chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 6 hr after administration of vaccines child c/o feeling nausea and vomiting per mom 2 hr later child felt feverish. No temp taken. 9/6/07 child c/o swollen R deltoid with redness-hot to touch 4 pm 9/6/07 saw provider at clinic Rx Benadryl every 6 hr with cold compress to site. 9/7/07 4 pm p.c. to mother per mom child much improved
Information has been received from a consumer concerning her 8 year old daughter with no known medical history or allergies who was vaccinated with a dose of varicella virus vaccine live over six years ago.  There was no concomitant medication.  On 01/28/2005 the mother reported that her daughter developed a significant case of varicella with over 300 lesions.  She was exposed to wildtype recently at her elementary school.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were performed.  There was no product quality complaint involved.  The patient's sister also had a similar experience following exposure to varicella virus vaccine live (oka/merck).  Additional information has been requested.
Patient also had a severe COVID case previous to having clots; Patient also had a severe COVID case previous to having clots; Patient also had a severe COVID case previous to having clots; This is a spontaneous report received from a contactable consumer via sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via an unspecified route of administration at Arm on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that About 2 weeks before the clots re-appeared received the Pfizer COVID vaccine in the same arm about 2 weeks before the first occurrence of clots in May. Patient also had a severe COVID case previous to having clots on 2021. Event took place after use of product. The patient underwent lab tests and procedures which included investigation: blood clots on 2021. Therapeutic measures were taken as a result of patient also had a severe covid case previous to having clots. The outcome for the event covid-19, drug ineffective was unknown and outcome for thrombosis was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up
Fatigue, myalgia, nausea, shivering, felt confused/disoriented for a couple of days after 2nd vaccine; symptoms self resolved
Pt started itching all over her body approximately 24 hours after vaccine was administered. Never had this type of reaction to any other vaccine.  Red areas were seen by patient on skin, but no pustules or any other physical signs.  Reaction seen on her head, arms and neck.  Pt was told by RPH to take Benadryl (she called us approx. 42 hours after vaccine was administered) and this seemed to have helped the reaction.
Local redness, cramping and abdominal discomfort, lasting 2 days. Began 6 hours after shots given.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "the caller's body is severely sensitive" (unspecified if ongoing), notes: Verbatim: the caller's body is severely sensitive; "blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: COZAAR taken for blood pressure abnormal; IBUPROFEN. The following information was reported: MALAISE (non-serious), outcome "recovering", described as "didn't feel great after the first dose". Additional information: Pfizer Covid vaccine: didn't feel great after the first dose - Related. Follow-up attempts completed. No further information is expected.
the vaccine was not diluted properly causing the patient to get a higher dose of vaccine than recommended. no adverse advents to patien
the 11 year old received the Fluzone HD with no side effects; the 11 year old received the Fluzone HD with no side effects; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site On 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Information has been received from a pharmacist concerning his wife with rheumatoid arthritis who in August 2010, was vaccinated with the second 0.5 ml pediatric dose of RECOMBIVAX HB (Lot# not reported). Secondary suspect included the first pediatric dose of ENGERIX-B on July 2010, and on an unspecified date, the patient was vaccinated with the third 1 ml dose of ENGERIX-B. Concomitant medication included ENBREL. It was reported that his wife did not sleep well the night after the third dose. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M035688 with expiration date of 10-AUG-2018, lot number M033906 with expiration date of 20-JUL-2018 or lot number M028551 with expiration date of 07-JUN-2018 (strength, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The administered doses with lot number M035688 were exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours (digital data logger) without any previous temperature excursion. The administered doses with lot number M033906 were exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours (digital data logger) with two previous temperature excursion at a temperature higher than -10°C but lower than 8°C for 16 hours and 52 minutes (digital data logger)  an at a temperature of  -2.8°C for 1 hour and 32 minutes (digital data logger). The administered doses with lot number M028551 were exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours (digital data logger) with two previous temperature excursion at a temperature higher than -10°C but lower than 8°C for 20 hours and 16 minutes (digital data logger)  an at a temperature of  -2.8°C for 1 hour and 32 minutes (digital data logger). No adverse effects were reported. There was no product quality complaint involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA008111:
patient got extremely dizzy immediately after administration, I had him place his head between his legs and he fainted. I then applied a cool compress to the back of his neck and called his name and he responded almost immediately.  I gave him a bottle of water and sat with him for 15 minutes at which time he stated that he was feeling much better.  I then had him remain in  the post-vaccination area for an additional 15 minutes for observation.  He was feeling well when he left the pharmacy
This spontaneous report was received from a female consumer of an unknown age, and refers to herself. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unspecified date in February 2017, the patient was vaccinated with a dose of (wistar ra 27-3) M-M-R II (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) for prophylaxis. Subsequently, on an unspecified date in February 2017 also reported as "within 15 minutes of receiving the vaccine", the patient had "outbreaks" on her skin which were described as "raised bumps that travel and run, biting and pinching sensation anywhere on body from seconds to minutes to days then disappear" (rash papular); additionally, she mentioned that her life had been unmanageable, she had dropped out of school and was stuck in her house all day. Consequently, she sought medical attention through a visit to five different specialists who were not able to diagnose her, nor treat her. At the time of reporting, the patient had not recovered from rash papular. The causal relationship between the therapy with (wistar ra 27-3) M-M-R II and the event was not reported. Upon internal review, rash papular was determined to be a disabling event.
