chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild Tinnitus.  Consistent mild tinnitus with intermittent moderate tinnitus.  I experienced mild tinnitus after 2nd dose of vaccine and just assumed it would go away.  I've never had chronic tinnitus and in general I am in very good health.  I am 5'11 and 170 lbs and very active. I have experienced tinnitus on occasion after a loud concert or other but this is different.  My hearing is otherwise perfect. Due to Covid I am still working from home and very much notice this adverse event as it is rather quiet at home with little background noise.  I have now had this issue for over 2 months and recently have had issues where it is quite bothersome which prompted this report.
pt recvd vax & 4hrs p/vax pt devel redness & swelling @ the inj site & a sore arm that looked like cellulitis;also exp a gen feeling of malaise, chills, aches all over & fever;presented to MD;recovered by 8OCT94;
Around March 8th 2023 I could feel congestion in my chest. I decided to go to urgent care on March 10th. I felt terrible, it was all in the chest and sinuses. My doctor did prescribed me benzonatate to take for 10 days and I also took MUCINEX DM for one week. After being on the medication it took three weeks for it to run its course and me to get my energy back.
Pt got ZOSTAVAX shot on 07/12/17, pt discovered red bloches/rash-like (no itch) on face on 07/14/17 morning. bloches/redness is about the same since pt discover the reactions.
I did a checkup with the Vsafe and then I got a call from the people who said I should report an adverse reaction. I don't know if this is useful at all or if the chain of events is all out of whack, but here's the info anyway:  I started getting more severe lower-right abdominal pain during a time when I was not ovulating or on my period and had to go to the ER to rule out appendicitis late last fall. They saw fluid in the area after a ct scan that showed what looked like a burst ovarian cyst.   I continued to have pain for several weeks on and off and had to see an obgyn who said it was just ovarian cysts. For other health reasons (allergies, severe medication reaction, migraines with auras) I can't be on birth control which might help to control this issue.   -- Then, in January, I got an upper respiratory infection (I got my booster in November) and then I got COVID right afterwards around the second week of January.
A red spot at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (A red spot at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A red spot at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (A red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not reported. Treatment information was included cortisone cream. Patient stated that the red spot is not gone completely but is fading away
The vaccine was administered after a high temperature event reported according to the thermometer. Patient did not present any symptoms out of the ordinary. The experience was similar to his third dose.
shortness of breath and n burning in center of chest. Like Lungs were hot.  Call to Nurse Pract. recommended I go to Emergency room as could be heart attack.  Went to Medical Center Emergency Dept as recommended. Took vitals and waited for additional tests.                                                                                                                                                           arrrived at Emergency Room of Medical CEnter
This spontaneous report as received from a consumer concerning her daughter of unknown age. The reporter mentioned the patient had the first dose of GARDASIL (lot # was unknown) when her and her doctor chose for prophylaxis. The second dose was provided 4 months after the first dose and the third dose was provided 6 months after the first dose. The outcome was unknown. Additional information is not expected.
pt noted pain, swelling & redness @ point of inj;3OCT97 AM area of redness inc by Saturday PM pt c/o pain, T101 was seen by MD 5OCT97 tx for cellulitis;
HIVES, ITCHY THROAT, PUFFY FACE - 1 hour after receiving vaccine. Previous flu vaccine 10/07. Went to ER - given1m BENEDRYL and then recovered and went back to work.
Received phone call from patient's daughter on 10/01/13 around 3:30 pm (day after injections). Stated patient had same side effects that started shortly after injections. She was choking, wheezing, cough, upset stomach, fingernails turned blue. These lasted well into the night but was beginning to feel better. I asked her if she needed medical care (emergency room or her personal physician). She indicated that patient didn't think she needed medical attn. I called Dr, her personal physician and reported the incident.
the evening of the vaccine, started with arm pain at the site of the injection. Within 24 hours, severe pain, lump at the site, heat at the site. 72 hours after the shot her thigh started with severe pain when touched- no injury noted to that area.  Left deltoid continued to be painful, hot to touch, and interfering with activity . Was scheduled for sick child visit on 1/20/2020 but since arm is much improved one week later, follow up appt cancelled
My left eye started swelling like I had the shingles again. I had the shingle previously in the same location.
Morning after receiving immunizations he had onset of swelling, redness, itchiness at the injection sites on both arms. He received immunizations on the 8/6, and after was on the right and HPV and Tdap on the left. Worsened yesterday, looked very red and swollen. Mom was using ice packs, giving benadryl. Not seeming to help. Today finally starting to go down, not as red. No more itching. There was no systemic symptoms at any time. Physical Exam:  Skin:  Left lateral upper arm with 11.5 x 9.5 cm area of blanching erythema that is Non-Tender, mildly edematous. There is small 2-3 cm area of induration right at vaccine site. Right lateral arm has 9.5 by 8 cm area if lighter Non-Tender blanching pinkness that is mildly edematous. No induration. NO hives, no rash anywhere else.
