chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received at 12:15pm. Other than a slightly sore arm nothing until 6pm.  Started at 6pm with the injection site being very warm and the whole right arm began to heat and swell all joints from knuckles to my neck began aching at a 7 on a 1-10 pain scale. At 6pm the rest of the joints in my body began aching but not as bad as the injection arm. By 10pm I was extremely nauseous and had a steady throbbing headache and was only able to sit as any movement was painful and nauseating. I vomited twice that night. By 6am the next day I was unable to grip or lift anything with the injection arm as moving it all caused intense pressure and pain in that arm a 8.5-9 on the 1-10 scale. By this time my entire body was a steady and constant 8 pain wise. Especially my lower back and hips my joints felt like they were being crushed and pulled apart.  I was unable to get out of bed except 3 times to pee for the entire second day. The pain in the lower back, hips and injection arm increased to the point where I would just cry and yell as it was the worst joint and back pain I have ever had in my life. I tried sleeping most of the day and would wake from the pain.  I have not had a period in about 4 years and had vaginal bleeding like a period that night with abdominal cramping as well. There was nothing that relieved the pain but time. By 10pm the pain finally subsided some and today 1/24 two days post injection the pain is now a constant dull joint ache like a normal flu ache. I am still very sore in the injection arm but can move it today, still causes too much pain and pressure to lift or pull with it. If I sit or stand up for more than 30 minutes my arm begins to throb and the headache and nausea come back.
Myalgia, Fever, fatigue, lower back pain, very 'sore' arm, could not lift it Narrative: would have stayed home from work with these symptoms
pt exp an unspecified reaction following vax w/MMR; no further details were provided;
During administration of the shot, some of the vaccine leaked from the joint between the syringe and needle.  It is unknown what amount of the dose was lost and what amount was injected into the patient (unable to quantify exact volume lost).  Called Moderna line for healthcare providers and described the situation and was advised not to give a third dose.  Contacted patient and informed him of information provided by Moderna.
Fever as high as 101.8 on 02/28/2021 Fever 99.1 morning of 03/01/2021 severe headache (starting to subside as of this writing 4:30 PM 03/01/2021) nausea (starting to subside as of this writing 4:30 PM 03/01/2021) Tiredness
Patient received 2nd dose of Pfizer instead of Moderna. Vaccinator failed to identify need for Moderna; both vaccination card and consent were indicating need for Moderna. The scribe caught the error after the vaccine had already been given and reported it to the supervisor. Pt was immediately provided counselling and 15 minute observation was tolerated without complications.
Tingling in lips and they were slightly swollen; Tingling in lips and they were slightly swollen; Little hard to swallow for a while; Face and whole body was itchy; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included diphenhydramine hydrochloride taken for pruritus, start and stop date were not reported. Consumer stated, " patient had the Pfizer COVID-19 Vaccine the first dose this (reported date) morning and after a few minutes, patient just had like a tingling in patient lips, and they were slightly swollen. And then, it was just a little hard to swallow for a while and then patient was fine after 20 minutes. And then after a few hours, it kind of came back again and then patient whole body itched like patient was (incomplete sentence), patient face and whole body was itchy and then patient took a Benadryl and then seem to ease a little bit. Patient was just wondering, if patient should continue taking Benadryl and then, patient was just wondering if that was an allergic reaction to it." Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. When offered the contact# for Pfizer Medical Information, consumer stated, waited for few minutes on hold for this call, consumer can't do that again. When requested for permission to probe questions, consumer stated, "What is this for?. When informed about the need to probe questions for a safety report, consumer stated, "patient need to find out if patient having an allergic reaction or not. Patient don't care about that. This was not helping to patient at all. Patient just going to call patient hospital. Consumer hung up abruptly. Hence further probing could not be done. Hence, limited information was available over the call. Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever, chills, body aches lasted for 6-7 hours the day after the shot , sore at injection site for 3 days.
Swelling and itching on RVA 7x8cm area of erythema lasting 5 days. Treated with Benadryl and ice packs.
A few hours had sore arm and tired and the next day starting to have a headache and the next AM I got a migraine. Saw the doctor about a month ago in Oct 2021. Prescribed migraine medicine. Had check up today. It's getting worse and now I get it 3 or 4 times a week.
