chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a consumer (the patient) on 17 October 2013. A 71-year-old female patient had received a dose of FLUZONE HD, (batch number: U4788AA, dose number not reported) intramuscularly in left deltoid on 15 October 2013. The patient was allergic to mercury preservatives and thimerosal and illness at the time of vaccination was not reported. On 16 October 2013, one day after vaccination, the patient developed 4 inch , red patch at injection site with hard lump at site. On 17 October 2013, the patient stated that the site was less red. Laboratory details and corrective treatments was not reported. At the time of this report, the outcome was unknown.   Follow-up information received from a health care professional on 10 March 2014. The patient was recovered on an unspecified date.
I usually have a lot of energy and now I have trouble staying awake and my energy is low ever since the day I got the flu shot, I noticed the morning after and it?s been bad since then.
Spoke with pt, he states he wanted to report the reaction he got to the vaccines. He read the literature given to him from the office and states he wanted do his civic duty and report his side effects.  He states that the first shingrix shot made him tired for about 24 hours  But this second one with the flu, he got nausea, shivering, frequency and was unable to sleep Friday night .  He denies any symptoms now. States that he recovered on Sunday.
pt recv vax 230PM 21MAR96 swelling,throbbing began 7PM worse 22MAR96 sl nauseous
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 08-MAY-2017, the patient was vaccinated with improperly stored doses of VAQTA injection, lot # N003194, expiry date 28-OCT-2017 (dose, route and site were not specified) and RECOMBIVAX HB injection, lot # N002920, expiry date 30-SEP-2018 (dose, route and site were not reported). The administered doses of VAQTA and RECOMBIVAX HB underwent temperature excursion at 9-25 Celsius degrees (47-77 Fahrenheit degrees; 10.8 Celsius degrees) for 30 min. No adverse events were reported. Product quality complaint (PQC) was not involved.  Additional information has been requested.
lower intestinal pain; red spots on the tongue; I can't keep my balance; I can't go back to work; chills; diarrhea; Whenever I eat, it burns; I can hardly stand up with this pain; My stomach started hurting - the pain is severe; nausea; vomiting; I couldn't even get out of bed; getting feverish; my stomach started hurting a little bit; My arm was very painful, I could hardly lift it.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (my stomach started hurting a little bit), ABDOMINAL PAIN UPPER (My stomach started hurting - the pain is severe), DIARRHOEA (diarrhea), BURNING SENSATION (Whenever I eat, it burns) and DYSSTASIA (I can hardly stand up with this pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm was very painful, I could hardly lift it.). On 10-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (my stomach started hurting a little bit) and PYREXIA (getting feverish). On 11-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (My stomach started hurting - the pain is severe), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (I couldn't even get out of bed). On 13-Apr-2021, the patient experienced DIARRHOEA (diarrhea), BURNING SENSATION (Whenever I eat, it burns) and DYSSTASIA (I can hardly stand up with this pain). On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (lower intestinal pain), TONGUE ERYTHEMA (red spots on the tongue), BALANCE DISORDER (I can't keep my balance), IMPAIRED WORK ABILITY (I can't go back to work) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (my stomach started hurting a little bit), ABDOMINAL PAIN UPPER (My stomach started hurting - the pain is severe), DIARRHOEA (diarrhea), BURNING SENSATION (Whenever I eat, it burns), DYSSTASIA (I can hardly stand up with this pain), ABDOMINAL PAIN LOWER (lower intestinal pain), TONGUE ERYTHEMA (red spots on the tongue), BALANCE DISORDER (I can't keep my balance), IMPAIRED WORK ABILITY (I can't go back to work), VACCINATION SITE PAIN (My arm was very painful, I could hardly lift it.), PYREXIA (getting feverish), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (I couldn't even get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient reported that she was not being able to get out of bed. In the follow up received on 18-Jul-2021, the patient reported that she couldn't go back to work  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Significant follow-up received on 18-Jul-2021.  New event of balance disorder.
