chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Just after receiving flu shot injection the site itched, stung and was tender with localized swelling. My wife is an RN and suggested ibuprofen and ice. The next morning it was fine. It was about 48 hours later I first noticed a rash. I only noticed it when showering because the area around the injection site felt oddly hard and lumpy. It did not itch and was not tender. Because I do not have any food or medicine allergies and had no other symptoms my wife gave me Benadryl and put some hydrocortisone cream on the rash. She described it as "small fluid filled vesicles, similar to shingles or a cluster of herpes-type blisters. As mentioned the skin and "rash" felt hard. The only thing my RN wife could come up with that may cause this reaction was the possibility of the preservative (Thimerosal) used in the multi-dose flu vaccine. When contacting the Pharmacy they denied using multi-dose vials and said they only use prefilled single dose syringes. The pharmacist told my wife they had been aware of the preservative being previously used in single-dose injections but we're not sure if the ones they used had the preservative or not. Two days later the rash has almost resolved. My wife did take a photo of the rash.
Daily headaches since second HPV-9 vaccine. Happens at various times of the day for various amounts of time. Described as being the whole head, sometimes throbbing. Some light sensitivity. No nausea. No blurry vision. Some improvement with ibuprofen. Had 48 hours of headaches noted after first HPV-9 vaccine.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concomitant medications and drug reactions/allergies was not provided. On 06-SEP-2018, the patient was inadvertently administered improperly stored PROQUAD (lot # R002934, expired date29-JUL-2019) for prophylaxis (Incorrect product storage), which was reconstituted with properly stored sterile diluent (MERCK). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 46 minutes. Data logger was involved. The vaccine was previously exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 28 hours and 24 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 35 hours and 21 minutes. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA011721.
On January 11, 2022 had a period of about 30 hrs with left hearing loss. Then hearing started to come back but with tinnitus and essential tremors on the entire body.
Erythema and swelling of face and erythema of skin in general - mild swelling of digits. No dyspnea, positive chest pain, negative EKG.
Patient had syncopal episode witnessed by nursing staff Patient appeared pale and diaphoretic Patient seen by medical team and provided with water Patient had history of syncopal episodes and hypotension Patient sent to The hospital via ambulance for low blood pressure and low heart rate
Client reported itchiness with minor rashes to left arm. Vital signs taken and within normal limits. Client denied shortness of breath,  dizziness. One dose of Diphenhydramine 50 MG given with effective relief. Client observed for additional 15 minutes. Vital signs taken post diphenhydramine. Rashes and itchiness subsided.
STABBING PAIN IN THE RIGHT SIDE OF CHEST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the patient experienced stabbing pain in the right side of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stabbing pain in the right side of chest was not reported. This report was non-serious.
Pt received TDaP and varicella in L arm on Tuesday 9/8. Pt reports significant HA and low-grade fever that night; itching started on morning of 9/9 and small, circular rash that developed increased irritation, redness, and pain in subcutaneous fat area of arm. Presents today with approx 4inch circular area od induration at varicella administration site.
Numbness in entire arm including fingers and part of left face 15 minutes after vaccination. After going home,  2 hours later I developed a fever that spiked to 103.7 degrees and remained for approximately 36 hours. Numbness in arm, hand and face still has not subsided 48 hours after incident. I don't know yet if the numbness in my face, arm and hand are permanent.
4-5 days after my vaccine, my arm started to swell and get red and itchy at the injection site, and it stayed that way for about a week until gradually the redness and itchiness went away.
Patient came into pharmacy a few days later and her are was swollen and red. It was also warm to the touch. The area affect was around the injection site, in a band-like shaping wrapping around the arm about 3 to 4 inches in width. Patient was sent to MD for examination.
Severe pain in joints beginning the day after vaccine and continuing for three days. Second dose, the pain and join involvement was worse, pain 10/10, missed work and unable to get out of bed
Put on shirt after it arm hurt since arm hurts-achy from after got shot down arm to wrist.
expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No Treatment medication was reported.
