chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received PNEUMOVAX on 8-29-13 in her left deltoid. The area was sore that evening and by the following day it was better. Patient noticed pain and redness in the left arm the day after the vaccine was given but not in the area of the injection. Patient came to the ER on 8-31-13 at 12:05 p.m. for the pain and redness of the left arm. Patient was given 1 gm of ROCEPHIN at the ER and instructed to use heat carefully to the area, use TYLENOL or MOTRIN for pain and sent home.
Intermittent swelling and discomfort/pain at injection site. Still occurring today,  7 months later.
I got my initial moderna shot on may 4th and have not had the time to get my second; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my initial moderna shot on may 4th and have not had the time to get my second) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my initial Moderna shot on May 4th and have not had the time to get my second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my initial moderna shot on may 4th and have not had the time to get my second) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant information was provided by the reporter. No treatment information was provided.
One week post-vaccine injection, sharp pains began on and off on the left side of my face. These moved from cheek to jaw to lip to left eye and at the nasal base. There was also stabbing pain in the left eye.  I thought this was due to just being tired from long days at work, but I was also aware it might have been related to the vaccine. Therefore, I took 1600 mg of acyclovir I had on hand to prevent occasional cold sores and went to sleep. The following day, unfortunately, these sharp pains persisted on and off throughout the day. I retook acyclovir and went to work. I reported this to my PCP, and she thought it was unrelated to the vaccine. I spoke with surgeons in my office, and after examination, they both clearly said it was a reaction in my 5th cranial nerve. They both recommended prednisone or methylprednisolone, but my PCP didn't agree, and therefore, I did not receive a prescription for prednisone. I retook acyclovir, and by the following afternoon of  Friday, January 15, I was no longer experiencing sharp pains on the left side of my face.
Information has been received from a physician concerning a cluster of six of seven patients who did not develop sufficient titer after vaccinations with RECOMBIVAX HB. 23-NOV-2010, 5 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666029/1456Y), thimerosal free (dose and site of administration not reported) and 2 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666806/0732Z), thimerosal free (dose and site of administration not reported). On 22-DEC-2010, all 7 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666805/0657Z), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 6 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 669597/0294AA), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 1 patient was vaccinated with a dose of RECOMBIVAX HB (lot number: 666809/1631Z), thimerosal free (dose and site of administration not reported). Titers drawn in June 2011 showed that six of seven total patients did not developed sufficient titers. The titers were repeated in July 2011 at a second laboratory. The patients did not seek medical attention. At the time of the report, the patients' outcomes were unknown. This is one of several reports received from the same source. Follow up information has been received from the physician concerning one of several patients who on 23-NOV-2010 was vaccinated with the first dose of RECOMBIVAX HB (dose and route not reported) and lot # 66806/0732Z, expiration date 09-NOV-2012. On 25-MAY-2011, the patient received the third dose of RECOMBIVAX HB (dose and route not reported) and lot# 669597/0294AA and expiration date 07-SEP-2013. On an unspecified date, the patient had a titer result of not reactive (NR) on titer #1 and #2. Follow up information was received from the physician who reported that his office does not treat any pediatric patients, the office only treats adults. The physician reported that the office purchased the pediatric vials "which are cheaper" and dispensed two vials to each patient to provide an adult dose. A standard lot check investigation has been finalized. All in-process quality checks for the lot numbers 66806/0732Z, 666805/0657Z and 669597/0294AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Raised red welt, about the size of a nickel, near the injection site on right thigh.
she is feeling sick all day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Second Dose, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Third Dose (1st booster), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 12May2022, outcome "unknown", described as "she is feeling sick all day".  Additional information: Caller said she did her second booster dose of the Pfizer Covid19 vaccine yesterday however she is feeling sick all day today and was asking for a recommendation for the next step she can do. Caller refused to provide personal information. Resolutions: Submitted manual AE form- Regulatory Authority  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After administration of vaccines, pt develop hives. Doctor of the day came and treat pt with ZYRTEC 10 mg and send them to ER for observation.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder by repeat tests; pt recvd a booster dose of Engerix-B on 15AUG91; 11NOV91 HBSAB test was pos & hence resolved;
The day after my shot I felt fine, my arm was really sore but I worked out and moved it a lot.  Around 5pm that night I was on a conference call with my colleagues when I started experiences facial twitching and a loss of control on the right side of my face near my mouth.   I was having trouble annunciating and was slurring my words when speaking. My colleagues were able to visually see the twitching happening over the zoom call.   The issue resolved itself on its own within 10 minutes. I have had no other symptoms.   I have my second dose scheduled for this Tuesday but I am really afraid that I it will be worse.   Please reach out and let me know if its safe to process with the second dose.
Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 046A21A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.   On 16-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021 at 12:04 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter. Company comment: This is a spontaneous case concerning a 64-year-old, female patient with no relevant medical history reported, who experienced the non-serious unexpected, according CCDS, AESI of Ageusia. The event occurred after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable. At the time of the report the event outcome was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This is a spontaneous case concerning a 64-year-old, female patient with no relevant medical history reported, who experienced the non-serious unexpected, according CCDS, AESI of Ageusia. The event occurred after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable. At the time of the report the event outcome was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: steroids" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid for COVID 19 Treatment. Known allergies: Demerol and steroids. Other medical history was No.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Extreme pain in left arm, shoulder and neck, all over itching, especially left appendages, itching and burning eyes, general malaise.
Pt. had an emesis 30 minutes after receiving vaccine.  Immediately had pt. put her head down between her legs and applied a cold compress on back of her neck.  After 10 minutes pt. stated she no longer felt nauseated.  Pt. left with mother.  Spoke to mother on 8/22/08 and stated daughter went thereafter to the emergency room and was sent home with an epinephrine pen.
Patient complained of throat swelling at 10:25am after receiving the first dose of the Pfizer vaccine in the right deltoid at 10:01am. Patient was treated by paramedics with Epinephrine and had no improvement, then received 50 mg of Benadryl IV and was transported to Medical Center. Patient has a history of an allergy to shellfish.
Information has been received from a nurse concerning a 70 year old female with blood pressure high, depression and history of shingles (unspecified time period) who on 14-JAN-2009 was vaccinated with ZOSTAVAX (Merck), lot number: 662971/1214X SQ. Concomitant therapy included (TEKTURNA), lovastatin (manufacturer unknown), (EFFEXOR XR), aspirin and (NAMENDA). On 23-MAR-2009 the patient developed shingles and had lesions on her left side with pain. The patient's shingles persisted. The patient was referred to unspecified dermatologist. Additional information has been requested.
Severe arm pain, unable to put down. Patient also experienced feeling cold a few hours after receiving vaccine.
6/28/06: fever, myalgias, sore throat, nasal congestion, HA. 7/4/06: felt better. 7/5/06: migraine HA. 7/6/06: saw PCP and spent the rest of day in bed. 7/7/06: went to ER for fever, feeling poorly. Had LP done. CSF positive for enterovirus. CSF sent for testing to CA Encephaltis project. Disposition: discharged home from ER.
Right deltoid red, hard and swollen per school Nurse. Area approx. 4"X2". Meningitis Vaccine given in that location.  Instructed to ice area and take Tylenol for discomfort.
Was given flu vaccine and later discovered that patient had received flu vaccine on 10/13/2022 as well.
I tested positive for COVID-19 on 5/17/22.  I developed slight fatigue.  I developed a fever of 101  over night and felt sick.  Woke up w/ body aches and headaches and bit of a sore throat.  I called my doctor on 5/17/22 and received paxlovid.
Has struggled his entire life; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a child male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced activities of daily living impaired (serious criteria disability). On an unknown date, the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the activities of daily living impaired to be related to DTPa vaccine.  Additional information was reported as follows: The age at vaccination was not reported. The reporter's child was injured by the DPT and had struggled his entire life as a result. But of course it was dismissed as unrelated coincidence.
Headache; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 21st May 2022, the patient received the 1st dose of Shingrix. On 21st May 2022, less than a day after receiving Shingrix, the patient experienced headache and fatigue. On 23rd May 2022, the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was reported by patient's wife. The patient received a dose of Shingrix on the afternoon and that evening he developed a headache and fatigue. The headache and fatigue lasted about a day and a half and were now resolved.  She had nothing else to report. The reporter declined to provide email addresses but might follow-up with heath care professional. The reporter consented to follow-up. Additional Supportive Information: This case has been linked to the US2022082828 case reported by the same reporter. Note: Duration was auto calculated as per mentioned date as partial outcome date and duration of 1 and half day we did not captured.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082828:Same Reporter
Pain in injection arm. Hives on arm as well as stomach. The hives were incredibly painful and itchy and lasted for over nearly two weeks.
Patient described shortness of breath and stomach pains. Sent to Emergency room via EMS and tested positive for COVID-19 Delta variant 12 days after vaccine. Upon X-ray of chest, small blood clot located into right lower lobe. Admitted into hospital for observation and released 2 days later with blood thinner and antibiotics. No other symptoms reported.
