chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in for 4th dose of Dtap series but was mistakenly given Tdap vaccine. Patient did not immediately have any symptoms or signs after the vaccination - to my knowledge patient still has not shown any reaction. The patient's mother was notified of the mistake later the same day of vaccination.
Initially had soreness to arm at injections site for 2 days and headache as well. Approximately 5 days later started getting rash with moderate itching on top of left foot and ankle area.  Now have rash and itching on top of right foot and ankle area , side of right leg near calf, inner part of left knee, and right shoulder at injection site. Still have rash and itching to this day. Urgent Care Dr. prescribed Hydroxyzine 50mg, Zyrtec, and Triamcinolone Acetonide 0.5%
PATIENT DEVELOPED SHINGLES WITH SX. APPEARING ON 04/19/2021 AND DIAGNOSED BY DR ON 04/22/2021
3 days after flu vaccine administration, experienced rash on lower abdomen, shoulders and back. Next hoarseness, lost voice, runny nose, fever, chills, sore throat. Tx: cold remedies.
FEELING OF RAPID HEARTBEAT AND SOMEONE SITTING ON HIS CHEST (STARTING THE AFTERNOON AFTER THE VACCINE) MOM DROVE HIM TO URGENT CARE- EKG AND VITALS TAKEN.  NO MEDS GIVEN.  ORDERS AFTER OBSERVATION WAS TO  GO HOME AND REST. MOM STATES PT. DIDN'T FEEL WELL THE REST OF THE NIGHT BUT BETTER THE NEXT DAY
Injection given (Ll deltoid). Local reaction red, swelling, warm to touch from side up to top of shoulder. Red flushing of face no SOB but tingling at site. Ice packs and steroids Prednisone 20 mg 2 tabs daily for 5 days.
Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022; Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in refrigerator on 31-Mar-2022 and the vial did not undergo any temperature excursions.  The expiry date was mentioned as 27-Mar-2022.  The reporter wanted to know whether the patient should revaccinate or not.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document received contains no new information.
Extreme fatigue; terrible headache; Felt very warm but no fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 34 years 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: FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "Extreme fatigue"; HEADACHE (non-serious) with onset 24Mar2021, outcome "unknown", described as "terrible headache"; FEELING HOT (non-serious) with onset 24Mar2021, outcome "unknown", described as "Felt very warm but no fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1st shot: Sore arm 24 hours after injection lasting for 2-3 days. No visible signs.   2nd shot: Red, raised area around vaccination site. Warm to touch. Itchy and painful.  Visible signs lasted for 24 hours. Itchiness and mild pain lasted for 48 hours. (Patient is allergic to latex and forgot to double check if band aid was latex free, so that may be a possibility). Treatment included cold compress to injection site.
swelling of throat on both sides of lower neck  base and slightly  to the side on right and left side --  swollen and  puffy  -- does not go away , stays about the same in size ....  and bad rash all over body that does not go away  - sever itch ... doctors have no idea about swelling on base of neck and suggested we watch it  ,,,  so I have no confidence in  what they say  --  the same is true of the persistent rash that will not go away  -- they prescribed  some sort of cortizone cream  and  zyrtek ...  another wrong  diagnosis and treatment  -- and my insurance does not cover these doctors visits because I have a high deductible and my employer does not offer health insurance  --  Looking  back , I wish I had never taken the vaccine .
This spontaneous report as received from a pharmacist refers to a 58 year old female patient. Patient had no pertinent medical history and no drug reactions/allergies. On 29-NOV-2013 the patient was vaccinated with ZOSTAVAX (.065 ml, once, subcutaneous) (lot # J006157, expiry date: 30-AUG-2014) (Physician recommended). There were no concomitant medications. Within 24 hours after receiving ZOSTAVAX, the patient developed a reddened area of skin that grew in size and was pink beyond the reddened area. The patient also reported that the area was warm to the touch. The patient sought medical attention by seeing a physician on 01-DEC-2013, who told her to use ice and prescribed Hydrocortisone, oral Benadryl and Cephalexin. The patient called the pharmacist on 03-DEC-2013 to report that the spreading was contained but the area is not itching and burning. The pharmacist stated that the patient had no hives, bumps, lesions or pustules present. The patient reported to the pharmacist that it looks like sunburn. No lab diagnostic studies were performed. No PQC was involved. Additional information has been requested.
