chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The recent follow-up received on 08-JUN-2022 contains non significant information.
expired dose of Tenivac was administered with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 80 years old female patient who was administered with expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jan-2023, the patient received 0.5 ml total dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (Strength: Standard; lot number: U6922AA, expiry date: 22-Jan-2023, frequency: once) via intramuscular route in the right deltoid for immunization.  On 26-Jan-2023, the patient was administered with expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  It was reported Caller reported an expired dose of TENIVAC was administered and is requesting validity and safety information.  At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered with no reported adverse event.  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 the guidelines. 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.
On 3/9/01, had low-grade fever and flushed cheeks. On 3/11/01, developed a fever of 102.4F. On 3/12/01, had PMD appt. and received RX for antibiotic; Zithromax. On 3/13/01, had not started RX yet. A rash developed all over child's body that burned and then itched. Took Benadryl. On 3/14/01, rash gone on antibiotic. On 3/15/01, child was tired and had a headache. On 3/16/01, returned to school. PMD dx'd it as a virus. Other children she was in contact with in the Synagogue were also sick with burning hands and feet, upper respiratory infections and headaches. After medical clearance, the 2nd dose of Hep-B was given on April 5, 2001 without any reaction.
shingles; Information was received from a lawyer regarding a case in litigation referring to a 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016 (also reported as when the patient was 63 year old (conflicting information)), the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), in April 2017, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
COVID 19 Treatment; COVID 19 Treatment; Adverse event: Rebound; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have any known allergies. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "Adverse event: Rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Aug2022 to 22Aug2022. Therapeutic measures were not taken as a result of disease recurrence. The device date was reported as 01Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Within 5 minutes  patient felt like she was having a panic attack, quick breathing , started to feel hot at the injection site and neck and chest turned red.  Had pt ice injection site for 15 minutes.  She refused to have her blood pressure taken.  Stayed in the store for 30 more minutes until redness resolved and pt said she felt better.
Hives in random parts of the body, swollen eyes- left eye more swollen than right eye, and over all itchiness. First day woke up with a few hives on neck and shoulders and took some allergy medicine; symptoms went away. Next morning woke up with swollen eyes and hives more wide spread and in new areas of the body.
Bruised, red, lump, warm to touch, sore/achy arm, neck hurts
Tingling in left arm. Flu Vaccine administered in Left deltoid. No treatment provided at time of report of symptoms. Instructed patient to seek medical attention if symptoms do not go away within 24 hours or get worse. Patient's provider aware as well. Patient reports symptoms resolving at 9:00 PM that same day.
Information has been received from a registered nurse concerning a 20 week old female patient who on an unspecified date was vaccinated per oral with the second 2 mL dose of ROTATEQ. About 2 weeks after receiving her second dose of ROTATEQ, the patient developed blood in her stool. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome is unknown. Upon internal review, patient developed blood in her stool was determined to be an other important medical event. Additional information has been requested.
PHARMACY LEFT PFIZER VACCINE VIALS IN THE FREEZER FOR LONGER THAN 2 WEEKS AT TEMPERATURE (-25 AND -15 DEGREES C). WE GAVE DOSES OUT OF THESE VIALS, RENDERING THEM POSSIBLY LESS EFFECTIVE
Information has been received from a registered nurse concerning a registered nurse concerning a female "65 years or older", who in October 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23. Subsequently, the patient developed swelling that encompassed most of the upper outer arm. The area was red and very painful. The patient had a low grade fever. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
On 4/17/2021, the day after getting a Covid-19 vax,  I had a sudden tightness in the back right side of my neck. Within a few minutes my entire right side, except my face started to go numb. I had pins and needle feelings in most of my right side also. I believed I had somehow pinched a nerve and thought that it would right itself. My right arm was uncontrollable if I tried to lift it. It would swing wildly up/down and sideways. I was unable to grasp or hold anything. No changes for better or worse on 4/19/2021 so I went to the ER. I had two CT scan, one with and one without contrast. They said they suspected a stroke. I still thought it was probably a pinched nerve, seeing as my face and speech weren't affected. After leaving the ER, my pcp had me get an MRI and the results came back as a stroke. I've also had a heart and carotid sono.  I had no previous health issues and was taking no medications. The stroke didn't prevent me from walking but the pins and needle feeling makes it painful. My entire right side is sill numb with pins and needle feeling in my hand and foot. I'm still unable to use my hand because I can't grasp or hold anything. I am going to occupational therapy for my hand. My doctor has me taking an aspirin once daily. I have had very little change since the onset. I was a young and healthy 58 yr old female with no medical issues.
