chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; received 3 doses of GARDASIL 9 at intervals not consistent with the recommended dosing schedule; This spontaneous report was received from a physician concerning an 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.    On 11-JUL-2016, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # L043213, expiration date: 28-AUG-2017, route unknown) for prophylaxis. Then, on 12-SEP-2016, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # L043213, expiration date: 28-AUG-2017, route unknown). Finally, on 05-DEC-2016, the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # L037554, expiration date: 25-DEC-2017, route unknown) which is an interval not consistent with the recommended dosing schedule. No other adverse event (AE) occurred.
arm swelling, fussy continuous thru next day. Reseen, found to be in SVT.
w/in approx 2 wk began noticing purple spots approx 1cm on torso, arms, legs, feet turned purple @ times, especially when elevated;exp leg pain (muscular apparently) & listlessness;rash cont;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A, expiry: unknown) dose was not reported, 01 total administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-NOV-2021, the patient experienced suspected coronavirus disease-19 (covid-19) infection hence patient had received only two months protection from covid-19. On an unspecified date the patient experienced suspected clinical vaccination failure. The patient's asthma symptoms were also addressed for which she received the monoclonal antibodies and was doing well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000201218.  T; Sender's Comments: V0: 20211119221-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
The patient recieved Moderna primary series #1 on 03/29/2021, Moderna primary series #2 on 04/26/2021. This dose was not present in the system at the time the 3rd dose of J&J was administered. It was entered historical 05/31/2022. The J&J vaccination was unapproved, yet administered 06/30/2021 (2 months after Moderna primary series #2). Patient then received 4th vaccination of Pfizer on 05/31/2022.
P c/o dizziness. Juice PO administered.  Pt improved p  5-10 min.  Released w/o interventions.  BP & HR wnl. Pt  required no primary medical help.
Pt complained of headache, chills, flu-like symptoms, nausea. Today worse. 05/29/2002 pt answered phone, much better felt like had a virus that happened about same time as shots.
sore arm; first Shingrix shot date November 2018/did not receive the second shot within the 6 month time frame; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had pain in arm. The patient did not receive the second shot within the 6 month time frame, which led to incomplete course of vaccination. Limited information was available. The reporter consented to follow up. Lot and expiration date was unavailable.
warm to touch; red rash at injection arm; sensitive to touch; itchy at times; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch), INJECTION SITE ERYTHEMA (red rash at injection arm), INJECTION SITE PAIN (sensitive to touch) and INJECTION SITE PRURITUS (itchy at times) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0121209 and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa medicatiion).   On 13-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021 at 3:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm to touch), INJECTION SITE ERYTHEMA (red rash at injection arm), INJECTION SITE PAIN (sensitive to touch) and INJECTION SITE PRURITUS (itchy at times). On 28-Jan-2021, INJECTION SITE ERYTHEMA (red rash at injection arm) had resolved. At the time of the report, INJECTION SITE WARMTH (warm to touch), INJECTION SITE PAIN (sensitive to touch) and INJECTION SITE PRURITUS (itchy at times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Mom reports patient developed rash over body and then face swelled and she developed wheezing.  911 was called to her home and child taken to ER where she was given BENADRYL and oxygen and observed for several hours and then discharged.  All rash and breathing difficulties resolved.  Noticed spots at 1PM & ambulance arrived 9:15PM. 6/30/08-records received for DOS 5/22/08-Impression: rash/allergic reaction. Presented to ED with 3-4 day pattern of decreased eating and urine output. Today woke up with rash, nonelevated on trunk, and soles of feet and palms and periorbital swelling.
PT STATES SWOLLEN EYE LID THE MORNING AFTER VACCINATION.  SHE TOOK BENADRYL AND ICE PACK APPLIED AND SYSTEMS RESOLVED WITHIN A COUPLE OF HOURS.
Patient states she developed a rash on the right upper thigh about 20 minutes after she received the 3 vaccines.  The rash looked like an area of scattered red bumps that had a pimple-like appearance.  She states that about one hour later the red bumps started to resolve and the skin started to look bruised. The bruise lasted for about 1 week and the spontaneously resolved.  The rash area was itchy for two days.   There were not systemic symptoms.
