chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/19/03 @ 17:00: Mom called 15:39 states baby had reaction to shots.  Shots given at 14:30 11/10/03, baby started screaming at 18:00 lasted 3.5 hrs until 21:30.  Baby was exhausted and would not nurse.  Slept until 03:00.  Looked pale, breast fed normally next day, baby was very sleeping and has continued to sleep more than usual, naps 1.5 -2 hours.  Fussy and grouching when awake-fights his feedings.  Injection site did not appear abnormal.  No fever, mom gave Tylenol x3.  Mom noticed pupils are small even when in dimly lit room-past 3 days 11/17-18-19.  "Zoning out", but responds when mom talks to him-pupils do dilate when mom uses flashlight, then takes it away.  Starin episodes started yesterday 11/18.  Over weekend 11/15-17, baby had hives after breast feeding-they went away after about 20 minutes, seem to be related to pressure points where baby was held while feeding.  None since 11/17.
Red, warm rash appeared over both buttocks with wheal formation pt seen on 09/20/2005 and 10/03/2005 improved with Benadryl, Zyrtec.
Started losing my appetite and then it has continuously got worse; I could not eat, I didn't have appetite; Started losing my appetite and then it has continuously got worse; I could not eat, I didn't have appetite; I could not go to the restroom very well; This is a spontaneous report from a non-contactable consumer (patient, self-reporting). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration, on 29Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, the first thing that happened after 29Apr2021, on an unknown date in 2021, she started losing her appetite and then it had continuously got worse and one thing was that she could not eat as she did not have appetite and she could not go to the restroom very well. So, her doctor/primary care physician put her on some laxative (Trulance) (corrective for I could not go to the restroom very well), it was a very expensive laxative but he had some samples, some physician samples, professional sample not for sale, they were called Trulance, gave her a blister pack of seven and she took those over a month ago and they worked for a while but they are not working, no more. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
fever, myalgia & arm swelling p/2nd soes; 3SEP93 f/u sx resolved p/3 days
Received Moderna vaccines on 2/26/21, 3/26/21, 9/23/21, 2/25/22; positive for COVID by PCR on 5/19/22. Admitted to hospital on 5/19/22 d/t mild/moderate COVID symptoms in pt with metastatic renal cell cancer on chemo.
BACK PAIN STEADILY GETTING WORSE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, back pain, latex allergy, nickel allergy, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-DEC-2021, the patient experienced back pain steadily getting worse, headache, and fatigue. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain steadily getting worse, headache, and fatigue. This report was non-serious.
Noticed minor itching at the site of injection the evening after receiving a flu shot. About 24 hours after receiving the vaccine, the itching turned into redness and swelling in the arm around the elbow (at a different area than the vaccine was given). The redness and swelling have gone down but have not completely gone away.
Patient stated on Day 8 post injection she noticed some armpit pain.  It then transferred to the outside of her arm and became inflamed, red and a hot rash.  She said it lasted 1-2 days.
rash after my 2nd injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash after my 2nd injection) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash after my 2nd injection). At the time of the report, RASH (rash after my 2nd injection) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
CELLULITIS DEVELOPED IN PATIENTS ARM. PATIENT SOUGHT OUT TREATMENT AT A CLINIC. TREATED WITH BACTRIM, HYDROCORTISONE AND IBUPROFEN.
Besides the expected exhaustion and sore arm, I got a red, warm, itchy spot next to injection site that started small and has gotten larger. Not sure if it's still getting larger, but per recommendation, I'm about to take benedryl, so... yeah. I did NOT have that with the first shot
Rash - raised, red, blotchy and warm - face, upper and lower extremities, lower front and lower back and trunk. Benadryl 20mg IM. Rash gone. Benadryl 1 tsp at home at 1930.
This medically confirmed report received from a pharmacist via a field employee (initial receipt 29-Apr-2014) concerns a 60 year old male patient. On an unspecified date, four months ago, the patient received flu shot (manufacturer and batch number not reported) and ZOSTAVAX (batch number not reported). On an unspecified date, after vaccination, the patient developed Bell's palsy. It was reported that the patient was not hospitalised. The outcome was not reported.
BROKE OUT IN HIVES ON ELBOWS, WAIST, GROIN, KNEES, BACK AND CHEST. ITCHING ALL OVER.
pt recvd vax & w/in 2 days p/vax exp a blotchy rash on torso;this adverse exp resolved w/o treatment;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as DOSE 1, SINGLE (lot number: EL33486), in the right arm; on 05Feb2021 as DOSE 2, SINGLE (lot number: EN5318), in the right arm; and on 02Oct2021 as DOSE 3 (BOOSTER), SINGLE (lot number: 301558A), in the left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 20Apr2022 as DOSE 4 (BOOSTER), SINGLE (lot number: 057M21A), in the right arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Aug2022) Positive, notes: "COVID-19 treatment." Therapeutic measures were taken as a result of Vaccination failure, Covid-19.; Sender's Comments: Based on the available information, the reported events Vaccination Failure and Covid-19 cannot be excluded for the suspect drug BNT162b2.
