chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abdominal cramping; pain radiating to lower back; constipation; soreness at the injection; A spontaneous report was received from a consumer concerning that 67 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abdominal cramping and pain radiating to lower back and has constipation, soreness at the injection site.  The patient's past medical history as provided by the reporter includes Knee surgery and shoulder surgery and does not have any allergies and concomitant medication.  On 16 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch No- 0273-99) intramuscularly on the left upper arm for prophylaxis of COVID-19 infection.  On 17 Jan 2021, patient experienced abdominal cramping and pain radiating to lower back. Has constipation. Has soreness at the injection site and no treatment taken for events.   No laboratory details provided.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events are unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Intussception at 9 months.  12/7/07 Reviewed hospital medical records which reveal patient experienced crampy abdominal pain, irritability, vomiting.  Was on antibiotics for otitis media.  Surgery consult done.  Admitted 10/15-10/16/2007 for observation s/p enema reduction of IS. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
rash right deltoid  Also note the lot number was in a different format than all other pfizer vaccines i have encountered, so i called pfizer customer support who confirms that the lot number was incorrectly reported by Pharmacy as 301458A when it should be 30145BA, and that they have had many calls as to the irregularity of the lot numer.
pt @ home 4hr p/vax & had just woke up from nap & was noted to be fussy;then became pale to gray inc color & floppy;would not respond to mom voice or make eye contact x 5-10min;pt was moaning;mom took pt to ER
Chest tightness; burning feeling in her chest; like heart burn thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest tightness"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning feeling in her chest; like heart burn thing". Therapeutic measures were taken as a result of chest discomfort, burning sensation.  Additional information: Reporter stated that his wife was vaccinated and like 9 days from now and since last Thursday she had been experiencing chest tightness, and kind of like burning feeling in her chest and so she thought may be it would be like heart burn thing but she was trying to take some heart burn medicines but that had not helped her. Reporter was informed about the role of the Pfizer Drug Safety and Pfizer Medical Information Department.  The lot number for bnt162b2 was not provided and will be requested during follow up.
c/o localized tenderness rt upper arm by 6PM on 2MAR92, Tuesday AM-redness noted rt upper arm, lateral, down to elbow, warm to touch; t100 per os, relieved tenderness w/cool H20, pt given APAP;
Swelling and redness, in face and neck, hands/wrists, feet - Mild (but severe enough to be noticeable to others); 1st dose occurred 2-3 hours later, was mostly gone by next morning; 2nd does occurred in about 30 minutes; even more mild, but still noticeable, Zyrtec allergy pill lessened it to very mild swelling Swelling in mouth (left lower lip and left side of tongue) only at 2nd dose; the Zyrtec did help, but it did not go away Slight tingling in hands, mostly fingertips - 2nd dose only; mild Extreme fatigue, headache, nausea - 1st dose only, lasted two days
has had numbness in her arm and now does not have any feeling down her entire left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001228 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose 2, 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 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "has had numbness in her arm and now does not have any feeling down her entire left arm". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "has had numbness in her arm and now does not have any feeling down her entire left arm".  Additional information: It was reported that a white patient started treatment on unreported date with Pfizer BioNTech COVID-19 vaccine primary series and booster for COVID-19 immunisation. It was reported that since her injections, the patient has had numbness in her arm and now does not have any feeling down her entire left arm. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300168693 Same patient/event, different dose;US-PFIZER INC-PV202300168695 Same patient/event, different dose;
Swelling in the face; Slow hands  movement; Headache; A spontaneous report was received from a consumer concerning a 37 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slow hands movement/ movement disorder, swelling in the face/swelling face, and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30-Dec-2020, about two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13-Jan-2021, the patient experienced the events headache and anaphylactic reactions which were characterized by slow hands movement and swelling in the face. Treatment included Benadryl and steroids and the symptoms disappeared.   Action taken with mRNA-1273 in response to the events was not applicable.   The events slow hands movement, swelling in the face, and headache, were resolved on unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Lethargy and sore arm with redness from top of right arm and underneath armpit 24 hours after immunization. About 2 days after, while on a flight, had dizziness, nausea and vomiting.
Fever 100 +; Extreme chills; Back ache / spasms and cramps; Overall body pain, inability to get out of bed; Lightheadedness, brain fog; Back ache / spasms and cramps; Back ache / spasms and cramps; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH; Lot number: EN6203) via an unspecified route administration in right arm on 26Feb2021 at 10:00 (at the age of 34-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6206) via an unspecified route in left arm on 16Mar2021 at 8:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16March2021 at 14:00, the patient had experienced fever (more than 100), extreme chills, back ache, spasms and cramps, overall, his body was in pain, inability to get out of bed, lightheadedness, brain fog. He was not comfortable to drive for 24 hours after the vaccination with the first dose. It was reported that, the patient had similar experience after first shot, but lesser effects. The office recommended the patient to take the following day off from work because so many people had experienced intense adverse events after second dose. The patient did not receive any treatment for the events. The clinical outcome of the events fever (more than 100), extreme chills, back ache, spasms and cramps, overall body pain, inability to get out of bed, lightheadedness, brain fog was recovering.   No follow-up attempts are needed. No further information is expected.