Presented with AMS; Covid + in ED; asymptomatic at arrival; pt declined 2 status; started on steroids, remdesivir, Vit C, zinc,  and supplemental O2 on 8/7; Intubated 8/10, started on veletri; 8/16 worsening infiltrates, 100% FiO2 on vent; 8/26 remains intubated; FiO2 55%; He was started with Solu-Medrol and also treated with remdesivir. He was treated also with supportive care with montelukast, zinc sulfate, and DVT propHe was started with Solu-Medrol and also treated with remdesivir. He was treated also with supportive care with montelukast, zinc sulfate, and DVT prophylaxis with apixaban. Patient was on mechanical ventilation in the ICU. He was also treated with empiric antibiotics with meropenem and IV micafungin. On September 7, patient noted to have atrial fibrillation, and around 9:43 a.m., then he suddenly developed wide-complex tachycardia with possible LBBB with prompt progression to asystole. There was a code blue called. After the round of ACLS, patient noted to have asystole, and he was pronounced dead at 10:07 by ICU team. anaphylaxis with apixaban. Patient was on mechanical ventilation in the ICU. He was also treated with empiric antibiotics with meropenem and IV micafungin. On September 7, patient noted to have atrial fibrillation, and around 9:43 a.m., then he suddenly developed wide-complex tachycardia with possible LBBB with prompt progression to asystole. There was a code blue called. After the round of ACLS, patient noted to have asystole, and he was pronounced dead at 10:07 by ICU team.
right groin became red and develop lymph node; right groin became red and develop lymph node; Fever/ temperature went up around 101.4; Chills; This is a spontaneous report from a contactable nurse (patient). This 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient was a nurse anaesthetist who received the COVID-19 vaccine on the 19Dec2020 and on 22Dec2020 after she got home from work that afternoon in the evening, her temperature went up around 101.4 and had the chills and the fever. Later that evening and next morning (23Dec2020) her right groin became red and develop the lymph node that patient did not never felt before. Patient called physician and they put her on Antibiotics Keflex (treatment) for four times a day for 10 days. After the reaction, patient had a COVID test and Flu A and Flu B test and all of them were negative. The outcome of events was unknown.
Case number PHEH2014US020026 is an initial spontaneous report received from a pharmacist on 03 OCT 2014. This report refers to a 66 years old female patient. Her medical history and concomitant medications were not reported. It was reported that she received a dose of expired FLUVIRIN 2013/2014 (batch number: 1309601) intramuscularly on 03 OCT 2014. No adverse events were reported after the medication error.
Rash appeared at injection site left arm down to 5cm before wrist. Pt did not complain of any discomfort. No pain at site, just redness. Remained for 10-15 minutes then rash disappeared.
pt recv vax on Monday & had redness & swelling @ inj site;MD saw on Tuesday & treated w/med;office visit Wednesday;adm to hosp wednesday @ noon;dx cellulitis & adverse rxn to med;
Day after vaccine given, large red bump appears over RIGHT eye. Then non stop throbbing headaches (still up til today), teary eyes. Then on 2/25/2021 very large (size of half dollar coin) red bump appears over LEFT eye. VERY swollen shut. Hurts, throbs and itches. Took photos and having tele med call with physician today at 1:50 pm. More bumps appearing higher up on scalp and skin on bump is red and pealing. Very swollen L. eyelid and swollen under eye as well. Hot to the touch. Bumps coming and going behind left ear.
Patient had perforated appendicitis / feculent peritonitis which ended up having open ileocecectomy
Within a few miniutes, became slightly dizzy. After a few more miniuts, I became very dizzy, short of breath, something was going on in the back of my throat, heart rate went way up and I felt like I was going to pass out.   About 09:10, I received an epi pen in my left thigh. After the epi pen, my symtoms resolved very quickly. I was then sent to the ED for a 4 hour observation. While in the ED, I received a unit of fluids. After which, I was discharged home.
Limb weakness.  No focal deficits, head CT negative on 4/15/21.  Patient experienced worsening weakness and was admitted to hospital on 4/16/21.  Diagnosed with right centrum semiovale stroke extending to basal ganglia per brain MRI.  Not detectable on head CT.
I developed a rash about 2 weeks after the vaccine. It started spreading to different parts of my body. I went to my Dermatologist and she performed an biopsy, which was negative. Prescribed a topical steroid.
VACCINE STORED 40 F TO 41.8 F RANGE FOR 4 DAYS; PUNCTURED VIAL USED AFTER 4 DAYS; This spontaneous report received from a pharmacist concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUN-2021, the subject experienced vaccine stored 40 f to 41.8 f range for 4 days. On 05-JUN-2021, the subject experienced punctured vial used after 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine stored 40 f to 41.8 f range for 4 days and punctured vial used after 4 days was not reported. This report was non-serious.