Information has been received from a physician concerning a female patient with autism who on unspecified date, was vaccinated with a dose of GARDASIL (lot number, dose and site of administration not reported). On unspecified date, the patient worsened after receiving vaccine. Upon internal review, autism was determined to be an other important medical event. The sister's experience has been captured in WAES1104USA00214. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
COVID/tested positive; COVID/tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL3246), on 29Jan2021 as dose 2, single (Lot number: EL9261) and on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID/tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Dec2022) Negative. Clinical course: The patient was very okay when she had COVID last year. She tested positive and was still okay.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366141 same patient, different dose/event;
bilateral axillary lymph node swelling, breast tenderness.  CT imaging performed, showed right breast density.  Mammogram and ultrasound ordered.
Stomach ache followed by severe vomiting (8 times between 8:00 PM and 4:00AM).  Pulse rate increased to 130 beats/minute.  Called Pediatrician office twice and then took daughter to ER because she could not keep anything down (even water) and was getting dehydrated.
Pt requested Pfizer COVID bivalent vaccine but was given Pfizer COVID monovalent vaccine in error due to provide moving quickly and not double-checking label.  Pt did report sore arm and "feeling crappy" for the following day but otherwise no other adverse effects.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient (age and gender not reported), who was vaccinated with a dose of vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
sharp high fever (106-107),  lingering low grade fever (101-103), chills, body aches, headache, cold extremities, fatigue
SVT, heart rate extremely high for several hours starting in August 2021. Emergency room 2 times in November and follow up appointments with cardiologist, Dr. and endocrinologist Dr., who diagnosed me with Graves? disease based on my blood work from my hospital visits in November.  I brought up the fact that I?ve never had any auto-immune disorder and it doesn?t run in my family and both of them ignored my concerns. I finally was able to get into my family doctor of over 30 years, Dr. and he verified my concern that this was all caused by my vaccination by finding medical journals recoding this same thing with other people!
Blisters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: EN6202, Anatomical location: left arm.), administration date: 21Feb2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "no adverse effect"; BNT162b2 (Dose  2, Lot: FF2590, Anatomical location: left arm.), administration date: 14Mar2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (Dose 3 (BOOSTER), Lot: WA84764, Anatomical location: left arm.), administration date: 12Oct2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: BLISTER (non-serious) with onset 09May2022, outcome "recovering", described as "Blisters". Therapeutic measures were taken as a result of blister included Cortisone 1% cream.  Additional information: The patient reported that the side effects she had was blisters, she did not have any other side effects with other vaccines in the past, this was the first time. She stated that she got the blisters in the night on the day of vaccination. She said they started and she still had them in her hot spots: under her chest right underneath her breasts, her midriff area where underwear begins at the top of her thighs. Midriff area clarified to groin area, reclarified to not groin, over the top of her thighs where it meets the legs where underwear sits. She had been putting Cortisone 1% cream on her blisters. She said she had been putting it on twice a day, once in the morning and once at night, or BID. She said the blisters were somewhat better, she still had them. The patient had been taking all the same medicines (unspecified) she had been taking. No further details provided about her medications.
11 yr old child got the adult covid booster instead of the 5-11 yr old booster.  No adverse reaction occurred.
I got the vaccination 1/23/21 and after 15 minutes I left. Later that night I was feeling a little off and thought it wasn't a big deal. Went to sleep woke up with 101 fever, body ached pain, and chills. Took ibuprofen and felt a little better. Then noticed the spot on arm got bigger and mother drew border, then this morning no fever but feeling uncomfortable joint pain and now the spot is bigger than the border. I went to the urgent care today 1/25/2021 after reading CDC recommendation and was diagnosed with cellulitis and was prescribed penicillin.