Upper left side  lip and mouth swelled when awakened next AM - took her regimen of Claritin (AM) and Zyrtec and Zantac (PM) and it cleared - has had angioedema in past from penicillin, black cohosh. Under allergists care and possibly may have had past reaction from flu shot but can't put a definite yes to this - forgot about it . Confirmed allergies were only penicillin.
Strong internal bruise on day 1 (which might be the nurses mis-hit; struck some larger artery that blood almost ran down to my elbow.)  General sickness so far making work rough enough to try to call out for the 2nd dose coming.  Still ongoing.   Nausea, Difficulty concentrating, General achiness starting from arm to ribs, then body wide.  Brain Fog.  Heavy fatigue, but it doesn't take as much to disable me more.  Warm forehead, but temp taken today is normal at 96.6.   Difficulty moving with aches.  A few moments of wanting to vomit.  No allergic reaction or rashes.  Just a greater tax on the system.   I just thought it's bad enough to report (and is still going on).  Left arm pain all but done as of 3/15/21 at 7pm.  Nothing life threatening, but concerned over second shot.  Strange yellow "Floating oil" runs and dark urine.
Patient received vaccine at 11:25 am. History of reaction to tetanus in past. Patient stayed to be observed for 30 minutes. At approximately 11:40 am, patient c/o GI-upset; continued to observe. At approximately 11:50 am patient c/o left arm heaviness and numbness to fingers and pain up and down left arm. Paramedics were radioed at 11:53 am and arrived at 11:55 am to assess patient. Patient left with daughter in stable condition at 12:15 pm.
Right shoulder pain- worse some days than others. Relieved with 2-3 ibuprofen each morning. Pain at 90 degree forward motion. Provider suggested continuing ibuprofen and abstraining from physical activity requiring related movements.
Lightheaded, clammy skin, rapid pulse. No nausea, vomiting, rash/pruritis, or difficulty breathing. No treatment at facility, however patient called EMS and was transported. NOTE that actual age/DOB of patient is unknown.
pt recvd vax 22OCT92 & 24OCT92 exp nausea, vomiting, stomach cramps, diarrhea, was jerky & fainted; resolved by 26OCT92; MD advised against cont series; could have been flu episode;
Case number PHEH2013US023739 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 66-year-old female patient. She was vaccinated with an expired vaccine of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 06 NOV 2013. No adverse event was reported following this medication error (expired vaccine used).
Significant swelling and pain left arm pit with pain radiating down left arm. No joint pain, no fever, took Tylenol after L IM Tdap. 8/24/06 took Tylenol to relieve pain.
My period is late by about 2 weeks at this point. While it is typically off by a day or two each month, it has never been this late, except for when I got my initial vaccination shots over the summer. I have also been experiencing severe cramping and stomach pain to the point where it is disrupting my life.
Swollen lymph node in left arm pit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 at 12:00 as dose 1, single (Lot number: FM7773) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; OXYBUTYN. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Jul2022 at 23:00, outcome "not recovered", described as "Swollen lymph node in left arm pit". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: Other medications in two weeks was supplements. No covid Prior vaccination, no covid tested post vaccination. Known allergies were none and other medical history were none.
Slight tenderness at injection sight; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EUA) via an unspecified route of administration in the left arm on 12Apr2021 at 19:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, pre-diabetes, allergy, food allergy (many foods and tree). The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), xylometazoline hydrochloride (SUDAFED), acetylsalicylic acid (ASPIRIN), levocetirizine dihydrochloride (XYZALL), vitamin-D  nos (VITAMIN D) and LOS for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 13Apr2021, at 07:00 the patient experienced slight tenderness at injection sight and headache. No therapeutic measures were taken as a result of the reported 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 event slight tenderness at injection sight and headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history and a drug reaction to minocycline who near the end of February 2007, was vaccinated with Gardasil (lot number unknown). On an unspecified date, about two weeks post vaccination the patient developed a scaly purplish rash over her entire body that was mostly on her extremities. Medical attention was sought. The patient was treated with ammonium Lac-Hydrin and at the time of reporting the patient is still recovering. Further information was not available. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Follow-up information was received. In February 2007, the patient developed an extensive pityriasis type rash on arms, legs and trunk. The patient was positive for pruritis. On an unspecified date the patient had a skin biopsy test performed and was consistent with the spectrum of pityriasis lichenoides. Additional information is not expected.
Muscle soreness, all over body aches. Lumps under skin on legs and back, last about 1 week, saw Dr. on 10/21/09, was told that it was a reaction to H1N1 vaccine, I also have Crohns disease and am treated with REMICADE and IMURAN.
