chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An increase of tinnitus in both ears within a week of the vaccination. The tinnitus in my left ear has been increasing in severity since the vaccination and it's almost unbearable.; This is a spontaneous report form a contactable consumer(patient). A 48-year-old non-Pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number ER8734), via an unspecified route of administration on 04Jun2021 into left arm (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medication(s) included levothyroxine sodium (TIROSINT). The patient had allergies to Red dye, penicillin. In Jun2021, the patient experienced an increase of tinnitus in both ears within a week of the vaccination. The tinnitus in my left ear has been increasing in severity since the vaccination and it's almost unbearable. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not hospitalized for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medications were received for the adverse event. The outcome of the event was not recovered.  Follow-up (01Jul2021): Follow-up attempts are completed. No further information is expected.
09Nov90 Pt vax w/ hepta B; felt high, later h/a, & exp sore arm.
Presented to hospital with febrile seizure. Also noted to be adenovirus positive during admission. Occurred approximately 10days after MMR vaccine was administered as outpatient.
pt recv vax 3/98 & 11 days later pt devel disseminated varicella rash w/at least 15 lesions. also flu like sx, max temp 99.8
About size of softball (L) deltoid area red, swollen, warm to touch also has blisters (water filled) x 3 about size of pea.
Patient was discharge from clinic, about 15 min. later, mom brought pt. back to clinic stating "he is having an allergic reaction to his shots". Pt. is coughing persistently, face is red and swelling was noted to face, chest, arms, legs and back. BENADRYL given and an albuterol treatment given. Pt's coughing resolved immediately after the albuterol treatment, his rash and hives improved after 30 min.
Client was vaccinated at 1611 on 4/1/21. Nurses were notified of client itching around 1645.  Client was still onsite doing 30 minute wait time. Upon examination, client stated her face was itching around her eyes. Her tongue also felt thick and throat felt dry.  Began slurring her words due to thickness of tongue. Also began having hives on arms. EMS called at 1649. VS at 1649: 142/92, 98%, 85 BPM. 0.5mg epi given at 1650 in R arm IM.  VS at 1653: 140/90, 97%, 77 BPM.  50mg Benadryl given IM in L arm at 1658. 98% and 75 BPM at 1658.  Client stated her tongue felt a little better and hives started to resolve.  EMS arrived at 1700. Client transported via EMS to hospital at 1704.
True vertigo. Pt states "I'm falling" and grabs onto something for stability. States "the trees are falling on me". Pt trips "as if drunk"; onset 24 hours after Prevnar. Symptoms lasted until 1/17/01.
No adverse event; Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No relevant concomitant medications were reported. It was reported that patient did not report any AEs after the vaccine was administered. Treatment medication was not provided by the reporter.
Fatigue, weakness, chills, sweats, headache. Soreness around injection site. No treatment. Went away with time.
After the first day my arm started to ache. Within the next morning you started chills and body aches. I didn't take any medication for the symptoms. Later throughout the day my teeth started to feel sensitive and ache. Also, my left arm was sore and swollen at the injection site. It was really sore that to the point that I couldn't lay on it. I again didn't take any aspirins or ibuprofen for the pain. I didn't have to see a doctor it wasn't that severe. Weeks after I had the vaccination I was feeling nerve pinch in the same are i got the vaccination. I am not experiencing the symptoms anymore it's been 7 months now.
(L) arm 9 x 3 area, red, swollen. Warm to touch. Painful.
Patient received 2nd dose of Moderna COVID vaccine during the day.   Patient had soreness at injection site but no other symptoms.  That evening woke up with extreme thirst, drank multiple glasses of water but did not void.    The next day had tingling sensation in the face and body, then generalized flushing of the body.    Within hours patient had emesis, diarrhea, watery eyes and palpitations.   Had telehealth visit and prescribed steroids.
Patient stated that arm has been sore since she recieved the vaccination. It is still sore.  She states that it was sore because it was administered too high.