3/09/21 - Took 2 regular strength Ibuprofen at 4:00 PM, as a precaution of swelling/inflammation or other adverse effects.  At approximately 11:00 PM, severe chills set in.  No fever at that time.  Took 2 regular strength Tylenol.  Started running fever at approximately midnight (approximately 100 F).    3/10/21 - By 1:00 AM, fever had spiked to 101.7F.  Chills still ongoing.  Headache and joint aches/pains as well.  Fever reduced to around 100F by approximately 2:00 AM.  Fever completed subsided by 4:00 AM.  Took  2 regular strength Ibuprofen around 3:00 AM.   Aches /soreness/pain lasted until around noon on 3/10/21.  Continued  alternating Ibuprofen and Tylenol throughout 3/10/21, stopped at approximately 10:00 PM.   Extreme fatigue  persisted  all day on 3/10/21.    3/11/21 - Upon waking, all adverse effects subsided.  Energy levels normal.
Received on 5/17, developed rash on left arm and hand, then rash on left chest and to right arm and hand. Rash moved to upper legs. Left ear rash started late 5/18, then developed right ear rash 5/18-5/19
Syncope, vomiting, grey skin tone. Syncope lasted ~20 sec, patient came to and combative, then began vomiting intermittently and skin tone grey X 30min. VSS called squad and transported to Hospital. Patient continued to throw up in ambulance. Observed in ER. Specific testing not done due to patient's strong history of syncope. In the past patient had tilt table test for diagnosis of vasodepressor syncope. Recently (2/09) pt had EKG and Echo for innocent murmur before nasal surgery. Patient passed out every time in ENT's office when painful stimulus per mom.
Ringing in both ears, high pitched that has not gone away.  Some intermittent dizziness and very mild nausea that is intermittent.
Vaccine was administered 9/29/2010, 09/30/10 there was redness, swelling, and fever to sight. 10/1/10 the swelling and redness has moved down the arm.
Extreme fatigue; intermittent dizziness and feeling of imminent loss of consciousness; popping in ears as if from sudden change in air pressure; need for inordinate amount of sleep.
Two days after vaccination there was slight swelling of my upper lip when I woke up.  It gradually subsided throughout the day.  I also noticed a quarter size red, warm, tender spot at injection site of my left arm on  the 9th day after receiving the vaccine.  12 hours later it had spread to be about 3 inches in diameter. Still warm and tender to the touch.  No improvement today (day 10).
low grade fever; body ache; chills; sweating; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), MYALGIA (body ache), CHILLS (chills), HYPERHIDROSIS (sweating) and RASH (rash all over body) in a 57-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever), MYALGIA (body ache), CHILLS (chills), HYPERHIDROSIS (sweating) and RASH (rash all over body). At the time of the report, PYREXIA (low grade fever), MYALGIA (body ache), CHILLS (chills), HYPERHIDROSIS (sweating) and RASH (rash all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.
swollen lymph nodes on left side arm pit and neck; soreness in her left neck; soreness in her left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 (Lot number: EW0185) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "carpal tunnel" (ongoing), notes: Approximately 10 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1, Administration date: 23Apr2021, Lot number: EW0170, Anatomical site: Left arm, ), administration date: 23Apr2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "sore arm", "she had a sore arm after the first vaccine, described as being a little heavy at injection site", "she had a sore arm after the first vaccine, described as being a little heavy at injection site". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15May2021, outcome "not recovered", described as "swollen lymph nodes on left side arm pit and neck"; NECK PAIN (non-serious) with onset 15May2021, outcome "not recovered", described as "soreness in her left neck"; PAIN IN EXTREMITY (non-serious) with onset 15May2021, outcome "not recovered", described as "soreness in her left arm". Therapeutic measures were taken as a result of lymphadenopathy, neck pain, pain in extremity.  Additional information: The caller was reporting, that she had a reaction, swollen lymph nodes on left side arm pit and neck, and soreness. It was clarified that she was calling about the Pfizer BioNTech Covid vaccine. She called her primary care physician because the Tylenol was not helping for the soreness. The caller clarifies that the soreness in her neck and not swelling of the lymph nodes and located on the left side. During the call, as the caller was typing, she expresses that she has trouble typing because of the soreness in her left arm. Treatment: Tylenol Extra strength, lot AAA052, expiration 20Oct2024. UPC unknown. The caller informs that the Tylenol did not work. Later in the call the caller explains that she also used hot and warm compresses beginning on Saturday 15May2021. She is still using the compresses. The caller remarks that she had a sore arm after the first vaccine, described as being a little heavy at injection site and it lasted about a day or two. She went with her husband and son to get the first vaccine and she felt nothing when she got the shot and even asked the pharmacist if she got the shot. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): first dose 23Apr2021; Expiration and NDC unknown. Lot EW0170 left upper arm, by injection. Relevant tests were none.  Follow-up attempts completed. No further information expected.