Assessed onsite by EMT for an allergic reaction.  Presented with a left swollen lower left eye,  vitals sign normal, no rash or hives, no trouble breathing.  Patient provided by EMT with benadryl 25 mg, self administered by mouth at 12:08 pm.  Patient was reassessed by EMT at 12:15 pm with notable improvement.  Released by EMT to caregiver.
This case was reported by a consumer via call center representative and described the occurrence of jaw pain in a adult male patient who received RABAVERT. On an unknown date, the patient received RABAVERT. In January 2018, less than a month after receiving RABAVERT, the patient experienced jaw pain and neck tightness. On an unknown date, the outcome of the jaw pain and neck tightness were unknown. It was unknown if the reporter considered the jaw pain and neck tightness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to manufacturer. The patient received booster shot of RABAVERT about two weeks before from the date of reporting. In 2018, the patient had a lower jaw pain and neck tightness after vaccination. The reporter asked multiple questions regarding if there was or had been a vaccine recall, for which the patient was advised there had not been a vaccine recall. The patient concerned if he would have acquired Rabies secondary to vaccine. The patient had been advised that he would need to follow up with his physician to be tested and assessed for any diagnosis of rabies. The patient had denied permission to contact their physician. The patient had no complaints of edema in neck. The patient had been advised to follow up with physician for an assessment as they were not allowed to give medical advice. The reporter asked, if the RABAVERT was a live vaccine or if it was mislabeled as synthetic, but actually it was live. The patient had been advised that the RABAVERT was not a live vaccine, it was a synthetically prepared.
Patient reported "hard lump in center of right armpit", feeling "hot and sweaty," and having "swollen, irritated, tight muscles in groin." Patient used OTC Ibuprofen for symptoms.
Noticed swelling around eyes 3-5 hours after getting flu shot. Went to bed that evening and swelling was game when he woke up. Has had flu shot previously.
Severe rash and itchiness. Hives day after vaccines given, benadryl given at home w/out improvement. Following day felt lightheaded, little cough and felt "weird". Paramedics called/arrived to home, assessment - normal and stable.  Course of treatment, MD prescribed Prednisolone soln. Advised to try Zyrtec or Allegra OTC.  Recommend to see allergist
immediately upon influenza vaccine administration, site of injection on right deltoid began to swell. this was second injection given and pt had no reaction in left deltoid. site swelled to size of quarter before bandage was placed. Triaged patient for signs of allergic reaction and went over allergy history (none). Patient stated that she had a similar reaction after her shingles shot last year in the same arm, but nothing prior.  Advised patient to keep benadryl on hand before she left premises although she was feeling fine, and contacted her MD office to let them know of reaction.
Severe headaches, joint pain 9 out of 10, fatigue, sleepiness.
Major dizziness and nausea; Major dizziness and nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 14:30 (Batch/Lot number was not reported) (at the age of 70) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced major dizziness and nausea on 25Feb2021, major dizziness and nausea on 25Feb2021. The events outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Information has been received from a registered nurse concerning a 16 year old female patient with no drug reactions/allergies who in September 2011 ("about 1 month ago"), was vaccinated with her first dose of GARDASIL (lot# unspecified). There was no concomitant medication. In September 2011, the patient passed out, came to, passed out again then developed tonic-like seizures. The patient had no history of reactions but "had been at the beach all day and was not well hydrated" and was otherwise healthy. The patient did not seek medical attention and was given oxygen. At the time of report, the patient was recovered (in September 2011). Upon internal review, tonic-like seizures was determined to be an other important medical events. Additional information has been requested.
pt taken to ER evening of the same day recv vax 4AUG98 for fever of 104-105;child was sent home w/meds;fever cont for 3 days;child returned to ER 3 days later when was adm;dx kidney infect;
Fever, headache, vomiting developed within 24 hrs of H1N1 vaccine administration.
