chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via out of hour services and described the occurrence of nausea in a 77-year-old male patient who received SHINGRIX (batch number 5ny3B, expiry date 13th July 2020) for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, pain in arm, chills and nerve pain. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the nausea, vomiting, pain in arm, chills and nerve pain were recovered/resolved. The reporter considered the nausea, vomiting, pain in arm and chills to be related to SHINGRIX. It was unknown if the reporter considered the nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The reporter declined to provide routine concomitant medications, but said there had been no changes to his routine concomitant medications or additions of any new concomitant medications when symptoms started. No other vaccinations besides SHINGRIX were administered or within four weeks prior. At 2:45 pm, the patient was administered SHINGRIX vaccine. On 30th May 2018, the symptoms of nausea, vomiting, and chills without fever started within 2 hours of receiving the vaccination. On the same day, the nerve pain started around the same time as the other symptoms and was tolerable, but the patient went to the emergency room the next day because of the other symptoms. The patient had nerve pain on the same arm as the vaccination. The pain radiating to the wrist area had a pain level of 3 to 2.5. As of 20th June 2018,  about 99 percent of the pain was gone. On 31st May 2018, the next day the patient went to the emergency room. The reporter described the other symptoms as disabling because those symptoms had required an emergency room visit.  The patient was jeopardized only because the patient had to go to the Emergency room for the symptoms. The patient was not admitted overnight to the hospital and was given Intravenous Zofran at the emergency room which relieved his symptoms of vomiting and nausea. All symptoms were resolved at the time of reporting, on 22nd June 2018 and the patient was no longer complaining of any pain. The emergency room performed a full laboratory work-up and all of his labs were normally described by the patient to the pharmacist as having checked out. The reporter granted permission to be contacted with any further related questions.
Sure if injection was sore right away even to slight touch. Red rash similar to a bug bite appeared on around say 3. Raised, red, warm to touch, and very itchy rash appeared by injection spot. Still there 10 days later.
Vagal response- turned very red, hand tremor, nausea, dizziness, clammy/sweating and started to fade out of consciousness. I had pt lie down and elevated her feet.  She started to feel better and eventually sat up.  She was given water and observed until she said that she felt fine.  Total event was about 30 minutes
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 08/13/2021 and 09/03/2021. They teste positive for COVID-19 twice on 01/21/2022. They died on 02/03/2022. I have no evidence of hospitalization for this person.
pt recvd vax;3 mo later exp progressive leg weakness,adm to hosp;exp hypertension & acute congestive heart failure;dx tests showed that condition consistent w/ GBS;recovered,w/ only bit of unsteadiness in gait;
April 24, 2022 Booster Vaccine and three days later symptoms began to emerge. Blowing sensation and sound that was in perfect step with my pulse.  I was diagnosed with Pulsatile tinnitus in my  left ear, the same side of my shot. I had to see PCP and have been set up with an MRI and MRA for further investigation. Bloodwork was done as well as EKG that showed completely normal levels and ranges.  My previous doses that were moderna, no reactions prior. Symptoms are still continuing have not improved.
This case was reported by a healthcare professional (nurse) and described the occurrence of extensive swelling of vaccinated limb in a 18-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 19 November 2012 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 19 November 2012, immediately after vaccination with PEDIARIX, the subject experienced extensive swelling of vaccinated limb ("left swollen leg 3 to 4 inches"), redness of leg at injection site, warmness to touch at injection site and fluid collection at injection site ("looks like fluid inside"). The nurse stated that "the parents complained of a left swollen leg (3-4 inches), it was warm to the touch and looked like fluid inside." At the time of reporting the outcome of the events were unspecified. The nurse stated that there was no additional information known at the time of reporting. The nurse reported two subjects with adverse events. See case A1004599A for details on the other case. Follow up received from healthcare professional on 2 January 2013. The healthcare professional clarified the onset of the adverse events. On 20 November 2012, one day after vaccination with PEDIARIX, the subject experienced extensive swelling of vaccinated limb, redness of leg at injection site, warmness to touch at injection site and fluid collection at injection site. The adverse events resolved on the same date of 20 November 2012. The healthcare professional documented that she did not consider this event to be serious. There was no biopsy performed. At the time of reporting, the subject has not received additional doses of PEDIARIX since the adverse event. The reporter documented that the subject had received PEDIARIX in the past; however, she had previously reported that this was the first dose of PEDIARIX. The immunization series was not delayed or discontinued. It was unknown if the subject experienced symptoms with subsequent administration. The subject has not experienced any adverse events following previous vaccinations.
