chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT SAID SHE HAD SEVERE PAIN AT INJECTION SITE THAT STARTED THE DAY OF AND EVENTHOUGH SHE HAS BEEN TAKING TYLENOL, IT HAS NOT GONE AWAY. SHE SAID PAIN IS SO BAD THAT SHE CAN NOT MOVE HER ARM. ABOUT 10 INCH AWAYB FROM SITE SHE HAD SOME REDNESS AND SHE WAS WOONDERING IF THAT HAS SOMETHING TO DO WITH VACCINE.
rash on her chest/rash on her neck and shoulder coming down the arm; itching on her chest; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 16Feb2021 at 15:15 hours as dose 1, single (at the age of 65-years-old) for COVID-19 immunisation. Patient had no medical history. Patient had a sister, and she had the Moderna vaccine and had no reaction. There were no concomitant medications. Patient had no prior vaccinations (within 4 weeks). No relevant tests were performed. On 16Feb2021, patient had rash started about 17:00 or 18:00 hours that evening, patient noticed that it was itching on her chest and when she looked at it saw the rash on her chest/rash on her neck and shoulder coming down the arm. It had gotten better at this point with the use of hydrocortisone and Benadryl as treatment. Patient had no emergency room and physician office visit, but she did call, and they just gave her the COVID hotline but got no answer. Patient wanted to know if this is going to happen with the second shot, what should she expect with the second dose. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected. Information about lot/batch number has been requested.
Breakthrough case admission after three vaccines Pfizer 2/25/21 Lot# EN6200;  Pfizer 3/18/21 Lot# EN6207;  Pfizer 12/13/21 Lot# FJ8757
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on 03-DEC-2014. Health professional reported that we accidentally administered expired FLUMIST Quadrivalent to four patients on 30-DEC-2014. The outcome of the event of accidentally administered expired FLUMIST Quadrivalent to four patients was unknown. The report was considered to be non serious.
Information has been received from a nurse concerning a 14 year old female with no known drug allergies who on 26-JUN-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 660393/0067X). At the same time the patient was vaccinated with hepatitis A vaccine (inactive) (HAVRIX). The patient told the nurse that she was nervous about shots. The patient was sitting on the table and a few minutes after GARDASIL vaccine (yeast) was administered the patient slumped down onto the table and her legs and arms were rigid and shaking. The patient's sister said her eyes rolled to the back of her head, The patient fainted and her hair was over her face. The patient was out for approximately two to three minutes. When the patient came to she said to nurse "did I fall asleep?" The patient was monitored at the office and fully recovered. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial information has been received from a nurse and follow-up information was received from a physician concerning a 14 year old female with no known drug allergies who on 26-JUN-2008 at 10:30 AM was vaccinated intramuscularly into the left deltoid with the first 0.5 ml dose of GARDASIL (lot no. 660393/0067X). At the same time the patient was vaccinated with HAVRIX (lot no. AHAVB248AA). The patient told the nurse she was nervous about shots. The patient was sitting on the table and a few minutes after GARDASIL was administered the patient slumped down onto the table and her legs and arms were rigid and shaking. The patient's sister said her eyes rolled to the back of her head. The patient fainted and her hair was over her face. The patient was out for approximately two to three minutes. When the patient came to she said to nurse "did I fall asleep?". The patient was monitored at the office and fully recovered. Additional information is not expected.
Soreness at injection site.  Fatigue and body ache with headache occurred approximately 10 hours post injection.  Subsided within two days.  Ibuprofen alleviated symptoms; however, they were acute and lingering.
Pt vaccinated with TD/Pneumo developed swollen, hot-to-touch, painful upper arm site of inject. Dx allergic reaction Rx: benadryl, heat, compresses. Condition improved.