Shortness of breath, feelings of breathlessness (2 days, starting on 10/14/2021)    Additionally, tiredness, malaise, aching in joints, soreness at injection site
By 7pm after I received the vaccine I was hurting in every joint of my body. I also developed a ringing in my ears the has turned into tinnitus. I did force myself to go into work the next day. I was sent home early I could not rest as the pain was so bad that i felt like I had been beat. My doctor did say the tinnitus that I developed may not ever go away. Some days are worse. The joint and body ache have gone away but the shortness of breath is still here.
I started spotting on 10/2/2021. I had some bleeding but not a lot. I have never had this issue before. It happened 3 weeks before I got my period. When I did get my period, it lasted 7 days instead of the usual 4 for me. The spotting stopped and then started up again on 10/31/2021. After the second dose, the spotting seemed to get heavier. It is like I am on my period but I am not. I am scheduled to see a OB/GYN to do an ultrasound and some blood work on 11/9/2021.
Acute upper blood loss anemia, s/p repeated transfusions, recurrent issue.  Portal HTN , with acute Upper GI bleeding, improved post TIPS procedure, improved and discharged home. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
tender at injection site, fatigue, headache, rash neck area chest area and both arms .  does not itch or burn
Vasovagal episode Records recieved 05/06/09 for DOS 04/10/09.  Office visit. Post anthrax vaccine c/o weakness, pale, slow to respond to verbal command. PE normal. Smallpox vaccine administered w/o incident.  Return to duty. Assessment: Vasovagal Syncope.
Patient fully vaccinated with Moderna 3/16/21 and 4/13/21. Patient had syncope/unresponsiveness for ~20 minutes. He did test positive for COVID-19 and is currently admitted. No other symptoms, may be incidental finding.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates approximately in 2015 (reported as "on unspecified dates since 18-NOV-2015") the patients were vaccinated with a doses of ROTATEQ lot # L00054 expiration date 30-NOV-2016, lot # L008057 expiration date 01-DEC-2016, lot # L009119 expiration 17-DEC-2016, orally which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. Additional information has been requested.
I could not even lift my arm starting about 4 days after injection and continuing for 3-4 days.
Patient developed temperature 99-100-102, nasal congestion, cough and severe headache 24 hours after receiving vaccine. Patient was referred to ER.
tested positive for COVID-19; experiencing mild cold symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Feb2021, the patient experienced tested positive for COVID-19 and mild cold symptoms. The patient is asking how he can proceed with the second dose of the vaccine. The outcome of the events was unknown.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Vials of Pfizer COVID vaccine were stored in the refrigerator with a use-date expiration on 10/19 at 1:30pm. On 10/19, approximately 2 hours after this, the patient was given their first dose of COVID vaccine with this vial. No harm detected.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 09-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
This medically confirmed spontaneous report (initial receipt: 19-Jul-2012) concerns a 33-year-old female patient, who had allergies to codeine, penicillin, promethazine and sulfa. On an unknown date the patient received flu vaccine (brand, manufacturer and batch number were not provided). The patient experienced swollen lymph nodes and throat after receiving the flu vaccine. No lab diagnostic studies was performed. No treatment was given for the event. The event outcome was recovered.
Pt reports stiff neck after flu shot 9/18. Went to PCP 9/20 and given Ibuprofen. 9/21 experienced (R) arm weakness above elbow. Went to ED 9/22 and diagnosed w/ inflamed nerve from flu shot. F/U'd w/ PCP and given referral to neurologist. Also started physical therapy on 10/21. No previous rxn to flu shot.
The pt developed fever, sore area on left arm and cranky and clingy for about 24 hrs post-vaccination.
The patient began feeling short of breath, stating that her ears were popping, and she was noticeably beginning to swell shortly after the vaccination was administered at 5:20 pm in her right arm.  Her blood pressure was 155/83 @ 5:28 pm and we administered 100mg of diphenhydramine tablets.  After 5 minutes of waiting the patient stated that she was still short of breath and we administered one dose of epinephrine 0.3mg (epi-pen auto injector) at 5:35 pm.  EMS was called and she was subsequently brought to her local hospital for tests.
