chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 19-SEP-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection, intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. On 01-NOV-2018, the patient was vaccinated with the second dose of PNEUMOVAX 23 intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. No known adverse effect was reported.
I noticed that I had some heart palpitations, and they are intermittent. Nothing really brings them on. I get them at rest and at times of stress at work. I saw provider on Friday. They ordered EKG. They are ordering further tests. I received a flu vaccine a week before this dose 3 of the vaccine, I think it was the week before, it was within the month before, but I don't know the date.
Patient has severe dizziness and cold sweat after receiving his Shingrix vaccination. Patient was able to relax and recover from it with ice pack and grape juice.
Patient developed L sided numbness, bells palsy on 8/1 - current. no other sx
Patient developed itching about 15 minutes post vaccination.  She then developed chills after drinking water.
This spontaneous report as received from a registered nurse refers to a 76 year old male patient. The patient's medical history and current conditions are not reported. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX23  of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. Additional information has been requested.
covered in red spots;started @ head & arms & extended arm entire body;was not seen by MD;mom called MD office;MD encouraged mom to bring pt in if seem to feel ill;
Covid Arm Redness,  swelling and pain at site,  headache, chills, fatigue, nausea  Symptoms lasted for 72 hours
have had shortness of breath, cough, tight chest.  was treated for asthma with inhaler and steroids - did not fix problem, have not returned to doctor -scared
Pain, redness, hives, fever. Right deltoid, antibiotics administreed for possible cellulitis. Ceftriaxone and Doxycycline.
Headache, Nausea, and Vomiting x3, and warm the following day.
Case numbers PHEH2011US008723 is a combined initial and follow up spontaneous reports received from a consumer and a physician on 03 Nov 2011 and 07 Nov 2011 respectively. This case refers to an adult female patient. She was vaccinated with flu shot (batch number: unknown) and 2009 H1N1 shot (batch number: unknown) provided by Novartis in the fall of 2009. She received both these vaccines intramuscularly. It was also reported that she received both flu shot and H1N1 shot at the Novartis Headquarters. In Jan 2010 she was diagnosed with Narcolepsy. The outcome of the event was not reported. Upon follow up, the treating physician confirmed that, the patient did not receive flu shot in his office, hence no more information was available.
-patient experienced pain immediately after shot.  -The pain became worst - over time approx. 1 week after shot area became itchy. Pain and itchiness radiating to left breast and shoulder blade.  -patient is still experiencing slight pain and itching.
Shoulder was very sore to the touch & had very limited movement during the 1st 24 hrs. I could not sleep the 1st night. The effected area grew to include entire upper arm, upper back on left side, & the shoulder. Discomfort lasted almost an entire week. Arm & back were hot. This was only the left arm, where the PNEUMOVAX 23 was given.
I got my vaccine at noon on saturday Feb. 6th. Within about 12 hours of my second covid vaccine, I started to become fatigued and had soreness in my arm. When I woke up the next morning (approx 20 hours post injection) I was drenched in sweat, fatigued, had a headache, body aches (back and neck), and a temperature of 100.9 (taken orally). The rest of the day I had hot/cold flashes. I would go from sweating to shivering every 10-20  minutes. I had a consistent fever of 100.3-100.7 until about 8pm when it read 96.5. I took Tylenol at 7am that day and ibuprofen at about 7pm. Hot/cold flashes continued through the night last night. I am still having cold/hot flashes (drenched in sweat then full body chills, but not shivering). I've taken my temp multiple times today and it has consistently read at about 97.1 without fever reducing drugs. My body temp typically runs normal (98.6). I currently still feel fatigued, have a slight headache and some aching in my neck and back.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    This case contains information for the 24 out of 77 adult patients described by the reporter. No concomitant information was reported. It was reported that, Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received co-administration of Menveo and Flulaval vaccines. After standing up and walking, patient fainted. Immediately after fainting, patient was responsive, although patient stated she was light-headed and dizzy. Patient caregiver requested calling EMS even though patient was responsive. EMS arrived and assessed patient. Patient was not transported and left the pharmacy of their own accord.
