chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The rash was almost gone when she got her second vaccine; She was on an antibiotic for a urinary tract infection and took her last pill Friday morning; This is a spontaneous report support received from contactable consumer (patient) from a sponsored program.  A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date, as Dose 1 single, for COVID-19 immunization. Medical history and concomitant medication were not reported. Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she had her second dose on Friday 05Mar2021. She said that she might have done some thing wrong and reported that she was on a antibiotic for a urinary tract infection, on an unspecified date and took her last pill Friday morning. She said that she took Benadryl for the rash, occurred on an unspecified date, while she was on the antibiotic. She clarified that the antibiotic was Cipro and the rash was almost gone when she got her second vaccine. The patient's daughter, who was a nurse, sent her to get the Covid-19 vaccine and her daughter told her that she did not need to mention the rash. She said that the rash was just about gone and she did not think that the vaccine did anything to the rash. No further details provided. Therapeutic measures were taken as a result of rash with Benadryl and urinary tract infection with antibiotic- cipro. The outcome of the event rash was recovering and urinary tract infection was unknown, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received half of the recommended booster dose (25 ug) instead of the full booster dose (50 ug). There were no adverse effects. Patient will come back to our clinic to complete the remaining half booster dose on 07/27/2022..
COVID; could not breathe; rash from head to toe; high fever; Dizziness; Vomiting; This is a spontaneous report from a contactable consumer (mother). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 13:55 (Lot Number: EW0171) at the age of 24-year-old as 1st dose, single, at right arm for covid-19 immunisation. Medical history included ongoing chronic bronchitis(so it was important that she was vaccinated), admitted to the hospital for pneumonia and chronic bronchitis. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Family medical history relevant to events reported as no. Relevant tests reported as none. 4 days after the first dose the patient received she had a rash from head to toe on 26Apr2021. After that the patient was rushed to the hospital because she could not breathe on 28Apr2021 and turned out the patient had COVID. The patient went to the pharmacy yesterday to get the second dose of the vaccine and showed her rash, the pharmacist would not give the vaccine to the patient until they spoke with Pfizer. Event rash from head to toe had gotten worse as it was down to her feet and hands and everything. Rash started off so small. The patient stopped experiencing event could not breathe around 5 days before. In the past the patient was admitted to the hospital for pneumonia and chronic bronchitis. This time that the patient went to the hospital after getting the first dose of the vaccine she was released from the emergency room. The patient was released with a pulse ox machine. Treatment received included paracetamol (TYLENOL) and guaifenesin (MUCINEX). The patient also experienced some dizziness on 22Apr2021, vomiting on 22Apr2021, and a high fever on 23Apr2021. The patient was diagnosed with COVID on 28Apr2021. The patient stopped experiencing dizziness around 01May2021 or 02May2021. Events require a visit to emergency room, no physician office visit. The outcome of event rash from head to toe was not recovered, of could not breathe, dizziness was recovered in May2021, of vomiting was recovered on 04May2021, of high fever was recovered on 05May2021, of COVID was unknown.
noted red, raised, warm area w/pruritus @ site of inj earl Saturday AM;swelling inc to point that was diff to raise arm;had dizziness & fatigue;saw MD 14APR;
pain; extreme swelling on left arm and could not lift her arm; extreme swelling on left arm and could not lift her arm; Second pneumonia shot/part of a two shot series; This is a spontaneous report from a contactable consumer. A 66-year-old female patient started to receive pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: EE8493), via an unspecified route of administration on an unspecified date at a single dose for second pneumonia immunisation. Medical history included was reported as none. There were no concomitant medications. It was reported that the second pneumonia shot caused extreme swelling on left arm to the patient and she could not lift her arm, she was off work several days due to the pain, she does not know the name and does not have lot, NDC, or expiration date. Stated the first pneumonia shot was fine. It was part of a two-shot series for those over 65 years old. The outcome of the events was unknown.  No follow-up attempts are needed. Information on lot/batch cannot be obtained. No further information is expected.
