chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt received her 1st dose of Lymerix in 5/00. One week later, she experienced right elbow pain and muscle pain. These symptoms resolved after an unspecified period of time. The pt received her 2nd dose of Lymerix in 6/00. The next day, she began to experience "extreme" pain in "every joint in her body". She was seen by a rheumatologist, who reportedly told her that she had "arthritis from vaccine". The pt also mentioned that she has an "impingement problem" in her shoulder, which will require surgery. It was unclear if the "impingement problem" developed before or after immunization. Treatment and outcome of the arthritis and "impingement problem" were not provided. The pt declined to provide contact information for herself and she declined to provide authorization for GSK to contact her physician. Therefore, no additional information will be available. The adverse events of "arthritis", "elbow pain" and "impingement problem" do not meet ICM serious criteria, but are being submitted as an expedited report by special request per the 6/28/00 letter.
RECEIVED 3 DOSES OF MODERNA. 1ST 01/15/2021, 2ND 02/12/2021 AND WE GAVE WHAT WE WERE TOLD WAS HIS 1ST DOSE ON 6/14/2021
Developed cellulitis after vaccine from injection. Not a true vaccine reaction. Family requesting that report be made.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "My husband and I have auto-immune diseases" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick".  Additional information: Patient reported that her husband and she had auto-immune diseases. Every time they had taken a Covid shot or booster, they got really sick for at least 5 days and wanted to know if there were ways to avoid becoming sick after every shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151354 same reporter/product/event, different patient;
Pt vaccinated with DTP/OPV experienced screaming episode lasting more than 4 hrs.
COVID-19   I received my 4th dose on  04/15/2022 . I tested positive for COVID-19 on 05/25/2022. My COVID-19 symptoms started on 05/28/2022  at around 01:00 in the afternoon with sore throat;  nasal drainage, cough, headache;  I did a tele health with my doctor who didn't recommend any kind of medications because of my hypertension.  it took me 12 days to clear and i tested positive for 12 days straight. i am ok now.
Immediately following vaccine, pain and heat at site of injection - radiating to lateral neck; saw neurologist. EMG was negative (L arm - pain has persisted for 1 month).
nonfebrile seizure w/in 20 hrs of vax containing DTP immunization;
Information has been received from a registered nurse concerning her daughter (age unknown) who on unspecified dates was vaccinated with first, second and third doses of Gardasil. Subsequently the patient developed swelling of the arm after all three doses of Gardasil. At the time of this report, the outcome was unknown. Additional information is not expected.
Patient complained of feeling flushed, sweaty, and nauseated.  She was given water and laid down.  Vital signs: BP 120/77, HR 89, O2 99% on room air.  Monitored for additional 20 minutes and patient's symptoms resolved.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 73-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. The reporter considered the injection site reaction to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown arm. The healthcare professional was unable to provide further details regarding the nature of the reaction as she had not seen the patient at the time of report. No additional information was provided.
Narrative:  COVID infections following completion of COVID vaccine series 01/05/21 COVID vaccine dose #1 01/26/21 COVID vaccine dose #2 02/02/21 COVID swab done - NEGATIVE 02/28/21 Pt presents to ED reporting double vision that lasted ~15 minutes; discharged and advised to see ophthalmologist and PCP 07/21/21 Pt reports chills, fever, muscle pain, runny nose, sore throat, temp 101.3, HR 103; COVID POSITIVE 07/22/21 Pt reports body aches, fatigue, fever, cough, sore throat, chills 07/23/21 Pt reports chills, cough, fatigue, fever, headache, sore throat 07/24/21 Pt reports cold sweats, chills, productive cough, fever, fatigue, headache, loss of taste or smell, muscle pain, runny nose, SOB, sore throat 07/25/21 Pt reports occasional cough that is improving, fluctuating fever, diminished taste, muscle pain, improving sore throat 07/26/21 Pt reports chest congestion, cough, fever, loss of taste/smell, mild sore throat, temp 102.8 07/28/21 Pt reports chest congestion, cough, fever, loss of taste/smell, mild sore throat, temp 100.4.; presents to ED for CXR c/o of muscle aches, chills, ? discharged with rx Z pack, medrol dose pack, albuterol MDI and benzonatate, zinc, vit C and D 07/29/21 Pt presents to ED and reports worsening cough, fatigue, fever, muscle pain, nausea, SOB, malaise; CXR indicative of COVID pneumonia; admitted inpatient for acute hypoxic respiratory failure secondary to COVID pneumonia; treated with remdesivir 07/30/21 Pt reports feeling better, decreased appetite and loss of taste and smell; being treated with dexamethasone, remdesivir, lovenox, supplemental oxygen and omeprazole 07/31/21 Pt reports not sleeping well, anxiety but improvement in breathing 08/01/21 Pt denies any acute issues, breathing has improved but has SOB on exertion 08/02/21 Discharged with rx for albuterol, ascorbic acid, benzonatate, cholecalciferol, DM/guaifenesin, prednisone 08/03/21 Pt reports feeling better with some sore throat, mild productive cough, and constipation
Injection site to left arm was extremely sore to touch. Could not raise arm for 3/4 days. After 4th day arm felt better.
