chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 29 year old female with no known drug allergies and no past medical history who on 03/30/2001 at 4pm was vaccinated SC in the left upper arm with a first dose of varicella vaccine. There was no illness at the time of vaccination. There was no concomitant medication. It was noted that the pt received MMR vaccine on 02/27/2001. On 04/13/2001 at 10pm, the pt experienced two watery blister lesions on the left upper arm close to the injection site. Unspecified medical attention was sought. No treatment was given. The lesions dried and scabbed after 5-6 days. The pt has recovered. Additional info has been received from a registered nurse who reports the pt had blood work prior to the first vaccination which showed a negative varicella antibody. On 05/14/2001 at 4:30 pm, the pt received a second dose SC in the left upper arm of varicella vaccine. There was no illness at the time of vaccination. There was no concomitant medication. on 05/15/2001, the following day, the pt had a 50 x 50mm injection site reaction that was described as itchy, red and swollen. Benadryl was given and the pt recovered in five days.
Patient was administered PNEUMOVAX 23 on 4.5.19 and within 24 hrs experienced redness, swelling, range of motion loss, and pain. Patient presented to pharmacy 4/7/19. Patient denied reports of sweating, chills, fever, or signs of infection. I reported to the patient the incidence of side effects from the drug monograph, and assured the patient that although they are uncommon, these side effects are possible from administration of PNEUMOVAX 23. I will follow up with patient 4.8.19. I offered to notify his physician, but patient refused the offer at this time. Additionally I recommended the patient take 25 mg on Benadryl, Ibuprofen 800 mg, and to ice the area four times daily for 15 minutes at a time.
Patient states that she was sickly days after and her arm two days after had limited mobility and is still sore and a bit painful 28 days post.
onset of abdominal pain on evening of vaccination (9/17), Went to Emergency room on 9/18 and had appendectomy on 9/19.  Her surgeon told her it was related to the vaccine.
VIAL PAST STORAGE REQUIREMENT; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced vial past storage requirement, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial past storage requirement and medication error was not reported. This report was non-serious.
Severe Headache and spine pain leading into 48 hours extreme fatigue, shivering, excruciating joint and muscle pain
Pt. reports itching and tender to touch at injection site - Left arm - several hrs. after receiving flu vaccination on 9/28/10. On 9/30/10 AM, pt. reports injection site is warm --> hot, has swelling at site, itching, rash (flat, red) upper (L) arm.
My mom, got her first Moderna shot on Feb. 4th, 2021 and developed trombosis in the legs about a week later.  She went to the doctor, who at first didn't want to see her and told her to elevate her leg. Pt. had a scheduled eye appointment on Feb. 12th  with an other doctor and when she asked if she had any other issues, pt. showed her her leg.  The eye doctor immediately told her to go to urgent care.  When she did she received blood thinners and started injections in her stomach for 5 days.  Feb. 18th pt. suffered a mini stroke and went to the hospital emergency room.  She was transferred over to another facility in the afternoon and kept overnight.  She had a phone appointment with the Dr. on Feb. 24th and on the 26th she received a heart monitor to wear for 2 weeks.  She also had a check up about her leg, which was still swollen.   On March 4, pt. received her second Moderna shot and she was feverish and very tired for days and weeks after.  By March 18th her condition didn't improve at all and in fact she was felling really bad over night, so on March 19th she was admitted again to the hospital.  She was  monitored and kept over night, but  during the early morning she suffered a stroke and a heart attack and passed way the next day.
Five days after receiving my booster (half dose), I started my period. I am 61 years old and have not had a period since December 2019.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 18:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfur drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "known allergies: Iodine", notes: known allergies: Iodine; Betadine, reaction(s): "known allergies: Betadine", notes: known allergies: Betadine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started from 07Jun2023 to 11Jun2023.  Clinical course: Covid-19 rebound after Paxlovid on 19Jun2023.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician and a licensed practical nurse concerning a 11 weeks old baby, who on 20-APR-2011 was vaccinated, orally, with a dose of ROTATEQ (Lot # and dose not reported). Physician reported that after receiving the ROTATEQ, on 21-APR-2011, the baby experienced severely dehydrated, became septic and lethargic and had a temperature of 101 degrees. After the physician examined the infant, rotavirus was detected in the baby's stool. On an unknown date, baby was hospitalized. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
PATIENT PRESENTED TO PHARMACY DUE TO PHYSICIAN REFERAL TO PHARMACY FOR VARES COMPLETION. PRESENTED WITH RED SWOLLEN, TENDER, FLATTENED IN APPEARENCE, SOFT BALL SIZE.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a seven-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medication were reported. The patient received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
pt recvd vax; to MD ofc for aches & pains;pain med prescribed;pt to hosp & was told that she had mononeuritis multiplex; sent to oth hosp for therapy; presently under MD 's care
Information has been received from a physician concerning a 26 year old female patient with a history of asthma and no drug reactions/allergies, who "last week" on approximately 15-JAN-2010 was vaccinated with the first dose of GARDASIL. Concomitant medications included unspecified birth control. On 22-JAN-2010 the patient had sudden onset and worsening of lower extremity leg pain to a point that the patient would not walk and was admitted to the hospital. Creatine kinase was mildly elevated. Sedimentation rate was performed (results not provided). At the time of the report the patient had not recovered. Follow up information has been received from the physician who reported that the patient's MRI revealed mild bilateral fasciitis of the lower extremities. The patient had elevated ESR and CRP level. The patient was treated with Non-steroidal anti-inflammatory drugs (not specified). The patient was referred to a Rheumatologist, Neurologist and infectious Disease specialist. The physician stated that the patient was able to walk at the time of her discharge from the hospital. "Lower extremity leg pain to a point that the patient would not walk" was considered to be disabling. Additional information has been requested.
Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site soreness) Symptoms resolved by the next day with ibuprofen.
Following shot on Monday afternoon, I had an unusually sore arm, including inability to fully lift my arm without discomfort, very hot around area of shot and redness. By Tuesday, the second day, I experienced muscle soreness, headache and continuation of very, very hot area at site of shot and continued discomfort on lifting arm. On Wednesday, the third day, the muscle aches had reduced, but a slight headache persisted, I was very fatigued, and the very hot area around the shot site had increased and the redness extended down my arm nearly to my elbow. On Thursday and Friday the aches and headache had disappeared, but the hot arm and redness continued. On Saturday the redness changed to hives and itching which persisted on Sunday.
This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck), Lot # K003406, expiration date: 06-MAR-16, via an unknown route of administration. Past medical history and concomitant medications were not reported. On an unknown date the patient was administered an improperly stored dose of VARIVAX. There were no reported adverse events and no need for revaccination. The outcome of the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported is unknown. The reporter considered the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported to be not related to VARIVAX (Merck). This is one of several reports received from the same reporter. Additional information is not expected.
Mixing error occurred, patient may have received only diluent. Patient declined to be revaccinated.
Patient came in for a Pfizer Bivalent booster shot and received a Mono-Valent booster instead. There was no adverse reaction just that the wrong vaccine was given. Patient is fine and has no issues at this time.
pt c/o sore, swollen red rt upper arm evening p/immun given; seen by MD that evening who felt was local reaction; arm improved softer to touch;
no adverse event; Product storage error; This spontaneous report has been received from the medical assistant referring a 1-year-old male patient.  The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not provided.  On 04-APR-2022, the patient was vaccinated  with  an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, administered subcutaneously as prophylaxis (strength was not provided) following a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours and -10 degrees C up to 8 degrees C for 1 hour 30 minutes, it was stated that a data logger was involved (product storage error). There was no previous temperature excursion reported. It was stated that the event was attributable to the device component malfunction, however there is no device involved. No additional adverse event was reported.; Sender's Comments:  US-009507513-2205USA008004:
Sore arm; Fatigue; Gastrointestinal distress; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: FC3180) via an unspecified route of administration in the right arm on 09Aug2021 at 14:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications and did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021, the patient experienced sore arm, fatigue and gastrointestinal distress. The patient did not receive any treatment for the reported events. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, fatigue and gastrointestinal distress was recovered with sequelae on 09Aug2021.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable other hcp from Pfizer-sponsored program. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 subcutaneous, administered in Arm on 28Jan2021 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. On 28Jan2021, it was reported that patient arm was squeezed, and second dose was administered in subcutaneous tissue instead of doing an intramuscular into the deltoid muscle and on a patient arm is even sore on an unknown date in 2021. The patient wanted to know about efficacy of the medication and if Pfizer recommends me to get another dose. Patient reported that a doctor meets up under the theme "Don't Grieve my Arm" as this subcutaneous administration was a "systemic problem". The outcome of the events was unknown.     Follow-up attempts are completed. No further information is expected.
Patient had lymph node swelling within a couple of days after first shot (1/28/21) and rash or hives on his body and head. He has continued to have this rash even after the second shot (2/26/21). It looks real bad on one day then not as bad the next. It is random where he breaks out from his legs, arms, back, abdomen, etc...not staying in any one particular area. Could not get him to go and see a doctor yet. Pictures available if required.  BIRTH DATE IS (disclosed) BUT PROGRAM KEEPS CHANGING IT TO THE 9TH INSTEAD OF THE 10TH.
Raised area, lump in the arm; Hives both arms; Itching; Swelling; Hurt as the vaccination site; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, (lot number: EN6206)) via unknown route of administration at right arm on 06Mar2021 at 14:00 (age at the time of vaccination was 58-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on Same Date of the Pfizer Suspect was no. There was no family medical history relevant to adverse events. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had hurt at the vaccine site on 06Mar2021, the swelling did itch unknown if from skin stretching or actual reaction on 07Mar2021, hives on the wrist of her right arm inside the forearm the upper bicep that they mostly stayed on her upper body. The next day the hives raised area went away, She stated 3-4 days later she noticed her upper bicep swelling like a bee sting started spreading and had blew up like a very large pork chop. She stated her daughter took pictures and outlined the area and dated it with a pen in case it got bigger as the width of her bicep and raised and that she had very big biceps. She stated she would put Benadryl, cool water on it and also alcohol for the itching and it seems to take the itch off on 08Mar2021 and raised area, lump in the arm like a Nickle in her arm and she could move it on 03Apr2021. The patient received treatment included benadryl cool water and alcohol for itching. The adverse events do not resulted to visit the emergency room and physician office. The event hurt at the vaccine site was recovered on 09Mar2021. The outcome of the other events was unknown. The patient received second dose of vaccination.  No follow-up attempts are needed. No further information is expected.