Two days post vax the pt experienced mild fatigue and headache and felt like she was getting the flu. She reported that she felt extremely tired as the day progressed. Around mid-day she experienced a quick onset of muscle and joint pain. Within an hour, her entire body hurt. She developed a headache across the eyes. She developed nausea that came in waves and vomited once. She became dizzy and developed a low grade fever and chills. She reported that she became so weak, she could barely walk. She developed pain in her rib cage and reported that it hurt if she took a deep breath. She reported that she was so weak, her arms and legs were shaking. This lasted for eight days and she was seen by her physician on 07/11/2000 and sent to the ER on 07/12/2000. She did not seek medical attention prior to this time as she was uninsured, but she was so sick she could not avoid it by 07/11/2000. All tests performed in the ER were negative, including a test for Lyme disease. She was started on doxycycline 100 mg bid and according the the pt, continued to receive doxycycline. After three day on doxycycline symptoms seemed to plateau. Between 07/15 and 07/20/2000, the nausea, vomiting, fever and headache resolved. On 07/20/200 she developed tingling and burning sensations and then the skin started to peel on her anterior feet and palms. The pt reported that the ER physician felt that these side effects were due to the doxycycline. As of 07/20/2000 the pt reported that she continued with generalized weakness, fatigue, muscle pain in her lower arm and thigh muscles.
Pediatric dose COVID 19 Pfizer vaccine, 2nd dose, administered in clinic by MA 3/20/22 at 1:10 pm. 1.4mL in deltoid. Intended dose was 0..2 mL. Patient monitored in exam room for 1.5 hours after. Mom with patient. Vital signs normal. Patient reports feeling well. Advised to monitor for any fevers, shortness of breath, fatigue, throat itching, rash. Ok to give prn children's Ibuprofen or Tylenol. Dosing chart provided. ER Hospital precautions advised should any adverse reactions to the vaccine occur. Advised to bring patient to hospital this week if needs further evaluation. Patient's mother called 3/20/22 at 4:50 pm. Patient is doing well.  Mom has no other questions at that time. I called patient's mother following day 3/21/22 at 8:01 am patient had some mild abdominal pain, headache, photosensitivity that morning but had not taken ibuprofen or Tylenol the prior day, evening or that morning. Advised if minor symptoms to take Tylenol and Ibuprofen and monitor. I called mother back on 3/21/22 at 2:19 pm and mother reported symptoms improved with Tylenol/ Ibuprofen. Hospital called mother on 3/22/22 and patient was having left upper arm tenderness, redness, itching. She was advised to bring patient into the clinic for evaluation. She was evaluated by a APC at 10:30 am on 3/22/22 who recommended cool compress to the area and antihistamine. She was called the following day 3/23/22 and a voicemail to call back was left on her phone. Patient/ patient's mother was called again 3/24/22 and spoke with patient's mother who reports her symptoms are better.
2 months off of work. Participant says she started experience the extreme panic June. Participant delivered her baby in January, weekly therapy. Participant is on sleep medication seeing a PCP.
pt exp inj site rxn of redness,swelling & itching p/vax.
Case number PHEH2016US027654, is an initial spontaneous report received from a nurse on 21 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX Quadrivalent (batch number: 185887) at a dose of 0.5 ml intramuscularly on 21 Oct 2016. The nurse stated that, the patient received a dose of FLUCELVAX that experienced a multiple temperature excursion above and below the recommended temperature (temperature range unspecified). No adverse event was reported following this administration error.
On the evening of 22FEB pt exp joint pain, h/a, body aches; These intensified & on 24FEB had inc temp 102, chills & c/o numbness in fingers & hands; pallor & duskiness noted around eyes; chills, fever sl h/a last x 4 days but dec intensity;
Pfizer vaccine was reconstituted with sterile water instead of normal saline and administered.  The patient is not reporting and adverse effects at this time.
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX M018766 15-OCT-2017. No adverse effects reported. The vaccines reached 15.5 c for 3 hours. Data logger was yes. This is one of the two reports received from the same reporter. Additional information has been requested.
No adverse effects that this time. The patient was given their second Moderna vaccine on 5/2/21, when their first was given on 4/15/21. The patient has dementia and did not remember the first dose, and the dose was not reported to immunization reporting tool and was not billed to the patient's insurance by the first facility.  Our facility had no indication that this was their second dose, and that it was too early.