Left arm went numb, extreme  soreness in the entire arm, could use arm at all. lasted 3 days. shortness of breath.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 at 10:00 as dose 1, single (Lot number: ER8730) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2022 at 10:00 as dose 3 (booster), single (Lot number: 939904), in left arm and on 16Sep2022 at 12:00 as dose 4 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "known allergies: Sulfur based drugs" (unspecified if ongoing), notes: known allergies: Sulfur based drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
pt recv vax 26SEP96 & pt devel 2 spots on back of neck which gradually progressed to less than 50 lesions;2OCT96 pt exp a fever;
Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, FATIGUE (Fatigue) outcome was unknown and ARTHRALGIA (Joint pain) was resolving.            Doctor told her to stop taking Rinvoq before taking booster injection for Covid 19. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
It feels like I have mono without the sore throat. My head hurts, my joints hurt, I?m tired, and the worst of all of them is brain fog. I?ve had brain fog to a point where i forgot which trashcan was mine at the curb.
Chills, fever of 101, muscles aches until morning. At 10am next morning still had muscles aches (all over body) and temp of 99.8. During the rest of day continuous muscles cramps in toes on right foot, leg cramps and fingers also right side.  So started a cough which still have (4.25.21). I had Covid 19 in November...these symptoms were worse although did only last 24hrs.
This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, units, frequency, route of administrations, anatomical location, lot number not reported). On an unkown date the patient experienced unspecified side effects. The outcome of unspecified side effects was not reported. The relatedness between unspecified side effects and GARDASIL was not reported. Additional information is not expected.
sore throat (morning) congestion (throughout day) wheezing (evening)  vomiting (evening -- 8:30PM continuing through time of this filing)
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 22-JUL-2013, patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date: 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Headache; Nausea; Stomach pain / colon wasn't calming down; Diarrhea / colon wasn't calming down; This case was reported by a consumer via and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, nausea, stomach pain and diarrhea. On an unknown date, the outcome of the headache, nausea, stomach pain and diarrhea were recovered/resolved.   It was unknown if the reporter considered the headache, nausea, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 60 years. The patient had her 1st dose in fall of 2018. The patient experienced headache, nausea, stomach pain and diarrhea following that dose.  The symptoms lasted for 2-3 days except for the stomach pain and diarrhea which lingered for about a week.  The patient described as her colon was not calming down. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2021AMR035701.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR035701:Same reporter.
pt recv vax 15MAR96 & pt exp a fever, fatigue & rash;no further details were provided because the reporter had no recollection of the pt;
Myalgia, Fever, chills, arm pain, swollen lymph nodes Narrative: Fever, myalgia, chills, arm pain, fatigue, swollen lymph node left axilla (side of injection.
Reddened skin with scabby areas on face and neck that started on Day 5 and lasted for 4 weeks.  Methylprednisone tablets taper for 5 days.
Patient tested positive for COVID-19 infection, admitted to hospital on 4/6/21. Patient received remdesivir for 3 days, dexamethasone for 3 days, azithromycin for 3 days, and ceftriaxone for 3 days. Patient discharged on 4/8/21.
vaccines were given on 4/23/04. patient presented to office on 4/26/04 with rash on left thigh around the sites where the vaccines were administered.  after evaluated by a doctor and was diagnosed with cellulitis.
Hospitalization for upper respiratory symptoms due to COVID-19 on dates 11/28/2022- 12/4/2022.  Treated with Remdesivir.
Child fussy and cried to point of lethergy for 4 days after shots. Taken to MD, mother reports child not able to hold head up. Low grade fever. Child on Tylenol, child placed on iron for low hemoglobin after visit to MD.
Seizure 3-4 hrs after vaccine administration and all other causes ruled out. Hospitalized for 2 days. Readmitted 3-26-13 for 3 days following abnormal EEG.
Fever; sore joints; very tired; injection site pain; Headache; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm left on 16Feb2021 11:00 (at the age of 51 years old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm left on 26Jan2021 (at the age of 51 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior vaccination. The patient experienced fever, sore joints, very tired, injection site pain, headache on 17Feb2021. No treatment were given for the adverse events. Patient did not tested for COVID post vaccination. Outcome of all the events were recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous day plus lethargy 2/27 woke up at 3:30 a.m. with SEVERE headache and partial loss of vision  Went to ER and they diagnosed me with a moderate stroke and mild cognitive issues with right hemisphere vison loss in both eyes.
On 10/15/10 client reported her right upper arm difficult to lift and began hurting and pain increased about 3 hrs after vaccines given. Client reports burning, radiating pain present the evening of 10/13 lasting about 3 hrs. This burning was in armpit area and right breast and radiated to right upper lung field and states when she took deep breath also had burning sensation. 10/15 - can lift arm, but states still painful, but pain is decreasing.
developed multiple tendonitis issues withing1-3 months after 2nd Moderna. Muscle aches, joint pain.  Multiple type of steroids tried both oral and joint injections to treat.  After steroid stopped developed severe neurological issues, peripheral neurpathy- bilateral feet to knees and hands to elbows.  Face numbness, back numb.  Feels like red hot pokers in legs and had to use walker.  Struggling with ongoing neurological symptoms for5 months.  I don't walk normal, can't type/keyboard normal, etc.  Sometimes i feel like I can't swallow.
