chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site became itchy, and then around the entire area, shoulder area, down arm.  Would lessen, then become worse again,  Injection site ice packed, hydrocortisone cream applied to area at 5:45pm and 6:10pm with some relief.  Small welts noted at times, but decreased with treatments.  Benadryl 25mg PO at 5:15pm, Benadryl 12.5mg PO Chewable at 5:45pm and Benadryl 25mg PO at 6:10pm, all on 1/5 Repeated 25 mg PO at 8:30 on 1/6 for slight itchy HR regular, no swelling in face or tongue, no shortness of breath, no headache or visual disturbances. No nausea or vomiting, or diarrhea.  Drove to home, took bath and slept well that night.  Still reports general itchiness throughout body on 01/06 with some relief from benadryl.
On 21-JUL-2000 the child received an injection of a Engerix-B. Subsequently, on an unspecified date he received an injection of a Recombivax-HB. In October 2001, the child's parent reported that he "started showing signs of autism" including not making eye contact, "several" unspecified developmental delays " a lot of" repetitive behavior and lack of speech. The parent reported that the child had been evaluated by a physician. Autism is considered medically serious.
Immediately after vaccines pt experienced blurred vision, nausea, dizziness and a headache. Ice pack applied to nape of neck and pt monitored x 30 mins; Pt was also pale. Pt recovered and was given water and crackers.
Tinnitus in both ears developed approximately 1 week after booster. Was intermittent at first. Became persistent and more severe in left ear (contralateral side from injection) within 2 weeks and has persisted 24/7 up through today (5 weeks after booster was given). Tinnitus in right ear is intermittent, now collectively lasting about 6-8 hours per day off and on and becoming more frequent.  Pt. is using anti-anxiety sleeping pills and masking noises to be able to sleep at night and masking sounds during the day. Pt. has attempted dietary and exercise modifications (increase movement, eliminate alcohol, reduce caffeine and sodium, reduce stress) to ease symptoms but has not noticed a difference.  Pt. went to urgent care at the 4 week mark, thinking she needed to have her ears cleaned out due to wax build up, but both ears were perfectly clean. No other notable cause for tinnitus detected (no recent loud noise exposure, etc.) Patient referred to ENT for consult and  and audiologist for hearing evaluation (both are still pending).  No previous history of tinnitus.   Patient. has history of inflammatory response to vaccine and still has a visible and palpable sub clavicular lymph node from the first dose in late July 2021 (has received ultrasound to rule out anything sinister. Was determined to be an immune reaction from first dose).
Day 1-3 after the dose flu like symptoms  Day 3-7 swelling in lymph nodes on left side of body (baseball sized) took ibuprofen and Tylenol  Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS   Day  9 raised red rash all over body and face still going on   Day 16- present: severe joint pain and fever, unable to obtain any relief
Woke up with chills, Myalgias, arthralgias , HA , . Next day also developed Rhinorrhea and fatigue.    Same symptoms continued for about 48 hrs then felt better but still with some arthralgias and fatigue.  I had covid-19 virus in MArch 2020.  Felt pretty much the same way post vaccine as I felt then. Wondering if this reaction could be due to fact that I had virus previously and also wondering about second dose? Have there been reports of worse S/E in people who have had virus previously?
