chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction to vaccine) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Severe reaction to vaccine). At the time of the report, VACCINATION COMPLICATION (Severe reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-348714 (Patient Link).
Left  extensor wrist drop and weakness in the forearm and brachioradialis muscle weakness  as well
Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
On 05/01/2022, I had a terrible, dry cough, but didn't think anything of it. The next day, I had a sore throat. I called the doctor's office, but missed their COVID-19 clinic time period designated for patients. So I went in the next day during the time; by then, I had terrible body aches and chills. They tested me for the flu as well because there was a flu outbreak in the area. I did an at-home COVID-19 on 05/02/2022, but it came back negative. However, 05/04/2022 at the doctor's office, the test came back positive. The nurse practitioner at the office had me go to the urgent care after mentioning having some chest pain to get x-rays done and prescribed oxygen inhaler, Paxlovid, and benzonatate. I've completed the treatment for the medications, and have recovered but still having some fatigue most days. The doctor and the radiologist confirmed I was experiencing COVID pneumonia.
On March 21st I started with a runny nose. I took THERAFLU. That following Saturday it got worse I started with a fever. That following Monday I went to see the doctor. I went to the local clinic. I had fever, nasal congestion, and some chest congestion. They prescribed me amoxicillin for 7 days and that resolved the issue.
No adverse reaction. Patient given Moderna Monovalent booster instead of Moderna bivalent booster. Patient notified.
AROUND 9PM BOTH ARMS FELT HEAVY AND WEAK. WOKE UP AT 11:30PM ENTIRE UPPER BODY WAS HURTING AND ACHING. HAD MODERATE TO SEVERE PAIN IN THE CHEST AND HURT WHEN TAKEN BREATH. THIS WENT ON FOR ABOUT2 HOURS. TOOK TYENOLAT 1:30A. EVERTHING CONTINUE TO HURT ALONG WITH UNCONTROLLABLE SHAKING. FELT BETTERAROUND 3:30A
6/30 fatigue 7/1 aches to whole body, flushed. 7/3 faint red rash to scalp and chest, itchy. 7/5 rash lighter, no itching.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included gabapentin, Tetanus vaccine, TRAMADOL and BACLOFEN. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever and shivering. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever and shivering were recovered/resolved. The reporter considered the fever and shivering to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received Tetanus vaccine on an unknown date in April 2018 and SHINGRIX in on left arm. The patient developed shivering and a fever of 102.1 degree F, 10 hours after getting the vaccination. The patient took Ibuprofen every 5 to 6 hours.
pt recvd vax; devel inject site rxn characterized by swelling, itching,erythema, warmth
The patient experienced no symptoms; an improperly stored dose of GARDASIL 9 was administered; an improperly stored dose of GARDASIL 9 was administered; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 14-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), prefilled syringe, lot # R028656, expiring on 27-JUL-2021, intramuscularly, for prophylaxis (dose, and site of administration were not reported).    The administered dose of the vaccine experienced a temperature excursion of 27 degrees Fahrenheit for 3 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  The patient experienced no symptoms. No product quality complaint was involve combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
headache; bitten her tongue; tongue somehow felt larger, and different; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took sulfur and had an allergic reaction. She said it caused her tongue, and throat to swell. On an unspecified date, the patient experienced headache, bitten her tongue, and tongue somehow felt larger, and different. It was reported that through the night, the patient must have bitten her tongue because when she woke up, it somehow felt larger, and different. The patient wasn't sure if it was a reaction associated with the vaccine, or if she just bit her tongue when she was asleep. The patient wanted to know if she could take Benadryl and Tylenol to treat these reactions. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Within 1 day of DTaP, MMR in right thigh entire anterior thigh was red swollen hot and painful limiting ambulation. 2 days after vaccination improving but exam shows 11 x 15 cm area of heat, induration, redness.
A few weeks after booster shot, I suddenly came down with severe appendicitis, with no prior health issues or pain. I went to the emergency room, they ran MRIs, etc. I assumed it was a kidney stone (as I had one in the past). The doctor told me that it was appendicitis and they noted that it was unusual in people my age. Appendix was removed in surgery (laparoscopy), sent home afterwards. I healed quickly and did not need to take any medication for pain. Besides the appendix, in the last month I have had a sudden increase in joint pain and swelling, there is a throbbing sensation that keeps me up at night. I had experienced very mild swelling, but it seems to have increased, possibly because of my autoimmune issues.
pt had a previous hospital admission, was dx positive for COVID; pt was dc'd to home with O2 and steroids; 1/14/22 pt back to ED with worsening SOB; chest xray showed bilateral infiltrates; readmitted with COVID pneumonia; given steroids, O2 supplementation; pt worsened requiring intubation; ventilated; transferred to ICU; critically ill; made slow improvements regarding vent liberation; family decided to withdraw care and pt passed away in the hospital
About 24 hours after vaccination, patient experience swelling in the mouth area, and did not have trouble breathing. After taking diphenhydramine, the symptoms improved. Patient was advised to seek medical attention if symptoms worsen.