I want to report mild side effects for my COVID booster. The evening after my booster I started feeling very tired. The next day my arm, arm pit and neck are sore on the side i had my shot. I am also very tired.
fatigue; fever; chills; sharp pain in joints; headache; nausea; stomach cramps; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot# EN 6199) via an unspecified route of administration (administered in arm right) on 08Mar2021 at 14:30 (at the age of 62-year-old) at single dose for COVID-19 immunisation. Medical history includes blocked coronary artery, diabetes, cancer, obesity and shellfish allergy. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication included carvedilol and topiramate. The patient previously took iodine and Plavix and experienced allergy. On 08Mar2021 at 14:45 the patient experienced fatigue, fever, chills, sharp pain in joints, headache, nausea, and stomach cramps. Patient was not received any other vaccine prior four weeks of vaccination and since vaccination patient not tested for covid-19. Patient was not received any treatment for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
bipolar disorder; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient historical vaccine includes 1ST dose of vaccination for covid-19 immunisation and had no reaction to previous exposure to vaccine. It was reported that, there are some trials for Pfizer and did psychotherapy and they gave me some pills they had me on 2 pills, and don't know nothing about them. They are supposed to be for night-time, have been doing bad, would like to try something new, got diagnosed with bipolar disorder, am barely taking my medication and want to see if you have any other trials. already got my covid shots I know you have other trials. The patient experienced bipolar disorder on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Two wks following 2nd vax pt developed rash w/target lesions; Dx of erythema multiforme was made; @ time of report the lesions had largly resolved;
On 1/6/00, pt had DTaP and 1/7/00 called doctor. Pt had red raised silver dollar on leg. On 1/8/00, pt had began to tippy toe on leg with shot swelling rash spread from groin to knee. Doctor advised to use cold compress and Benadryl. Took him into audiologist receptive and expressive language was gone. Later diagnosed with PPD-NOS.
Dose 1.- 3/4/2021. Within 5 minutes stiffening of left side of neck and blurred vision on left side only.  Only lasted a few minutes.  Flu like symptoms developed night of 3/5/2021 through night of 3/8/2021, stayed in bed with body aches, chills, dizziness.  Flu like symptoms ended on 3/8/2021 around 8:00pm after profuse sweating.  Brain fog and cough remained until 2 days before 2nd dose.  Nose bleeds.   2nd Dose 4/1/2021-  flu like symptoms, in bed 4/2/2021.   Profuse sweating overnight ended flu like symptoms morning of 4/3/2021.  Skin rash on back and chest, Dizziness continued.  Blood vessel burst in right eye 4/11/2021, ear pain, headache 4/13/2021
Child developed bumpy rash around each injection site and a fever per foster parent.  Did not report or seek care.  Foster parent stated later that child had similiar reaction while under care of biological mom and another physician.  Records obtained from that Physician but no mention of this reaction was noted on patient records.
Fevers 100.7-103.3. Rash on 6/24. Headache. Loss of appetite.
Initial reaction was soreness in arm around injection site. No signs of bruising or swelling around area seen.
On 09/09/2022 I received my Covid-19 vaccine. On 03/09/2023 I started feeling a really intense headache with clogged up sinus. The next day I took a home Covid 19 test and was tested positive. I reached out to my doctor and was prescribed PAXLOVID. Symptoms are ongoing.
7"x5" red area, swelling, 8/13/09 8:00 AM.  Treatment diphenhydramine 1/2 tsp TID.