numbness in chin; jaw tightness in throat; redness on hands and upper back; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 12:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing; and allergy to intravenous (IV) contrast red dye from an unknown date and unknown if ongoing. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had not been diagnosed with COVID-19 prior to vaccination. Concomitant medications included propranolol hydrochloride (INDERAL), irbesartan, and atorvastatin all from unknown dates for unknown indications. On 06Apr2021 the patient experienced numbness in chin, jaw tightness in throat, and redness on hands and upper back. The events required an emergency room/department or urgent care visit. The patient was treated with diphenhydramine hydrochloride (BENADRYL) and received an electrocardiogram (EKG) and a computerized tomography (CT Scan), the results of which were not reported. The outcome of numbness in chin, jaw tightness in throat, and redness on hands and upper back were recovered in Apr2021. It was also reported the patient had not been tested for COVID-19 since vaccination.   No follow-up attempts are needed. No further information is expected.
Redness, Swelling, large red ring around injection site that was spreading up and down the arm.
In March patient was diagnosed with Prostatitis, he was placed on Bactrim and developed a ?red blotchy sunburn type rash, all over? his entire body after approximately one week on the antibiotic. His physician switched him to Cipro 500mg for 28 days, the rash cleared, and he completed his medication on April 30th.   Patient received Moderna Covid vaccinations on 4/11/21 and 5/9/21.  He was first seen at Dermatology on 5/20/21 he was suffering from a second ?angry itchy red rash? that started a little over a week before.  The rash began on his back, extended up the neck and ears and down the legs.  New spots of rash continue to pop up every day.  He had been using OTC cortisone cream and Benadryl without relief.  Patient was diagnosed with urticaria.  He was prescribed Triamcinolone Acetonide 0.1% cream and a Medrol dose pack.   On 6/3/21 he returned to Dermatology, he completed the Medrol dose pack and was using the cortisone cream 1-2 times daily.  Only one patch of the rash remained on his right flank.  He was instructed to continue using the cortisone cream and to refill the Medrol dose pack if the rash returned.   On 6/25/21 patient presented with persistent urticaria, he reported the hives came back and he started another Medrol dose pack on 6/20/21.  He felt like the rash is getting worse.  He reports feeling well, no fever.  Scattered patches of erythematous papule on the chest, abdomen, back and nape were visualized.  At this point Dr prescribed 10mg Prednisone tablets #100, instructing patient to take 4 tablets a day and taper as directed.  He was also instructed to increase his Claritin dose to twice daily and to continue with triamcinolone.  Dr. discussed the fact that this was unlikely due to Bactrim due to the prolonged nature of the rash.   Patient returned on 7/9/21, he stated that he is unable to stop the Prednisone,  as soon as he attempts to stop the urticaria and pruritus return.  He is having trouble sleeping due to the Prednisone.  The rash is currently calm.  Patient instructed to continue taking oral Prednisone pills as needed, likely 1-2 tablets a day for the next few days.  Discussed performing a biopsy if rash persisted.  Patient telephoned on 8/10/21: He has continued to take Prednisone but the hives are the same if not a little worse.   Patient seen in the office on 8/17/21, stating the least amount of Prednisone he is able to take to control the rash is 10mg three times a day.  He continues to apply triamcinolone.  It has been 3 months of the rash, he is feeling aggravated and depressed.  He is now having side effects from the Prednisone including difficulty sleeping, elevated heart rate, he feels fluttery, and is having joint pain. Patient c/o he has swelling of face and neck and increased appetite.  At this point the rash appeared more follicular in nature, patient instructed to taper the prednisone and use cool compresses and Aspercreme with 4% lidocaine to control the itch.  Discussed probability that this rash is due to the Covid vaccination.
Thursday the 28th in the morning my head felt a little off so I took some Tylenol. I went to work that day, my sinus felt like sinus pressure from my allergies and around noon I picked up some Sudafed. And around 3 pm I got out of my car and stood up and I felt so woozy like I was gonna fall down. I was at my doctor to pick up some med and I also grabbed some COVID-19 test. When I got home I took and test and it was positive. By the next day I had no energy, nauseous, congestion and my nose was running more then it was with a cold. I had a fever it was about 102. I was nauseous but nothing throwing up with a little dihedral. It was really hard to stay awake. I called to get a hold of my doctor they set me up with a telehealth. The prescribed paxalif. I had a very strong cough in my chest, but i was progress cough and a lot flehm would come out. My husband picked up my meds for me. By Saturday i lost taste of smell and everything else was still going. Those symptoms kept going until 05/05/2022. I was not sleepy as much and was still draining a lot of flehm. I realized on the 05/05/2022 that i was not taking the meds correctly. I called my doctor to get the right dosage. By that time my husband also tested positive for COVID-19. I think it around 05/07 where i was testing negative. I was feeling more energy but still had a lingering cough and congestion.
