chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain on the injection site; more tired than normally do; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do). On 01-Feb-2021, VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
I got a flu shot simultaneous to my COVID-19 booster at the same time at pharmacy on the same day.   I don?t know the name of the flu shot so I am unable to enter it   Very sick on day two and three and pretty sick on day four.  Extreme swelling in left arm pit and arm with a great deal of pain for four days. Runny nose for almost one week, headaches for one week, extreme fatigue for one week. A lot of muscle pain for the first few days but by the end of the week muscle spasms in upper back, chest tightness, persistent fatigue  and all over body pain.  Too tired to function.
Patient had swelling and a rash in the arm where she received the vaccine. It got better with benadryl and a ice pack
the improperly stored temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  Approximately in August 2020, the patient was vaccinated with doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S038175, expiration date 26-NOV-2021 (dose, route and vaccination site were not provided), for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot# S020160, expiration date 30-JUN-2021 (dose, route and vaccination site were not provided), for prophylaxis which were improperly stored on 06-AUG-2020.   Temperature- 50F Time frame - 6°F to 14°F (l0F) for 1 hour and 15 minutes; 15°F to 46°F (44.8F) for 1 hour and 30 minutes; 47°F to 77°F (50F) for 2 hours and 30 minutes Previous temperature excursion? N Was call because of a "data logger"? Y
Information has been received from a health professional concerning approximately 20 patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #658673/0990U).  Subsequently, the patient's experienced swelling and pain at the injection site, fever, chills and severe arrhythmia.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  A lot check has been requested.  Swelling at injection site, pain at injection site, fever, chills and severe arrhythmia were considered to be disabling.  Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose, route, lot number and expiry date were not reported)for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009621: US-009507513-1612USA008828: US-009507513-1612USA009619.
Day of red and hot site and headache took Tylenol; 24 hours after shot red and hot itchy site, headache, pulsing feeling in body, anxiety middle of night took Tylenol; next day fatigue,  red and hot itchy site, headache; red dry hot rash on face cheeks, took Benadryl. Headache and red hot itchy site from day got shot for 2.5 weeks.
Severe pain in joints, lower back pain, headache; small red scattered papular lesion in chest, abdomen, and back. Severe pain in wrists and knees, leg muscles. 29 y/o male c/o H/A, back pains, and joint pain after taking the anthrax vac. Friday. Generalized papular erythematous rash in chest/abdomen x 3 days. (+) arm pain, knees. (+) lower back pain. Joint pain improved. Exam: small red scattered papular lesion in chest/back. No joint swelling. Back: (+) lower back spasm ROM. No bone tenderness. Generalized reaction - CBC, SMDIU, Sec Rate, Viral vs Allergy - MOTRIN 800 every 12 - BENADRYL 25 every 8 hours. VALIUM 5mg qHS.  1/20/09 Reviewed PCP medical records of 6/21/2000 FINAL DX: anthrax reaction, allergic reaction vs possibly viral Records reveal patient experienced HA, back spasms & pain, joint pain, papular erythematous rash on chest & abdomen x 3 days.  Tx w/meds, labs ordered, deployment deferred.  RTC 6/28 & was improving.
fever 102 23SEP97, 25SEP97, 26SEP97;vomiting 23SEP97, 25SEP97, 26SEP97;
Severe chills, nausea, headache, vomiting, diarrhea for 5 hours 2½ days after vaccine. Weakness, tired, headache, lack of appetite  for two more days. This is now the 8th day since the vaccine, I have had weakness, digestion issues, lack of appetite, periods of feeling overheated and tiredness.
Had Tdap for physical 7/21/14 2 days ago on 7/26 developed erythema, raised blotchy hive like 7 x 9 cm at injection site right deltoid. Advised BENADRYL, PEPCID f/u if not improved.
Client reports abdominal discomfort started ~ 3 hours after vaccination.  Described discomfort as intermittent sharp pains.  Further reports discomfort subsided the following day to an ache-like discomfort.  Denies N, V, D.  Also reports site of injection discomfort day of vaccine that continues to time of report.  Reports injection site started to feel itchy today.  Denies redness or visible rash.  Reports she can feel a lump/bump at site of injection which is decreasing in size since day of injection.  Reports injection site feels warm and slightly puffy.