I finished a course of KEFLEX antibiotic on 09/22/2022 and received the COVID-19 vaccine and the flu vaccine that same day. The next day, I noticed an almond sized bump on the inside of my labia. I noticed a stinging burning sensation while urinating. It was not terribly painful but sensitive to the touch and minor itching. I later realized that there were multiple bumps of varying sizes from pea sized to almond sized that seemed to be in pairs and were also perineum area as well as the labia area. Before seeing my doctor, I also noticed a bump on the outside of my vagina as well. I described my issue over the phone to my OBGYN's office and I was able to be seen that same day on 09/27/2022. She performed an exam and wasn't terribly concerned with what she saw since there was no open wounds or need for drainage. She advised that I use warm compress and cotton underwear while keeping the area as clean as possible.
24AUg93 @ 545PM recvd a call from mom stating pt had huge hives on rt arm where pt had rcvd DTP vax; mom immed brought pt by clinic who observed hives over pts rt arm from wrist to shoulder & over entire back; pt was in no distress; to ER;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple sclerosis (diagnosed in 1999, takes AVONEX injections for the same). Concomitant products included AVONEX. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, chills, fever and influenza-like symptoms. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the general body pain, chills, fever and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, chills, fever and influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: In 1999, the patient was diagnosed with Multiple sclerosis and took AVONEX injections for the same. The patient had only one AVONEX injection in her arm ever, which was several years ago, the patient had a similar reaction as after vaccination with SHINGRIX, since then the patient had always had AVONEX at alternate sites and never had reaction to the same again. The patient stated that after vaccination with the first dose of SHINGRIX, the patient had severe pain in her arm where was vaccinated. There was no redness or swelling experienced by the patient. The patient also developed bad flu-like symptoms. The patient had fever, body aches like someone was beating her up with a sledgehammer and bad chill. The patient was taking ibuprofen at the time of reporting and it was only taking the edge off a little. It took a full week for the events to resolve. This case was linked with case US2018GSK188899 (2nd dose), reported by the same reporter for the same patient.
Began feeling unwell 10/31/2021, then tested positive for COVID 11/1/2021, Progrssively getting worse.  Hospitalized about 11/16/2021-11/26/2021  When treated as an outpatient was given infusion, but pneumonia was so bad she was then admitted.
This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of GARDASIL that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported, indication default) on unspecified dates since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that he was aware that the administration of improperly-stored products to patients posed a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Blood clot in my left leg.  Swollen, tender to the touch, pain for 1 1/2 weeks.
This spontaneous report as received from a Medical Assistant refers to 11 weeks old infant, gender not reported. On 04-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
p/ pt recv vax same day pt exp breakthrough chickenpox w/5-10 vesicles & rash on chest. MD rpt f/u 6/8/98 pt developed shingles.
Redness and itching to hands and forearms. also itching to head and behind ears. Took Benadryl 50mg. and applied hydrocortisone cream to affected areas. Continued treatment s needed.
Information has been received from a consumer to report an adverse event on behalf of her 13 year old male son. No drug reactions/allergies were reported. No pertinent medical history was reported. On 12-APR-2013 the patient was vaccinated with a dose of GARDASIL (route of administration, lot and dose # not reported). No concomitant medications were reported. About one week after receiving GARDASIL (19-APR-2013), the patient suffered from right supraclavicular lymphadenopathy. Patient did seek medical attention from the physician and was treated for this adverse event. He was recovering. Additional information is not expected.