Moderna COVID-19 Vaccine EUA  22 min after vax, pt complained of itching, chest tightness, diphenhydramine 25 mg capsule administered. BP 141/91, HR 93, O2 100% 27 min after vax, BP 136/97, HR 83, O2 100% 33 min after vax, BP 143/90, HR 83, O2 100%, pt reported less itching, less chest tightness, but symptoms remain 34 min after vax, RAPID RESPONSE called 40 min after vax, RAPID RESPONSE team arrived 43 min after vax, report given to ER, pt moved to ER by charge RN 90 min after ER, pt discharged
Started getting sick after 10/16/2021: shortness of breath, tightness of chest and palpitation. Went to hospital ER on 10/23/2021.
I have had muscle cramps in both legs, toes and hands randomly and chronically at night. The RLS symptoms are not cramps and are not chronic.  I have never experienced such strong muscle cramps that disrupt sleep, cause me to get out of bad to stretch to resolve and I now take muscle cramp relief pills.
Temporary, minor brain fog for a few hours, approximately 18 hours after injection. Noticed when working on a simple excel spreadsheet and had trouble concentrating. I was able to complete the task in about 5 minutes with focus. I was back to normal a couple hours later. Would have not realized the brain fog had it not been for the spreadsheet project.
patient received dose that was not diluted properly. Pharmacy was able to get hold of patient after 2nd try and leaving message for her. Patient called back on 3/20/21 at 5:08 pm and reports she was groggy and felt like she was drunk for most of the day along with headache and arm soreness. She reports she is feeling better at time of call.
I couldn't stop vomiting so I went to the ER. They gave me fluids and nausea pills. I can't hold anything down and I'm in a lot of pain.
Per patient, took dose 1 of Vivitof on 6/17/06 and 7AM. Rash developed about 7:15 AM. 8:00 AM, patient took Claritin; rash cleared. Per patient, also felt slight discomfort breathing.
This case was reported by a nurse and described the occurrence of generalized achiness in a 52 year old female pt who received Engerix-B. On 1/6/04, the pt received the 1st dose of Engerix-B "in her arm". At an unspecified time following the administration of Engerix-B, on the same day, the pt experienced general aches all over her body, a headache, a fever of 101F, chills and injection site swelling, redness and soreness. The fever resolved on 1/9/04 and all the other events resolved on 1/13/04. The nurse considered the events to be related to vaccination with Engerix-B.
12/28/20 - first dose of COVID Vacc; 1/11/21 - R sided tinnitus; 1/12/21 R sided hearing loss and loss of balance; visited ENT and diagnosed with Sudden Sensorineural Hearing Loss; 1/13/21 began 60mg Prednisone 7 days; 7 day taper off - no improvement in hearing by 1/24/21; ENT scheduled before second covid vaccine
believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine; reports being tired for 2 days.; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine) and FATIGUE (reports being tired for 2 days.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 prophylaxis.  Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (reports being tired for 2 days.). On an unknown date, the patient experienced POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine). In January 2021, FATIGUE (reports being tired for 2 days.) had resolved. At the time of the report, POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine) outcome was unknown.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.    No treatment medications were provided by the reporter.   This case was linked to MOD-2022-648279, MOD-2022-648281 (Patient Link).
Rash, redness, and itching around the injection site. Rash and redness is spreading around the arm.
Information has been received from a health care professional concering a patient who was exposed to her 1-year-old son who was vaccinated with 1 dose of varicella virus vaccine live. On approximately, 06/12/2000 the mother developed a rash with greater than 50 lesions. Additionally, it was noted that the father also developed a similar reaction. Additional information has been requested.