Patient states she has "bumps on the side of her face, swelling of her face, and that it feels hot".  It is slightly improved on 11/20/2014.  She has not had any evaluation or treatment.
PT STATED SHE FELT WEAK. SKIN TURNED RED. A KNOT FORMED ABOVE HER RIGHT EYEBROW. ARM PAIN
Youth received an erroneous 3rd dose of Pfizer COVID-19 immunization.
pt reports 2 days p/vax devel swelling in rt leg;eval for DVT negative;saw MD several times & referred to circulatory specialist;CT scan indicated abd mass w/lymph node involvement;biopsy done dx lymphoma;pt felt vax triggered immune
This is a spontaneous report from a contactable consumer or other non hcp. An unspecified age female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lor number and Expiration date were not reported), dose 1 via an unspecified route of administration on 14Jan2021 as SINGLE for Covid-19 immunization. The patient medical history included palpitations. The patient concomitant medications were not reported. It was reported that patient had the first dose of the Pfizer vaccine on 14Jan2021, followed by a strange surge in the body and experienced heart palpitations throughout the day until the night. Patient mentioned that she had palpitations in the past, but she described the adverse event as consistent. She experienced the palpitations until the next day (15Jan2021) and it was recovered. Patient was scheduled to take the second dose on 04Feb2021. She asked if she should be concerned in getting the second shot. The outcome of event palpitations was recovered on 15Jan2021 and outcome for other event feeling abnormal was unknown.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I had a sore throat, fatigue, upper respiratory congestion, no fever, bronchial congestion, my eyes felt funny like I had a fever but I didn't. I used a home COVID-19 test that came back positive, I called my doctor and he prescribed PAXLOVID and a cough medication. I feel like I am 99 percent recovered.
Vomiting (1-2 days) Diarrhea (2-3 days) that lead to dehydration High Fever (3 days)
Information has been received from a physician concerning a 54 year old female patient who on 06-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y). On 07-JAN-2010 the patient experienced an injection site reaction after the PNEUMOVAX 23 was given. The patient contacted the physician for medical attention. At the time of this report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
Aug 29 my husband tested positive for COVID. Exposed on Aug 25. We both started getting sick. I tested positive Aug 30. I continued to get sicker. Sept 4 I took my husband to the ER. I never saw him walking and talking again. I was very sick that day. Tired, not eating, coughing. Sept 7 I was taken to the ER by a friend. I was in the ER for 9 hours. 3 hours waiting and 6 hours in the ER. Chest X-ray, MRI, blood work, 2 bags of fluids. They gave me an inhaler and lots of meds. They thought I had some blood clots in my chest but I did not. They sent me home with meds and an inhaler due to pneumonia.  I was very sick, weak, stopped eating, hair is now falling our like crazy,
5 First dose-67 patients received doses beyond the use date (30 days on refrigeration); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (5 First dose-67 patients received doses beyond the use date (30 days on refrigeration)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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 PRODUCT STORAGE ERROR (5 First dose-67 patients received doses beyond the use date (30 days on refrigeration)). At the time of the report, PRODUCT STORAGE ERROR (5 First dose-67 patients received doses beyond the use date (30 days on refrigeration)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-354434, MOD-2021-354436 (Patient Link).