diagnosed COVID positive; diagnosed COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (003110). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: diagnosed COVID Positive; Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took the five-day Paxlovid (nirmatreivir) treatment package. His symptoms mostly disappeared and felt much better afterward but still tested (on a home test) positive. Where can find information about the experience of others and if something similar happened. Patient was told he could test positive for three months after treatment. Is this normal, patient wants to know. Patient diagnosed COVID positive after Pfizer Covid primary series and both boosters. Initially tested positive after taking 5-day regimen of Paxlovid, but now testing negative. Patient states the product was very, very effective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PT WAS SEEN IN OUR OFFICE ON 3/26/2007 FOR REDDENED AREA AROUND THE INJECTION SITE. PT C/O SITE ITCHING AND HURTING. PER MD, UPPER OUTER RT THIGH RED, WARM SWOLLEN, TENDER, AREA OF INDURATION 2.5 INCHES BY 2.5 INCHES. SIGNIFICANT LOCALIZED HYPERSENSITIVITY REACTION TO VARICELLA VACCINE. PT TO APPLY ICE X15MIN PER HOUR PRN, TO TAKE CLARINEX RT 2.5MG PO Q24 HRS AND MOTRIN 200MG PO Q6 HRS UNTIL REACTION GONE X24 HRS. NO MORE VARICELLA VACCINE IN FUTURE.
Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 11-Apr-2021, VACCINATION SITE PAIN (Soreness in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-168633 (Patient Link).
Information has been received from a medical assistant (MA), concerning a 61 year old, male patient who on 11-JUL-2007 was vaccinated SC in the left arm, with the second dose of PNEUMOVAX 23 (Lot #657039/0698U).  Subsequently the patient experienced extreme pain and warmth at the injection site, had difficulty lifting his arm, and developed "extreme edema" of the arm (treatment was not specified).  At the time of this report, the patient had recovered from the events (date and duration not specified).  The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 3 additional patients experienced similar symptoms involving pain, warmth, swelling, redness at the injection site, difficulty with arm movement, and fatigue (WAES 0707USA04971, 0708USA04276), 1 patient developed cellulitis (WAES #0707USA04634), and 1 patient experienced a "minimal reaction" (WAES 0708USA00702).  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory.  The lot complies with the standards of the center, and was released.  No further information is expected.
I have a mosquito bite looking mark on my arm from the injection. around 2 pm I had 102.5 fever and I had a headache and felt really tired.   I asked the nurse when I went in to get the vaccine if I could get the vaccine if I have already had covid, she said that I could still have the vaccine. The nurse proceeded to vaccine. My boss then told me that she was wrong and that I should not have been given the vaccine if I have already had covid. Is the nurse wrong?
Extreme fatigue lasting about 48 hours.  Mild body aches in left arm, lower back, left jaw
Pt had fever of 102, was shaking, vomiting, decreased appetite and having a hard time breathing.
Admitted for Pneumonia due to COVID -19  Acute respiratory failure with hypoxia. Decadron, ZINC, magnesium, Pepcid, LOVENOX. Remdesivir 2 L nasal cannula.
During 15 minute waitin gperiod the patient slumped over and fell out of her chair. the patient was slow to reorient to her surroundings. patient reported feeling really hot and lightheaded prior to passing out. patient evaluated by EMS that was on site already as precautionary measures and refused transport to hospital. patient was advised to follow up with pcp. husband was called, he came and took her home.