Isolated "itchiness" with no visible rash.  Denies any other symptoms - No sob, tongue/lip swelling, chest tightness.  Pt has never been to hospital for any allergic reaction.  Reports she just takes antihistamine and is fine.  Declined IM Bendadryl (no PO available) bc has to drive 1 hour home.  Pt preferred to drive to store and pick up nondrowsy antihistamine, and advised to add H2 blocker (Pepcid).  VSS and looking well at time of leaving site.
I woke up at 2 am on Wednesday 5/5/2021, not quite 7 full days since second shot.  My tongue was extremely swollen, almost filling my entire mouth, and almost to a point of blocking my throat.  I looked at it in the mirror and it seemed most of the swelling originated under the tongue on the left side towards the front.  I could talk, but it was very garbled.  I was afraid to fall back asleep in case it were to get worse.  By morning it was down about 75%.  I googled the issue and realized it could be allergies to the spring weather, also took a Zyrtec 10 mg.  By noon it was only about 10% swollen.  Today, May 7, 2021, my tongue is still a bit tender, as if I'd had coffee that was too hot and burned the taste buds.  I realize this may or may not be a side effect from the vaccine but just wanted to report it.
Redness, warmth, induration to size of "an orange" (R) shoulder after vaccines.
12-17-2012 -  Acute Respiratory Illness, ? SIDS.
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 1:14 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.74.  Concomitant medication of the patient was not reported.  Batch number 022M20A underwent temperature excursion on 17-Feb-2021 with temperature of 22 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 11-Feb-2021 and beyond use date for the vials was reported as 13-Mar-2021. The vaccines moved to clinic on 17-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Shoulder Injury Related to Vaccine Administration. Continues to be painful and my arm is becoming less usable and more like it's partially "paralyzed" because of the pain.   Also, and this may be totally unrelated to vaccine but since I got the vaccine I've been have muscle cramps all over my body and very painful muscle aches. It's been months but it could be from anything. I thought it might be one of my medications I've been taking for a couple years. However, my pharmacist said it was the vaccine and not my medications that caused it. So I thought I should report it.   I am pro vaccine and would get it again despite these adverse affects.
Chest pain, shortness of breath, high body temperature, feeling tired - hospitalised and diagnosed with acute myocarditis of medium severity, should do no phisycal activity for 6 months
PATIENT STATED THAT ABOUT 1 HOUR POST VACCINATION SHE STARTED WITH A RASH AND HIVES LOCATED ON THE SIDE WHERE THE VACCINE WAS ADMINISTERED. THE HIVES PERSISTED TO SPREAD AND WELPS OCCURED OVER THE WEEKEND THROUGH BODY.
Vaccine given 5-10-16, pt returned 5-13-16 with redness and slight swelling at and around the injection site. Advised BENADRYL by mouth and to apply ice.
Had TDAP, had sensation like rushing warm water down arm. Soon after started feeling tired and weak, "felt like flu" about 1hr later, felt heart rate was - irregular (has hx of afib with pacemaker). Got home felt worse, called cardiologist. Seen in office next morning in afib by EKG. Per pacer-afib during night.
10/7/02 received flu vaccine. 10/14/02 reported visual problems. 10/22/02 cranial neuropathies believed to be flu vaccine demyelinating polyneuropathy or G.B.S. Follow-up received on 02/12/03: received vaccine at work - mft and lot # unavailable. there. Medical records state nystagmus. msv
Information has been received from a nurse concerning a 2 month old female with no pertinent medical history or allergies, who on 06-OCT-2008 was vaccinated with the first dose of 2 ml oral ROTATEQ (lot # 659916/0964X). Concomitant therapy included PREVNAR, ACTHIB, DTaP and IPOL. On 08-OCT-2008, the patient developed blood in her bowel movement after receiving her first dose of ROTATEQ. The patient is reported to be recovering. Unspecified medical attention was sought. No laboratory tests were performed. No quality complaint involved. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 71 year old male patient. No relevant medical history of the patient was reported. On 10-JUL-2014, the patient was vaccinated with an expired dose of MMR II (lot # 0184AE, 18-JAN-2014), first dose (strength and site of administration were unknown). There was no concomitant medications reported. The patient experienced no adverse effect. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Felt adrenaline rush right after shot, light headed, voice change, cough, scratchy throat, headache, aches and pain like having the flu, feeling of hives on arm, truck and all over body.