During administration the needle came loose from the syringe and the vaccine was expelled to the floor and patients arm. Determined that no vaccine was given and dose was repeated
Having problems in my left arm where I got my shot at; still paining; pain that was in shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Lot number: HD9876, Expiration Date: Oct2024), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "not recovered", described as "Having problems in my left arm where I got my shot at; still paining"; ARTHRALGIA (non-serious) with onset Nov2023, outcome "not recovered", described as "pain that was in shoulder". Additional information: consumer stated, "I got my COVID-19 shot on the 18th (18Oct2023) and that time I got my shot I did not have any problems. The first week of November, I have been having problems in my left arm where I got my shot at and I would like to know why or what I can do to stop this problem from time to time, by 6 to 7 times a day and that is left arm where I got the my COVID-19 shot, do you have any advise or what would be causing it or what?". Stated that it was still paining. Patient does not know what to do to get rid of the pain that was in his/her shoulder but he/she went to the Pharmacy. They told him/her to call because after 2 weeks, it should not be a problem but the patient was still having problem in his/her left arm.
this is one of 4 individuals, out of 25 vaccines to devel a red, hard knot @ the inj site p/vax;
Within the day of vaccination, area next to vaccine shot became read and hurt. The redness grew as big as a half dollar size and was hard, soar, and warm to touch. Child complained constantly that it hurt. it's been 5 days and redness has gone down but it's still a hard half dollar size and soar to the touch. Child has began itching it.
This spontaneous report as received from a physician refers to a 12 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 17-APR-2015, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (lot # K015310; expiration date reported as 17-DEC-2015) (dose and route not provided) in error, instead of (Merck) VARIVAX. At the time of the report, the patient had not demonstrated any adverse effects. Additional information has been requested.
Face became reddened. Swelling across eye brows, left eye and down to cheek. Dr notified. TYLENOL and BENADRYL were given. BENADRYL given by mom every 4 hours.
Mild angioedema. No urticaria, no resp distress, no anaphylaxis.
arm was sore; fever; chills; headache; lethargic; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Age at Vaccination 39-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arm was sore, fever, chills, headache and lethargic. It was reported that patient reported that he took COVID-19 vaccine. After that in the evening he had fever, chills, headache and was lethargic. The next day those symptoms resolved but arm was sore. The outcome of the event arm was sore was unknown. The outcome of the events was recovered on unspecified date.  Information about batch/Lot number has been requested.  Follow-up (28Jun2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
On August 15, 2021, the patient noticed a red area of skin around the site of injection. She had no itching or pain. On examination from the pharmacist on August 16th, the area looked slightly inflamed and warm to the touch. The pharmacist traced the red area with a marker so the patient could evaluate whether the area was growing or shrinking. The pharmacist recommended OTC options such as ibuprofen, benadryl cream, or hydrocortisone cream.  The patient also had a small bruise right at the site where the needle was inserted.
Systemic: Lymph Node Swelling-Severe, Additional Details: extreme lymph node swelling under right arm on same side as injection
pt recv vax & exp rash, redness & pain in the muscle;13SPE96 pt exp heel pain which moved up leg;
Patient states that she didn't feel well after flu vaccine. Went home, had a light supper, became delirious and required ambulance transfer to hospital. Profound hypoglycemia of 29.  11/07/2007 MR received for DOS 10/15-16/2007 with DX Hypoglycemia. Diabetes Mellitus type 2.  Pt was brought by ambulance to ER for delirium.  Pt c/o not feeling well fater pm meal, but became delirious.  BS in ER on arrival was 29. Pt was given IM Glucagen IV Dextrose which rapidly brough BS to over 200.  Pt remained somnolent, but improved o/n.
I felt nauseous, I did not pay any mind for awhile, but then I continue to feel bad, so i took a pepto bismol.  32 minutes after the pepto bismol I still felt nauseous.  The nauseating feeling got so bad I began to vomit.  Then I took my mother prescription strength 12.5mg of nausea medication.  I vomited a little more after the medication, then I started dry heaving,  A few minutes later the nausea went away, but I now had stomach that was not caused by my vomiting. However the prescription strength medication took my stomach pain away.