Patient c/o perioral tingling and unilateral tongue numbness about 40 minutes after vaccine.  No swelling, difficulty swallowing, sob.  HR 83  RR 16  BP reported as normal.  Advised patient to take Benadryl 50 mg po now and have supervisor escort her back to vaccine clinic.  Patient waited in the vaccine clinic for 1 hour.  Symptoms resolved without further incident.  Advised contact health care provider before receiving second dose of vaccine.
Ten minutes after injection, patient began vomitng, diaphoretic and then nauseated, sounds amplified, and stated she felt like she could pass out. Patient reports she does experience these symptoms often with injections and blood draws. B/P was 86/52, pulse 79, spo2 99%. After a few minutes, reported feeling better. Vitals at that time 12:56 102/70 pulse 82 SPO2 98%. Feeling back to normal after another 10 minutes; B/P 104/70 Pulse 70 and SPO2 98%. Patient returned to base-line and left the facility at the conclusion of the 30 minute observation period.
RASH WAS COVERING WHOLE FOREARM ON LEFT AND RIGHT ARMS FROM ELBOW TO WRIST; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included amlodipine, ezetimibe, furosemide, hydrochlorothiazide/lisinopril, metoprolol tartrate, potassium, rosuvastatin, and zolpidem.  On MAY-2021, the patient experienced rash was covering whole forearm on left and right arms from elbow to wrist. On 19-AUG-2021, treatment medications included: betamethasone dipropionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash was covering whole forearm on left and right arms from elbow to wrist. This report was non-serious.
Systemic: Joint Pain-Medium, Additional Details: Patient called pharmacy on 3/31/23 to inform that since receiving the Shingrix vaccine she has had pain in her right hand, right elbow, and right hip. She said this started after her vaccine. The pain started in her hand then went to her elbow and now has affected her hip. She has not been to the dr. Informed pt if it continues/worsens to see her provider.
April 13 - April 14, 2021  Numbness in fingers and toes. May14, 2021 confirmed GBS (Guillain Barre syndrome) Admitted to hospital May 14, 2021 for IVIG treatment
Heart Palpitation and difficulty breathing because of the heart beating. I called the doctor's office and was told to go to hospital. So that's what I will do. Will see what happens.
Formulation was mixed with .3 of  diluent instead of the 1.3 of diluent. Instead of pt receiving the recommended 10mcg dose of the vaccine, pt received 20mcg dose.
Day 1- no mark, day 2- swollen and painful to touch, outline of Bain aid that was removed the day prior at injection site., day 3 large red blotch on arm.  Painful to touch and painful to move arm.
I am not sure if it is directly related to the vaccine but I figured it was worth notifying as you can keep track and see if there is a trend or if my case was simply coincidental. I was 34 weeks pregnant when I received my first dose of Pfizer and the very next day, my water broke and I went into labor. Delivered a 34 week preemie. Again unsure if related or coincidence but I had no complications with my pregnancy so figured it was worth mentioning. Thank you.
Arm where vaccine give was very swollen to just above elbow, warm, erythematous, painful.
Pain in right arm, swelling of lymph nodes under arm right ear and neck area. Right ear ringing and pain. extremely tired. This are the same issues I had previously after the 2nd dose of Moderna vaccine in 3/10/2021 (010m20a). My Lymph nodes on left side were swollen with same symptoms as above and continue to periodically swell on the left side only. Left arm has a hard lump still present at injection site. Went to urgent care and has prescribed antibiotics a few months ago. Appears that every time a get slight ill I have a lymph node flare up issue. Recent booster on 11/9/2021 appears to have cause this issue again but on the right side this time (same side as the injection)
Left deltoid discomfort on 10/8, pt took 800mg that night with no relief. On morning of 10/9 increase tenderness and some local swelling with 2-3 spots rash, swelling and tenderness incrase and spread down to mid-bicep region around arm, up into arm pit and on back side of should. Due to increase and spread of swelling pt presented to pharmacy at approx. 6:55pm.  Pt denied any difficulty breathing and no chest tightness. Left deltoid was tender to touch and warm to the extent of swelling as described above. Pt denied a diphenhydramine injection due to the tenderness.  She was give and took 50mg diphenhydramine oral liquid and 150mg oral tablet. She was direct to go to ER for further evaluation and agreed she would.