Breakthrough case admission after 4 vaccines  Pfizer 1/14/21 no lot#;  Moderna 2/11/21 no lot#;  MOderna 4/21/22 Lot# 048L21A;  Moderna 10/6/22 lOt# 053D22A
Started getting itchy during the day and specially if I didn't take my ALLEGRA; I started breaking out in hives when I got mosquito bites.
After receiving the vaccine, my arm would feel heavy, tired, and achy. It's also sore to the touch at the top part of my arm. It has been in the last 2 months that I noticed it a lot more. My arms hurt and my body would hurt sometimes too. One day I got a headache and then the next day my arm hurt. A week later my feet were really swollen. I went to the doctor and had bloodwork done. They gave me ibuprofen and a water pill. At night it is more uncomfortable. The next day my whole body hurt. I used a one a day women's vitamin and that helped a little bit with my arm discomfort. I can't do anything for extended periods of times without my arms hurting. My left arm hurts more than my right arm most times.
pain @ site of inj;entire upper rt arm became edematous, taut & red;sx migrated down to lower arm;
On 4/14/06 the patient received three vaccines Hib/IPV/Prevnar.  Within 4 hours of administration, the patient began with severe inconsolable crying with was episodic.  The episode persisted for approximately 4-5 hours.  He did not have fever, vomiting, or diarrhea.  He seemed to have severe abdominal pain.  On 6/22/06 only Hib vaccine was administered and once more within 3-4 hours the patient had the same crying/screaming episode and seemed to have abdominal pain.  Episode resolved within 2-3 hours without intervention.  He did have a low grade fever 99.7 rectal.
Heart murmur; Increase in her blood pressure 190/105; Tightness in chest when breathing; Blurry vision; A spontaneous report was received concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing and a heart murmur.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient received the Moderna vaccine and after 30 minutes, she experienced an increase in her blood pressure (190/105), blurry vision and tightness in the chest when breathing. She remained at the site for an hour for observation and then was brought to the urgent care. An electrocardiogram (EKG) was performed and treatment included oral lisinopril. She was sent home, and she also stated that she had a heart murmur.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing, and a heart murmur, were not reported.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of blood pressure increased, and non-serious unexpected event of chest discomfort, vision blurred, and cardiac murmur. The events occurred 1 day (15 min) after first dose of mRNA-1273, lot # 037K20A. Treatment included lisinopril. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
No additional AE reported; She inadvertently administered an expired dose of VARIVAX TO A PATIENT ON 10/16/2020; This spontaneous report has been  received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 16-OCT-2020, the patient was inadvertently vaccinated with an expired dose of  varicella virus vaccine live (oka/merck) (VARIVAX) formulation not reported but defaulted to subcutaneous injection, 0.5 ml,  Lot # R026715,  expiration date 18-SEP-2020 for prophylaxis.       It was reported that the varicella virus vaccine live (oka/merck) (VARIVAX) did not experience any temperature excursion and no additional adverse events were reported.
By mid-afternoon (3 pm) on the day of the injection, I was suffering from moderate pain in my left arm, and was unable to lift it more than about 60 degrees from its downward position.  Although it may not be correlated, I also suffered from severe intestinal gas throughout the night.  The day after the injection, I had severe tiredness, diarrhea, generalized aches, and both fever and chills.  I was constantly adjusting my clothing to warm up or cool off, and was unable to ascend one flight of stairs without resting.
REcived 1st dose at facility 11/9/2021, 2nd dose 12/10/2021 Covid.  On January 3 2023 parents noted erythematous papule on pt back. 1/4/23 fever started1(02) visit ED where covid, flu, RSV and strep negative, concern for rheumatic fever ED prescribed Augmentin. 1/5/23 woke with sore throat and one episode of vomiting, rash had spread throughout trunk, abd, face and extremities. on admit 1/5/23 noted peeling of lips, few small ulcers along floor of mouth and mild exudative conjunctivitis. No recent illness, no sick contacts. Mild CAD coronary artery dilitation noted on echo.