2-3 weeks after the vaccine, the muscular tissue between the shoulder and the arm had pain. Anytime I tried to lift arm up or move the arm side to side across the body like putting on a seat belt was painful. Most of the time there was still a dull pain but when I used my arm to do just simple things like combing my hair or putting ponytail in it was sharper pain in that area between arm and shoulder. It was more of a stabbing pain than aching pain. A couple of time it was really bad where it woke me up while I was sleeping and it seems to be worse in the morning when I get up, when the muscle has been sitting for awhile. It hurts to use it, but when I don't use it then use it, it hurts worse. I didn't know if something was wrong or where it was from and so I made appt with PCP and she was the one that recommended to get the vaccine. I explained what was happening to me and she said it was normal to have pain and they wouldn't be surprised that it would last upwards three months after the vaccine to have this pain. I had a shoulder x ray and she said it came back negative and if it would have came back positive they would have done an MRI. Treatment would be just to ice it and take ibuprofen. When I take ibuprofen it does help but I don't want to take that the rest of my life. I'm a JR high orchestra teacher so its a little awkward to ice it in middle of class so I don't ice it very often. She told me if it doesn't help to come back in two weeks. After the initial visit and conversation with PCP and the x ray I have not been back. I've done ibuprofen twice and it does help somewhat. I have 6 month follow up in December so if it isn't better by then I will talk to my PCP.
No additional information available or provided; multiple excursions over approximately 9 weeks / warmest recorded was 73.1 F; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 04-NOV-2021, 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) 0.5 mL, lot # T026323, expiration date 22-FEB-2023 (route of administration and anatomical location were not provided) for prophylaxis (incorrect product storage). The administered vaccine experienced multiple temperature excursions over approximately 9 weeks, the warmest recorded temperature was 73.1 degrees Fahrenheit (F). Previous temperature excursion was also reported as multiple, details were unknown. No additional information was available nor provided (no adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA002429:
Severe sleep apnea, quit breathing 90 times an hour sleeping, crippling joint paint.   I lost 30+ pounds with body in stress sleeping over 6 months waiting for sleep study.  Put on morphine and Norco for pain.
I received the moderna covid vaccine in my left arm from pharmacy on Oct 12th.  The injection did cause me quite a bit of pain. Since then I?ve had very bad and consistent pain, mainly in the upper left side of my back.   The pain became worse 2 days after and hasn?t let up, making it difficult to relax, sleep, sit...just about everything.  At times the pain even shoots down as far as my left foot.  On Oct 18th (today's date) I tried getting an appointment with my health care facility but haven't been successful you...but I'll continue trying.
After first one, I was little bit tried; 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), administration date 10Apr2021 (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: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "After first one, I was little bit tried".  Additional information: Reporter stated, well, patient just have two questions patient just got my booster the other day on Monday and patient know that you will have side effects but is it but do they typically only last, patient guess about 1 to 3 days because with my first 2 doses, patient didn't feel too bad, but patient don't, but this time seems patient was experiencing flu like symptoms. So, patient didn't know like if they don't clear up with in like 3 days should patiently call my primary physician. Reporter confirmed the name of the product as Pfizer Covid-19 vaccine. When paraphrased the concern, consumer stated, patient read the paperwork, but it says typically, because patient felt fine today that patient had it and in past with the first two doses she didn't really have. Reporters mean the second dose patient didn't really have any issues that patient could remember, after first one, patient was little bit tried but patient didn't have any flu like symptoms or anything but this time patient having some flu like symptoms. So, patient just didn't know like will those hopefully pass at some point or patient just want to know if they last longer than three days should patient call physician. Reporter was informed about the Pfizer medical information department for the concern. Reporter other question was so my vaccination card patient was looking at so patient got my first one 10Apr and then patient got my second one 29Apr and so you supposed to get it 6months after your second booster right, after your second dose is that correct.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pain at the injection site; chills; muscle aches everywhere; headache; nausea; extreme pain / painful to move the right arm; arm is feeling too heavy to lift / feels like deadweight with extreme pain when I go to move it; arm is feeling too heavy to lift / limited mobility around the injection site (from the upper arm to the shoulder) / painful to move the right arm / feels like deadweight with extreme pain when I go to move it; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 3 days after receiving Shingrix, the patient experienced injection site pain, chills, muscle pain, headache, nausea, pain, heaviness in arm and mobility decreased. In October 2020, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain and pain were not recovered/not resolved and the outcome of the chills, muscle pain, headache, nausea, heaviness in arm and mobility decreased were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the injection site pain, chills, muscle pain, headache, nausea, pain, heaviness in arm, mobility decreased and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the upper right arm and not feeling well. The patient experiencing chills, muscle aches everywhere, headache, and nausea.  These lasted from the evening of getting the shot up to 48 hours after and stated everything had resolved, except the pain at the injection site.  The patient was still had extreme pain; arm was feeling too heavy to lift.  There was limited mobility around the injection site from the upper arm to the shoulder, feels like deadweight with extreme pain when go to move it and states it was painful to move the right arm. The reporter did not consent to follow up. Not all information was available.