DIFFICULTY BREATHING; FAST HEARTBEAT; DIZZINESS; WEAKNESS; WEIRD FEELING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to Left Arm for covid-19 vaccination. No concomitant medications were reported.  On 06-MAR-2021 (at night), the patient experienced difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. Symptoms have not worsened or improved since onset. The patient stated that "he doesn't feel that bad, but feels weird, like he is in the water." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling (outcome also reported as unknown). This report was serious (Other Medically Important Condition).; Sender's Comments: Difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.
Lightheaded, dizziness, numbness in site arm. Trigger finger and elevated heart rate
No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case was considered as 2nd patient out of 13 patients.  It was reported that age group of patients were mostly over 65.  No concomitant medication information provided.  It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 13 doses total given from 3 vials.  Vial size was multidose vials 5.5mL.  It was reported that vial was never put in the fridge. Vials went from freezer to room temperature on days of administration.   Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:master case
Case number PHEH2014US019157, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 74-year-old male patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
27ARP92 pt recvd Engerix-B same day pt exp arm swelling @ site of inject; tender to touch @ site of inject; warm @ site of inject;
Patient reported that the flu shot was given too high on the arm causing shoulder pain. She reports shoulder pain all night, numbness and tingling in the arm down to the fingers
FOOT NUMBNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 69 inches.  The patient's concurrent conditions included penicillin allergy, smoking, and abstain from alcohol, and other pre-existing medical conditions included no illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced shortness of breath. On 04-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced foot numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from headache, and had not recovered from foot numbness, and shortness of breath. This report was non-serious.
Pain in groin area within one hour of receiving vaccine.  Felt bloated, pressure in groin area. Was difficult to walk due to pain.  Lasted 4 days until Monday, Feb.15, 2021, when it eased.
Patient came a week earlier to get her vaccine but she didn't say anything. On the COVID-19 immunization card, it showed "5/27/21" but it looked like "5/22/21" by the volunteer administrator. After she gave the shot and started to look closely since she wasn't sure.  She went to CAIR to check and realized it was 5/27 that means patient got it a week earlier. I went to speak to the patient and told her that she was getting it a week earlier. She was aware of that and thought she could get it earlier.  We made patient waited a little longer than 15 minutes to monitor.  She was fine.
nausea, vomiting, vertigo, coughing, itchy throat about 10 minutes after vaccination
Ovarian cyst; irregular spotting; Severe headache; injection site pain; Carpal tunnel Syndrome flare; Carpal tunnel Syndrome flare; Psoriasis Flare; myalgia; fatigue; joint pain x 3 weeks; This is a spontaneous report from a contactable other health care professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EK4176, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 19Jan2021 at 10:00 (reported as 10:00 AM) (at the age of 40 years old) as second dose, single for COVID-19 immunisation. Medical history included Gilbert's Syndrome, Psoriasis, and Carpal Tunnel Syndrome, all from an unknown date. Patient was not pregnant and has no known allergies. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medication included amoxicillin, clavulanate potassium (AUGMENTIN [AMOXICILLIN;CLAVULANATE POTASSIUM]) reported as "2nd dose only" taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. The patient was previously given the first dose of BNT162B2 (Lot number: EJ1685), via an unspecified route of administration, administered in left arm on 28Dec2020 at 10:15 AM (at the age of 40 years old) as single for COVID-19 immunisation and experienced menstrual irregularity: much heavier period, joint pain for 2 weeks, psoriasis flare, Carpal Tunnel Syndrome Flare, Fatigue, chill, myalgia and injection site pain. On an unspecified date, the patient experienced Ovarian cyst, irregular spotting, Severe headache, injection site pain, Carpal tunnel Syndrome Flare, Psoriasis Flare, myalgia, fatigue and joint pain x 3 weeks. Treatment was received with current treatment for Ovarian cyst. Events resulted in Doctor or other healthcare professional office/clinic visit. After vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Soreness/tenderness and visible swelling/redness in the upper left arm.  Extends from the injection site down to two inches above the elbow, and wraps around from the back to the front.  Left arm is also hot to the touch.  Seemed to start after receiving the Shingrix injection (both Shingrix and HEPLISAV-B injections occurred in the same session, but the Shingrix injection was significantly more painful).  Peaked during the early morning of 7/14.
