 07Jun & hit by cytokine storm worse than initial event. This fad supplement may lead to morbidity as it appears to be an immediate vaccine antagonist. Cetrizine suppresses cytokine cascade.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
get sick after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and got sick.
Day after vaccines-developed fever, headache, some disorientation.  Advised ER visit.  To the ER on 6/11-no testing done.  Symptoms improved after acetaminophen and ibuprofen
Started having minimal amount of pelvic pain on Thursday Jan. 27th that progressively became worse with each day that passed. Pelvic pain started off as intermittent pain and turned into constant pelvic and lower abdominal pain that intensified around the times I had to urinate. I eventually sought medical treatment as the pain was not tolerable anymore. I went to a Clinic on Sunday Jan. 30th. I provided them with a urine specimen and was prescribed Macrobid and Pyridium for a possible bladder infection. I took the medications as prescribed but was still having a significant amount of pain and called and was seen by my Gynecologist who also performed test. I eventually received a call from the Clinic informing that my urine did grow bacteria in it and that the antibiotic I was taking should be effective. I still have a minimal amount of right groin and lower back pain but was told it should get better over the next week.
Patient reports redness and swelling at injection site.  Patient also experiencing runny nose and scratchy throat, but she believes it could be a cold unrelated to vaccine.
Fast heartbeat; lower Abdominal pain; Fatigue; soreness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), ABDOMINAL PAIN LOWER (lower Abdominal pain), FATIGUE (Fatigue), PAIN (soreness) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat), ABDOMINAL PAIN LOWER (lower Abdominal pain), FATIGUE (Fatigue), PAIN (soreness) and NAUSEA (Nausea). At the time of the report, HEART RATE INCREASED (Fast heartbeat), ABDOMINAL PAIN LOWER (lower Abdominal pain), FATIGUE (Fatigue), PAIN (soreness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
This spontaneous report was received from a healthcare worker refers to a 4 year old patient of unknown gender. On 04-NOV-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry; 19-DEC-2015, therapy type: HSA, dose number 2) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; This is a spontaneous report from a contactable nurse.  A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in right arm, on 18Dec2020 at 09:00 ( at the age of 40 years-old) as a single dose for COVID-19 immunization. The patient was administered the vaccine at a hospital. Medical history was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On approximately 25Dec2020 (reported as one week after vaccination on 18Dec2020), the patient experienced hives and itchy rash. The patient was not hospitalized for the events but received treatment  with  diphenhydramine (BENADRYL), loratadine (CLARITIN) and generic loratadine. clinical outcome of hives and itchy rash was not recovered: the patient reported that the hives and itchy rash continued despite multiple doses of BENADRYL, CLARITIN, and loratadine. Since the vaccination, the patient has not been tested for COVID-19.     Information on lot/batch number has been requested.
Injection site pain, Nausea, Body aches, Fever, & Headache
Client had a fever, nausea, and a headache the day after this vaccination.  She had a sore arm in the injection site from the day after continuing until today when someone reported it to me for her (6-18-19).  The fever, nausea, and headache have stopped but her arm is still sore today.
Patient received her MODERNA COVID-19 vaccination at 7::31 am and at 7:40 am the patient stated she was feeling like she was going to faint, she was currently sitting in a chair and she asked for some water. The patient was very pale and she broke out into a cold sweat. The patient was given a cold compress to advised too stay sitting until she no longer felt faint. After about 10 minutes, the patient stated she needed to lie down. The patient was escorted to a place where she was able to lay down with a cold compress on her forehead. The patient continue to lie down for about 10 minutes and then she stated she was starting to feel better and that point she asked if she could use the restroom. She was then escorted to the restroom and then back to a bench to remain seated for several for minutes. The patient remained seated for approximately an additional 15 minutes and her symptoms improved and the patient was able to leave. The patient then called back into the pharmacy at 11:10 am and stated that she was experiencing chills, swelling of her face (around her eyes) and a rash that was covering her arms and chest. The patient was advised to take Benadryl and seek medical attention if the swelling worsened or if she began to experience any difficulty breathing or other symptoms. The pharmacy called the patient at 2:50 pm and the patient stated she took the Benadryl and her swelling and rash were still present, but not progressing. Patient also stated that the chills were starting to resolve.
Vaccine administered on 1/14/2009 and developed neurologic symptoms on or about 1/23/2009.  He was subsequently diagnosed with Guillian Barre.  He was treated with IVIG and did remarkably well.  He is almost back to baseline but not quite.  In PT. Follow up received 03/15/2010. Some resolved neurologic symptoms the last I heard. Mostly recovered.  4/10/09 Received hospital medical records for 1/27-2/5/2009. FINAL DX: Guillain Barre syndrome Records reveal patient experienced progressive difficulty walking, dysesthesias, paresthesias, loss or reflexes x 2-4 days.  Admitted ICU.  Tx w/IVIG x 5 days.  Gradually improved but reflexes remained absent at transfer to inpatient rehab facility.
