chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin sensitivity/pain; skin sensitivity/pain; whole body achiness; sore throat; fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 36-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 12Feb2021 at 12:30 (at the age of 36-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included irritable bowel syndrome (IBS) and degenerative L5 disc. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levonorgestrel (MIRENA), vitamin B6, cranberry, and fish oil from unknown dates for unknown indications. The patient received BNT162B2 (dose 1; lot number EL3248; left arm) on 15Jan2021 at 13:00 for COVID-19 immunization. The patient previously received neomycin from an unknown date for an unspecified indication and experienced allergy. On 13Feb2021 at 10:00 the patient experienced whole body achiness, skin sensitivity/pain, fatigue, and sore throat. The patient did not receive any treatment for the events. The outcomes of body achiness, skin sensitivity/pain, fatigue, and sore throat were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
One week after vaccination I was dizzy and fell down at home. I went to emergency room , had an MRI  and was discharged with a prescrition of analgesics. Since then I have had dizziness, loss of balance and headache, as well as a hardened zone in the right leg
pain from the elbow to shoulder; pain from the elbow to shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A 90-decade-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 30Jan2021 14:00 (Batch/Lot number was not reported) as single dose for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. In jan2021, the patient experienced pain from the elbow to shoulder. The outcome of the event was unknown.
Did not receive 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) had resolved.            No concomitant medications reported.  Treatment information not reported.   Reporter did not allow further contact
Patient received Pfizer Pediatric Bivalent (5-11y.o) vaccine, 0.2mL undiluted. Patient was stable at time of discharge after 30 min observation. No further needed at this time.  Patient's parents advised to inform PCP.
A few hours after receiving the vaccine, I went to hand something to my son and dropped it because my arm wouldn't really function anymore. It became swollen, tender to the touch, and extremely painful. Laying on it and putting pressure on the vaccination site was just about impossible. Waking up the next day it was even worse. I could barely move my right arm and had to use my left arm as support when I did need to move it. I was unable to lift my arm higher than shoulder height, painful arc and rotation, grip was minimal, I struggled to wash my hair, put on deodorant, drive my kids to school and struggled with every necessary daily task. Almost 5 months later my arm is still not the same.
pt recvd vax; c/o redness, swelling, itching; induration 5x4.5mm; MD aware, area v'd rct 30jan for re-v on 30jan95;
Extreme fatigue, spontaneous stomach pain (followed up with doctor and on 9/11/10 with ER - all blood work and urine confirmed no infection); the Gardasil vaccine was the only thing different that has occurred in my life.  ER gave antispasm prescription and has sent me back to primary care doctor.
Numbness and tingling in extremities after 2nd Moderna COVID-19 vaccine shot. Initially felt tingling after first shot half hour after administration in left hand. Felt again half hour after second shot in left hand (10 am). Numbness returning to left hand and feet same day as second shot at 8:30 pm.
Large red area around shot area on left shoulder, warm to the touch. No pain or itching.
Slight headache; Little nervousness; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 10:45 (Lot number: EN8207, Expiration Date: 03Jul2021) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Depression" (unspecified if ongoing), notes: Verbatim: Chronic depression, Caller says this was diagnosed about 5 years ago. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021 12:00, outcome "unknown", described as "Slight headache"; NERVOUSNESS (non-serious) with onset 11Mar2021 12:00, outcome "unknown", described as "Little nervousness"; FATIGUE (non-serious) with onset 11Mar2021 12:00, outcome "unknown", described as "Tiredness".  Additional Information: Patient had his first dose yesterday on 11Mar, and his vaccine card has a sticker on it and other than his name and L for left arm and date given, nothing is provided on there. He says "my eyeballs" while looking at handwritten vaccine card with a sticker and does not clarify this statement. He says that the NDC is not provided on vaccine card, but EXP is. He says his first dose was injected at 10:45AM, and his side effects began at approximately at 12:00PM 11Mar. He says he started to feel something, a slight headache and a little nervousness around the edges and an all over feeling tired like he had gone to the gym and worked out his entire body. He says everywhere feels blah. Documented as provided. He says he got home yesterday and went straight to bed. He says if it was a 10 yesterday, then today is a 6, it is a little bit better, just kind of, not bad at all really, it is just annoying. He says he would do it again and will do it again. He says he didn't treat the slight headache. He says he got his first dose, which was a monster event, and it was provided. He said they have not had any other recent vaccinations or started any new medications.  No follow-up attempts are possible. No further information is expected.