I received the Feb 8th did not have immediate reaction only sleepy. Started Wed night Thursday morning. Got very constipated lasted 3 months had to take Dulcolax every 3/4th day, then had to increase it. Ate more fibrous food. When I would go to bathroom, sloothing would occur- skin would come out. It's a part of SJS. Skin on body started peeling, prominent on hands and feet. Got really bad headaches and radiated to my neck. Because of SJS I cannot really take medicines for headaches. I had to go to immunologists she gave me a drug challenge test and skin started to burn so bad, she had to stop. She said we had to wait until all the Pfizer vaccine is out of my system. Went to see dermatologist he prescribed Triamcinolone acetonide apply 2x daily until skin stopped peeling and hydrocortisone ointment usp 2.5% 2x daily on face. Had a very sore throat and had to go to ENT specialist because it would not go away.
Fifth day p/immun began w/temp 104.6F & resp sx of coughing, sneezing, stuffy nose & wheezing; Seen by MD-dx viral synd; not hospitalized;
About 2 weeks after the vaccine I started experiencing what I thought was oral thrush. Appears as a rash on my tongue and upper inner lip. I went to the Dr on 5/17 and she thought it was oral thrush as well and provided RX Nystatin. Used it for 3 weeks w/no improvement. Was referred to an ENT who stated there was no sign of oral thrust and he noticed a fever blister on my upper lip. He referred to it as herpes simplex. He RX Valacyclovir, which I've been taking for 1 week. Condition has improved drastically but still persist.
Headache, Myalgia, Arthralgia, Fever, right shoulder pain, chills Reported to PMD.
Started feeling like liquid moved down arm and leg on R side of body. R pisky finger went numb and R foot went numb. Client was nauseated and disoriented. Client found out she was dehydrated. Origin unknown for dehydration.
Information has been received from a physician concerning a female who was vaccinated with the first two doses of the Gardasil series (0.5 ml, intramuscular).  Subsequently the patient experienced a positive prostatic acid phosphatase (PAP) test.  The patient was negative before being vaccinated with Gardasil.  The patient sought medical attention.  The patient's outcome was not reported.  Additional information has been requested.
Patient under age 12 was vaccinated with Pfizer, which is a vaccine error.  Troubleshooting: Scribe and vaccinator indicated that the father stated she is "almost 13" and that the DOB in our registration system is incorrect. Per the contractor, father "would not allow" the vaccinator to talk with his daughter. Reported at the direction of the medical director.
Urticaria, itching noticed by mother in am when she awoke.  Given Benadryl by physician on day of event.
Cardiac Arrest/Respiratory Arrest around 2000 on 25 Sep 05 at home. This was over 72 hours following vaccinations below.  11/28/2005 Via phone call again to ME.  Child was put down to sleep in prone position because of GERD.  She also had a comforter on her.  She was given a bottle at 1 pm, and was found unresponsive at 8 pm.  Father started CPR and child was taken to the ER where she was pronounced.   ME says the preliminary report is SIDS, final awaits the lab results. 4/10/06 Received autopsy report which states COD: Unexplained Infant Death.
On 6/2/00, the pt received her 1st dose of Lymerix. Six hours later, on 6/2/00, the pt experienced generalized arthralgias and a bullseye rash at the injection site. The vaccinee had no fever, rash or pruritus. She was treated that day with NSAIDS (NOS). The most recent information, received on 6/5/00, reports the condition of the vaccinee is resolving.
Right leg slightly swollen, red, and warm to touch. No fever today - had  low grade temp on evening of vaccination but fever went down after mother administered MOTRIN. Pt was given Rx for ZYRTEC. Area was marked and instructions given for mother to bring pt in for follow up on 4/09/10.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Vaccine was administered & approximately 30 seconds afterward, patient started to get pale. Staff member asked if patient was okay & told patient to remain in vaccination chair at staff member's side. Patient was asked if she felt she was going to faint & if there is hx of fainting after vaccinations.Patient & mother confirmed that this has happened before. Pt sat & lied down intermittently for appx 45 minutes post-vaccine. Pt was given water & orange juice, & walked out with mother but without assistance.