Patient presented to the ED and was subsequently hospitalized for mesenteric vein thrombosis within 6 weeks of receiving covid booster.
Immediate swelling at injection site with blood coming out as needle was drawn out. Starting feeling a little dizzy immediately. Rested for 10-15 minutes. No change in dizziness. BP 155/101. Rested for another 15-20 minutes. Started to feel better. BP 132/80. Patient was able to get up and felt fine to leave pharmacy.
URI SYMPTOMS WITH 24 HOURS, CONGESTION/COUGH/FEVER OF 100.6F/BODY ACHES DAY 3, RASH OVER FACE/ABDOMEN AND TRUNK, MACULOPAPULAR RASH BLANCHING.
12/17/2021 - Patient alerted to Covid + status on discharge 12/15  for (VRE UTI). Patient came back to ED 12/17 with weakness/SOB. Temp 99.1 initial then 103.2, HR 107, RR 18, sat 95% on 2L NC. BP WNL.  Received Vancomycin, Meropenem, Daptomycin, and decadron. Chest XR reveals bil pulm infiltrates. Admit for Sepsis/Covid pneumonia/Recurrent UTI failed to continue treatment - too weak.  12/18 - Remdesivir/Lovenox started, Dapto/Meropenem,Decadron continued. Saturating 96% 2L (norm). Fever/Tachycardia - sepsis resolved 12/21 - SOB resolved. WBC increased from initial 8.7 to 10.9. Remdesivir course complete. Meropenum d/c. Daptomycin continued 12/22 - WBC improved 9.9.  12/23 - Dapto stopped. transitioned to oral Linezolid.  12/24 - Discharged to home.
Pt received first dose Pfizer COVID 19 vaccination at 12:40, 10 minutes later while in observation area started complaining of heat in bilateral arms. At 12:55 pt presented with pruritic rash on bilateral arms and chest.  Pt VS remained stable, had no c/o SOB, symptoms on face, throat, or mouth. Pt self-reports history of rashes.    Per protocol, administered 50mg/1ml Benadryl IM to L deltoid at 12:55.  At 13:00 pt's symptoms began to subside. Monitored pt for 20 more minutes, pt's rash and symptoms of itching/heat in arms and chest significantly diminished.  Pt requested to leave observation area, instructed pt in self-monitoring, directions for further OTC Benadryl use as needed,  s/sx to report to MD and ER precautions. Pt reported understanding, was able to ambulate under her own power out of the clinic area, was driven home by her friend.
LARGE RASH / WELTS ON ARM AND TORSO, PINK RAISED AREA
migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RELPAX (ongoing). The following information was reported: MIGRAINE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "migraine".  Additional information: patient experienced migraine in the morning of 12Mar2021, after taking the final dose of the Covid-19 vaccine. Proprietary medicinal product name: RELPAX eletriptan HBr, action taken with drug 4 dose not changed, Product Concentration: 40. Narrative case summary: Initial Source Narrative Information 12Mar21 12:51 PM Inbound call on 12Mar2021 at 10:27AM from primary reporter who is consumer refusing to disclose any contact information and on behalf of his wife taking RELPAX eletriptan HBr 40 mg manufactured by a Division of Pfizer, stating she started experiencing migraine in the morning of 12Mar2021 after taking the final dose of the Covid-19 vaccine on 11Mar2021. No RA 12Mar2021 at 12:37 PM Primary reporter is consumer (calling behalf of wife) at unknown phone number (consumer husband refuse to provide any demographic information to initial agent). Consumer called initially for medical information regarding RELPAX (eletriptan HBr) 40 mg manufactured by a Division of Pfizer additionally reported an adverse event. On 12Mar2021, consumer reported she (wife) started experiencing migraine in the morning of 12Mar2021 after taking the final dose of the Covid-19 vaccine on 11Mar2021." The patient felt the event was related to related use of RELPAX (eletriptan HBr) 40 mg. As of 12Mar2021, the event subsided, and use of RELPAX (eletriptan HBr) 40 mg continues. The patient had unknown changes in medications, medical history or lifestyle at the time of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 6 days old male baby who on 17-JUL-2007 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 23-JUL-2009 the baby was checked in his first visit, it was reported that the baby was spitting up his formula with loose bowel movements. The baby's height was 19.25 inches, weight 6pd and 12 oz, pulse 150 and respiratory rate 42, otherwise physical examination was normal.  The baby had no known allergies but a family history of allergies/asthma (mom), diabetes and stroke (maternal grandmother) from his mom. The physician also reported that the baby icterus (mild) on face and trunk. The patient was diagnosed with jaundice. A total serum bilirubin test: 0.5mg/dl (normal range form 0 to 0.2 mg/dl). This is one of two reports from the same source. Additional information has been requested.
supraclavicular painless lymphadenopathy noted ~ 1 week after first injection. lymphadenopathy was on same side that injection was delivered to. after second dose, lymphadenopathy became slightly tender to palpation and noted additional palpable lymph node next to first one.  three weeks after second dose, lymph nodes still palpable but smaller and nontender.
