chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports feeling numbness and tingling sensation to left side of face approximately 40 minutes after vaccine. Reports numb sensation worsened with feeling described as "feeling after dental anesthesia".  Pt reported to vaccine adminstrator the above reactions at 1:45 pm.  After reporting symptoms she started to feel a bit anxious and faint, but recovered shortly.
KINRIX give about 9:45 on 6/5/18 then morning of 6/6/18 parents noted a little erythema on right deltoid (where shot was given). By late afternoon the area was larger warm and somewhat tender. I saw him at9 am on 6/7/18. Mom says it seemed a little less tender but about the same size. It was about 2"x2" warm erythematous and mildly tender. Child happy. Tx suggested cold compress and Tylenol or Motrin.
No additional AE reported; Varivax administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 13-month-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reaction or allergies was reported.  On 09-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # W006412 was confirmed to be valid, expiration date 23-FEB-2023, intramuscularly in the right thigh for prophylaxis. On 20-JAN-2023, the administered dose had temperature excursion range of -14 degree Celsius to -10 degree Celsius for 1 hour (product storage error). The call was because of a digital data logger. No additional adverse event reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:
This is a spontaneous report from a contactable nurse. This  nurse reported similar events for five patients. This is the first of five reports. A 7-month-old female patient received a third dose of PREVNAR13, via intramuscular route of administration, in the left thigh, on 11FEB2011. There was no relevant medical history. Concomitant medications and past product history were not reported. On 12FEB2011, the day after administration of the vaccination, the patient developed a reaction at the injection site consisting of site redness and swelling. It was reported that no treatment was required. Subsequently, on an unspecified date, the patient recovered from the events. According to the reporting nurse, PREVNAR13 was permanently withdrawn. The reporting nurse started that there was a reasonable possibility that the events were related to PREVNAR13. Follow-up (28APR2011): New information reported from the same contactable nurse included patient demographics, dosing information, reaction details, treatment information, updated event outcome, action taken with drug and reporter causality assessment. Also, additional adverse events of site redness and swelling were reported. Follow-up attempts completed. No further information expected.
My son was registered to receive the second dose in his MODERNA Covid-19 series. We confirmed this with the person at the registration desk. After receiving our vaccines, I looked at his vaccine card and noted that the Pfizer sticker was present, not Moderna, indicating he had in fact been given Pfizer instead. My appointment confirmation, and confirmation with the woman registering us--both indicate our need for the second Moderna vaccine in our series.
SEVERE MYALGIAS AND CHILLS,LOSS OF APPETITE,LOSS OF TASTE DAY AFTER SECOND DOSE OF MODERNA COVID VACCINE, VERY PAINFUL INJECTION SITE, ERYTHEMA ON INJECTION SITE FATIGUE,LOSS OF TASTE ,PAIN ON INJECTION SITE,ERYTHEMA INJECTION SITE 2 DAYS AFTER,DIARRHEA,NAUSEA,STOMACH UPSET DAY 3 HEADACHE, HOT AND COLD,ERYTHEMA ON INJECTION SITE
Seasonal and H1N1 influenza immunizations given is separate upper extremities at 1340. Pt was observed for 30 min in clinic with no noticed side effects. both injection sites were negative for redness or induration. 1900 - Pt felt flushed, nauseated, red eyes. 2000 chills noticed tongue swelling throat swelling. BENADRYL x2 with not help. 2230 Pt went to ER - 500ml Fluid, SOLUMEDROL 125mg IV, epinephrine 1:1000 0.3 ml IM, TAGAMET 300mg IV, prednisone 40mg po x5 days. 12/29/09 itching.
2 wk after receiving MMR booster, Pt developed pain in both wrists, both ankles and right knee.
cellulitus on left arm at injection site, fever for 24 hours, pain, cellulitus lasting a week that spread to another area of arm that was hot to touch and itchy
Pt called pharmacy, got flu shot on 9-27-10 says she has very bad itching that has gotten worse over the week. Pt will try some antihistamine to see if it helps.