got the Flu shot and ended up having the flu/ suspected vaccination failure; flu; This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a 68-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included post-traumatic stress disorder and herpes zoster. Concurrent medical conditions included thyroid disorder, blood cholesterol increased, stress and diabetes. Additional patient notes included White. Concomitant products included metformin, sitagliptin (Januvia), clonidine, rosuvastatine, paroxetine hydrochloride (Paxil), amlodipine, levothyroxine and alprazolam (Xanax).   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient received flu shot and had flu. The patient is taking Metformin 100 mg twice a day for diabetes, Junavia 100 mg once a day for diabetes, Clonidine 0.1 mg for cholesterol, Rovustatin 20 mg for cholesterol, Paxil 1.5 tablets daily, Amlodipine 2.5 mg for blood pressure, Levothyroxine 100 mg once daily, and Xanax. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming flu were unknown at the time of reporting. For tolerance of other flu shot, refer case US2021AMR222561 and for tolerance of Valtrex, refer case US2021AMR221277.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR221277:same reporter US-GLAXOSMITHKLINE-US2021AMR222561:same reporter
23 year old female presented to Student Health Center at TAMU on 11/25/08 with complaint of right arm pain ever since she got her flu shot in mid october 2008. It hurts to lift her arm and it is tender to touch. She wakes up when she lies on it during the night.
Fever, vomiting, diarrhea, headaches, body aches, myocarditis, hypotension
I had a runny nose cough and fatigue.  I took Paxlovid twice daily for five days.
Caller states it was very low, didn't think much of it, then it got worse.; she got a severe rash all over her body; she has her neck and back in flame red color with spots; This is a spontaneous report received from a contactable consumer (reporting on herself). A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 01Apr2021 14:00 as single dose for COVID-19 immunization. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included oxytetracycline (TERRAMYCINE [OXYTETRACYCLINE]) taken for blood pressure measurement, start and stop date were not reported. patient got the first dose of the BNT162B2 on 01Apr2021 and she got a severe rash all over her body: she has her neck and back in flame red color with spots on her body and spots on her legs. She wants to know if she can take, Benadryl. Patient mentions that she was sorry the she got the shot and if she knew all the trouble she had to go through he would have never got it. She says that she will not going for the second shot after this. Aside this she mentioned that she was tired of being on the phone for 45 min while waiting for someone. And wanted to know if her insurance covered the vaccination or how does it worked. Patient states she has a bad knee and doesn't have it with her right now. Patient states she takes blood pressure pills but she feels okay. Patient states it was Terramycin, the generic. The outcome of the events she got a severe rash all over her body and she has her neck and back in flame red color with spots was not recovered and for event Caller states it was very low, didn't think much of it, then it got worse was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient her first dose of the vaccine  and 15 minutes after vaccination she fainted for a few minutes.  She  was responsive, but had a low blood pressure of 90/70. She was observed over a period, her blood pressure up to normal. She was counseled  on signs and symptoms to watch out for and if so seek medical attention.
Information has been received from a physician concerning a female in her 20's with intermittent problems with asthma and no known drug allergies, who on 22-SEPT-2006 at 13:00  was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot #653650/0702F). Concomitant therapy given that day included a first dose of DTaP (unspecified) given IM into the left arm, a first dose of TWINRIX (lot# AHABB0583A) given IM into the right arm and a first dose of typhoid vaccine. On 27-SEP-2006, the patient experienced intense itching all oer her body. The patient self medicated with BENADRYL. The itching was mostly on theinside of her legs and her back. She was treated with ZYRTEC. No diagnostic laboratory tests were pereformed. Subsequently, the patient fully recovered. No product qualitycomplaint was involved. It was noted that the vaccines were administered at different anatomical sites. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 29-MAY-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J002302 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Started her period for the first time on 11/23/2021 at 10 years old. (Probably coincidence, but wanted to report it)
Covid positive 10/10/22. Symptoms include sinus pressure and drainage, headache, body aches, shortness of breathe, lethargy. Quarantined. Tele Health visit with general practitioner on 10/11/22, started paxlovid and progesterone that evening.  10/12/22: Felt 80% better.  Tested positive again on 10/14/22, 10/15/22, and 10/16/22 (last day of paxlovid and progesterone, final dose in AM) Tested negative on 10/17. Went to work, still short of breath and easily winded 10/19/22: Saw general practitioner for shortness of breath. Put back on progesterone dose pack. Tested positive again on 10/22/22. Symptoms the same as before, but more mild. General practitioner closed on weekends, so called into Well Via and got another course of paxlovid, started that morning. Felt 50% better 10/23/22 and 85% better on 10/24/22. Still short of breathe and a little lethargic. Positive Covid test 10/24/22 10/24/22
This spontaneous, prospective pregnancy report was received from a registered nurse and refers to a 20 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2017, the patient was vaccinated with VARIVAX lot # M034583 with expiration date on 27-JUL-2018, subcutaneously, because it was a required vaccination for nursing school. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (strength, dose, frequency, lot # and expiration date were not reported). On the same date, the patient reported to the clinic to receive a Purified Protein Derivative (PPD) test. The nurse reported that after receiving a PPD test, the patient informed that she was pregnant. On 11-JUL-2017, the patient verified pregnancy by ultrasound at an unspecified physician's office. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported and could not be calculated. The pregnancy outcome was pending. The fetus outcome was unknown. No adverse effect was reported. Additional information has been requested.