Seen at ER on 8-16-13. Fever began the day before, which was also one day after immunizations. Fever con't into 8-16-13 on which day the seizure occurred. Patient had not been medicated with fever reducers prior to having seizure. ER noted cough, nasal congestion, vomiting and diarrhea, and fever 102.9 degrees F.
Full body Rash starting at 7pm 9/30/21- small reddened and slightly raised. Covering entire skin in close proximity. (Febrile to 101.2 at 0530, full body aches/generalized malaise, headache, and slept all day.)
I began to break out in fever blisters alternating between lips and the roof of my mouth. We would get one area clear and about 2 weeks later the other area would clear. (I do have periodontal issues and am prone to these, but previous brake-outs were rare.) This has continued since. At fist I used the cream or rinse but they were not working.  I am currently on my third round of VALACYCLOVIR 1gm tablets.
A half hour after nursing my child, who received the PCV 13 and hib vaccines, I developed hives on my left breast. They spread to my torso and extremities. I have tightness and swelling in my hands and feet. The hives and swelling dissipate during the day, but reappear before every feeding and are present throughout the night. The swelling in my hands and feet is becoming more intense as the days have passed.
Fever, Headache, Chills, Nausea, Muscle weakness, deep Bone ache, Exhaustion
Day 21 after vaccination: Headache, vomiting of unknown etiology.  4/2/03 and 4/4/03 ER visits, LP and CT negative.
Phototoxicity -Severe burning to sun exposed areas esp areas not previously having tanned.  Fever and chills for 24 hrs and severe pain lasting over 1 week and multiple day long dermal reaction consisting of numerous evenescent  vesiculo  bullous lesion that responded well to antihistamines and steroid
16JAN91 fever 102R screaming type cry lasting 45min w/out stopping; then to ER; ER MD states not to given Pertussis again;
Resting heart rate had increased from 68 pre vaccine to between 98 and 105 after vaccine; It was very hard to do even light physical activities without getting dizzy; Feeling heart race; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 13Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included type-2 diabetes mellitus and hypogonadism. The patient had no allergies to food, medications, or other products. Concomitant medications included testosterone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE) and fenofibrate (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient's resting heart rate had increased from 68 pre-vaccine to between 98 and 105 after the vaccine. It was very hard for him to do even light physical activities without getting dizzy and the patient felt his heart racing. The patient had been out sick from work and went to the emergency room due to this very scary reaction. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events resting heart rate increased, hard to do light physical activities without getting dizzy and heart racing were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient did not report any adverse effects after administration, but the vaccine was expired when administered. The vaccine expired on 12/17/2020
Patient with 2 Moderna vaccinations, last dose 04/28/21, who admitted from rehab facility with progressively worsening dyspnea after positive COVID test who subsquently died of COVID complications.  Provider discharge note below:  "62 y/o M who was transferred from a rehab facility to other facility for dyspnea and hypoxia. He was positive for COVID and his breathing status worsened. He received aggressive treatment and eventually required intubation after failing BiPAP therapy. He required very high ventilator settings and was paralyzed but ultimately continued to worsen and had extremely high WBC that was refractory to treatment. Given the patient's very poor prognosis and worsening status despite aggressive treatment, family agreed to transition to comfort care and terminal extubation.."
Heart rate 150 at rest 16 hours after vaccines administered. Right arm red, slight induration at site of administration.
I have been getting shooting pains in my ovaries randomly since getting the shot.  I should not start my period till the 25-27.   The pain is not as consistent as normal cramps and was shorter but has been very intense a few times.   In total I have experience roughly 7 shooting pain incidence in my lower abdominal area most noticeable on the left side and always when I am in a standing position.
Information has been received from a nurse concerning a male patient who on 09/11/1996 was vaccinated and subsequently experienced chicken pox. Unspecified medical attention was sought. Additional information has been requested. Per F/U 6/18/02: Pt was vaccinated SC, in the left arm with a 1st dose of varicella (lot 617694/0772D). The nurse indicated that on 3/6/01; the pt developed chicken pox after exposure at school. As of 5/1/01, it was noted that the child recovered from the chicken pox. The nurse also reported that the pt's sister developed chicken pox in 3/01, after exposure to her brother, and receiving varicella vaccine on 11/16/95 (WAES01042615). Additional info is not expected.