4X4 sized red area; Wrong Route of Administration/ given SQ instead of IM; Vaccine Administered at Inappropriate Site/vaccine was administered lower than the deltoid area; This non-serious case was reported by a nurse via call center representative and described the occurrence of erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (On 12th June 2021). Previously administered products included Shingles vaccine (In 2016 received shingles vaccine).   On 04-FEB-2023, the patient received the 1st dose of Shingrix (subcutaneous, left arm). On 04-FEB-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong Route of Administration/ given SQ instead of IM) and vaccine administered at inappropriate site (Verbatim: Vaccine Administered at Inappropriate Site/vaccine was administered lower than the deltoid area). On an unknown date, the patient experienced erythema (Verbatim: 4X4 sized red area). The outcome of the erythema was resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.   It was unknown if the company considered the erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JUL-2023 The case was reported by the patient. The reporter reported that she received Shingrix and she believed that a pharmacy technician might had administered her vaccine and because the patient was a nurse herself, she thought that the vaccine was administered lower than the deltoid area (Vaccine administered at inappropriate site) and probably given SQ instead of IM (Wrong route of administration).  The patient also reported that a couple of days after the injection (no specific date provided), she had a 4X4 sized red area below the injection site that lasted a week to ten days.  The patient also reported that she received another shingles vaccine (unknown vaccine) prior to Shingrix in 2016.  The patient also reported that she had shingles (preexisting Shingrix). The patient did have photos of the red area adverse event and could send them, if needed. The reporter consented to follow up. The patient thought that the vaccine was administered lower than the deltoid area and probably given SQ instead of IM, which led to Intramuscular formulation administered by other route and vaccine administered at inappropriate site.
patient called on 11/29/2021 and said she got additional booster dose instead of flu vaccine . checked consent form  and she marked  flu vaccine but on the form  technitian marked moderna 3rd dose. (she got 3rd dose at pharmacy and 4th dose(0.25ml) here). patient is ok. she recieved flu shot on 11/29/2021
pt experiencing hives, itching, hot to touch--pt has had to take Benadryl
G62.9 NEUROPATHY 4/20/2023 SYNCOPE DUE TO ORTHOSTATIC HYPOTENSION
Second vaccine was worse / infected spread from shoulder to elbowarea / required antibiotics again; Second vaccine was worse/ Redness at the injection site; Second vaccine was worse/ Left her arm red; Second vaccine was worse/ fever; This case was reported by a consumer via other manufacturer and described the occurrence of infection aggravated in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced infection aggravated, injection site erythema, erythema of extremities and fever. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the infection aggravated, injection site erythema, erythema of extremities and fever were unknown.   It was unknown if the reporter considered the infection aggravated, injection site erythema, erythema of extremities and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling on behalf of someone else (general public). There were no information on patient's history. The person received Shingrix from Pfizer on an unspecified date. The batch number was not provided. The reporter stated that, it was told on the news that if a person had an adverse event to other vaccines, that person should not receive Covid vaccine.  The reporter was calling for information as to whether this person should receive the Covid vaccine. The reporter wanted to know how she would know if the ingredients in Covid-19 vaccine and Shingrix vaccine were similar. The representative informed the reporter that the ingredients in Covid-19 vaccine could be found in EUA fact sheet and she may compare those to the ingredients in the Shingrix vaccine. The reporter asked for link to EUA fact sheet by email. The reporter also wanted a list of Shingrix vaccine ingredients. The reporter was provided with telephone number. The reporter was inquiring if it was accurate that someone who had an adverse event to any other vaccine should not take the Shingrix vaccine. The reporter mentioned a reaction to a previous Shingrix vaccine, on 2nd dose, the reaction was worse and was infected from shoulder to elbow area and required antibiotics again like 1st dose. The reporter consented to follow up and provided her name and email address, but did not provide patient's details to protect privacy. For the tolerance of 1st dose, refer linked case US2020AMR249478.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249478:1st shot,same patient, same reporter, same suspect
red circle, puffed & tender, rust red; has remained sore & tender to touch since receiving vax; red circle & puffiness devel @  unk time p/vax;
Pink rash flat, non-palpable, Not warm onset 12/1/14. No treatment. MD uncertain if related to vaccine, parents certain it is.
10x10cm area of erythema/bruising that developed over the course of about 24 hours after vaccine was given.