Patient was given the menveo diluent and sterile diluent together instead of the actual menveo vaccine and menveo diluent
pt recv flu vax & MD realized this was last yr vax & pt given flu shot again w/in 4 days of the first one;pt states has been extremely ill w/flu type sx;MD called CDC for advice told to give 2nd shot this years flu vax would not effect last
8 hours later patient awakened at 11:45pm on day of injection. Attempted to get out of bed to go to BR-unable to get up due to vertigo and nausea. Also c/o "cricket sounds" in both ears. Sx persisted since, but slowing improving. Also c/o palpitations in chest on 12/12 when sx started.
Mom states" came into my room complaing that his stomach didn't feel right and his arms and legs felt weak." When mom questioned about symptoms states, " they started this morning."  Mom denies any fever, vomiting, diarrhea, swelling or redness at the site.  Client still able to ambulate despite arm and leg weakness. Mom encouraged to make appointment with pediatrician or if symptoms worsen proceed to nearest ER.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
To this day (12/12/16) I am having intermittent pain at the injection site in the muscle (two months after receiving the shot). The pain is sharp and lasts no longer than a few seconds. The occurrence is approximately 4 or 5 times a day. No other issues and no treatment received.
Suboptimal dosage with sx, pt given < 1/2 the vaccine. Pt called and left message. No call back as of yet. Called to reschedule correct dose to be re-administered. Spoke with wife and son who all got sub optimal dosing.
Local rxn below site of injection of DTaP on both arms all the way to elbow. Swollen, tense, redness. Lasted 3 days. Onset 24 hours after vaccine.
Tingling in finger tips. Flushed feeling. BP 138/88. F/U with primary care MD reported no action needed at time. Continued to monitor. Retake BP -> 128/80. F/U with patient at 15:00. Denies any needs. Reports no symptoms. F/U on 10/16/14 -rpt no symptoms.
rash on arms and chest, 9:50am gave injection, 10:05am patient noticed rash 15 min after injection, 10:07am 22 min after injection gave Benadryl, 10:10am checked on patient rash the same, 10:15am checked on the patient- rash started to clear up, 10:25am checked on patient, 10:30am let patient leave the clinic
arm was hurting and was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was hurting and was sore".  Additional information: With the second one her arm was hurting and was sore. The patient had taken all three Pfizer shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild
Big knot at injection site; Weakness; Shooting pain inside her head; Chills; Nausea; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big knot at injection site), ASTHENIA (Weakness), OFF LABEL USE (Extra dose administered), HEADACHE (Shooting pain inside her head) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Extra dose administered). On 10-Sep-2021, the patient experienced VACCINATION SITE MASS (Big knot at injection site), ASTHENIA (Weakness), HEADACHE (Shooting pain inside her head), CHILLS (Chills) and NAUSEA (Nausea). On 09-Sep-2021, OFF LABEL USE (Extra dose administered) outcome was unknown. On 11-Sep-2021, HEADACHE (Shooting pain inside her head), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE MASS (Big knot at injection site) and ASTHENIA (Weakness) had not resolved.            No concomitant medication reported. No treatment medication reported.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 13th February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 14th February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On 19th February 2019, the patient experienced myalgia, fatigue and headache. On 27th February 2019, the patient experienced stiff back and stiff joint. On an unknown date, the outcome of the pain in arm, fatigue and headache were unknown and the outcome of the general body pain, myalgia, stiff back and stiff joint were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, myalgia, fatigue, headache, stiff back and stiff joint to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The physician on the line reporting a patient who received SHINGRIX two weeks ago was still complaining of diffuse myalgia and pain. On 14th February 2019 the patient had soreness in the arm and significant body aches, but felt better on 15th February 2019. On 19th February 2019, the patient relapsed and had myalgia and fatigue with headache. On 27th February 2019, the patient reports overall achiness and back and joints are stiff and these events are ongoing. The product was administered in a different location. This case has been linked with the case US2019037727, reported by the same reporter.