Information has been received from a registered nurse referring to 4 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 31-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 18 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I got a rash that was 4 inches in diameter and a knot at the injection site which lasted over 7 days.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabestes 2" (unspecified if ongoing); "myasthenia Gracie" (unspecified if ongoing), notes: myasthenia Gracie. The patient's concomitant medications were not reported. Past drug history included: Scopolamine patch, reaction(s): "known allergies: Scopolamine patch", notes: Scopolamine patch; Zantac, reaction(s): "known allergies: Zantac"; Prevacid, reaction(s): "known allergies: Prevacid"; Codeine, reaction(s): "known allergies: codeine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was not taking any other medications, products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Expiration date booster: 26Sep2021; skin rash/ it also is less frequent and less invasive further I get from most recent vac. date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Sep2021 15:00 (Lot number: FE3592, Expiration Date: 26Sep2021) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "A Fib", start date: 15Apr2017 (unspecified if ongoing), notes: Ablation 15May2021; "Type 1 Diabetes", start date: 15Jan1986 (ongoing), notes: Diagnosed; "RA", start date: 15Sep2019 (ongoing), notes: Diagnosed; "Blood pressure" (ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis, start date: Dec2019 (ongoing); HUMALOG taken for diabetes mellitus, start date: Jan1986 (ongoing); LANTUS taken for diabetes mellitus, start date: Jan1986 (ongoing); ATENOLOL taken for blood pressure measurement (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time:10:00 PM, Intramuscular, Anatomical site: Left arm, Batch number: EL9262, Exp date: 31May2021), administration date: 21Jan2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Skin rash", "pressure on his skin", "a red rash normally on my arms, thighs, stomach, back", "sting"; Bnt162b2 (Dose 2, Time: 10:00 PM, Intramuscular, Left arm, Batch number: EL9267, Exp date: 31May2021), administration date: 10Feb2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Reports treatment first dose 24Jan2021 ;second dose 10Feb2021". The following information was reported: RASH (non-serious) with onset 2021, outcome "recovering", described as "skin rash/ it also is less frequent and less invasive further I get from most recent vac. date"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 26Sep2021, outcome "unknown", described as "Expiration date booster: 26Sep2021".  Additional information: Patient reported his rash is related to skin being pressurized is his skin up, sex, tagging shoes, blood pressure ups etc. It is a red rash normally on his arms, thighs, stomach, back. It stings but not badly. It goes away in 10 mins after the aggravating factor nor stopped. Exercise itself won't cause it i.e jogging won't cause it but yoga will. It also is less frequent and less invasive the further. he got from most recent vaccination date. Family medical history relevant to AE's and Relevant Test were None. Specific relevant test for thromboembolic events with thrombocytopenia: None  Follow-up attempts are completed. No further information is expected.
pt recv vax 30OCT96 & 8NOV96 pt devel a sl swelling @ site inj, severe pain in lt shoulder, & a knot @ the inj site;also exp inability to have full mobility of arm;difficult to dress self;also devel erythema & pain @ site of inj;
fall she had; bursitis of her hips; not received the second shingrix dose/because of COVID-19.; This case was reported by a consumer via call center representative and described the occurrence of fall in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fall, hip bursitis and social problem. On an unknown date, the outcome of the fall, hip bursitis and social problem were unknown.   It was unknown if the reporter considered the fall and hip bursitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she experienced bursitis of her hips and she was sure that it was due to a fall she had three months after receiving her first dose of Shingrix vaccine.  The patient received her first Shingrix dose in September 2019 and had not received the second shingrix dose because her pharmacy was not administering it because of COVID-19. The pharmacy was not planning to get 2nd Shingrix vaccine. The physician recommended to get a cortisone shot for bursitis in hip sometime after 2nd Shingrix vaccine. The patient wanted to know how long she should wait after the 2nd Shingrix vaccine to get the costisone shot for bursitis.  The reporter consented to follow up.
It wasn't a big deal., but I wanted to share in case more people report the same thing.  The day after I became incredibly cold and turned the color of ash gray. I felt strange for several hours. And my arm was the most sore it has ever been in my whole life for about 4 days.   But-what I wanted to share, is I am a perimenopausal woman, who has been having severe hot flashes for about 8 months. Sometimes 10 an hour, sometimes just 10 a day since I added in some OTC hormone support.  But, I have not had a single hot flash for 18 days, which has not happened in over 7 months.  It was like after being so incredibly cold after the vaccine, something in my body reset. I do not know if this will be permanent, but it has been the best three weeks in a long time. And, I just wanted to put it on record, as other women my age (almost 50) are vaccinated if it improves their menopause symptoms.