Approximately 8 hours after vaccine, high fever ranging 102-103 degrees began.  Severe chills set in.  Shaking and teeth chattering to the point one tooth was chipped (small) Fever and chill continue through the rest of the day. Down to 100 by 5pm on 5-20-21.  Also extreme fatigue, joint and muscle aches, as common with the flu.
1st dose on 13Jul2022, 2nd on 06Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 6th October 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was 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: 06-OCT-2022 Reporter's Comments: The reporter wants to know how to proceed with the Twinrix series. The patient received the first dose of Twinrix on 13th July 2022 and the second dose was administered 6th October 2022. The reporter wants to know when patient would need the third dose. The reporter did not give consent to follow-up. Additional Supportive Information: The patient received the second dose was on 6th October 2022 which lead to Drug dose administration interval too long.
Pain at injection site same pm as injection.  Following AM, site swollen and reddened.
Bright red bloodshot eyes, extreme fatigue, watery/mucousy eyes, coughing, fever, shaking chills, running nose, headache, aches and pains all over body, and dizziness.  It all started at about 12:00 and progressed as the afternoon went on.  It lasted all night and into the next day.  I had to call off work due to the fatigue, headache, dizziness, fever, and body aches.
2 hours after receiving vaccines felt very tired, slept for 3 hours then had H/A, cough, congestion, upset stomach with mild diarrhea, general aches.
body aches, headache, chills, fever, nausea, sweats lasting about 12 hours
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild
dry heaving; Got the COVID booster shot Thursday, 04Nov2021; She sees by the Booster dose is Pfizer, expiration 04Apr2021; she started to feel bad; muscle pain on her back near shoulder/ feels like a sore muscle; lymph nodes are under the arm; Vomiting/throwing up.; This is a spontaneous report from a contactable consumer. This 83-year-old female consumer (patient) reported for herself that:  A 83-years-old female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 85441937, Expiration Date: 04Apr2021), via an unspecified route of administration in left arm on 04Nov2021 at 13:00 (at the age of 83 years old) as single dose for COVID-19 immunisation. The patient received expired product. The patient's medical history included blood pressure high. The patient's concomitant medications included losartan and amlodipine taken for hypertension from an unspecified start date and ongoing. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 8753), via an unspecified route of administration, administered in arm left on 30Mar2021 as single dose for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in left arm on 20Apr2021 (at the age of 82 years old) as single dose for COVID-19 immunisation. No investigation assessment. On 04nov2021, the patient got the booster dose then came home and was okay. Then on Thursday night, the patient started to feel bad. The patient did not remember Friday and experienced vomiting and was terrible. On 05Nov2021, the patient had dry heaving. The patient felt like underneath where her bone was on her left side is black and blue, but it was not. Previous day (at the time of reporting), the patient first time had food. The patient could not keep anything down and found the paper. The patient wondered if it was her lymph nodes, but her daughter said that the lymph nodes were under the arm. It was more like where the chicken bone was and experienced muscle pain. It was right where she hooks her bra on her back, but toward the lung on the left side. She finally tried Pepto Bismol, and that helped a little, but then it came up. The Pepto lot number is 123417195U and expiration of 20Jul2023. Last night, 07Nov2021, she had a small slice the size of her finger of meat and mashed potatoes. She has improved. The pain may be because she slept wrong. It is on her left side. Her daughter thinks it is a side effect. It feels like a sore muscle. She can move her arms, but if she lifts up it catches. The outcome of the event she started to feel bad was recovering and muscle pain on her back near shoulder/ feels like a sore muscle, vomiting/throwing up and dry heaving were not recovered. Other events outcome were unknown.  Follow-up attempts are completed. No further information is expected.
Persistent headache found to be a large subdural hematoma. Hospitalized after surgery x 7 days from 5/22- 5/28.  Also onset of AFib.
Vaccine given7/13/06. 7/14/06 c/o chest burning, dry heaves. Came to office 7/17/06. Had vomited 7x that AM. Had episode chest burning with Triaminicol 11/30/00 with hospital admission. Was seen by Cardiologist in hospital. To ED 7/18/06 with Chest pain. d/c summary includes gastritis. 60 day Follow-up Information 10-OCT-2006: Only heard from pt by phone to request increase in HR NLNO related to vaccine.