REDNESS/SWELLING TO LEFT DELTOID (Multiple patches);  HEADACHE; FEVER (99.5-101F); DIARRHEA; FATIGUE.
Patient is 16 yrs old and was given the Moderna vaccination which is not approved as of the date of vaccine for individuals under 18yrs old.  There were no untoward events or reactions to the medication.
Hive like rash, large swollen red areas with red lines around on body from the waist down and some below knees including buttocks -no rash on front of torso   Pt. using Benadryl Caps, and cream to control situations Trying to us loose clothing and try to keep skin cool. Heat seems to encourage the rash.
Information has been received from a consumer concerning her daughter an 18 month old female with otitis media since 24-MAR-2007 and reactive airways disease and a history of being a premature baby, gastroenteritis rotavirus, bilateral otitis media and ear tube insertion who on 29-MAR-2007 at 5:30 pm was vaccinated with a dose of VAQTA (lot # 652295/0250U). Concomitant vaccination administered that day included a fourth dose of SYNAGIS (lot # 510134), a dose of IPOL (lot 3Z0548-s), and a dose of TRIHIBIT (lot # C2628AA). Concomitant therapy included PULMICORT, albuterol, CIPRODEX and AUGMENTIN. On 31-MAR-2007 the patient's parent noticed on the right thigh that the three vaccination sites were clearly visible. Two of the sites were flat and the third injection site was raised and hard and red-extending from that site was a 2.5 inch in diameter red area which was hard swollen and warm to the touch. The patient had no fever and was acting normal. The pediatrician was notified. Pain medication was recommended and she was instructed to call back if it became worse. The patient was given acetaminophen and ibuprofen for a day and held a warm wash cloth to the thigh. As of the evening of 01-APR-2007 the area was not as red. The warmth and swelling had resolved but the area around the injection site was still hard and raised. The patient recovered completely on 04-APR-2007. Additional information is not expected.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and gender. Information about medical history, concurrent condition and concomitant medications was unspecified. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (lot # L034931 with expiration date of 03-MAR-2017 and lot# M006106 with expiration date 01-AUG-2017; strength, dosage, frequency and route unspecified). No adverse event was reported. Excursion details: Temperature/ time frame of PROQUAD with lot# L034931 was 10.8 F for 4 hours 48 minutes and previously temperature excursion was 30 F for 10 hours 45 minutes. Temperature/ time frame of PROQUAD with lot# M006106 was 10.8 F for 4 hours 48 minutes and there was no previously temperature excursion. This is one of two report received from the same reporter. Additional information has been requested.
pt recv vax & exp 10-15 small, raised spots on chest, arms, legs & face;it was stated that rash did not look like measles;
DIZZY, REPORTS "SEEING SPOTS", NAUTIOUS, CLAMMY, SHAKY.
Covid-19 positive case, fully vaccinated with Pfizer Covid-19 vaccine. Shortness of breath, Cough, Oxygen needed.
broken out in a rash; itching that turned into a rash last night; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 (Batch/Lot number: unknown) at the age of 17 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 05Sep2021, outcome "unknown", described as "broken out in a rash"; PYREXIA (non-serious) with onset 04Sep2021, outcome "unknown", described as "low grade fever"; PRURITUS (non-serious) with onset 05Sep2021, outcome "unknown", described as "itching that turned into a rash last night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number and UPC number of the suspect were unknown. When the Reason for no lot number asked, it was reported that reporter did not had patients card at the time of report. Grandmother (reporter) was seeking guidance on behalf of her 17year old Granddaughter (patient) who had her first dose on 03Sep2021 of the Pfizer Covid-19 Vaccine. She had broken out in a rash. It started on Saturday with a low grade fever and yesterday, with itching that turned into a rash last night. The reporter was to take Granddaughter to the Emergency Department because it was the holiday today. Transferring agent stated that they already addressed that and do not provide treatment recommendation but advised to reach out to her grand daughter's pediatrician or Physician and she agreed to speak with them. Investigation Assessment was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Complaint of dizziness and feeling warm. Alert and oriented x 4. Respirations even, skin within normal limits. Denies shortness of breath, chest pain and palpitations. BP 122/60, P 84, O2 94%, R 16.  Patient states that she was feeling dizzy before she came in to clinic and that she had not eaten anything. BP 124/64, P 84, O2 95%, R 16. Patient discharged from clinic.
No adverse event; patient received expired Moderna Booster Dose  Vaccine expired on 10/13/2021 and patient received it on 10/14/2021.