Patient had sore arm the first day, the second day patient had slurred speech, couldn?t remember or say words, went to the hospital, CT scan and it showed a stroke, AFib came back that had been resolved, he had to be bagged for 2 minutes because he stopped breathing, MD told him the covid shot may have reacted negatively with his previous heart surgery
pt recvd 1st dose of Hep B vax on 6FEB92 & On 20FEB92 pt exp achiness around shoulders; pt's nurse noted that pt exp achiness @ other times even a/receiving vax; pt devel fever & body aches; presented to MD & throat cult was pos for strep ;
My uncle had a heart attack following receiving his 2nd vaccine with Pfizer; This is a spontaneous report from a contactable consumer (patients relative).  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included Heath problems, he had underlined health problems. The patients concomitant medications were not reported. On an unspecified date, the patient experienced a heart attack. patients relative reported that uncle had heart attack following receiving his 2nd vaccine with Pfizer. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
coughing; chills; fever; fatigue; headache; arm sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced COUGH (coughing), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE PAIN (arm sore to touch). On 06-Feb-2021, CHILLS (chills) had resolved. On 08-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, COUGH (coughing), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE PAIN (arm sore to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The follow-up received on 5th May 2021: Patient contact details was updated.
Injection site was Itchy after 1st dose; Injection site was red after 1st dose; Injection site was painful after 1st dose; Arm was swollen at injection site after 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose). At the time of the report, VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.   This case was linked to MOD-2021-262880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Form attached included no new information.
Patient reports feeling itchy throat, metallic taste, chest pain, burning, and shortness of breath. Doctor is consulted and authorized administration of Dexamethasone r. 1ml= 4mg wait for 10 min for reaction. we consult with Doctor again and recommends 10 more minutes in observation and also therapy when she gets home.
Fever started 9/13 around 6pm, temp 100, sweats, my uniform was soaked in sweat from 7pm to the time I arrived home at 8:30pm, chills, body ache, had to bundle up to be able to sleep, temp went up to 102.2 on 9/14 around 10:30 am, fever broke  by 4pm completely.  Only took tylenol as advised by nurse administering vaccine, sore throat. 9/15 I woke up with hives on both my legs, body ache, chills and sore throat.
expired MENACTRA was given yesterday with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Global Medical Information (GMI) (Reference number- 00707969) and transmitted to Sanofi on 03-Aug-2021.  This case involves a 12-year-old female patient who was given expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] yesterday (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 02-Aug-2021, the patient received 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot: U6641AB and expiry date: 31-Jul-2021) (Frequency = once) (Strength = standard) via unknown route in the right deltoid for prophylactic vaccination (expired product administered)  This was an actual medication error case due to expired vaccine used (latency same day)  At the time of reporting, no 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 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.
Woke up 11-5-11 with fever 101. That night had "amnesia" episode/disoriented. Complain of room going "in & out". 11-7-11 doing fine.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-10 and patient does not plan on getting revaccinated.
46yo male experienced minor allergic reaction following dose #2 of COVID-19 vaccine (Pfizer). Tolerated dose #1; hx of COVID-19 in January 2021. About 90 minutes after vaccine, pt became lightheaded with blurred vision while in physical therapy gym (inpatient rehab due to spinal injuries). RN noted rash on both arms and welts to L arm and L trunk. No SOB or CP. Patient treated with diphenhydramine 50 mg with apparent resolution of sx.
Severe headache, vomiting, pain so severe in arms that they could not be raised above waist level.  Lower back pain.  Feeling of body being on fire.  Did not affect legs at all.  Day 2 took Aleve and headache began to subside.  Used ice packs on head and Right arm.  Day 3 and the right arm is still very sore.
Suspect breakthrough case  Aspirin, tylenol,  Remdesivir  Inpatient
On and off fever since 3/10/16 - 101F/rectal for 5 days circular blanching rashes on trunk since 3/10/16 (intermittent macular).
starting approx 8PM 3AUG95-began to feel very shaky legs were aching & felt dizzy; could feel temp inc; was sick through the noc; temp got up to 103 oral; had 1 2hr block of time when felt very shaky & had chilling & nausea; took APAP;
Shoulder soreness; Body aches; Fatigue; Muscle aches; Itching; This is a spontaneous case initially received from other non-health professional via Company on 05-Dec-2019 with additional document received on the same day (being process together), concerning a 65-year-old female patient.   The patient's historical vaccine included Flucelvax (QIV) which she was administered last year. It was reported that the patient had no side effects at all. The patient's concomitant medications were not provided.   On 02-Dec-2019, the patient was administered Flucelvax (QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: right deltoid, route of administration: intramuscular (IM), batch number and expiration date: not reported] for influenza prophylaxis.   On the same day, one hour after vaccination, the patient experienced shoulder soreness, mild itching, fatigue and muscle aches. The patient also experienced body aches. The patient did not receive any treatment.  On 04-Dec-2019, the outcome of the events shoulder soreness, mild itching, fatigue, body and muscle aches was resolved.   The case was assessed as non-serious per patient. The reporter did not provide causality assessment to Fluclevax (QIV).  Company Comment: The patient experienced musculoskeletal pain, pain, fatigue, myalgia and pruritus after vaccination with the suspect product, Flucelvax (QIV). Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced musculoskeletal pain, pain, fatigue, myalgia and pruritus after vaccination with the suspect product, Flucelvax (QIV). Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Complaing of pain in right shoulder.  No redness, knot, streaking or drainage noted at injection site or right arm.