Client reported itchiness to her left leg 6 hours after the Moderna shot.  Two weeks later she reported general numbness and was treated by her MD with steroids.  She currently experiences intermittent numbness when stressed out.  MD approved her to get the Janssen and she received it on 11/3/21
Red, itching, swollen, "like a half an egg " size. Started about 4 days later. Internal swelling like a ball under skin. Ice and TYLENOL. No temperature reported.
rash within 36 hours of receiving Shingrix vaccine / rash as pretty severe and very itchy; This case was reported by a consumer and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Within 36 hours after receiving Shingrix, the patient experienced severe and very itchy rash. The reporter consented to follow up.
COAGULOPATHY, UNSPECIFIED TYPE ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 12/15/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Dizziness, headache  and tired. Arm at injection site was sore. Lasted two days.
Swelling, redness, unable to use right arm do to tingling felt on tip of the fingers.
Developed hive like rash approximately 12-15 hrs. after Hep B immunization. Presented to ER Dept and was given Benadryl IM. Rash then began to subside.
Started noticing the injection site painful and swelling from the next day of the shot, then formed a knot, size of a quarter, the knot lasted more than 7 months until recently it formed to a head and pus was coming out.  no treatment was needed, area is drying out, no more knot but the fact the knot lasted over 7 months and formed to a pus pocket 7 months later?
Felt really tired/fatigued, but didn't feel ill.  I stayed in bed much of the day, except going to lunch with a friend.  I went to bed again immediately upon returning home.  I had little appetite at lunch (small bowl of soup only). I eventually (about 6:45 PM) decided to check my blood pressure with my home unit.  It was 150/100 with a pulse of 100.  I called my doctor's night clinic and the nurse told me to go to the ER.  At that point my head hurt (all the way around my head) and the base of my skull really hurt.
Face turned extremely red.  Right eye almost swelled shut, nose, lips, ear swelled and very red on Friday, March 5, 2021.  Swelling began to subside somewhat on Monday, March 6 after taking Benadryl.
Shot was given in the Joint of the shoulder not the upper arm in the muscle. Extreme pain, Nausea, Fever, Dizziness.
Patient received her second dose of the Moderna COVID vaccine in 3/2021 (unknown which specific date) and presents on 4/10/21 with feeling ill, shortness of breath, myalgias, and loss of appetite.  Patient has h/o asthma, DM, HTN, COPD, CHF with pEF, severe OA b/l knees/r hip, and neurogenic bladder
RN reported to hlth dept nurse that pt had swelling @ site where was given;RN used 5/8" needle;
Acute onset of frequent uterine contractions. This had not occurred previously in this pregnancy or during my previous pregnancy. Contractions continued to increase in intensity and frequency for two weeks following vaccination. At this point gradual improvement has been evident and freqency and intensity of contractions has declined. It is still necessary to limit my activity to keep contractions to a minimum.  11/30/09 Medical records received for DOS  10/29-11/12/09 and includes additional OB records. 18 weeks gestation.  Contractions.  Belly hard. U/S showed 18 week and 1 day viable IUP. No anomalies. Contractions stop w/rest.  H/O SAB.
A nursing assistant reported temperature excursion for vaccines that were administered to patients after excursion occurred.; This spontaneous report was received from a nursing assistant and refers to a patient of unknown age and gender.    On 21-AUG-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002846 with expiration date of 23-JAN-2022, for prophylaxis (route of administration was not reported), the vaccine was under temperature excursion, temperature -10.2C, time frame 1 hour and 53 minutes, with no previous temperature excursion. The call was because of a "data logger".         This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705:
Information has been received from a physician concerning a 5 year old male who was vaccinated with a 0.5mL, second dose of varicella virus vaccine live (Oka/Merck). It was reported that a few weeks after receiving the vaccine he developed a few lesions on his back. The patient did not have any adverse events after the initial dose which was on year prior to the second dose. Subsequently, the patient recovered. No laboratory tests were reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Intensification of FMF, with 6 flares from  May 14 through Dec 12, 2021, requiring medical intervention.