Have had significant joint pain on both sides of body that have continued since second vaccination to now; This is a spontaneous report from contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 15Feb2021 at 16:30 (at the age of 43-years-old) and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 08Mar2021 at 10:30 (at the age of 43-years-old) for COVID-19 immunisation. Medical history included asthma and seasonal allergies. Concomitant medications included SINGULAIR and NASONEX for unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 at 23:00, the patient experienced joint pain on both sides of body that had continued till day 9 after 2nd shot. The patient did not receive any treatment for reported adverse event. The clinical outcome of the event joint pain was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
48 hrs after vaccine. purpura LE, Buttock, arms with med prolonged. Pt sibling vaccinated as well with same symptoms. May be Henoch Schonlein Purpura.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient blood pressure was 120/101, O2 sat is 100%, and pulse was consistently around 70.  patient monitored for 30 minutes and states they were comfortable and the pain disappated.  Patient stood up and went home of their own accord.
Harden chin; Swelling upper lip; Swelling face; Itchy legs; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 45-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 11Apr2021 at 10:00 (at the age of 45-year-old) (Batch/Lot Number: ER8735) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot number: EP6955, vaccine location: Left arm) on 21Mar2021 for covid-19 immunisation. Patient had no known allergies. On 12Apr2021 at 02:00 the patient experienced harden chin, swelling upper lip, swelling face and itchy legs. Patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient received treatment for the events. The treating medications was 2 doses of Allegra. Outcome of all the events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
twelve little red spots; bright and dark red bumps; twelve little red spots; bright and dark red bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (twelve little red spots; bright and dark red bumps) and INJECTION SITE REACTION (twelve little red spots; bright and dark red bumps) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Concussion (Patient had five concussions in 1990) in 1990 and Ulcer (Patient had three ulcers). Concurrent medical conditions included Diabetic.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced RASH MACULAR (twelve little red spots; bright and dark red bumps) and INJECTION SITE REACTION (twelve little red spots; bright and dark red bumps). At the time of the report, RASH MACULAR (twelve little red spots; bright and dark red bumps) and INJECTION SITE REACTION (twelve little red spots; bright and dark red bumps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) Patient had a complete physical and his blood work showcased he was doing good health.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact
Woke up in the middle of the night feeling body aches, chills, feverish- flu symptoms. I tried to sleep. Took Tylenol my arm was extremely sore. Felt crummy for days. Due to asthma my breathing was a little labored. I do have oxygen because I sleep with a CPAP machine. I was unable to do much and stayed in bed for about 2.5 days.
No treatment needed. Patients only symptom was soreness on vaccine sit the next day after administration.
Case number PHEH2011US01623 is an initial spontaneous report received from a health care professional (medical assistant) on 10 Aug 2011. This report refers to an adolescent male patient. He was vaccinated with MENVEO (batch number: X100030, expiry date: Sep 2012) intramuscularly on unspecified date. But, the patient received only the Men CYW-135 liquid conjugate component which was not reconstituted with Men A lyophilized powder component. No adverse reaction was reported following this drug administration error.
has not had a 2nd dose yet.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th December 2019).   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. The physician  reported that he had a patient who received their first dose of Shingrix and has not had a 2nd dose till the time of reporting, which led to incomplete course of vaccination.  The reporter asked if the patient need to restart the series. The reporter consented to follow up.
About 20 minutes after receiving the shot, I started feeling uneasy.  Realized that my fingers were getting tight with swelling.  I could feet the sides of my chests getting tight - felt like pressures were building up with swelling.  I did not have problems with breathing.  About 10 minutes later I could feel my lips swelling, but stopped after about 10 minutes.  In the evening, felt nausea.  Did not feel well for two days.  Got a little better on the third day but not completely well.  Completely recovered on the fourth day.  Should I get the second shot?  I am afraid it might be worse on the second shot if what I was feeling were due to allergy.
Elevated temp (approximately 100 degrees F), upset stomach, extreme pain and stiffness at injection site, headache, fatigue, and pain and achiness all over the body. Treatment was bed rest 12-16 hrs.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Outbreak of  urticaria (hives) on back of head, then noticed on hands and arms. Also on waist, ankles, knees, buttcrack.  Taking type 1 and type 2 antihistamine, applying hydrocortisone cream. 2 days of symptoms so far, symptoms are only worsening.
After receiving the HPV #1, patient passed out falling out of chair and hitting face on exam bed foot stool.  Patient eyes rolled in back of head and left side patients body got stiff.  Blood in mouth.  Patient bit lip causing mouth to bleed.  Hit nose on stool.  Ambulance called immediately.  Gave patient oxygen in office.  Checked blood pressure and O2, resp.  Everything o.k.