Patient received Pfizer COVID-19 vaccination shot #1 from pharmacy on 7/23/2021. Patient returned for Pfizer shot #2 on 8/13/2021. At the time of the second shot the patient admitted to having received the Johnson and Johnson COVID-19 vaccination in march from another provider. Pfizer shot #2 was not administered. Patient did not report and Adverse event.
Mom reports that other family members told her infant was playing on the floor with her toys and she "tipped over and her eyes rolled back." Infants dad put her in car seat and drove her to Hospital.  Infant was not responsive for one minute and then was sluggish.  At hospital all vitals were with in normal limits and infant was fine that evening.  Mom also stated right side of infants face had a rash and was gone within one hour time.  Infant was sent home from emergency room and has had no ill effects.  Mom reported this incident to this office on 02/19/2010
Slight fever on same day of vaccine.; This is a spontaneous report from a non-contactable consumer. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient experienced slight fever on same day of vaccine on 28Jan2021. Outcome of the event was unknown. The reporter considered the events as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Myalgia, Arthralgia, "SKIN HURTS" LARGE PAINFUL SWOLLEN RIGHT AXILLARY AREA, GENERALLY FEEL LIKE CRAP, INJECTION SITE SORENESS: Narrative:
I felt a lot of pain about half hour after flu shot was given, but thought it was normal. It's getting worse now as the days go on. Severe pain in that spot where I got flu shot. I cannot lift my arm fully and when I sneeze, the pain goes directly to flu shot spot and it feels like someone punched me in that spot. It hurts so much.
Injection site wheal - Information has been received from a physician concerning a 16 month old male patient who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 632532/1270J in the arm.  Concomitant vaccinations administered that same day included one dose of varicella virus vaccine live (msd) in the arm.  It was noted that the 2 vaccinations were administered in opposite arms.  Within 5 minutes of vaccination, the patient developed a local reaction at the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation injection site described as a twentyfive cent urticarial lesion.  There were no other symptoms.  The patient was treated with diphenhydramine HCL Benadryl.    The patient's symptoms resolved in less than 1 hours.  There was no reaction to varicella virus vaccine live (MSD).  The patient had a serum multiallergen radioallergoeorbent test and was found to be negative for gelatin and egg.  It was noted that 2 months later the patient was vaccinated with Hib (lederle vaccine) and had a similar reaction.
Wheezing. Swelling, inflammation  Know allergic to chicken, peanuts mustard.  Now have an epi pen.
Pt awoke without vision in the right side (completely blurred). Saw MD this morning and has corneal inflammation.
Patient c/o throat closing, SOB, and chest pain within minutes after receiving the vaccine.  Her vital signs showed tachycardia, increased respirations, and elevated blood pressure.  She had a hard time speaking in full sentences.  She does have a history of anaphylaxis to certain medications.  She was administered epinephrine auto injector IM and brought to the emergency department by rapid response team.
two weeks of swelling and pain of left upper arm after influenza vaccine.   pain and swelling resolved.  A 1.5cm indentation in the upper arm at vaccine site has developed.   appears to be lipodystrophy of the area over the left deltoid the area is no longer painful.  the area is itchy there are no signs of infection. The patient was seen a health center a school based health center.  the vaccine was received at PCP.   The patient and parent were referred to PCP. recommended to contact pcp for appt. Parent plans to take patient as a walk in to the PCP. it is unknown if this is permanent damage to the tissue of the left arm.  permanent scar is possible and likely
Patient complained of "burning in her throat" immediately after receiving the vaccine. I gave her a bottle of water to drink. She then complained of a lump in her throat. I gave her a dose of benadryl, and I monitored her for over 30 minutes. She said she did not feel any better and went to the ER where they monitored her for several hours, sent her home, and told her to take more benadry.
2 hours after injection patient states she spiked 102 fever, had chills/body aches, a migraine, pain and bruising at injection site, and a rash on her upper back. Called her MD and was told not to get the second shot.
Within 5-6 hrs post vax, pt noted to have redness, warmth and induration around immunization area. Pt also was fussy and whimpered when right thigh moved. He was brought back in to office 6 hrs after immunization for recheck on area. A very faint, circumscribed area around IPOL with faint blue ring with clear center (2" in diameter) noted. He was treated with Benadryl. Site of reaction treated with warm moist compresses.
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 12-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 12-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
Flucelvax flu vaccine approved for 18 and older and was administered to 17 year old.
Patient was sitting for 10minutes when husband reported she started to slurr speech and inability to communicate  Upon entering the room patient has head tilted against wall with arms and legs spread out  Patient was responsive, but weak, reporting she felt paralyzed and couldn't open eyes  Vitals taken, vitals we're stable Pulse ox-98%, BP-144/90, Pulse 90, glucose-110 After 5 minutes, patient was still weak, unable to open eyes, pupils had no response to light EMS called  1 hour post vaccine, symptoms have improved as per husband  ER doctor told patient symptoms should resolve over course of day