Patient began vomiting 3 minutes after injection.  BP 110/72, HR 82, O2 98%.
The vaccine had been sitting for over an hour in the refrigerator as it had not been used when first drawn up the morning of 3/28/22. This vaccine was used at 420 pm instead of being disposed of.
2-3 hrs p/vax pt began to cry described by mom as being hysterical & non-stop for 1 hr-then fell asleep; no fever, no redness or swelling @ inject site;
Patient came to our clinic for vaccine. Foster parent did not have vaccine records. Vaccine where given at that time. A a later time the report of the vaccines came in. Agency call to ask why a second dose of HAV was given. We explained  that we did not have record on hand and when we updated the SYSTEM it showed that HAV was need to be given. MA spoke with Agency regarding  incident. They did not report any adverse reaction at  that time.
Child had Rec'd vaccines in AM and was fine all day.  She went to a martial arts class in the pm and after class became faint and had seizure.  She was seen at a hospital ER-checked over and released.
Initial report received from a patient on 15 November 2006.  A 25 year old, female patient developed a sore throat, runny nose, cough and malaise for 5 days, approximately 24 hours after she received Fluzone (lot number unknown and route of administration not reported) in the left deltoid on 07 November 2006.  She also received a tetanus booster (Tradename, manufacturer, lot number and route of administration not reported) at the right deltoid.  She also complained of soreness at the sites of both injections.  It was reported that the adverse events had resolved.  Follow-up information received on 18 December 2006.  The patient received Fluzone, lot number U2285AA, intramuscularly and Td toxoids, manufacturer Massachusetts Public Health Biologic Laboratories, lot number Td-165, intramuscularly.  The patient previously received Fluzone on 16 September 2004 and no symptoms were observed.  Her medical history was hay fever, hernia, hemorrhoids. The patient did not report any treatment or therapy for the symptoms.
Severe tendinitis, ongoing shoulder pain and limited range of motion.  Problems ongoing and severe.
2/27/21 developed a headache similar to a tension headache.   3/6/21 my injection site was red and swollen.
4 yr old imm. adm. - KINRIX/MMR/Varicella. Within 5 min. pt. noted to have difficulty breathing. Face swelling. O2 sat 93%. Breathing Tx with O2 given. EPI given x2. Transported to emergency room.
Patient received the Janssen vaccine (rx number: 1473565) on 3/7/2021. On her immunization card, it is reported that she received dose #1 of the Pfizer vaccine that day. Per her immunization card, patient was given another Pfizer shot on 3/29/2021 2:00 PM to complete the series. Later that day around 5:00PM, it came to realization that our records show she received Janssen, which would not have required her to get Pfizer. Patient was contacted and claims she wanted the Janssen shot on 3/7/2021 but actually received Pfizer. The possibility may be that the wrong vaccination was entered in the system on 3/7/2021. Nonetheless, patient claims no harm occurred from both vaccinations.
Pt received Covid vaccine BUD. Vaccine expired on 7/7/22 and was given to patient on 7/19/22
This spontaneous report as received from a registered nurse, refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the nurse reported that the vaccines of MMR II (Lot # and expiry date were not provided); vaccines of "Tetanus" (therapy unspecified) and "Diphtheria", were exposed to temperature excursion and were administered to unknown number of patients. The vaccines were exposed to 50F for 1 hour and 5 minutes, and were administered to unspecified number of patients since the temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 12JUL95 & 24SEP97 pt exp a vesicular rash all over the body, was febrile & was seen by MD who dx chickenpox;pt recovered;
Initial report was received from a consumer, who was also the patient's parent, on 22 October 2012. A female patient (age and date of birth not reported) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced significant swelling to her upper arm and a hot, red indurated area which was itchy and painful. Treatment included a 7 days course of Cefadroxil 500 mg twice daily (BID) and BENADRYL as needed. No additional information was available. The patient's outcome was not reported. Documents held by sender: None.
Mild Headache; Low grade Fever of 100-101ºC; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild Headache) and PYREXIA (Low grade Fever of 100-101ºC) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (Mild Headache) and PYREXIA (Low grade Fever of 100-101ºC). At the time of the report, HEADACHE (Mild Headache) and PYREXIA (Low grade Fever of 100-101ºC) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.