Constant muscle twitching in upper portion of left arm, same arm in which Tdap was placed.  Twitching lasted three days, through 8/18/2011.  On 8/19/2011, I noticed a supraclavicular swollen lymph node or other nodule on the left side of my neck.  It was slightly tender to touch.  Today, 8/20/2011, that node has gotten larger and is irritatingly painful.
Patient presented common side effects the first 24 hours (headache, mild fever, tiredness, vomiting & nausea).  On 8/2/21 around 2pm, patient began complaining that his "heart hurt".  He laid down to rest, but his chest continued to hurt and the pain level increased.  By 8:30 pm that same day, patient's heart hurt to the point of crying and he was taken to the emergency room.  At Hospital, patient was diagnosed with Myocarditis as a result of the second dose of the Covid-19 vaccine.
Vomited x1; Flushed all over, especially in the face; Vitals stable; Itchy all over initially (1st 10 minutes).
generalized not feeling well, some GI complaints, bad joint pain, headache and a fever; headache and a fever; GI complaints,; joint pain; headache and a fever; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: and Expiration date was unknown), via an unspecified route of administration on 26Jan2021 (at the age of 43-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient concurrent conditions included depression, anxiety, relapsing remitting multiple sclerosis, allergies (stuffy nose); all from an unknown date and are ongoing. The patient concomitant medication included ocrelizumab (OCREVUS); acetylsalicylic acid (ASPIRIN); cetirizine hydrochloride (ZYRTEC), prenatal multivitamin; all taken for an unspecified indication. The patient previously took penicillin and had allergy. On 26Jan2021, the patient had experienced generalized not feeling well, some gastrointestinal complaints, bad joint pain, headache and a fever. The outcome of events was resolved on an unspecified date in 2021.   No further information was reported.  Information about batch/ lot number has been requested.
I got spasms within minutes of getting the injection, and ever since I can't lie down without getting spasms all over my body. Over the coming months I started getting a plethora of neurological symptoms (tingling, crawling sensations, flashing lights in vision, nausea, etc.), and was eventually diagnosed with RLS/WED, which as it turns out can affect your entire body. This doesn't explain the spasms, although it may be related. It affects my breathing. My brain has trouble processing moving scenes/screens (real/virtual) sometimes now, which affects my work.
Shot straight to end of my finger. Slowly developed headache. Had to go to bed. Slept 3 hours. Three days later arm has red splotches, very sore.
ARM IS JUST A BIT SORE; BODY WAS SORE; CHILLS; EXHAUSTED; AWFUL HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 20-AUG-2021, the patient experienced chills. On 20-AUG-2021, the patient experienced exhausted. On 20-AUG-2021, the patient experienced awful headache. Treatment medications included: paracetamol. On 21-AUG-2021, the patient experienced body was sore. On 22-AUG-2021, the patient experienced arm is just a bit sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body was sore, had not recovered from awful headache, and arm is just a bit sore, and the outcome of exhausted and chills was not reported. This report was non-serious.
Redness to arm; swelling to arm 6 cm redness below site of injection, warm painful to touch.