My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster) and everything else, booster twice and we both ended up with COVID; My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster) and everything else, booster twice and we both ended up with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster) and everything else, booster twice and we both ended up with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment with paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given 1st dose of Pfizer covid vaccine at approximately 950am by RN. Patient notified RN that her mouth was starting to itch and she felt like she may pass out. RN administered 50mg of oral diphenhydramine hcl at 955am. Vitals: BP 125/79, HR 96, O2 98% Patient's face began to redden in a splotchy pattern. RN called 911 at 10am. At 10:01am began began coughing and her alertness started to decline. I administered 1 dose of Adrenalin 1mg/ml 0.3mg in her right outer thigh per protocol.  10:03am Vitals: BP 122/75, HR 89, O2 98% 10:04am Patient stated the itching in her mouth was improving. 10:07am Vitals: BP 122/78, HR 80, O2 97% 10:10am Vitals: BP 104/74, HR 78, O2 97% Patient stated that the itching was continuing to improve. She was also able to tell me the day of the week and her weekend plans with clarity.  10:15am RN called 911 again; Vitals: BP 114/75, HR 84, O2 96% 10:17am Patient states all symptoms have resolved. 10:20am Vitals: BP 117/74, HR 87, O2 98% EMS arrived at 10:21am and took over care of the patient. Patient was to be transported to the ED.    Meds given: 2 capsules of Diphenhydramine Hcl 25mg, Lot 202451 Exp 8/2023 NDC 0904-5306-61   Adrenalin 1mg/mL 0.3mg IM x1, Lot 342523 Exp 10/2021 NDC 42023-159-01
Mild and temporary Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Mild and temporary Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   In October 2022, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild and temporary Injection site pain). At the time of the report, VACCINATION SITE PAIN (Mild and temporary Injection site pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient is a retired registered nurse. Patient received flu shot on October on an unknown date and year and had flu on 26- Dec of an unknown year. Patient's husband and daughters had COVID at different times in 2022, all were vaccinated and recovered with no residual effects.   This case was linked to MODERNATX, INC.-MOD-2023-694623, MODERNATX, INC.-MOD-2023-694625 (E2B Linked Report). This case was linked to MOD-2023-694621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Live follow-up includes Non-significant information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-694623:Husband's case MODERNATX, INC.-MOD-2023-694625:Case for daughters
CHEST PAIN  AND UNABLE TO DO PHYSICAL ACTIVITIES.   NO PE AT SCHOOL .  NO LIFTING. NO EXCERTION OF ANY TYPE.     NO DESIRE TO DO ANYTHING    ABSENT FROM SCOOL ALL THE TIME BECAUSE OF PAIN  TREATMENT RECOMMEND TYLENOL PATIENT STILL HS CHEST PAIN  IT IS NOW 5 MONTHS SINCE THE SECOND VACCINE
Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; This is a spontaneous report from a contactable consumer. This 33-year-old male consumer (patient) reported that who patient received bnt162b2 (BNT162B2 solution for injection, dose 1 via an unspecified route of administration at arm left on 15Apr2021 15:00 (at the age of 33-years-old) (Lot Number: EW0161) as single 1 dose, for covid-19 immunisation. Medical history included n/a from an unknown date and unknown if ongoing. Concomitant medication(s) included fish oil (FISH OIL). l-arginine acetate (L-ARGININE ACETATE). ascorbic acid, tocopherol (VITAMIN C + E) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had no allergies. Other medications the patient received within 2 weeks of vaccination: Multivitamin, fish oil, l-arginine, vitamin c/e. On 15Apr2021 15:30 the patient experienced swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination. No treatment was taken for the adverse events. Outcome of the events was recovered in 2021.    Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Mild Lightheaded after 15 min of injection. Patient was monitored additional 15 minutes and recovered during that time; patient recovered and was able to  leave the pharmacy on her own.
Generalized malaise p/6 hrs; nausea, diarrhea 36hrs p/; 2 days post vax, nausea, diarrhea, laryngitis, h/a lasting 5 days;
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 02-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
moderate/severe headache starting 3/27/2021 evening and going to 3/29/2021. Some relief with tylenol. Muscle aches starting 3/27/2021 evening and going to 3/29/2021. Some relief with tylenol. Chills 3/27/21- resolved on own during the night. Fatigue starting 3/27/2021 evening and going to 3/29/2021.
About 3 hours after vaccine became very dizzy and tired.....slept for 3 days.....and felt better.  On 11/01/21 had trouble getting out of bed, am very dizzy and have to hold onto something so I don't fall.....very sleepy
Chills, feeling feverish, all-over muscle pain, fatigue, pain in arm at injection site
Pt given DTP/OPV & w/in 6 hrs pt had temp & was given dose of APAP & had onset of staring, shaking arms & legs clenching of jaw lasted 60-90 secs; no postictal; pt recovered quickly;
I started to have severe joint pain  on my left side the day after my injection in my jaw, elbow, hip, knee, ankle.
PALM-SIZED RASH, RED, HOT RAISED PAINFUL AT INJECTION SITE. 12 DAYS TO RESOLVE.