AFTER PATIENT RECEIVED SHOT FROM INTERN, PATIENT GOT UP FROM CHAIR AND THEN FELL AROUND 12:30 PM. PATIENT WAS THEN TAKEN TO SIT DOWN BY INTERN. PHARMACIST THEN ASKED IF PATIENT HAS EATEN. PATIENT DID NOT EAT OR DRINK ALL DAY. INTERN RETRIEVED SODA FOR PATIENT. PATIENT WAS ASKED TO STAY SEATED UNTIL 1 PM. PATIENT LEFT AT 12:55 PM AND SAID HE FELT FINE.
A 38 year old male pt developed benign positional vertigo, decreased peripheral vision, nuchal rigidity and signs of anaphylactic reactions after receiving RabAvert.  RabAvert was given on 07/16/03 and 07/19/03.  The pt has a history of possible glaucoma.  The pt came to the ER on 07/16/03 with three marks on his left arm and two marks on his right leg, possibly due to bat bites.  The wound was cleansed and he was administered human rabies immune globulin (HRIG) and the first dose of RabAvert.  On 07/19/03, he received the second dose of RabAvert.  On approximately 07/20/03, the pt developed vertigo, dizziness, insomnia, weakness, fatigue, neck pain, sinus congestion, red eyes and light sensitivity.  On 07/30/03, the treating physician noted findings of benign positional vertigo, gaze deviation, decreased peripheral vision, without acute focal weakness.  No fever, nuchal rigidity, change in blood pressure or anaphylactic signs were present.  A neurologist confirmed the physical findings on 07/31/03.  MRI results were negative, specifically for demyelinating findings.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported.  Upon internal review on 21-May-2021, the age was corrected to unknown.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
The pt reports "lump" appeared at injection site nine days after MMR administered. Seen by nurse in clinic on 05/31/2002. Rasied area 30mm X 30mm, no redness, no tenderness. Went to his primary MD who feels area is a cluster of white blood cells responding to the vaccine that will resolve on own.
Red rash in groin, front and back torso, chest, itchy Took 2 Benadryl tablets
Severe swelling in one foot progressed to disabling pain and stiffness in multiple joints. I also developed swaying vertigo and neurological symptoms including nystagmus, tremors and twitching. Diagnosed with seronegative rheumatoid arthritis on August 5, 2021. Vertigo/neurological symptoms have not resolved; I'm awaiting an appointment with a neurologist to address them.
Severe rash over the patient's entire body (from the neck to his toes) for 10 days. Swelling and tenderness of lymph nodes on (L) side of the body. Hives on/around the injection site (patient was seen at local facility and given BENADRYL and CLARITIN). Patient taking BENADRYL and CLARITIN and was placed in quarters/patient not to receive SP vaccine.
This spontaneous report was received from a female patient of unknown age and refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2017, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). The patient was re-vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) on 25-OCT-2018. On an unknown date in October 2018 (also reported after re-vaccination), the patient experienced redness and pain at injection site. The patient mentioned that on 25-OCT-2018, she had the second vaccination at rehab and after having it, she fell in the basement and experienced a plateau fracture in her right knee and humerus and ulna fractures. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
one dose of Janssen COVID-19 vaccine (.5mL) was given to a patient under age 18
right>left neck stiffness and pain, Frontal HA, as well as tingling, cold pins and needles sensation from back of head, radiating up to forehead and to bilateral jaw/cheeks. Onset: on her way home from getting Pfizer #1 on 8-17-21 (which was probably 30 min after the injection). Started with bilateral jaw / facial tingling only. She ignored this as she though she was tired from night shift in ER. On 18th she had HA and left arm pain ( left side injection). No other symptoms. On 19th neck pain and stiffness onset, with continued HA and left arm pain at injection site. Evening of 19-20 numness and tingling began at posterior neck radiating to forehead and to face, jaw line. Continued HA, neck stiffness. Arm pain resolved. On 24th some dizziness: intermittent , and worse when she is driving or focusing on something. Not associated with change in position.
