chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not been able to sleep/can't sleep at all; my brain is very tired; Chills; Fever/High fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 09Dec2021 16:30 (Lot number: FE3594) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot:30125BA , Location: My right arm), administration date: 18Nov2021, when the patient was 39 years old, for COVID-19 immunisation, reaction(s): "high fever", "feel tired". The following information was reported: PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Fever/High fever"; INSOMNIA (non-serious) with onset 09Dec2021, outcome "unknown", described as "not been able to sleep/can't sleep at all"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "my brain is very tired"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills. Therapeutic measures were not taken as a result of insomnia.  Additional information: Caller stated she received first dose of Pfizer COVD vaccination on 18Nov2021, and second dose on 09Dec2021, she called to report her experience after second dose: "I got the second dose of Pfizer COVID vaccine on Thursday 09Dec2021, and I am calling because since that day I have not been able to sleep at all, I have had insomnia, and the thing is that I am not sleepy, my brain is very tired, but I am not sleepy and I am very alert. I have not been able to (sleep) close even one eye since that day... I was going crazy, I did not know what to do, the thing is that I used to sleep well but this happened from the second dose, the first one did not cause me anything like this, and I have been going crazy I can't find out what to do. I told my husband about this and he did search online, and he says yes, there have been cases of people suffering from insomnia after (vaccination)". Consumer stated, "Because I had my second dose last Thursday on the 9th and since then I haven't been able to sleep at all. I don't know if that's something to do with the vaccine because I was fine, that day after I had the second vaccine, I had the reaction like the first one, I had like the high fever and feel tired but they last maybe like two days but 'being' able to sleep it was since that day like I can't sleep at all, I don't know what else to do." Patient took only Tylenol (treatment) and Motrin (treatment) because had high fever and chills.  No follow-up attempts are possible. No further information is expected.
No additional adverse effect.; the patient was inadvertently administered a dose of VARIVAX on 12/3/2019 that had been improperly stored; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 03-DEC-2019, the patient was inadvertently vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S005084, expiration date: 19-FEB-2021; frequency, route and dose details were unknown) for prophylaxis (product storage error). The sterile diluent used for reconstitution was properly stored.  The vaccine was stored at 9.3 degrees Fahrenheit for 1 hour. There were no previous temperature excursions. The digital data logger was involved. No additional adverse effect was reported.
101.3 temp, excessive sweating, blurred vision, weakness when standing (extreme dizziness/sharp pain in front head), sick stomach, all over aches for about 30 hours. Could not stay out of bed!!!
Chills, aches and pains, felt like a fever but didn?t register as one.
I'm a 67-year old male, 6?0?, 170 lb, retired, a former pediatric infectious diseases specialist, M.D., Ph.D., healthy, no habits, currently a marathon runner and competitive cross-country skier. Hx of severe recurrent acute sinusitis until the age of 40. Being sheltered in place since Apr 2020.  Beginning Jan 2021 I started experiencing a little yellowish nasal discharge with slight nasal congestion and occasional pressure in the maxillary sinuses. On Jan 21 received the 1st dose of the Pfizer COVID-19 vaccine. Because of no improvement with symptomatic treatment of sinusitis, on Feb 3 started Augmentin 500 mg 3 times a day. On Feb 7, symptoms became much worse: fever 38.2C (100.7F), chills, muscle aches but the most troubling symptom was severe (level 8) face pain. Bouts of pain lasted for a few seconds but repeated about every 30 sec. It felt like an electric shock originated in the nasopharynx and extending to the maxillary sinuses. Pain affected both sides of the face but mostly the right side. Additional symptoms: scalp tenderness, neck pain and light stiffness while moving, skin hyperesthesia. On Feb 8, underwent PCR COVID-19 testing, which was negative.  On Feb 12, canceled the 2nd dose of Pfizer COVID-19 vaccine, rescheduled for Feb 19. Since Feb 14 no pain and fever.  Treatment:  1. Because I had a thought that I may be developed a nasopharyngeal Herpes zoster infection, on Feb 11 I started  Famciclovir 500 mg 3 times a day. 2. Ibuprofen 400 mg 3 times. 3. Augmentin (stopped after 4 days, on Feb 7).
Pt states he woke up around 9pm and arm was swollen on the injection area. Pt states he started to experience some cold like symptoms.
fever started approx 24hr p/vax;fever over 103;approx 48hrs p/vax;pt had a gen tonic-clonic sz lasting 3min;went to ER later that day, devel ataxia which resolved p/24-36hr
no adverse reaction.  Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Large swollen welt at injection site (one inch by three inches wide), hot to touch and sore
No additional AE; Medical assistant reporting a temperature excursion for VARIVAX and states one dose has been administered on 8/15/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 15-AUG-2022, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot # W003822 was confirmed to be valid, expiration date 02-FEB-2024, for prophylaxis (route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 1 hour and 55 minutes in the temperature ranging from 6 degrees Fahrenheit (F) to 14 F (around 9.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Patient was nervous and shortly after injection reported that she had vision changes and got diaphoretic.  While assisting the pt into a reclining position she briefly lost consciousness; total duration 3-5 seconds.  She regained consciousness immediately once she was flat and her feet were elevated.  I monitored her blood several times and it was normal.  Over the course of 30-40 minutes she recovered and left the pharmacy.