April 9, 2021, after taking a shower, paresthesia began in left foot, toes, calf muscle and then became numb. General Practice doctor prescribed Medrol Pack to treat. Symptoms continued post Medrol pack. Symptoms expanded in to left thigh by 05/01/2021 - atrophy identified in left calf muscles. Orthopedic Surgeon performed L5-S1 intervertebral fusion to remediate symptoms. Post surgery - paresthesia and numbness symptoms continued and expanded into buttocks and right leg by 10/21/2021. Symptoms expanded to left arm on 12/18/2021 and then in right arm 01/13/2022. Cortisone epidural administered to lumbar and cervical spine 01/24/2022 & 02/01/2022 - no effect. Paresthesia and numbness spread down spine from neck to pelvis on 02/09/2022. Paresthesia spread across abdomen on 02/19/2022. Orthopedic surgeon(s) and neurologist have not been able to diagnose cause or effect of paresthesia, numbness, and atrophy. Hospital ER for dizziness, shortness of breath, and weakness 02/24/2022.
A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a 9-year-old female subsequent to FLUMIST.  Neither medical history nor concomitant medications were reported.  On 06-Jan-2009, FLUMIST which expired on 28-Dec-2008 was administered to the patient.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009: product complaint investigation results.  Additional information was received on 24-Apr-2009:  route of administration of suspect FLUMIST, where the patient was vaccinated and that no delayed adverse events resulted from this error.
Developed redness, pain, swelling, induration within 4 hrs of receiving her first anthrax vaccine.
mom phoned & reported that baby stopped breathing approx 1-2hr p/vax;T98.2, R36;dx breathing holding spells ? apneic;pt irritable;final dx immun side effect, periodic  breathing, URI;
fever of 104 F on 6/19.  papular diffuse rash on abdomen and upper back since 6/19 evening
18 yo female requests to have injection in supine position due to previous history of passing out with injections.  Mom at pts side and sts pt first passed out at the age of 4 years old when she witnessed her father having blood drawn for a health screen.   She also reportedly passed out after receiving a vaccine at Pharmacy in 2017.  Due to her history of injection related syncopal episodes, pt is placed in a supine position on the cot as precaution. Approximately 30 seconds after receiving the injection, the pt was witnessed becoming unresponsive by this HCP.  Pt was then witnessed having her eyes roll up and back followed by a  few seconds of generalized seizure activity.  HCP remains at pts side.  The cot has a suspended cloth and is soft, therefore, pt is safe from harm on it.   Seizure ends after seconds and pt awakens.  She is initially confused but orients quickly.  She remains AOX4 and has no complaints.  Spoke with mom extensively about pts condition and presenting symptoms.  VS- HR initially 52 but quickly improves to 77, BP 107/64, RR 16, sats 98%.  Pt will follow up with  pts pediatrician.  Mother and pt do not want pt evaluated at the ER today and do not want an ambulance.  VAERS info given.
12 hrs after vaccine experienced typical adverse side effects of arm pain, fatigue, headache, myalgias and arthralgias. 24hrs after vaccination the initial symptoms persisted and also developed urticarial macular exanthem from scalp to waist along with decreased urine output, joint swelling, edema, Had intermittent tachycardia.  Symptoms lasted for 72 hours.
CLIENT STATED HAD NOT HAD A FLU SHOT FOR SEVERAL YEARS. SHOT ADMINISTERD WITHOUT ADVERSE RESPONSE. UPON DATA ENTRY NOTED CLIENT HAD RECEIVED FLU SHOT 10/19/2022 APPROPRIATE PROTCOL FOLLOWED FOR BEST PRACTICES.
c/o numbness R side of face, with inability to close R eye; course of prednisone prescribed; resolved within 1 week; client had a right ear infection with significant purulent drainage which was being treated and had been seen by the audiologist 1/27/10.
Shingles after receiving Shingrix; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter stated that the patient developed shingles a few days after receiving Shingrix vaccine. It was unknown if this was the first or second dose. No additional information reported. The reporter consented to follow-up.
Approximately 1 hour after receiving vaccines, patient complained of generalized itching (no observed rash), abdominal discomfort and body ache.
This spontaneous report was received from a healthcare professional and refers to multiple unspecified patients with unknown demographics. Information about the patients; pertinent medical history, drug reactions allergies and concomitant medications was not reported. On an unspecified date in 2016 (reported as from 01-MAR-2016 through 08-MAY-2016), the patients were vaccinated with doses of improperly stored RECOMBIVAX HB, lot # L018501 with expiration date 22-JUN-2017, (dose and route of administration were not reported). No adverse effects were reported. The vaccine experienced the following temperature excursion: 7.2 F, on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.