chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right after administration, pt experienced injection site redness, swelling, and warmth that subsided after 30 minutes of observation.  Injection site bruise on left arm appeared two days after injection. Pt reported to pharmacy 6 days after injection about bruise; pt was counseled to take a photo of the bruise everyday to monitor changes in color or size. Pain not reported.
Severe headache, cough , congestion, hoarse voice, pain in arm to touch not to move. Went to the doctor on Tuesday, cough and headache was much worse. Did a covid test it was negative . Was given steroids to take.
After getting vaccines patient was sitting in chair and said his eyes felt funny. When asked what he met by his eyes felt funny he stated he couldn't see things were looking black. This nurse assisted patient to exam table to lay down. Upon getting on exam table patient stated his stomach hurt and he became diaphoretic and pale. Nurse gave patient a juice. After taking a few sips of juice patient was able to sit on the exam table and color had returned. Patient complaining of headache and being tired, but other wise doing better. Snack given to patient and blood pressure obtained and WNL.
Covid breakthrough. At first I thought I was having an allergy attack. I was sneezing and had sinus congestion. The next day, it was a little worse I had some fatigue. The following day I had aches, low grade fever, and diarrhea. Since then the only symptom remaining is the congestion.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX. Concomitant products included Herbal Supplement. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache and muscle discomfort. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the headache and muscle discomfort were recovered/resolved. The reporter considered the pain in arm, headache and muscle discomfort to be related to SHINGRIX. Additional details were provided as follows: The concomitant medication also included unspecified vitamins. The patient stated that she received the Shingles vaccine on left arm, last week from reporting date and was almost certain it was the SHINGRIX vaccine. The patient states that she experienced headache, muscle discomfort and her left arm was painful to touch which was resolved. In the morning of reporting date, after swimming, the patient experienced shooting pain down her left arm.
This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. The patient was vaccinated with ZOSTAVAX on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles on flank sides of his body after receiving ZOSTAVAX. No treatment information was reported. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
After receiving my first Moderna Covid vaccination I started experiencing tinnitus.  I asked the nurse when receiving my second vaccination, if they'd received any other complaints and was told no.  Subsequently, I have googled and discovered that, indeed, others have experienced tinnitus after their first vaccination.  The long and short is that I now have constant ringing in my head with no relief in sight.  It has been over a month since its onset.
Woke up March 12th at about 8 am with severe welling in left hand and arm - ballooned up - and right eye. Started to subside after a few hours. Did telehealth visit, who recommended urgent care. No medication was given; advised to wait and watch. By afternoon, swelling had eased considerably; completely disappeared after 48 hours.
arm has lumps; red at the site of injection; arm is tender; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 25-Jan-2021.    A spontaneous report was received from a Consumer concerning a 78 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like myalgia, vaccination site erythema and vaccination site induration.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 21-jan-2021, The patient experienced the events like tender arms. On 22-jan-2021 vaccination site became red. On an unknown date the patient also developed lumps at the vaccination site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 22-jan-2021, the outcome of the events like myalgia, vaccination site erythema and vaccination site induration was not resolved. At the time of this report, the outcome of the events events like myalgia, vaccination site erythema and vaccination site induration was not resolved.
Patient had a fever of 104 degrees at 5:30 in the evening.  He was sore, nauseated, vomiting.  He felt bad all over.  He took Tylenol and his fever started going down about 3 AM.  He was feeling alright the next morning.
CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER,  CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD.
Five days p/immun given pt devel a high fever 105F; On 11MAY91 was hospitalized for dehydration & septicemia identified; Thrush identified during fever elevation; Treated w/Augmentum;
Horrible headaches; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Horrible headaches) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Horrible headaches) and CHILLS (Chills). At the time of the report, HEADACHE (Horrible headaches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Acetaminophen 500 mg twice; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Thrombocytopenia - developed petechiae, prolonged epistaxis 6 days after vaccination. Found to have platelet count of 1
MILD ACHINESS; MADE IT DIFFICULT TO SLEEP; LITTLE BIT OF CHILLS; MILD FEVER; MILD SIDE EFFECTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On APR-2021, the subject experienced mild side effects. On APR-2021, the subject experienced made it difficult to sleep. On APR-2021, the subject experienced little bit of chills. On APR-2021, the subject experienced mild fever. On 06-APR-2021, the subject experienced mild achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild side effects, mild fever, mild achiness, made it difficult to sleep, and little bit of chills. This report was non-serious.
p/1st inject pt had itchy red rash on arms, legs & scalp but thought it was an allergic reaction to something in the house; p/2nd vax pt w/exacerbated rash arms, legs, scalp & swollen lip;
Employee the day after receiving Td vaccine to right deltoid she felt swelling and discomfort to site that radiated to right axilla.  Reports extreme tenderness to glands at right axilla region.