For 4 days p/vax had edema plus redness upper arm from shoulder to 2" above elbow. Redness only on upper & lateral side of arm. Stiffness & discomfort feels like a tiny hardness @ site.
Case number PHEH2014US000829, is an initial spontaneous report received from the consumer on 08 Jan 2014. This report refers to a 49-year-old female patient. Her medical history included multiple sclerosis. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13391P) intramuscularly on 26 Oct 2013. On the same day after vaccination, she was feeling sick and saw her physician on 28 Oct 2013, who immediately hospitalized her for the next four days. During hospitalization, she received fluids and 100 milliequivalents of potassium. It was reported that no diagnosis was made during this hospitalization. After she was discharged, she was still feeling so bad. She visited her physician again on 11 Nov 2013 and was hospitalized on 12 Nov 2013 where she stayed until she was discharged on 16 Nov 2013. During this hospitalization, she was diagnosed with orthostatic hypotension and was treated with potassium and magnesium to raise her blood pressure to normal. The event outcome and causality was not reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 02-DEC-2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX vaccine, the patient suffered hearing loss, Bell's Palsy and shingles. As a result, the patient was diagnosed with Herpes zoster auricularis on or about 08-JUN-2017. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX vaccine, plaintiffs sustained severe and permanent personal injuries.  Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, of ZOSTAVAX vaccine, patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Herpes zoster auricularis (considered as Ramsay-Hunt Syndrome) was unknown. Upon internal review, Herpes zoster auricularis was considered to be medically significant. Herpes zoster auricularis was disabling. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a multiple unknown patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On approximately 27-FEB-2017, reported as multiple unknown dates since 27-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034780 with an expiration date 15-APR-2019 and lot# M041212 with an expiration date 21-JUN-2019 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion between 0 and 2 degrees Celsius for 1 hour and 26 minutes. A digital data logger was involved. There was no previous temperature excursion. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001517: US-009507513-1703USA005123: US-009507513-1703USA005121.
Rash starting @ DTP inject site rt thigh spreading up back to neck; Rash lasted 1 1/2 days;
Information has been received from healthcare worker (pharmacy technician) who reported that a dose of PROQUAD lot number reported as H015644 exp. date 23-FEB-2014 (dose and route not reported) that was improperly stored at 36-46 degrees F in the refrigerator for possibly 816 hours on 01-NOV-2012 was administered on 07-NOV-2012. The patient's identifiers were not available at the time of the call (age, gender not provided). No adverse effect reported. This is one of several reports from the same source (MAARS # 1212USA011256, 1212USA011257, 1212USA001732). Additional information has been requested.
swollen lymph nodes underneath my arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes underneath my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes underneath my arm). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes underneath my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment medication were provided.
Given Shringrix Vial Kit (Mfg: GlXOAMITHLINW).  Receive shot at 10/02/2019, second shot of series @ 16:16PM.  On 10/03/2019 @ 3:00am I got up to use restroom.  Black out in bathroom, came thru. Pulled myself up to go back to bed, blacked out again. Came back through and climbed into bed, it  was 5am. Woke up at 6:00am with a real bad headache.  Got up at 8am.  My head was really hurting, took an Alive.  Had 2 big knots on both sides of my head, cut on my arm and bruises from where I fell.  Laid back down.  Had cold chills and flu systems and a fever the rest of the day (10/03/2019).  Cold sweats that night..
The evening of the day shot was given, right arm became very painful, (inner aspect of arm, unrelated to site of injection. Shoulder to hand very painful. Used ice and Advil. 2nd day, some improvement. 3rd day, inner right arm area became very reddened. 3rd day was able to raise arm.