High fever 102.7 to 103,2; general full body malaise; Chills; extreme soreness at injection site; Nausea; Headache; body aches; This is a spontaneous report received from a contactable consumer (patient). A 15-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217 and expiration date not provided), via an unspecified route of administration, in arm left, on 04Jun2021 15:45 (at the age of 15-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were reported as "none". Patient had no known allergies. No other medical history. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264 and expiration date not provided), via an unspecified route of administration, in right arm, on 14May2021 15:45 (at the age of 15-year-old), at single dose, for COVID-19 immunization. On 05Jun2021 02:45, the patient experienced high fever 102.7 to 103.2, general full body malaise, chills, extreme soreness at injection site, nausea, headache, and body aches. The patient underwent lab tests and procedures which included body temperature: 102.7 to 103.2 on 05Jun2021 02:45. Since the vaccination, patient had not been tested for COVID-19. No treatment received for events. The outcome of evens was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history/other medical history. The patient had no known allergies. There were no concomitant medications and no other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and the patient received treatment with anti-viral Paxlovid from 18Sep2022 to 22Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
Rash on hands.; Red and splotchy at first, not itchy; Then peeled.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of the COVID-19 vaccine. On 12Apr2021 at 08:00, the patient experienced rash on hands, red and splotchy at first, not itchy. Then peeled, still red. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on hands, red and splotchy at first, not itchy. Then peeled, still red was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt has developed severe myocarditis and heart failure requiring ECMO. Reported by parents to have gotten the pfizer COVID vaccine ~2 weeks prior. Card not available at the time of this filling but will ask them to get it if possible, given critical illness. We are looking into other etiologies of myocarditis as well. Has only received 1 dose of the vaccine and 2 weeks following seems to be  a bit out of the range of usual but no other reported illness
4/8/11 Pt reported  having 20 -30 vesicular "pox" on trunk & scalp. Felt well otherwise. Rash itchy, "pox" opened, crusted & scabbed over 5 - 7 days. Onset was 4/6/11.
About 2 days after receiving the vaccine she began noticing an itchy, burning rash primarily on the dorsum of her hands. It has not responded to moisturizers or hydrocortisone cream.
Flu like symptoms including fever, dizziness, heart arrhythmia, muscle aches, headache.
found patient unresponsive with agonal respirations, episode lasted 1 minute, they provided rescue respirations with BVM, and patient returned to baseline then brought to emergency department and admitted
Female pt. c/o itchy throat, nausea, vomiting approx 20 min after vaccination. Pt. c/o dizziness, headache. Pt's mother states hx of allergic rxn's to antibiotics with hives, nausea/vomiting. Pt. denies difficulty breathing. Pulse 88, 19:35. BP 94/78, 19:40. 25 mg BENADRYL, 19:35. 12.5 mg BENADRYL, 19:47.
Severe muscle aches, severe headaches, sever joint pain, low grade fever and  hyper fatigue. All of these symptom's occurred  the next morning  after the shot on April 18th.
My cycle, which is routinely 21-26 days has been 37 and 42 days.; Flow is also much heavier/ My periods are always 3 days. The last two have been 6 and 8 (and counting).; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy, hypertension. The patient had no known allergies. Concomitant medications included montelukast sodium (SINGULAIR), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), fluticasone propionate; salmeterol xinafoate (ADVAIR), multivitamin (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 00:00, the patient experienced periods had been affected by each dose. Her cycle which was routinely 21-26 days had been 37 and 42 days. periods were always 3 days. The last two have been 6 and 8 (and counting). The flow was also much heavier and the side effects more intense. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events cycle which was routinely 21-26 days had been 37 and 42 days, periods were always 3 days, the last two have been 6 and 8 (and counting), the flow was also much heavier and the side effects more intense was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
RECONSTITUTED WITH BACTERIOSTATIC SODIUM CHLORIDE 0.9% CUSTOMER DID NOT EXPERIENCE ADVERSE EVENT
pt exp sore throat, swollen glands, diarrhea, bad headache, pain & swelling in calve of legs/ankles, t101x 1wk, nausea;
Muscle aches from her left arm to her chest, 2 inches below her neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches from her left arm to her chest, 2 inches below her neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FAMOTIDINE (PEPCID AC), BUDESONIDE and IBUPROFEN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Muscle aches from her left arm to her chest, 2 inches below her neck). On 10-Mar-2021, MYALGIA (Muscle aches from her left arm to her chest, 2 inches below her neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received second dose on 24 Mar 2021 (Batch number: 017621a) in left dominate arm . Patient did not report any adverse reaction after the second dose of vaccination. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up was received on 24-May-2021 and contains non-significant information.
Awoke with headache on Tuesday, 10/17/06. By Wed he felt weak, had chills and hot flashes. Temp check was normal. To force fluids, rest, and take Tylenol Q4 hours today and if needed, tomorrow. Still c/o fatigue.
Starting with a headache the next morning at 0700, by 0900 I had a 102° fever. I maintained the fever, chills, and body aches through the next 18 hours. Everyday since over the last 8 days i have had a headache that will not go away.