Slight itching for a few hours and the injection site.  It did swell up and became red and warm; an area approximately the size of my hand.  Has occasionally itched since then but nothing like on April 7th.  You can still slightly see the injection area/slight redness.
Itchy and swollen right eye, swollen right cheek right side corner of mouth seemed droopy, but may have been the swelling right side of chin swollen
Rash formed on chin, jaw area. Reddish in color. Small and blotchy. Noticeable to him, but not painful or irritating.  Also, appeared on his chest up to 10 days after. Nothing else in his life had changed...no new detergent, bed sheets, etc.
Body Aches, Chills, 101 degree fever, cough, loss of taste and smell.  Started 1/3, lab tested on 1/5 after visit to Dr. Office with positive Covid-19 result returned.
Faint two times; This case was reported by a pharmacist via call center representative and described the occurrence of faint in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date 9th May 2022) and (batch number CD9MZ, expiry date 4th September 2022) for prophylaxis.   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 17th November 2020, less than a day after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and on the same night faint two times. The reporter consented to follow up.
Severe hives. Hives from head to toe, including eyelids, around mouth, etc.  The hives were itchy, and became bloody. The hives did not go away until he was over 6 months old. Also developed severe crying, severe reaction to bright lights and noises. Had one more single shot (DTap) at 12 months, and once again had severe hives and itching.  Developed eczema, allergies, and asthma.  His speech was delayed, and he continues to have severe allergies, as well as sensory issues, and is being evaluated for autism and other developmental delays.
The patient should have recieved the Modena 12 years and older SPIKEVAX form, not the 6-11 years of age form. The patient has no symptoms.
Headache, Myalgia, shaky, weak, tired Received vaccine at 1030 am, 100 pm started feeling shaky, tired, weak. Advised that this is a normal response to vaccine and should subside in a few days, If anything becomes worse or difficult breathing should follow up with PCP.
Red, raised itchy rash at injection site within an hour or so of getting DTaP and VARICELLA injections. No mucus membrane or respiratory involvement. This may have happened before with PREVNAR (hives at site within a week).
This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment for the event included none. Patient scheduled for 2nd dose of Moderna COVID -19 on 1st Apr2021.
Patient developed pallor immediately following vaccine administration. Was advised by administering MA to remain in a seated position. Patient tried to stand up and had vasovagal syncopal event. Was placed in supine position, awakened immediately. Ice water was administered orally. Patient observed for an additional 15 min, was well appearing. Was allowed to leave clinic under mother's supervision at that time.
Erythema with swelling around injection site. Induration of swelling measured to be 2.7in x 1.9in. Temp at 97.2 at 4:20pm on 04/20/18 during nursing visit. No warmth noted upon touch to site.
Skin reaction to immunization diffuse maculopapular rash of trunk and extremities. maybe 10 small spots scattered over body per mother 10/7/02. No other symptoms.
In the morning it started as a lower quadrant pain that continued to get worse that was not alleviated by ibuprofen and kept me from going to work. I considered going to the emergency room, but the pain started to subside. I called my primary care physician and described what was going on, she ordered a pelvic exam, I am awaiting to get that scheduled. The dull pain did linger for a couple of days and now it gone.
Sore Arm day after getting Vaccinated: Lasted a few days and faded away until there was no pain. Felt very Fatigued the day after getting the Vaccination: Lasted several days. But, got better with time.  Adverse event I wished to report: Seems this Vaccine might have, temporarily, hindered the effectiveness of a medication I take.  I'm on Amytriptyline 25mg, 2 a day at one time, for Postherpetic neuralgia on the right side of my face & right ear. This Amytriptyline medication has helped to cease all pain, including migraines, that I get from the Postherpetic neuralgia, and has also helped with the pain of pinched nerves in my back. Due to that, this medication has really helped improve my quality of life.  After getting the Vaccine, I went home and felt fine the first night. When waking up the next day, I found myself experiencing pain on the right side of my face and in my right ear. Thought this was odd as I took my medication the night before. But, as the day went on, it got a bit worse. That night i had trouble sleeping due to it. Then, the next day, I awoke with not only the pain at a level that it was before having treatment for it, but it also caused light sensitivity, migraines, and I could feel the right upper part of my jaw hurting as if teeth were aching that have been pulled years ago. I was also having vertigo when the ear pain got too bad.  This went on for several days and then faded away around the 20th of April 2021. Although I was confused as to why the Amytriptyline didn't seem to work as well on those days, I figured that it must be something to do with the vaccine effecting my nerves, or interacting with this medication. I did not seek medical advice for this reaction, as it went away. But just wanted to report it using this form. Thankyou.
The first day, it was just a little sore, but by day 3, it had a big lump and was getting red.  It is still a round red rash but the lump is gone.  I think it will get better but I think the rash is like the covid rash I have seen in articles.  It is not as big as the ones I have seen, but it is red.  It is getting better and hopefully be gone when I get my 2nd shot.  I am getting that one in my right arm.  Just wanted someone to know that after 3 weeks, I still have the rash.  The lump was there for about 2 weeks and half, but it is gone now, just the rash is there.