I developed a itchy oval raised rash that started on my lower abdomen and has spread to most of my body. My physician is treating as it Pityriasis Rosea and prescribed Clotrimazole-Betamethasone cream to help with the severe itching.
This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. No information on medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 1 injection, route and site of injection, lot# and expiration date not reported. On an unknown date the patient experienced cellulitis and had to be admitted to a hospital (dates of hospitalization not provided). The outcome of cellulitis and relatedness between use of ZOSTAVAX and the adverse event were unknown. Additional information has been requested.
Patient c/o dizziness right after vaccination lasting only a short time then approx 20 min later left arm felt "numb" and "heavy", reported she couldn't  move arm. however did not report this at time of event. This lasted approx 1 1/2 - 2 hours. Symptoms resolved. Went on with daily school activity - 17:00 same date no symptoms, 19:30 c/o sickness, dizziness, and a feeling of "burning" in L arm, full ROM. TYLENOL was encouraged to be taken. 23:45 c/o throat tightness, however breathing without difficulty. AM no symptoms. Decreased 11/12/09 L arm anterior sore to touch and firm @ injection site.
Patient presented to ER with lightheadedness, pain under left breast, neausea, diarrhea, abdominal pain and headache. Patient was sent home from ER.
some leaked out from the injection site/vaccine leaked out during administration; vaccine leaked out during administration; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE EXTRAVASATION (some leaked out from the injection site/vaccine leaked out during administration) and ACCIDENTAL UNDERDOSE (vaccine leaked out during administration) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022, the patient experienced INJECTION SITE EXTRAVASATION (some leaked out from the injection site/vaccine leaked out during administration) and ACCIDENTAL UNDERDOSE (vaccine leaked out during administration). On 28-Jan-2022, INJECTION SITE EXTRAVASATION (some leaked out from the injection site/vaccine leaked out during administration) and ACCIDENTAL UNDERDOSE (vaccine leaked out during administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient did not experienced any symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Suspect product batch number and patient demographics were added.
0.5ml H1N1 given to child less than 36 mos instead of 0.25ml.
Pfizer BioNTech COVID-19 Vaccine EUA: Administration Error - Diluted Incorrectly Patient received Pfizer Vaccine on 8/25/2021 that was inadvertently, serially diluted. Per CDC's interim clinical considerations, advised to be revaccinated ASAP in opposite arm.
Pt. states that she received the 1st pfizer covid vaccine to left arm at 0930 on 3/19/21. Pt. states that she started to have heart palpitations around 15 minutes after receiving the covid vaccine. Patient noticed arm redness to bilateral arms. Pt. states that heart palpitations have resolved. Pt. denies shortness of breath, denies chest pain, denies difficulty breathing.
no adverse event we are aware of. Vaccine given 1 day s/p expiration date
Red, mildly itchy, and warm rash appeared at injection site 1 week after moderna dose 1. Approximately 2 inches by 2 inches.
Chronic head pain; headache; This is a spontaneous report received from a contactable consumer.  A female patient received BNT162B2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 02Apr2021, outcome "unknown", described as "Chronic head pain; headache".  Additional Information: The patient got the second dose of Pfizer the day before the reporting and right now, she was having really chronic head pain. The patient's husband was wondering (can't find anything to the patient) if he can give her anything like paracetamol (TYLENOL) or ibuprofen (MOTRIN) to help it first. The patient's husband can actually go down to the whole list if the company wants him. The patient's husband needed to know what type of medicine that he can give for her headache, she has a bad headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rt upper arm (deltoid) cellulitis-area orange-size diameter, red, warm, swollen/firm tender w/assoc tender ax adenopathy;rx ATB;
Shot reaction (redness, soreness, warm, inflammed) - about 6 inches in diameter around one of the vaccination sites (either Pneumovax or FluzoneHD)
redness 3by4 inches rashand  slight swelling, itching...Improviing (02/21/2021)