She became symptomatic for Covid 19 two days later and tested positive 4 days later; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.   The patient's concomitant medications were not reported.  It was reported that the patient received dose 1 of COVID vaccine and then two days later (08Apr2021) she got COVID with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Apr2021. Patient's dose 2 was scheduled for Monday and inquired if she should take it or reschedule.
Baby received the immunizations on 10/12/02 and was found lifeless in early morning of 11/13/02. Autopsy results are pending. Autopsy report received on 12/30/2002 indicates SIDS.
TOOK TWO DOSES OF VIVOTIF IN A ROW; This spontaneous case report (PVX2019-2942) was received from a pharmacist on 02-Dec-2019. It described a 7-year-old female consumer who "took two doses of Vivotif in a row" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for an unknown indication.  Case report: The consumer took first two doses of Vivotif in a row, which were taken a day apart.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company Comment: A consumer tool first two doses of Vivotif a day apart (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer tool first two doses of Vivotif a day apart (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.
The next morning after the vaccine I woke up to my arm at the injection site was severely stiff.  I could barely raise the arm vertically.  I took Tylenol for the pain and did various stretches until it finally reached 90% mobility,  but it still is not fully functional to date without pain
Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours.  Saturday 1/9, just had tenderness to injection site until 1030pm when the headache returned.  Hurt to move my head.  Woke up on 1/10, extreme headache and nausea.  Hurt to move head and was nauseated whenever I bent over.
Patient came into pharmacy to receive a Pfizer COVID vaccination on 07/24/2021. He made another appointment to get the second dose of Pfizer/his 4th COVID vaccination shot on 08/14/2021. Per database, patient already received 2 doses of Moderna back in June 1st, 2021 and June 29th,2021 at a different pharmacy.  As a date of 07/24/2021, 1 additonal COVID vaccination (Pfizer) was administered to this patient in our pharmacy.
mom states pt cried continously from time of inject about 230 pm till 7 pm, there was no T duration, pt had approx 4 breaks in the crying, ea lasting less than 10 min, mom notified no one.
Patient is a 69-year-old female with a history of a kidney transplant that was performed at Hospital in 2018 presents the emergency department ambulatory complaining of shortness of breath as well as dehydration.  Over the last 3 days she has not been able to sleep well.  She states that she has been drinking up to a liter to a liter and a half of water every day and has not been able to pee yet.  She is also complaining of some shortness of breath.  She has been vaccinated for COVID-19 including a booster.  She is currently on antirejection medications.  Husband states that she has been very short of breath especially when she lays down.  Patient denies any chest pain Associated Symptoms: chills, fatigue, fever, orthopnea, shortness of breath, URI symptoms, weakness
This spontaneous report was received from a registered nurse and refers to a 28 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # M008173 with expiration date of 16-FEB-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Per client's mom, his entire arm was swollen, hot and red. The skin was tight, but no wounds. She took him to his PCP Dr on 8.22.18, were she prescribed antibiotics. Mom stated that the swelling continued for 2 more days and spread to chest and back of shoulder blade. Client had low grade temp of 99.2. Symptoms resolved by 8.24.18.
Case number PHEH2014US017308 is an initial spontaneous report from a medical assistant received on 26 Aug 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of MENVEO (batch number: M14044) intramuscularly on 25 Aug 2014. On 26 Aug 2014, twenty four hours after vaccination, his arm felt heavy and was tingling. Outcome of the events was reported as condition unchanged. Seriousness and causality of the events was not reported.
The evening of receiving the vaccine developed body aches, chills, fever, fatigue, headache and sore throat. tested on 12/24/20 for covid results negative. After 10 days developed full body tremors, now improving and then after 2.5 weeks had difficulty walking and leg pain/discomfort. Blood work on 1/13 revealed CPK of 934
The pt is 5 YO and was to be administered Pediatric 5-11YO Pfizer Vaccination.  This vaccination should have been diluted to the manufacturer's specification but was not and undiluted dosage of 0.2ml was administered.  Upon discovery.  Pt's mother was contacted and notified to watch for increased local and systemic reaction and to utilize the emergency services if needed.  Mother was asked to place cool compress wrapped in clean paper towel to minimize local site reaction and watch for high fever, nausea and vomiting.  To update us on progress of the child.  Mother stated pt's is doing ok so far and will update us and monitor the child.
I started having severe tinnitus. I previously had tinnitus, but the severity was greatly increased. It went from a scale of 1-10 from a 2 to a 7 or 8. It subsided after a few hours, then came and went sporadically. It still comes and goes periodically. I have also noticed an increased sensitivity to high end noises, to the point where I must now bring earplugs to avoid pain.