Bell's palsy which started on 4/19, patient was seen in the emergency department and given steroids and symptoms resolved
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Arm was feeling tingling, fingers tingling.  Seemed to resolve before she left site.  Also complained of being a little lightheaded after vaccine.  monitored patient for 60 to 70 minutes until she felt better.
mom reported pt recv vax 21MAY98 1030AM & then had fever up to 103;MA 22MAY98 around 820AM had sz;was unable to keep fever down & was 103 when got to MD office;
Red, raised, warm to touch areas on arm below injection site appeared 24-36 hours after injection. Lasted 48-72 hours.
A maculopapular purity rash started on n my arms 2 days after my second injection. It spread over much of my extremities and trunk. I was startled on antihistamines and topical steroids. The rash resolved after 5 days. No lasting sequellae
I had a runny nose; sore throat; fever and I took Paxovid from 06/18/22 through 06/25/2022 and started to test negative.
Had  a hot red knot  in my arm,  fever and felt really bad like weak  and extreme exhaustion for a good 6-7 days . Then I got a very high pitch and annoying buzz in both my ears,  which is still  there to this day., it never goes away. I have never had issues like this before ever. I also have bouts of extreme exhaustion & dizziness  still.
pt recvd vax; fever of 102 & cellulitis 48 hrs p/ vax;
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history was not reported. On 23-APR-2014, the patient was vaccinated with the first dose of GARDASIL (lot #, dose, route and site of administration were not reported). On 21-MAY-2015 the patient was vaccinated with the second dose of GARDASIL (lot #, dose, route and site of administration were not reported). Patient just didn't show when they should be vaccinated. No adverse symptoms were reported. Additional information has been requested.
Patient complained of lot of pain after shot was given in (L) deltoid area. Was initially or subsequently in 3-4 mm noticed to be looking "pale, faint. Did not pass out was found in trended position. Decreased HR, decreased BP pale, sweaty, felt nauseous and faint -> improved over 15-20 min or so.
Accidentally gave a 16 year old patient a vaccination; A spontaneous report was received from a nurse, concerning a 16-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) (lot number unknown), where nurse had accidentally gave a 16-year-old patient a vaccination.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Nurse reported that they were doing vaccination for a large group of patients and on an unknown date, one of the nurses had accidentally administered vaccination for a 16-year-old patient. However, the patient had done well post vaccine without any issues. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event accidentally gave a 16-year-old patient a vaccination was considered to be resolved on unknown date.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration (16-year-old male patient, who received Moderna's vaccine) for mRNA-1273, lot # unknownThere were no reported AEs associated with this case of inappropriate age at vaccine administration. The reported event is unlisted and company causality was assessed s not applicable.
Chills, headache for one day, achy feeling, blood pressure below 120 for 2 days, SpO2 between 92-94 for 2 days.  Acetaminophen for 1 day at maximum dose for headache, reduced appetite for 2 days.
Patient received influenza vaccine on 10/28/11 and called pharmacy to report the following symptoms: swollen throat, sore muscles, chest tightening and itchy eyes.
Patient was vaccinated on 9/26/17. She noted soreness to right deltoid immediately after. She continued to feel soreness during the night. The next AM, 9/27/17 patient noted swelling and redness to deltoid area. She took some benedryl and iced the area for that day. On 9/28/17 patient called clinic complaining of swelling and redness. She stated that the area had increased in size from the day previous and she requested to be seen. Patient was given the next available appointment. Patient described the area of swelling as a circular patch of 3"x3" and approximately raised 2" above the arm. Patient was advised on how to treat this while at home and advised of then to seek emergent cares. Patient was seen the next AM at 10:00. The redness and swelling had reduced but was still visible. Patient advised to reconsider future flu vaccinations, to continue use of benedryl and ice until area is again comfortable.