Headache, body aches, left deltoid area - red, swollen, hot to touch.
Felt woozy after she left from receiving the vaccine. Later she started feeling nausea and felt like that for 3 days. Headaches and tiredness. Couldn't go to work because she was feeling very weak and disoriented. After 3 days she stated to feel better.
terrible case of the flu; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who got terrible case of the flu (Influenza), while the patient received 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 in 2007, the patient received a dose of INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, within 3 days of receiving INFLUENZA VACCINE, he/she got a terrible case of the flu (Influenza) which took him/her nearly 3 weeks to get over.  It was not reported if the patient received a corrective treatment.  The event was resolved on an unknown date at the time of reporting.  There will be no information about the batch number in this case.
Patient received her vaccination and was fine. Then had a syncopal episode upon watching her brother receive his. patient fell and hit her head. no chest rise was seen so a couple of compressions were performed and patient became awake and alert. 911 was called as soon as patient fainted and she was taken to er. Upon testing as er mother said that they believed it to be a case of fainting when seeing the shot given to brother.
Developed painful and itchy  rash that keeps me up at night   . Doctor  is treating with antiviral drug and cream for pain Not sure what to do
pain in sinuses; pain in  throat; pain in ears; pressure in sinuses; pressure in throat; pressure in ears; This non-serious case was reported by a consumer via call center representative and described the occurrence of sinus pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. In APR-2023, 5 days after receiving Shingrix, the patient experienced sinus pain (Verbatim: pain in sinuses), throat pain (Verbatim: pain in  throat), ear pain (Verbatim: pain in ears), sinus pressure (Verbatim: pressure in sinuses), throat discomfort (Verbatim: pressure in throat) and sensation of pressure in ear (Verbatim: pressure in ears). The outcome of the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear were resolved.   It was unknown if the reporter considered the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear to be related to Shingrix.     It was unknown if the company considered the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter was the patient who stated that she received Shingrix first dose at the beginning of April 2023 and 5 days later she developed pressure and pain in her sinuses, ears and throat that she believed was an outbreak of Shingles. No rash or other symptom reported. Patient did not notify her doctor and she was not diagnosed with Shingles. The reporter did not consent to follow up.
Info has been received from an RN concerning a 35 month old male pt reported as a healthy child, who on 5/28/03 was vaccinated with varicella virus vaccine live. It was reported that he experienced chickenpox starting on 5/4/05. The chickenpox were described as 20 lesions, scattered on his trunk, upper arm, abdomen and buttocks. Treatment was symptomatic. At the time of this report, the pt's outcome was not recovered. There was no product quality complaint reported. The pt sought unspecified medical treatment. Additional info has been requested.
Prior to giving the injection, the Moderna Bivalent vaccine instructions we were given were to give 0.25 mL to non-immunocompromised patients, and 0.5 mL to immunocompromised patients. We found out shortly after the patient left that 12 years old+ are 0.5 mL always. No adverse reactions, however it was a smaller dose than we were supposed to admin. Patient was informed.
Approx 1 hr after 3rd human diploid cell rabies vaccine, became extremely fatigued with aches, chiefly in legs and low back.  2 hr after vaccine reported to our clinic.  Looked pale.  BP was 180/110.  Placed in bed to rest for 1 hr and symptoms seem to resolve, except BP remained elevated at 166/103.  To be followed.
Claustrophobia got much worse resulting in nightmares and inability to ride in elevators prior to vaccination
4:00PM onset of severe headache, extremely hot face. very cold body with shivering, whole body aches, mild nausea which lasted 5 and one-half hours. For next 2 days, August 12 and 13, had residual headache and mild weakness, since reaction have several days of hot face, cold body, and generalized body weakness.
Approximately five minutes after the shot, I experienced vasovagal syncope.  I was, reportedly, non-responsive for about three minutes.  When aroused, my heart was reportedly beating about 40 beats per minute, my blood pressure was low, and it took me quite a while to regain my senses.