Patient woke up the day after FLUZONE was administered with a red, swollen and itchy area around the injection site.
I take levothyroxine and prenatal vitamins for nursing my newborn. The first vaccine I felt no side effects. The second dose and the booster, afterwards I was flu-ish for a day. I was nauseous, vomiting with muscle aches.
h/a, chills, weakness, nausea 3 hrs p/vax; was advised to take APAP every 4 hrs, fluid, rest; pt was better in 48 hrs;
Started getting a runny nose.  Condition worsened for the next three days with acute runny nose, cough and fever coming on.
green stool/Sometimes it would be tan, other times green; Sometimes it would be tan, other times green; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FAECES DISCOLOURED (non-serious) with onset 16Mar2021, outcome "not recovered", described as "green stool/Sometimes it would be tan, other times green"; FAECES PALE (non-serious) with onset 16Mar2021, outcome "not recovered", described as "Sometimes it would be tan, other times green".  Additional information: Patient (Age: 67, Unit: Unknown) received the 1st shot on 15Mar2021, the day after, she started having green stool daily since then. Sometimes it would be tan, other times green. Not diarrhea. She has scheduled an appointment with her doctor on 19Apr2021. Patient would like to know whether she should get the 2nd dose of the COVID vaccine after the side effects she experienced.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Metallic taste in mouth for about 4 hrs after vaccine. Ringing in left ear overlayed when any sound was heard above background noise for about 1 hr. Light-Headedness for 1 hr after vaccine.
The patient went into a pharmacy to receive the PNEUMOVAX 23 vaccine about 1 week ago. One or two days later, his arm turned red. / redness on his arm where the vaccine was administered all the way down to his elbow; a doctor who looked at the patient's arm told him that he must have received the Covid vaccine instead of PNEUMOVAX 23; patient reported to her he is experiencing "something", but she couldn't remember what "something" was.; "the patient feels like he received the Covid vaccination instead of the PNEUMOVAX 23"; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On approximately 20-APR-2022, reported as about 1 week ago, the patient went into the pharmacy to receive the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, injection site, lot number and expiration date were not reported) for vaccination (prophylaxis). On approximately 21-APR-2022 (reported as one or two days later; discrepancy, also reported as 1 week ago), his arm turned red. He sought medical attention in the emergency room and the physician, who looked at his arm told him, that he must have received the coronavirus disease (COVID) vaccine (COVID-19 vaccine) (dose, route of administration, injection site, lot number, expiration date and indication were not provided) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (wrong product administered, adverse event onset date 20-APR-2022). The patient received benadryl as a treatment of the vaccination site erythema. The patient was unsure which vaccine was administered to him, but he felt like he received the COVID vaccine (feeling abnormal, adverse event onset date unknown date in April 2022). The reporter stated, the patient told her, that "he is experiencing something", but she could not remember what it was (ill-defined disorder, adverse event onset date: unknown date in April 2022). It was reported, that the events were not considered as an overdose. The outcome of vaccination site erythema was reported as recovering (discrepancy, also reported as "arm is no longer red nor swollen"- recovered). The outcome of ill-defined disorder was not recovered/ not resolved at the time of the reporting. The outcome of feeling abnormal was unknown.  The relatedness between the events and suspected therapy was unknown.
patient vaccinated, waiting the 15 min, left clinic. in 30 min. Sudden onset of Headache.  38 min.  Horse voice, Cough.  eventually improved.  Reported reaction at 1pm.
Granulare annularum 5-10-11. Diffuse papules 3-1-11.
p/vax pt devel bloody stools,confirmed by blood stained diaper; pink tinged vomitus; crying; hosp; barium enema neg; disch from hosp
12/08/2011 He received his first of two Hepatitis A vaccines at the Health Department. 06/18/2012 he received his second of two Hepatitis A vaccines at the Health Department. Today, 09/12/2012, less than three months from his last of two Hepatitis A vaccines, he received a third (and unnecessary) Hepatitis A vaccine at the pediatrician's office.  The staff at the office should have asked to see his Official Immunization Record before giving him any vaccines. He never should have received this third Hepatitis A vaccine.  The staff were negligent.
.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I recently contracted the virus and I know without your vaccine, I would not have survived it.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Neuropathy pain (continuing) being treated for pain, Flu like symptoms (ended after a week), extreme fatigue (continuing), low grade fever (continuing) on and off.
NUMBNESS ON LEFT SIDE OF THE FACE; TINGLING ON LEFT SIDE OF THE FACE; PRESSURE BEHIND THE LEFT EYE/THROBBING PAIN BEHIND LEFT EYE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 12-APR-2021, the subject experienced numbness on left side of the face. On 12-APR-2021, the subject experienced tingling on left side of the face. On 12-APR-2021, the subject experienced pressure behind the left eye/throbbing pain behind left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on left side of the face, and tingling on left side of the face on APR-2021, and had not recovered from pressure behind the left eye/throbbing pain behind left eye. This report was non-serious.