Pregnant; Sore throat, throat irritation; Cough; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), OROPHARYNGEAL PAIN (Sore throat, throat irritation) and COUGH (Cough) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced OROPHARYNGEAL PAIN (Sore throat, throat irritation) and COUGH (Cough). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved and OROPHARYNGEAL PAIN (Sore throat, throat irritation) and COUGH (Cough) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.; Reporter's Comments: This is a case of product exposure during pregnancy associated with sore throat and cough for this 57-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
pt devel a large swollen red arm following pnu-immune/fluogen; later also devel some red streaks from inject site;
NO ADVERSE EFFECTS to Patient.  I have entered  the 2 Moderna doses given  on 5/19/21 and 6/25/21.  The patient had 2 primary doses of Pfizer on 1/19/21 and 2/9/21.  (These were administered by Walgreens 3269.)  She was told by Dr. to get an additional dose for her immunocompromised condition.  This should have been a Pfizer dose, not a Moderna.  The 2nd error is the time interval to the 4th booster shot.  I have consulted with Pfizer (Case # 0053774) and CDC (Case # CDC-2324013-V7R8V9) and been given information that the additional dose may be a different mRNA vaccine if vaccine information is not available or the 1st 2 doses are unknown AND  "booster dose administered prior to recommended interval, do NOT repeat dose" (CDC Administration Errors Revaccination Guidance).  NE NESIIS counts the 3rd dose as the additional dose.
Woke up with extreme pain in arms, fatigued, nausea, stomach cramps, diarrehea. 11/07-11/11 stomach cramps, nausea, diarehea continued. 11/10 PM started developing itching on body 11/11 itching got worsed developed bad hives by afternoon 6:30PM on way home from doctor started experiencing chest pain, felt like someone was squeezing my heart every few minutes. Went to ER heart ok, could not explain why I had the pain. Gave me a steriod by IV after received steriod IV pain got better and so did hives. I have never had hives before and now I am continuing Medrol steriods for 6 days.
No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003248: US-009507513-2108USA003331: US-009507513-2108USA003332: US-009507513-2108USA003334: US-009507513-2108USA003335:
Painful injection, arm trembling just after injection. Ongoing pain and tenderness for one month. Unable to use arm with ADLs with loss of ROM
Adverse event: notified on 4/11/2022 that vaccine was expired on 4/4/2022. Patient given vaccine. Reports no adverse reactions.
Large red itchy rash/hives on the inside of my thighs (also had soreness in my are later on 2/11 and a bit on 2/12, but that subsided). The rash persists until present date (3/4) but it has faded a bit. The itchiness lasted about 2 days but has intermittently returned although not as intense
Date unknown but approx. 5/4/21 stomach started feeling bloated.  Sometime after that, I noticed ankle/feet swelling.  The stomach bloating got more uncomfortable and GasX didn't help. I looked about 3-4 months pregnant, I weigh approx .115lbs at 5'7 . I started taking IB Gard and Culturelle products. approx. 5/7. Saw Dr on 5/26. She said to stop taking Culturelle and IB Gard. She ordered pelvic and abdomen ultrasounds, blood and urine tests. All were ok. Next test is Echocardiogram on 6/15/21. Psychiatrist found a case study that Seroquel could cause edema in foot/ankles, he said to stop taking it. Last dose was 5/26/21.  Started taking tums, didn't help . On 6/7 3:30a, threw up yellow/green liquid, again at 5:30a. 6/9, threw up yellow/green liquid 7a & 7:50a.  The stomach distention is extremely uncomfortable. Dr. said ok to take Dramamine, Started 6/9. Also started Pepcid a/c.  Still feeling nauseous. She also wrote a prescription for Odansetron. Have not started that yet.
Severe Shingles in right eye, forehead, and scalp. Severe eye ulcerations with light sensitivity and vision loss
Extreme shoulder pain, forearm pain, and wrist pain. Pain was sharp and traveling when shot entered and hasn?t gotten better.  It is almost a week later. Pain in thumb are as well. No outward sign of infection.