Vasovagal syncope post injection approximately 10 secs. Vital signs taken, patient observed 20 mins.
A report has been received from a Physician concerning, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 27-Jan-2014. The patient experienced expired FLUMIST QUADRIVALENT administered which started on 27-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
GIVEN FIRST DOSE AT AGE 17 YEARS AND 8 MONTHS.  MODERNA  APPROVED FOR 18 AND OLDER.  IDENTIFIED WHEN RETURNED FOR SECOND DOSE.
pt recvd vax; 31jul95 devel 2 or 3 small blisters around inject site;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Felt very lightheaded/chills for about 30 minutes. Patient walked out along with her fiancee. she felt back to normal upon getting into they're car.-Mild
Patient developed shortness of breath and wheezing within 12 hours of receiving dose #2 Pfizer. These side effects were not noted with her initial vaccine. She required ER visit for this. Received Benadryl, Ibuprofen, Duoneb, CXR, EKG. She required continued albuterol over the next few days. She also required outpatient MD visit on 6/23/2021 and was placed on Flovent as well.
Shot bled at time of injection (10:30am)  Bruise appeared almost immediately.  Shot was given high on the arm. Arm became stiff and pain developed early evening (6pm).  Pain radiated across back of neck and down arm causing inability to use arm or sleep that night and the following day.  Tylenol helped by the end of the second day pain subsided.  Bruise is still very apparent today, day 7.
Sickest I've ever been 104 temp; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 19-Oct-2020.  This case is linked to case 2020SA295897 (Cluster).  This case involves a male patient of unknown age who reported that he was sickest ever been 104 temp (illness), while he received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported to be sickest he had ever been 104 temp (illness).   It was not reported if the patient received a corrective treatment.  Outcome of both the events were unknown, at the time of reporting.  Information on the batch number was requested.      The reporter assessed the causal relationship with suspect vaccine as related.
Patient states that she had ear, cheek bone, some teeth and chin numbness. It started on the car ride home after the 15 minute period of sitting by pharmacy for evaluation. Pt said it was about 25 minutes after vaccine. The numbness was only on the left side of her face. The vaccine was also in the left arm. She said her symptoms had completely resolved after 24 hours.
High fever, chills and shaking, body aches, nausea, pain in all joints and extremities.  This lasted for approximately 5 hours.
Information has been received from a pharmacist and a registered nurse concerning a 23 year old female with sickle cell anaemia who was vaccinated with Pneumovax 23 (Lot # 654982/0675F). Subsequently the patient experienced excessive swelling in the mid upper arm injection site, that was all the way down to the elbow, that was 1 and 1/2 times the size of the normal circumference of the arm. The arm was warm to the touch, tender and there was pain with the swelling. The patient was examined in the emergency room (ER) and released. The patient was instructed to put a hot pack on the affected area and take basic analgesic or nonsteroidal anti-inflammatory drug (unspecified) NSAID. There was no fever and no induration at the site of injection. The patient was instructed to take acetaminophen or NSAIDS to manage the discomfort. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
72 hours after these vaccines, my son became very lethargic, starting vomiting & had a heart rate of 300
Vertigo, headaches, fatigue, malaise, muscle weakness.  The symptoms come and go randomly and have continued up to this day.  I have taken Tylenol and ibuprofen with minimal relief.
Roughly 4-5 days after each dose of my COVID-19 vaccine, I began to feel pelvic cramps and burning, as though I had a UTI. It stopped after my first dose, but returned more strongly after my second dose. It has been more than two weeks since the second occurrence, and the pain has now spread to my upper abdomen and back, with the pelvic pain and burning continuing.
Itchy tongue tip, slight dizziness, nausea. BP 143/72 (pulse 76), O2 sat 98%. BP 143/76 (pulse 77), O2 sat 99%.