30 minutes after the injection, developed urticarial hives causing swollen eyes, nasolabial area and earlobes; smaller urticariae in arms, legs and trunk. Given Benadryl and cortisone injection; lesion faded.
This case was reported by a physician and described the occurrence of inability to speak in a 27-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2012 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm). On 10 October 2012, within hours of vaccination with FLUARIX, the subject experienced headache and arm pain. On 15 October 2012, five days after vaccination with FLUARIX, the subject experienced inability to speak, stuttering speech and numbness in arms and legs. On 16 October 2012, six days after vaccination with FLUARIX, the subject experienced worsening inability to speak and went to the emergency department where a dystonic reaction was suspected. At the time of the report, the subject was currently in the ED because of worsening ability to speak. A computed tomography scan was performed and normal. The mother of the subject reported to the primary care physician, that the ED was "saying it may be a dystonic reaction caused by flu vaccine"; the subject never had a flu vaccine before. At the time of reporting the inability to speak was worse; stuttering speech and headache were unresolved. The dystonic reaction, numbness in arm and leg and arm pain were not specified. The physician considered the numbness in the arms and legs as unrelated to vaccination with FLUARIX. Follow-up information was received on 26 November 2012 via healthcare professional who reported the events occurred on 15 October 2012 resolved on an unspecified date. The healthcare professional considered the event serious and the subject required hospitalization.
Aching in shoulder, all around neck and into upper back.  Almost fainted, so laid in the floor.  Heart was racing.  Horrible headache.  Weak and laid in floor for 30 minutes b/c couldn't get up.  Event lasted about an hour.
Post vax, she experienced generalized joint pain. This was reported to have been ongoing for a while.
Patient was pregnant but not known at at time of first shot.  She then got the second vaccine and had a miscarriage diagnosed 7/7/21 at 8w6d
I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad; I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad; I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad; I couldn't sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad"; INSOMNIA (non-serious), outcome "unknown", described as "I couldn't sleep at night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days after vaccination, patient developed generalized maculopapular rash; red in color and p ruritic.
Symptoms began with severe abdominal pain and cramping, nausea, forceful vomiting and diarrhea (at same time). After vomiting, throat felt tight, like it had closed up a bit because there was a lump in it, but didn?t affect my breathing much. It just felt extremely dry even after having drank a lot of water. I constantly felt the need to swallow. An hour after this, my skin began to have a flushed appearance on my upper and lower body, specifically my face, shoulders, and upper and lower legs. My body felt hot to the touch and looked as if it had a rash. Legs were tingly. I felt dizzy.
Per pt. Mom - had to leave school following day due n/v and diarrhea. Possible sore arm at injection site.
For 48 hours post vaccine, I was very lethargic and fatigued and then the symptoms subsided. Seven days after the vaccine, I was itchy at my injection site and found that I had a rash about 7 cm in diameter. The rash cleared within 24 hrs.
pt recvd vax & w/in 24hrs post vax exp dizziness & vertigo;pt was seen by MD who treated w/Antivert;sx resolved p/1wk;
pt recv vax 22OCT97 & 2NOV97 pt devel chickenpox consisting of less than 50 lesions;pt also devel dime sized petechiae around inj site;
Patient reported about 3 minutes after getting her vaccine that she was feeling light-headed like she might pass out. I went out to check on the patient at which time she vomited. Patient was taken back to bathroom to clean up and then was brought back to a chair where she could sit down and prop her feet up. Patient was provided an ice pack to help with controlling temperature, as well as a bottle of water and a snack to help with nausea symptoms. Patient reported having no serious side effects from a vaccine in the past, including never vomiting or passing out. I remained with the patient for another 15 minutes monitoring her for resolution of current symptoms or development of more. No local reactions noted around injection site. Patient reported no pain, soreness, or loss of mobility around injection site. Patient contacted a family member to pick her up and bring her back home. While waiting, patient continued to report feeling warm due to her pants, but other symptoms of light headedness, nausea, and clamminess had subsided. When family member arrived to pick her up, I escorted the patient to the family member's vehicle. I also encouraged the patient and family member to continue to monitor for any additional side effects and to call the pharmacy if any reported. Patient was also encouraged to seek additional medical attention for any continued severe vomiting or episodes or fainting. I advised the patient that we will contact her tomorrow morning to check in on her progress and to assess for any additional reactions.