Left arm swollen, tender erythematous area 12 x 26cm, 1.5cm larger circumference than right.
patient had a rash in area where vaccine was administered.  Provider treated with Benadryl on site kept patient in room for 45 mins rash went down no other adverse reactions.
Pt's left arm at injection site was red, warm, and swollen to half the size of a softball per mother. No drainage, no fever. Mother reported pt "did not feel well" and was "dizzy in the shower." RN triage advised pt to mother to apply cold packs to the arm for 20 minutes at a time, and may take ibuprofen for pain/swelling. Advised mother to draw a circle around the swelling and to call back if it continued to get worse. Mother verb. understanding, and did call back the next day 3/29 to report that the "rash was getting worse" and "spreading across the arm" with red dots also. Report forwarded to pediatric MD available who advised mother to take the pt to the ED for evaluation. Family has not returned calls regarding this incident.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298672, 2018SA298673, 2018SA298675, 2018SA298676, 2018SA298677, 2018SA298678 and 2018SA298679. This case involves a 59 years old female patient who was inadvertently administered a 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot UJ039AA and Exp. Date 15-MAY-2019) via intramuscular route in the left deltoid on 25-Oct-2018. The patients past medical history included Hysterectomy. It was an actual medication error due to inappropriate age at vaccine administration and accidental overdose. No any information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Gave soldier the small vaccination. After soldier left the nurses station another nurse told me that the smallpox vaccine that I had used had to much dilutent in it. I checked with the person who made it and she said that she had put 1ml more dilutent in it than it was supposed to have. Found patient in P.A.'s office and let the patient and P.A. know what had happened. I was told P.A. would find out what was to be done about it, patient was watched for 15 minutes and P.A. Patient was asked to come back in 10 days so that we can check on smallpox reaction. If there is none we will revaccinate. and was let go. Then P.A. came and told me that they had let patient go and he was coming back to get reaction checked.
Menstrual bleeding even though I am a post-menopausal woman. Same thing happened after first booster last year and after initial Covid vaccine series even though I didn't report it
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. An 80-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "classic Kaposi sarcoma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Covid-19 vaccine treat his cancer; reporting therapeutic effect with regards with the Covid-19 vaccine/ he has positive result with the cancer". Additional information: He mentioned that he received the Covid-19 vaccine and luckily the Covid-19 vaccine treat his cancer. So, the caller is reporting therapeutic effect with regards with the Covid-19 vaccine and he also mentioned that he has positive result with the cancer. Consumer stated, " I am great (voice not clear) certain years ago and I have cancer now. It's called classic Kaposi sarcoma. It is a very rare cancer and they treat this with your vaccine (not clarified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red rash in area of shot, slightly warm to touch. covering around 3" of arm but not in any specific pattern  Called Dr. Office on the 29th and talked with nurse who suggested taking Benedryl orally, asked if my breathing was ok (it was fine).  I took one Benedryl on the 29th and the rash started to improve and I followed up with one Benedryl on Saturday and Sunday and the rash was then gone.
5x5 inches of redness (bright red) of Left upper arm on outer surface around puncture site, warm, slightly tender. No systemic effects.
Rotarix was administered IM; 4YO was administered Rotarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 4-year-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K33EZ, expiry date 15th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 10th October 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 10th October 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate route of vaccination and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's comment: The reporter reported that Rotarix lyophilized administered intramuscularly to a patient. The Vaccine Administration Facility was the same as primary reporter. Outside phone number for GlaxoSmithKline medical information given for future reference and transfer provided. The reporter consented to follow up. Additional Supportive Information: The four years old patient received dose of Rotarix lyophilized intramuscularly, which led to inappropriate route of vaccination and inappropriate age at vaccine administration.
This case was reported by a pharmacist and described the occurrence of injection site soreness in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to TYLENOL, chronic pain, codeine allergy and penicillin allergy. Concurrent vaccination included varicella virus vaccine (non-gsk); Merck; subcutaneous; right arm given on 20 December 2013. Concurrent medications included LEXAPRO, Bupropion hydrochloride, Alendronate sodium, LYRICA, ADVAIR diskus, SPIRIVA, BUSPAR, TOPAMAX, LIDODERM, NORCO, Metformin hydrochloride, Furosemide, LIPITOR, ZOLOFT, and VALTREX. On 20 December 2013 at 13:15 the subject received a doe of BOOSTRIX (.5 ml, unknown, left deltoid). On the evening of 21 December 2013, 1 day after vaccination with BOOSTRIX, the subject experienced "site soreness below the injection site near the medial tricep of the left arm" (injection site soreness). At the time of reporting the injection site soreness was improved. The pharmacist considered the event was possibly related to vaccination with BOOSTRIX.