Low grade fever, chills, headache, general malaise, body aches, urinary urgency and frequency, stool frequency, mild nausea
Dose #1-sore right arm at injection site and slight muscle pain. no other symptoms. lasted 10 days. Dose #2 - sore right arm lasted 2 days. Hot and sweaty 12 hours after injection for 24 hours. Muscle ache all over and no energy starting 20 hours after injection. Lasted 24 hours. Rash on right arm noticed 36 hours after injection. Still present. no pain, slight itch.
A nurse reported that a male, now 27 years of age, received an injection of tetanus toxoid adsorbed, purogenated in 1980. Subsequently, he developed a fever and flu like symptoms. No further info was available at the date of this report. This is 1 of 2 patients from this facility who had an adverse experience following receipt of tetanus toxoid adsorbed, purogenated. Follow-up info received on 08/07/2001 indicated that the pt is a 47 year old male who received an injection of tetanus toxoid adsorbed, purogenated in 1980 at the age of 27 years. The reporter also indicated that he recovered.
Dizziness, loss of consciousness, nausea, joint pain, general body aches, chills, headache
njection site started to itch; Swelling of lymph nodes under left arm; 5 inch red, round circle around injection site; A spontaneous report was received from a consumer concerning a 76-years-old ,female patient ,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  5 inch red, round circle around injection site(injection site erythema), injection site started to itch(injection site pruritus), swelling of lymph nodes under left arm(swelling).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced  5 inch red,round circle around injection site. On 8 Feb 2021, the patient experienced itching in the injection site and  swelling of lymph nodes under left arm.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, 5 inch red, round circle around injection site,injection site started to itch, swelling of lymph nodes under left arm,  were considered as resolved.
Pt came in asking for the latest vaccine, I knew she was retired, and was excited about giving our first dose of the new recommendation, failed to verify that she was at least 65 years old.  No reaction reported.
Above vaccine given 11/4 that evening spell of staring for 2 min. Mom did not attempt to stimulate child. 2nd staring spell Mom stimulated & child "came out of it". TYLENOL 5pm. Child woke 2:45 am Temp 103.9 responded to mom, no pallor, no abnormal movements. Family called 911 pt taken to ED. There exam ok except fever. ED Dr recommended labs, sepsis eval family declined. Pt seen by me 11/5 3:20pm. Normal exam. Most likely fever secondary to vaccine. No seizure.
the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022).    No concomitant medication were reported.  BUD was 01-Oct-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Patient stated after she got vaccine she waited 30 minutes, and an hour after she left the facility, she started having pains in her side, and her injection site started hurting and swelling. Patient had nausea and dizziness and itching.  Patient stated that her right side (where pain was) was swollen, and she had a severe headache. Patient also reported pain in legs and feet. An hour later, patient used restroom and urinated blood. Patient also reported sore throat. Patient stated she bled this way for 3 days after vaccine. Patient has been trying to contact PCP with no answer. Patient reported severe cramping every 30 minutes. Patient is still having severe headaches, and pain in legs and feet, and body aches. Patient stated that lower abdominal pain doesn't come as often anymore. Patient stated that she went to restroom on 06/15/2021 and her urine was reddish colored.
niece had the same side effect, cramping in her hands; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (niece had the same side effect, cramping in her hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (niece had the same side effect, cramping in her hands). At the time of the report, MUSCLE SPASMS (niece had the same side effect, cramping in her hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Pt reported flushing/sweating and dizziness. Vitals: 14:15 110/62, 74,19, T 97.8F -- > 14:25 121/74, 60,18, 98.0F, 100%
Upon administration patient passed out in chair with in minutes.  Patient became very limp and jerky.  With in minutes patient came to and was able to respond to questions
It was reported that a patient (2 of 5) received a rabies vaccination on 5-Mar-2001. Reportedly the patient developed a headache, sore muscles and a local reaction lasting 2-7 days. Further information is requested.  From telephone conversation on 6-Apr-2001, it was reported that the patient  recovered from this experience.  From additional correspondence received on 18-Apr-2001, it was reported on day 2 the patient experienced an increase in sore muscle, nausea and headache. Day 4-8 the patient experienced a continuous dull headache. Reportedly the patient did not experience nightmare and insomnia as previously reported. The correct vaccination date (5-Mar-2001), the adverse event onset date (6-Mar-2001, additional patient, vaccine, vaccine administrator and responsible physician information were also provided. This case is closed.
PEDIARIX, PREVNAR given 6/17/16 - Started with fever and rash 6/18/16. BENADRYL and TYLENOL/MOTRIN given, helped with fever, rash worse. Seen back in office 6/20/16, sent to ER for evaluation. Dx.  suspected viral exanthema.
Red raised rash to bilateral arms several hours after receiving vaccination.  Face also flushed.  Rash gone in 1-2 days.
Intense itch full body, no rash or hives. Subsided to localized on hands, palms, ankles and feet. Still no rash, hives or dry skin.