second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart; Got Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Got Shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT) and AMLODIPINE for Hypertension, LEVOTHYROXINE for Thyroid disorder NOS.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HERPES ZOSTER (Got Shingles). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart). The patient was treated with GABAPENTIN at a dose of 100 milligram; VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 g and ALUMINIUM CHLOROHYDRATE, METHYLPREDNISOLONE ACETATE, SULFUR (MEDROL COMP) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Got Shingles) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart) 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.   Treatment details included Gabapentin 100mg, valacyclovir 1gm, medrol dose pack.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: New event added
Received the shot at 2:30PM....started experiencing increasing pain at injection site from 8-10PM. At 1AM started experiencing tingling and numbness from left arm all the way down to left toes.
Received #1 MMR and #1 varicella 2/5/03 and #2 MMR and #2 varicella 4/7/03. On 4/8 noted early AM onset of joint pain (generalized) requiring 400 Motrin TID. Pain resolved in 2 days and nor further problems.
Patient developed localized swelling at the site of her DAPTACEL vaccination on her left upper arm which gradually became edematous leading to a 3 cm difference in circumference. 18 1/2 cm right arm/21 1/2 cm left arm. Otherwise well. Using BENADRYL orally.
Shingles diagnosis. 6 days after my 2nd Pfizer vaccine I woke up with a linear rash on the right side of my body (waist area). It is painful and itchy. I scheduled a telehealth appointment and the doctor stated it was classic shingles presentation. I was prescribed a regimen of antiviral medication.
On the evening of the 16th, I experienced pain in my left underarm area.  The following day my left arm developed a rash and the pain in my left underarm increased.  On the 18th I noticed that my left underarm was swollen as was my injection site.  The rash had spread to cover my whole bicep and the swelling was approximately the size of a lemon in that area.  My left underarm was very painful and I felt several very large and swollen lymph nodes under the arm.  On the 20th the pain was still present, but the swelling had decreased.  On the 21st the pain was almost non-existant but most of the joints in my body hurt.  By the 23rd I felt more normal and was moving and exercising as normal.
Patient received 2 month vaccines (Pediarix, HIB, Prevnar, Rotateq) on 5/9/08. That evening, he developed fever up to 101.6, had emesis x 1, had eye deviation and became unresponsive with fixed gaze and moaning for 30 min- 1 hr. Parents brought patient to ED, where patient was responsive and exam was normal.
Evening of vaccine began to feel chilled, achy, fatigue but no fever. During the night noted difficulty sleeping due to joint pain especially the hips, back and shoulders.  Upon waking the following morning (12/29) had a moderate to severe headache, neck pain, continued joint pain which now included the knees, achiness, fatigue, nausea.  Left work after 3 hours and went home, slept for 3 hours.  That evening continued to have headache, fatigue and joint pain though they had improved somewhat.   Woke up  12/30 with only a mild frontal headache but other symptoms resolved.