Late for / second dose / first dose was / on September 5 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th September 2019, batch number 3rn95, expiry date 6 December 2021).   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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter did not consent to follow up.
one year old child was accidently administered a dose of unspecified HPV vaccine.; one year old child was accidently administered a dose of unspecified HPV vaccine.; No additional AE reported; This spontaneous report has been received from consumer concerning to an 1-year-old patient of an unknown gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was accidently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (also reported as unspecified HPV vaccine)(manufacturer unknown) (strengths, lot numbers, expiration dates, anatomical locations, vaccination scheme frequency and routes of administration were not provided) for prophylaxis. The consumer was not able to provide the brand name of the unspecified HPV vaccine (manufacturer unknown) (product origin unknown).  No additional adverse event (AE) reported.
Pt received immunization on 12/24/03 then on 1/7/04 noticed arm was swollen and red.
pt recvd vax 6OCT95 & that same day pt devel an inj site rxn characterized by redness & inflammation the size of a fifty cent piece;rxn subsequently spread to elbow & lt arm became red & hot;pt was unable to bend joint;body aches;t102-3
None. Resident was given Shingrix vaccine (2nd dose in series) on 12/14/2020
HEART RATE 210, BP 180/120.PALPITATION.WENT TO ER. HR DID NOT GO DOWN UNTIL MIDNIGHT. BP WAS UP 140/110 FOR 2 DAYS.
This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a 80-year-old male patient who received Shingrix for prophylaxis. On 8th October 2018 12:30, the patient received the 1st dose of Shingrix. On 8th October 2018, less than an hour after receiving Shingrix, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was not recovered/not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. Additional details were reported as follows: The reporter was the patient's wife. This case was previously reported to the physician. The patient received Shingrix in right arm. At 1:30 PM, on the same day, the patient was in the emergency room being treated for Bell's palsy.
hardness; pain/tenderness; swelling in the arm of the injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (pain/tenderness), VACCINATION SITE SWELLING (swelling in the arm of the injection site) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (pain/tenderness), VACCINATION SITE SWELLING (swelling in the arm of the injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (pain/tenderness), VACCINATION SITE SWELLING (swelling in the arm of the injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.            No concomitant drug and treatment drug details were reported.  Patient enquired if ice pack could be used. Company comment includes This case concerns a female patient, unknown age, with no disclosed medical history, who experienced the non-serious, expected events of vaccination site pain, vaccination site swelling, vaccination site induration, and vaccination site erythema. The events occurred  one day after the booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no disclosed medical history, who experienced the non-serious, expected events of vaccination site pain, vaccination site swelling, vaccination site induration, and vaccination site erythema. The events occurred  one day after the booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date the patient had her spleen removed. Upon internal review spleen operation was considered medically significant based on the list of medically significant events. No outcome was reported. No causality assessment was provided. Additional information has been requested.
major headaches, heart burns and body aches; major headaches, heart burns and body aches; At 11am today, the patient stated that he started feeling worse.; major headaches, heart burns and body aches; Fever; covered himself with 4 covers and broke into sweats; This spontaneous case was reported by a consumer and describes the occurrence of Fever, HYPERHIDROSIS (covered himself with 4 covers and broke into sweats), HEADACHE (major headaches, heart burns and body aches), DYSPEPSIA (major headaches, heart burns and body aches) and MYALGIA (major headaches, heart burns and body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced Fever and HYPERHIDROSIS (covered himself with 4 covers and broke into sweats). On 01-Apr-2021, the patient experienced HEADACHE (major headaches, heart burns and body aches), MYALGIA (major headaches, heart burns and body aches) and FEELING ABNORMAL (At 11am today, the patient stated that he started feeling worse.). On an unknown date, the patient experienced DYSPEPSIA (major headaches, heart burns and body aches). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, Fever was resolving and HYPERHIDROSIS (covered himself with 4 covers and broke into sweats), HEADACHE (major headaches, heart burns and body aches), DYSPEPSIA (major headaches, heart burns and body aches), MYALGIA (major headaches, heart burns and body aches) and FEELING ABNORMAL (At 11am today, the patient stated that he started feeling worse.) outcome was unknown.        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.