At about 12:45AM on 4/2/21 I noticed I had a fever, a headache, chills, and injection site pain. My fever broke about 5 hours later and my headache and chills went with it. The injection site pain continues even now on 4/6/21.
Induration to left arm 85 x 85 cm, warm to the touch and painful. Tx->Ice packs, TYLENOL and BENADRYL if it worsens pt to return to clinic.
VACCINATED WITH JANSSEN COVID-19  VACCINE WHICH WAS LEFT OUTSIDE  IN ROOM TEMPERATURE MORE THAN  2 HOURS; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a 31 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: 1821281, and batch number: 1821281 expiry: 23-JUL-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours. On 27-MAY-2021, the subject experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556814 and 20210556611.
A 20-year-old who presents today for a follow-up appointment. She was seen yesterday. She has sarcoidosis that has responded well to steroids in the past. She also has asthma. She did receive her pneumonia vaccination yesterday after she saw us. She called in this morning complaining of left arm swelling. She did apply some cold and warm compresses on her left arm. That did not seem to help. She has a problem moving her arm. It is also warm. She presented for an urgent appointment. She is on ASMANEX for her asthma. She is also on SINGULAIR. She tried BENADRYL for her postnasal drip which made her sleepy. No night sweats. No leg swelling. No fever or chills. She does have swelling of her left forearm posteriorly at her triceps muscle expanding 15 x 10 cm. The area is warm. No pus or drainage. It is sore to touch. No area of bleeding and it is hard to appreciate the redness due to the dark skin. For her left arm cellulitis, I did give her a prescription of KEFLEX 500 mg every 6 hours for the next 7 days. I am giving her a MEDROL Dosepak to decrease the swelling. She is going to apply warm compresses on the arm. She will be calling me tomorrow to tell me if she is getting any better. I did also draw a line around the arm to delineate where the swelling is. I instructed her companion fromt he place where she lives to take a look at that. If the swelling gets worse and goes beyond the line or if things are not better in the next 24 hours, then I might put her in the hospital for some IV antibiotics. She will be calling us tomorrow and we will decide based on that. TYLENOL for fever and for pain.
pt recvd vax & 8 hrs later devel flu-like sx, nausea, vomiting & diarrhea; sx subsided p/3 days;
Redness, swelling, and pain of left upper arm. Provider advised cool compresses to reduce swelling . Use TYLENOL 500 mg every 6 hours as needed.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported; therapy type: digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced nausea, vomiting, diarrhea the day after the injection.  This lasted for about 6 hours. After that, I experienced excruciating stomach pain so intense that it was impossible to get to sleep.  This pain lasted about 3 days.  After the pain lessened and I was able to rest, the symptoms of stomach upset endured for 7 days.  I was unable to eat and lost 10 pounds.  On day 9, I began having blacking out spells because of extreme dehydration.  I began to take small amounts of gatorade.  My eating intake did not return to normal until about day 13 following the injection.
Nov 26th 11pm: itchy armpits Nov 27th 10 am: itchy scalp Nov 27th 3pm: itchy lower back Nov 27th 11pm: noticed hives on thighs/groin Nov 28th 9am: itchy all over body, rotating scalp, legs, arms, neck Nov 28th 11am; took 1 Claritin pill Nov 28th 6pm: swelling/itching on back of neck.. Swelling bad enough to limit head movement Nov 28th 7pm: went to Urgent Care, received Kenalog 40 mg Dose 60mg intramuscular shot. Nov 28th 11pm: no relief. Have noticed swelling coming and going in different areas. Currently left index finger is swollen from base to first knuckle and unable to fully bend. Back of neck still swollen enough to be hard to the touch. Feels difficult to get a deep swallow, and indigestion pain comes and goes in waves. Intense itching sensation is rotating over body as well; arms, legs, back of neck, base of scalp.
At 15 min mark patient complained of feeling dizzy, paramedic  present + spoke with patient.  BP 132/80, HR 82, SPO2 98 extended monitoring for another 15 min.
Patient received a total of 6 covid vaccines due to failure to check vaccine records by various entities. Moderna series completed appropriately by PCP office (3/10/2021, 4/7/2021). J&J dose administered inappropriately on 5/15/2021 by another site w/in same system as PCP clinic. Pfizer series administered inappropriately by a Pharmacy (6/24/2021, 7/15/2021). J&J dose administered inappropriately on 9/15/2021. Patient presented to ED on 12/16/2021 and was found to have Covid 19 Pneumonia.
On Tuesday 11/19/13 patient developed red spot at injection site with fever 3 inches in diameter. By Wednesday 11/20/13 the site had expanded to about 6 inches - patient started on 1/2 table of BENADRYL 25 mg twice daily on Wed, Thurs, and Fri. By Sat rash was resolved.