Pt. said she felt anxious & nervous said throat felt dry. Later stated throat might of felt a little swollen. (Pt. previous had anaphalatic reaction to pcn & is very anxious about getting shots.) Sat in Pharmacy for about 15 min. I called her MD & they suggested the ER. Informed pt. said she was feeling better and was going to go home & relax. Husband was with her and also stated that she gets herself worked up about shots.
Shortly after vaccine as I was driving home, I got floaties in my right eye and had flashes in my peripheral  vision.  The flashes are finally gone, (2 months later), but the floaties are still in my eye.  After my very first Pfizer vaccine, shortly after the dose as I was driving home my upper lip on my left side went numb.  This lasted several days and is gone now.
I have had Fibromyalgia for over 10 years but it has been very well controlled over the last two years.  Three weeks post-vaccination I started experiencing the worst fibromyalgia flare-up I've had in 11 years. My treatment for fibro flares is to use strict sleep hygiene protocols, keep stress levels to a minimum, stay in motion as tolerated, and be extra careful with my diet - no alcohol, leftovers, canned, food, or anything that may have mold or yeast in it.  This routine clears a flare-up within 10 days at most. Nearly 11 weeks later, the flare-up has lessened but I am still not able to perform regular activities of daily life.  Five months ago I was highly active, social, and living a normal life.  Now I have to plan my energy to wash my hair.  I had no such reaction to the first three vaccines.  I am new to this area and do not have a fibromyalgia specialist, so have followed the guidelines given by my doctor. I have visited a psychologist to determine how to handle the psychological components to this prolonged setback.
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL9265) via an unspecified route of administration in arm right on 16Feb2021 (age at Vaccination 66 years) as dose 2, single for COVID-19 immunization. Medical history included palpitations (she had them for about 8 years now), hypothyroid and a nodule on her thyroid. She did not suffer from anxiety. With the palpitations, she get shaky, teeth chatters, she do cold packs, and breathing exercises. There concomitant medications were none. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL8982) via an unspecified route of administration on 25Jan2021 (age at Vaccination 66 years) as dose 1, single for COVID-19 immunization. On 19Feb2021, the patient experienced nausea, pain at the injection site and increased palpitations. On an unspecified date, the patient experienced dizziness, weakness, headache, tiredness, lethargy, diarrhoea and dry mouth like she was dehydrated. She said that last night she was up until 5am with severe palpitations. She said that she has a nodule on her thyroid and is trying to rule everything out. She has a biopsy scheduled for next month. They gave her alprazolam 3 mg and she took it early and it did the trick. She was prescribed metoprolol. Therapeutic measures were taken as a result of nausea and increased palpitations. She took some Pepto Bismol. She said that 3 days after the injection she had increased palpitations, nausea, and pain at the injection site. The nausea subsided, but she reported that she also had dizziness, weakness, diarrhea, slight headache. She said that always has headaches though. She said that she also had tiredness and was lethargic. She said that her main concern was the palpitations. She also had dry mouth like she was dehydrated. She was wondering if it trigger something with her thyroid. On an unspecified date in 2021, the event nausea was recovered. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
Patient return to vaccination site 2 hours and 20 minutes after getting their third dose. Patient presented with cheif compaint of severe abdominal pain. Roughly 20 minutes later chest pain developed with  the abdominal pain. The medic onsite administered the patient 25mg Benadryl PO with no relief. The facility nurse then administered the patient's prescribed nitro and evacted the patient to the ER.
Swelling at the site of administration that lasted approximately 1 week.  A red streak appeared on my arm, approx. 2" long,the day after I received my shot and remained about 1 week.
10/18/2001 the patient developed a significant varicella outbreak, greater than 20 pox.
MODERNA COVID VACCINE #3 GIVEN 10/25/21, LOT #012F21A; Patient had a hospital admission on 9/8/21 and was diagnosed positive for COVID; did not require O2 and no sx of COVID; Patient was weak with impulsive behavior and metabolic encephalopathy; out of isolation on 9/18/21; Patient was unable to tolerate oral intake; DNR; family with COVID and unable to care for Patient at home; requested inpatient hospice; Patient transferred to inpatient hospice where he expired.