Diarrhea; Not feeling well; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of DIARRHEA (Diarrhea), MALAISE (Not feeling well) and VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea), MALAISE (Not feeling well) and VOMITING (Vomiting). At the time of the report, DIARRHEA (Diarrhea), MALAISE (Not feeling well) and VOMITING (Vomiting) outcome was unknown.            Patient received first vaccine from Pfizer. The concomitant medications and treatment details were not provided.
Information has been received from a physician concerning a patient who on an unspecified dates was vaccinated with the three doses of ROTATEQ (Lot# unknown) per the recommended schedule and subsequently on an unspecified date, the patient had been diagnosed with rotavirus gastroenteritis. The patient's outcome was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Information has been received from a registered nurse (R.N.) reported that there had been several instances of local site reactions like warmth, hardness of skin and redness when patients had received injections of PNEUMOVAX 23 (lot # not reported). At the time of reporting, the outcome of the patients was unknown. It was unknown if patients sought medical attention. Follow-up information was received from a doctor of pharmacist who stated that the 65 year old female patient came in for redness and swelling in her right arm after receiving IM in a PNEUMOVAX 23 (lot # 1852AA,exp 05-AUG-2013) on 11-JUN-2012. She reported that within a few hours of taking the vaccine, she began to felt achy and unwell. The patient denied chills, fever or sweats. Area medial aspect of the right upper arm. The injection was given in the right deltoid. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
First day post injection: runny nose, sinus pressure, headache, fatigue, throat tingling and discomfort, pain and swelling around the injection site Second day postinjection: headache, prolong dry coughing, lungs hurt, fatigue, pain and swelling around the injection site
Typical reaction to the shingles vaccine, according to the Internet sites, but I want to report because I wonder if the occurrence is indeed 1 in 3 and not MORE prevalent. At the injection site, or actually beside it, there is a 1.5" X 3" oval red rash that is hot and itchy and thick like a bruise -- but without little bumps -- just flat and red. Surrounding this oval red rash is a larger oval, pink area of raised skin -- looks like a welt. It was smaller at first but "spread" as the days wore on. It has been four days. On day #2, I had a slight headache. I noticed online, in the ingredients, that there is MSG -- something I avoid since I had an adverse reaction to soup years ago. I had shortness of breath and a burning sensation around my neck. I was not asked if I were allergic to MSG before the injection. Why is this even IN the vaccine? I hope this diminishes soon. Thank you.
Narrative:  FATIGUE HAS NOT RESOLVED AS OF 1/27/2021 Symptoms:  & FATIGUE Treatment:
On March 24, 2022 I had an antiphallic reaction (hives, low blood pressure, tingling of lips and tongue) and went to the ER. After a follow up with an allergist, based on my blood test, I possibly have Mast Cell Disease
1 hour later after being home from after my shot at 1:30 PM, I could hardly walk to my chair or stand up straight. I was hurting and dizzy. My body was aching and felt hot and weak all over. All the sudden I had explosive diarrhea. I could not control my bowels. This was worse than my IBS. It was vile smelling stool that came through me. It was like soap suds. It was foamy and sudsy looking. It lasted for about a week and let up. By the time it was time for my 2nd dose I was better. I did not take any medicines during this time to relieve the diarrhea.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; BODY ACHES; MILD FEVER; This spontaneous report received from a patient concerned a 58 year old female. Initial information was processed along with the additional information received on 12-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included interstitial lung disease, narrow angle glaucoma, hearing loss, arthritis, allergy, and hypersensitive pneumonitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on left arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced mild fever. On 23-MAR-2021, the patient experienced body aches. On 26-APR-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided),1.90 (positive),which was a low titer value as reported by the pulmonologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and mild fever on 23-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with the product quality control number 90000179304.; Sender's Comments: V0: 20210518116-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sick for 5 days, slept 18 hours a day for 3 days, 101 fever.
Cellulitis at site of injection. Vaccine administered on 4/7/11, redness at site on 4/8/11 & only slight improvement by visit at Provider office on 4/11/11, red warm to touch throughout shoulder & midway down bicep of arm.
rash on her arms, torso, back, and a little on her legs and rash was very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on her arms, torso, back, and a little on her legs and rash was very itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ATORVASTATIN and FAMOTIDINE for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced RASH PRURITIC (rash on her arms, torso, back, and a little on her legs and rash was very itchy). The patient was treated with PREDNISONE for Rash pruritic, at an unspecified dose and frequency and HYDROCORTISONE for Rash pruritic, at an unspecified dose and frequency. On 28-Jan-2021, RASH PRURITIC (rash on her arms, torso, back, and a little on her legs and rash was very itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Came to ER with chest pain and abnormal workup. Had abnormal ekg and elevated troponin.  Diagnosis Pericarditis
chills, fever of 100 F, extreme soreness throughout body, confined to bed for 12 hours
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-OCT-2014 the patient was vaccinated with a dose of VARIVAX (Merck) lot # H019449, expiration date 25-OCT-2014, 0.5 ml) which were expired on 25-OCT-2014 subcutaneously. No adverse events were reported. Additional information has been requested.