Painful rash on both legs; Painful rash on both legs; Colors range from red with variations of purple looking and feeling bruised  with no injuries, sometimes brown also,; my legs and they are swollen; tingling sensations in my right and left hands; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received second dose of BNT162B2 (lot number: EN6203) on 19Mar2021 (41-year-old) on left arm at single dose for COVID-19 immunization. Medical history were none. Concomitant medications included bupropion hydrochloride (Wellbutrin), topiramate (TOPAMAX), phentermine, montelukast sodium (SINGULAIR). Historical vaccine included first dose of BNT162B2 (lot number: EN6202) on 26Feb2021 (41-year-old) at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered Hospital. 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 had not been tested for COVID-19. Patient had Painful rash on both legs that continues to change on 31Mar2021. It has been on knees down in different places. The spots on the back of her lower legs continue to hurt. Colors range from red with variations of purple looking and feeling bruised with no injuries, sometimes brown also, mornings it is painful to stand on my legs and they are swollen , also some tingling sensations in her right and left hands. The events were occurred on 31Mar2021. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event: Steroid shot, prednisone, antibiotic. The outcome of the events was not recovered.
I began to have pain in my right arm with 3 hours of injection. Within 30 minutes the pain was a +10 and I couldn't lift my arm from shoulder down.
Swollen eyes; Facial swelling; she had a little ache where she got the COVID-19 Vaccine shot; Dry eyes; Eyes tearing; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 19Feb2021 (at approximately 10:50 - 11:00) (age at vaccination: 78 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing dry eyes started 2-3 years ago, saying her dry eyes are from aging, ongoing drug hypersensitivity to any form of penicillin for years. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1288) in her left arm, on 29Jan2021 for covid-19 immunisation, tylenol with codeine and experienced drug hypersensitivity. She was allergic to strawberries, raspberries, shell fish and tomatoes. She said she had allergies since she was a little girl, but wasn't diagnosed with the allergies until she was an adult. On an unknown date in December2020, the patient underwent blood test with unknown results. On 20Feb2021 (Saturday), she had a little ache where she got the covid-19 vaccine shot for which she put some icy hot cream, so she put some icy hot on the spot, and she had no further problem with her arm (left), dry eyes and eyes tearing. For dry eyes and facial swelling patient took Xiidra 5 percent (Lot Number: 20647, Expiration Date: June2023). She was still taking it. On 21Feb2021 (Sunday), after she woke up, the patient experienced swollen eyes, facial swelling. She said she immediately took Benadryl 25mg tablets (Lot number: AAF001, Expiration Date: September2022) . She said her allergy doctor told her to take Benadryl any time she has an allergic reaction. She said her doctor told her to put a warm compress over her eyes to help with the swelling, as well. She said she did not have any problem with the first COVID-19 Vaccine shot. The patient did not require emergency or physician's office visit. There were no prior vaccinations in four weeks. The outcome of lacrimation increased was not recovered; eye swelling, swelling face, dry eye was recovering; vaccination site pain was recovered on 20Feb2021.  No follow-up attempts are possible. No further information is expected.
Red eyes, "goopy", feverish/ chills/ sweats, achiness in legs, fatigue, N&V and diarrhea
patient had a very sore arm and a large bruise extending around her deltoid area of the arm and onto a small area of her back.  the symptoms started within hours of getting the immunization and are still occurring today
Case number PHEH2012US015828 is an initial spontaneous report received refers to a patient of an 18-year-old male patient. He was given only the MenA powder component of MENVEO vaccine (batch number M11047 and expiry date: Apr 2014) reconstituted with sterile water on 24 Jul 2012. He was revaccinated with the correctly reconstituted MENVEO (batch number: M11051) on 25 Jul 2012. No other adverse reaction was reported following this administration error. Follow-up received from the nurse on 28 Aug 2012: Updated date of revaccination and batch number of MENVEO.
Patient stated that she broke out into itchy hives on her arms, hands, back , and neck.
HIVES BEGINNING ON R SIDE OF NECK AND PROGRESSING OVERNIGHT TO BILAT FLANKS, AND BEHIND R KNEE, AND BILAT SHOULDERS