Case number PHEH2014US018213 is an initial spontaneous report from a nurse received on 09 Sep 2014. This report refers to a 49-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1412701) at a dose of 0.5 ml intramuscularly on 09 Sep 2014. It was reported that the vaccine received by the patient reached 50 F for 30 minutes before administration to the patient. No adverse event reported following this medication error.
25 mins after the vaccination his right arm became tingly ranging from the lower part of the arm to his pinky. fell asleep. He was touching it and could not feel it, like it was "asleep" .  Felt himself get hotter and sweaty. Patient was advised to go to the ER, but refused. Called patient one hour after the event, and they reported that arm started to feel less tingly.
Case number PHEH2015US020606, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 65 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration.
No additional AE.; After patient was admitted to hospital for 'really bad headaches' and while patient was still in hospital, Patient was administered an unspecified Merck-manufactured 'Pneumonia shot' on 06/25/2015; This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's pertinent medical history and concomitant medications were not reported.  On an unspecified date in 2015, the patient had "really bad headaches" which were determined to be "weird migraines" and the patient was hospitalized due to it.   On 25-JUN-2015 (when the patient was still hospitalized), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (reported as unspecified Merck-manufactured pneumonia shot) as prophylaxis (concentration, dosage, route of administration and anatomical location were not reported; lot number K021881 and expiration date was not reported but upon internal validation established as 30-JUL-2016). The patient requested pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prescribing information (product prescribing issue). No adverse events were reported.
Sore arm, headache, treated wit 500 mg Tylenol that night and again the following day.
pt recv 13MAY98 c/o lump/induration, redness & pain x several days;
mild pain at the injection sites; 9-valent HPV vaccine used in a 98-year-old patient  for treatment of locally metastatic cutaneous basaloid squamous cell carcinoma/ intratumoral doses of the vaccine; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 98-year-old female patient. The patient had multiple locally metastatic basaloid squamous cell carcinomas (SCCs) on the right leg that recurred 2 years after Mohs surgery. The patient was again treated with Mohs surgery for 4 of the largest lesions. The authors stated that additional surgery was impractical given her tumor burden. She was offered systemic chemotherapy and radiation therapy but declined. The authors reported that due to recent evidence suggests that Human Papilloma Virus (HPV) vaccination may be protective against the development of SCCs in immunocompetent patients and several vaccines are injected intratumorally for other malignancies they initiated treatment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). On an unknown date, the patient started treatment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), intramuscularly and intratumorally (strength, exact dose, lot# and expiration date were not reported) for locally metastatic cutaneous basaloid SCCs. The patient developed a local inflammatory response after both the intramuscular and intratumoral doses of the vaccine. Clinical improvement was observed 2 weeks after the second intratumoral dose, with complete resolution confirmed by reflectance confocal microscopy and biopsy 13 months after the first intramuscular dose. On unknown dates, the patient experienced mild pain at the injection sites. The authors stated that aforementioned event was the only side-effect of the treatment. The patient has remained recurrence free for 7 months since her last intratumoral dose. The authors stated that their extraordinary results highlight a novel potential treatment for patients with SCC who were poor surgical candidates. They reported that whether the observed response was specific to HPV or represents a nonspecific immune response was not yet clear. The outcome of the event was not reported. The authors considered pain at the injection sites to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.
Pt w/left focal sz the evening p/DTP/HIB; temp a/sz was 103.4; pt required Phenobarbital in ER to stop seizure;
Left arm redness and swelling noticed by patient yesterday at injection site. No pain or itching/patient has full movement of arm.
@14:15 about 15 min after injection patient noted with red hands and feeling warm in observation. Palms red. No other signs of symptoms noted. @14:26 pt reported feeling better, not feeling warm, redness from palms and hands improved.
Dull pain (blood clotting?)  in lower right leg, in calf area; Swelling in lymph nodes in armpits; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included breast feeding. The patient had recently stopped breastfeeding and otherwise the patient had no other changes or ongoing health issues. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included norethisterone (NORA-BE),  fish oil (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and women's multivitamin (unspecified); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 06Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, immediately following the second vaccine, the patient experienced swelling in lymph nodes in armpits which subsided after 1-2 weeks. On 30Aug2021, the patient was experiencing dull pain (blood clotting?) in lower right leg, in calf area at the time of report. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in lymph nodes in armpits and dull pain (blood clotting?) in lower right leg, in calf area were unknown at the time of the report.
Dull shoulder pain at onset - intensified overnight limiting mobility in shoulder - severe shoulder pain by following morning and very limited mobility - pain intensity lessened over the following month, but mobility remained restricted.  Doctor diagnosis was rotator cuff injury and adhesive capsulitis.