A spontaneous report has been received from physician concerning a child patient of unknown gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST QUADRIVALENT (intranasal), 0.2 milliliters, unknown started during 2013. The patient was diagnosed with influenza infection on 10-Dec-2013 which was captured as lack of effect. The action taken with FLUMIST QUADRIVALENT was not applicable. The outcome of the events of influenza infection and lack of efficacy was unknown. The reporter considered the events of influenza infection and lack of efficacy to be non-serious.
Suspect SIRVA.  Severe (and intense) pain in arm near shoulder when move arm a certain position. Cannot lift arm above shoulder. I did not have these conditions before injection. It has not gone away and seems to be intensifying,
Seizure started with lightheadedness then sweating about 4PM 2/4/05 then severe vomiting. Donor took Pepto Bismal but vomited again symptoms subsided about 12:30 AM Sat.
Right lateral upper arm with approx 10cm of well-demarcated circular, erythematous patch that is indurated in the center and slightly warm to touch. No red streaks or fluctuance.
Information has been received from an office manager concerning a 49 year old male patient, who on 28-OCT-2005 was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expire date and route not reported). On 01-NOV-2010 the patient received the second dose of PNEUMOVAX 23 (lot # 665903/1427Y) (expire date and route not reported). On an unspecified date, the patient had a systemic reaction, developed a fever of 102F which lasted 2 days and malaise. He was not seen in the office but he called. No treatment was recommended. At the time of the report, the outcome of the patient was unknown. Office manager indicated that on an unspecified date, the patient recovered with no problems and also said that physician felt that the case was closed. This is one of several reports received from the same source. Additional information is not expected.
GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR). On 25-Feb-2021, EXPIRED PRODUCT ADMINISTERED (GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: fallow up was received and contains no new information
After she got home she noticed she had headache, nausea, injection site was warm, hot, and itchy. 01/01/2021 she had "usual" side effects including headache, body aches, chills which subsided on their own. 01/02/2021 she started having heart palpations that later subsided on their own. 01/03/2021 heart was racing again, elevated HR up to 125 bpm measured by patient, plus dizziness; both of which again eventually subsided on their own. 01/04/2021 she had vomiting (30 min of constant fluid loss) and diarrhea (twice just prior to the vomiting). She called me (PCP) 01/05/2020 to discuss this reaction.
3? welt at injection site. It?s red, painful and warm. Antihistamine on 3/10 with no change
Patient received first dose on 21-may-2018. Never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st May 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Details were reported for 1st dose.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. No other details of vaccine were provided. The vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
At time of injection lips felt swollen, hot/cold flashes. Skin felt like it was burning . Was in ER with skin infection yesterday. Migraine. Today 5/19/2021 I started my period. I have been post menopausal for over a year so this is a bit concerning.
Went to ER on 12/15 after waking up that day with left testicular pain. ER showed left sided swelling of epididymis and testicle and he was diagnosed with epididymoorchitis. A UA was normal. Seen in office for follow-up 12/21 and symptoms resolving but some swelling remains.
Patient admitted to hospital as inpatient on on 10-10-21 due to pneumonia due to Covid. Patient was tested for COVID-19 and was positive on 10-10-21.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 29-MAY-2015 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for RECOMBIVAX HB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event reported. This is one of several reports received from the same reported. Additional information has been requested.
Patient received shots 48 hours prior to death.  9/30/08 Autopsy states COD as sudden unexpected death of an infant.  Manner of death undetermined.  Report also states patient found unresponsive, face down on comforters, in bed surrounded by pillows.
On April 8, 2022, A Licensed Immunized 10 patients with an expired dose of Moderna, which I immediately realized when I filed the documents and stopped the vaccination process. The Covid-19 Vaccine delivery document stated that deadline date and time to use these vaccines was day 6 of month 4 and year 2022 at 7:10am.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: patient started calling for help about 5 mins after receiving the vaccine.  stated she felt dizzy while sitting. I asked if she could stand up for me to get her on the ground but she could not. her eyes started to roll, i took off her mask to help her get a deep breathe. she was still somewhat responsive but started to fade in & out. paramedics were called using my phone. She did not fully pass out but had slurred speech, complained of dizziness, chills,& was confused