10 days after the vaccine injection site developed a baseball sized lump that was red and hot to the touch and hurt to touch it.  went away after 24 hours.  14 days after vaccine developed a red rash at injection site about 3x6 inches it is red warm and itchy; there is a second site about 1 inch below the first that is larger, red, warm and itchy also.  as of this report the rash is still present
Tested Positive for Covid April 24-2022. Sore throat -body aches - headache- dizziness - head/facial congestion   Received Monoclonal  April 28th 2022.  Dizziness and headache gave continued .
About 15 minutes after flu shot, child c/o of stomach ache, watery eyes and itchy eyes. No respiratory distress. Respiratory and pulse within normal limits. Temp 97.1 degrees F and BP 110/70 mmHg.
The day after vaccine was administered she developed itching and buring around eyes and some edema.  She took 2 benadryl at around 17:30 and 2 benadryl around 20:00.  Edema still present under left eye, no blurred vision noted
Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received/Expiration date for this lot was extended to a date beyond the date of administration/Department of health considers considers her booster invalid dose) had resolved.            No Concomitant product use was reported.  The reporter was calling on behalf of their wife who was the patient and stated that their department of health considered the patient's booster vaccine, an invalid dose. The reporter stated that according to the vaccination site, the lot number 022C21A original MFG Expiry Date was Sep-2021 and it was extended to 23-Dec-2021.  It was reported that the patient was given a booster shot on 02-Nov-2021 from a vial that contained the above lot 022C21A.  No treatment information was provided.
Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injection ( this happened when I got my first one too)
Information has been received from a physician concerning an approximately 5-year-old patient that was "immune healthy" who was vaccinated with a dose of Varivax (Oka/Merck). At an unspecified date the patient developed herpes zoster ophthalmicus. The patient has permanent eye damage from the presumed herpes zoster. This is one of several reports received from the same source. Additional information has been requested.
THE STUDENT BECAME PALE AND LIGHTHEADED IMMEDIATELY AFTER ADMINISTRATION OF MCV4, TDAP AND VARICELLA. STUDENT AND PARENT VERBALIZED THAT HE WAS VERY NERVOUS PRIOR TO VACCINE ADMINISTRATION. PLACED STUDENT IN SUPINE POSITION AND RESTED FOR 10 MINUTES. BP IN SUPINE 112/71, HR 86. SITTING 126/85, HR 89. STUDENT STATED HE WAS FEELING BETTER AND AGREED TO THE HEP A AND FLU VACCINE. PARENT DECLINE THE HPV AT THIS TIME. STUDENT RESTED FOR 20 MINUTES MORE WITHOUT INCIDENT.
p/ pt recv vax approx 2yr later devel 3 varicella-like lesions
No additional AE information reported; improperly stored vaccine administered; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-AUG-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneous injection, lot #U039955, expiration date: reported as 03-OCT-2022, but determined as 14-JUN-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of 9.3 degrees Fahrenheit for 5 minutes. The previous temperature excursion of the vaccine was reported as 14 up to 46 degrees Fahrenheit (25.9 degrees Fahrenheit) for 1 hour 20 minutes.  There was no adverse event reported (No adverse event).
Pt complained of right forearm tenderness, redness, swelling with below elbow circumference 26.5 cm on (R) arm. Left arm below elbow circumference 25 cm. Symptoms just noted in AM on 9/11/09. Prescribed warm compresses and MOTRIN.
Congestion, cough, sneezing and difficult breathing in the afternoon and evening of 05/06/22. Went to Urgent Care at 11:30am on 06/07/22 where a Covid-19 test was performed. Test was positive.
fainted; dizziness; brain fog; nausea; general malaise; significant headaches; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. This consumer reported for a consumer (patient) that female of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : Not reported), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date in Apr2021, the patient experienced fainted; On an unspecified date in 2021, significant headaches; dizziness; nausea; brain fog and general malaise. It was reported that patient to had a very bad reaction to the Pfizer COVID vaccine. She received the 2nd dose in April, fainted on the night of the 2nd dose and 6 days later had the sudden onset of significant headaches, dizziness, nausea, brain fog and general malaise that have not abated and if anything have gotten a bit worse 4 plus months later. She's been seeing a Neurologist in addition to her PCP, but no one seems to have any answers. Event took place after use of product. The clinical outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.