3 year old female patient received a dose of Flublok, no AE; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 year old female patient who received FLUBLOK QIV (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 18-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2029 and expiry date: not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No additional adverse effects were reported.; two patients received improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 28-FEB-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022109 with expiration date of 12-JAN-2021, for prophylaxis (route of administration and frequency were not reported). The sterile diluent (STERILE DILUENT MRK) used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.    No adverse effects were reported.    It was stated that the vaccines underwent a temperature excursion of 47°C (degrees Celsius) to 8°C (-7C) for 41 minutes on 20-DEC-2019. Previous temperature excursion was done. The call was because of a "data logger".  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2004USA000404: US-009507513-2004USA000405:
Started with falling for no reason. Diagnosed as dysautonomia with orthostatic hypotension.
This spontaneous report was received from a registered nurse refers to a four unspecified patients of unknown age who on an unspecified dates, in August 2012, were vaccinated with a doses of GARDASIL (lot number 660393/0067X) (doses and routes not reported) that were expired. The vaccines expired on 20-OCT-2010. No adverse effects had been observed or reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Mother and patient came by office to show his left deltoid that had a redness and swelling.
Passed blood in urine/on two occasion he passed blood in urine; This is a spontaneous report from a contactable consumer (caregiver/patient's parent) via h. An 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, NDC number, UPC number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter called on behalf of son, aged 18 and reported he received first dose of Pfizer Covid 19 vaccine last Friday and then experienced blood in his urine the next day. Then today (unspecified date) he had blood in his urine again. It has happened twice, and the reporter asked was there any information on this. Father declined transfer to drug safety, has no insurance, son has no PCP Response and after searching  and spoke as per No Information and was referred back to HCP. Reporter questioned was that common for the vaccine, he has been transferred three times. Reporter was informed about health authority and was provided with the number. Reporter stated could they transfer or not; Please transfer me. Call could not be transferred to Pfizer Medical information department as the lines were busy. Product details (LOT, Expiration Date, NDC and UPC) and Pharmacy details could not be probed as the reporter hung up the call abruptly. Limited information was available over the call. After listening to a recording of the call, I can confirm the caller/reporter spelled his last name. He did give his first name, and it did sound, but he said it so fast it was not clear, and the Med Info agent did not have him confirmed the spelling of his first and last name and the caller did not spell his first name. It was stated that Could they help to confirm if reporter provided first name of reporter self since agency report provided first name and last name, they identified that the reporter of agency and this report was the same person since phone number was the same and event was similar. It was said that caller provided the name as however it was not spelled on call so was erroneously captured. help to confirm on the name of reporter was seeker since previous report was provided reporter first name and last name was unknown and it was identified that reporter of previous report and this report was the same person since phone number was the same and event was similar. The patient underwent lab tests and procedures which included passed blood in urine/on two occasion he passed blood in urine. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
As reported by patient on 2/6/21:  Within 10 minutes of receiving vaccine patient developed pruritis, urticaria on chest, tongue tingling and thickness in throat. P118 BP 180/100 Treated with diphenhydramine 50mg PO, observed for 40 min, discharged home, told not to get a second COVID vaccine and with the instruction to go to ER if anything else developed.  Subsequently she was told by an allergist she could not get a second dose unless there are specialized facilities.  She did NOT recieve a second dose.   FYI - under our protocol she should have recieved epinephrine
THIRTY MIN ONSET OF DIZZINESS, PALENESS AND TINGLY NUMBNESS IN FACE AND ARMS(LASTED TEN MIN.) RESTED. DOING FINE.
on 1/8/2020 a dose of improperly stored PROQUAD (Lot S013712 Exp 11/1/2020) was administered o a patient; This spontaneous report was received from nurse regarding a patient of unknown age and gender. The patient's medical history was not reported. The patient's concomitant therapies included sterile diluent (DILUENT MERCK).  On 08-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA))(PROQUAD) , at a dose of 0.5 milliliters (lot # S013712, has been determined to be valid, expiration date was reported as 01-NOV-2020) (strength, dose number, frequency, and anatomical site of vaccination were not reported) for prophylaxis.  The temperature was of -12.2 degrees Celsius, for a time frame of 25 minutes, without a previous temperature excursion. A digital data logger was used. The sterile diluent (DILUENT MERCK) that was used for reconstitution of varicella virus vaccine live (Oka/Merck) (VARIVAX)a was properly stored.
Major joint pain and inflammation in knees and ankles Major tiredness.  Did not wake up on May 7.  My husband had to call 911 as my Blood sugar dropped to  a low of 17  I almost died
Pt developed a rash on thigh, neck, chest and arms. A few with crusted centers.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to five female patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 02-OCT-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004980, 1805USA004981, 1805USA004982).
5/23 64y.o. male with history of DM, HTN, GERD, A fib (normally on coumadin) and supermorbid obesity and VHR s/p IPOM patch repair in 2013 at hospital complicated by hernia recurrence who presented to hospital 5/5/22 for open ventral hernia repair and panniculectomy 5/5 discharged 5/16 now presenting with SOB and increased drain output.