chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient displayed signs of allergic reaction after administering ZOSTAVAX vaccine. Gave EPIPEN and called 911. Paramedics took pt. to hospital.
Regarding this issue, though the issues occurred not long after the shot, I don't know the exact month or date of occurrence of the flareups of itchiness in my upper left arm which would later include a knot.  The flareups would occur at random times in the exact spot that I received the shot and I was unsure if maybe my arm was still healing from the shot. Time went on and the flareups would go away but later that year would occur again and I became very concerned when I started feeling a lumpy knot in that same area and it felt close to the skin.  I made contact with the clinic where I received the shot and told them about the matter. Nurse, with that clinic, asked me about the timeframe that I received the shot and I informed her, then she mentioned about the possibility of it being unlikely that the shot caused it and talked about me getting a referral to dermatology.  Sometime afterwards and in the same arm, I would also notice a different type of knot which was further down from the previous knot area and seemed closer to the bone. Jan 5th, I contacted my primary provider Nurse about the matter including the information from Nurse. Jan 6th, my primary provider responded that I would need to have an appt with someone for pictures to be taken of the area in order to be referred to dermatology.  Employee contacted me to make an appt to be seen and I offered to be seen the same day she called but they could not see me until Jan 12th.  On Jan 12th, she checked the knot on my arm which by that time was smaller and she wanted to check with my provider to see what she wanted her to do. My provider came in the patient room to check my arm and talked about the probability of the knot being a lymph node and for me to not touch it for about a month and if it goes down then that is good. They did not take any pictures nor do any ultrasound.
Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; pain with any and all movement of left arm, pain at rest; This is a spontaneous report from a contactable physician (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL926L, Pfizer NTEC), via intramuscular route of administration in left arm on 01Feb2021 at 10:30 (at the age of 61-years-old) as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic/veteran's administration facility. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took naproxen for hypersensitivity and experienced periorbital oedema. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL2183, Pfizer NTEC), via intramuscular route of administration in left arm on 11Jan2021 at 14:00 as 1st dose, single for covid-19 immunization. On 02Feb2021 patient experienced constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder, i.e., 40% reduction in range of motion, positive tenderness to palpation, pain with any and all movement of left arm, pain at rest, but no redness or swelling or bruising. Events resulted in disability or permanent damage. Treatment received for the events included NSAID and physical therapy. The clinical outcome for the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1/08/21 I was very fatigued, and a little bit of body aches.  01/09/21 I was very lethargic and had body aches, mostly in my joints
5 days after injection have a red welt around injection site 2 in wide by 1 in up and down
Migraine; fever; muscle soreness; chills; issues staying asleep; shortness of breath; This is a spontaneous report from a contactable Other HCP (patient).  This 24-year-old male received the second  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),LOT# EL0140 at right arm on 06Jan2021 02:15 PM at SINGLE DOSE for COVID-19 immunization. The patient received his first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on  16Dec2020  02:30 pm at right arm Lot # EK5730 .Medical history included : Ilioinguinal neuralgia and  Migraine without status migrainosus, not intractable.Patient had past drug allergy to Valacyclovir and Nsaids.No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital .The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received concomitant medications within 2 weeks of vaccination.On 07Jan2021 at 08:00 AM, upon second dosage of vaccine, the patient experienced Migraine, fever, muscle soreness, shortness of breath, chills and issues staying asleep. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. No treatment received for the events.The outcome of the events was recovering.
On 1/15, a week after vaccination, left arm swelled up. Site had red raised rash, itchy, hot to touch, and discoloration around outer border. Affected area was 9 x 17 cm. Armpit lymph node was swollen on left
she is not thinking straight; she is able to hear her heartbeat in her ears; having a ringing in her ears; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; She feels fuzzy in her head; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot no: EN5318), intramuscular injection in left arm on 01 Feb 2021 for covid-19 immunisation. the patients' medical history included ongoing high blood pressure and High cholesterol. The patient's historic vaccine included Shingrix for shingles on unspecified date in 2020. The patients Concomitant medication included Amlodipine 5mg tablet once a day orally, Hydrochlorothiazide 12.5mg tablet once a orally, Olmesartan 40mg tablet once a day orally, Meloxicam 7.5mg small tablet orally, three times a week, Preservision Eye Vitamin one soft gel capsule by orally, probiotic two gummies once a day orally, apple cider vinegar gummy two gummies once a day orally  for Cholesterol, Citracal + D, calcium and vitamin d supplementation two tablets twice a day orally. on 01 Feb 2021, the patient experienced tingling/ numbness on tongue, lips, and roof of her mouth, felt fuzzy in her head. On 03Feb2021, she experienced Ringing in ears. The outcome of events was not recovered.
Administered 1ml to five patients; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Administered 1ml to five patients) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On an unknown date, the patient experienced OVERDOSE (Administered 1ml to five patients). At the time of the report, OVERDOSE (Administered 1ml to five patients) had resolved.        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.   The reporter was a Nurse who reported that they administered 1 ml to five patients on 30-Mar-2021 . The patients were monitored, and nurse planned to inform the patients that they received 1ml.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-062195 (Patient Link).
12-24hr p/vax 6 pt devel >101C associated w/shaking chills;
Pt states body aches severe headache within 2 hrs after receiving vaccine. Then as day progressed increased temperature increasing to 102.0. Patient states woke up feeling like a bus hit her.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. Information regarding the patient's concurrent conditions and medical history was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly (anatomical location was not reported) which had a lot number of L026602 and expiration date on 19-OCT-2017. There were no concomitant medications provided. No adverse effects reported. At the reporting time, the GARDASIL 9 experienced a temperature excursion of 32.5 F for 3 hours and 50 minutes (1 cycle). Also, on an unspecified dates, there had been previous temperature excursions, one of 34.3F for 40 minutes and the other one of 34.9F for 10 minutes. The total cumulative excursion details were reported as "4 hour and 40 minutes; 34.4F with 3 total cycles". Furthermore, no product quality complaint was involved. Additional information has been requested.
DTaP and IPV administered to L thigh-presented to office this AM with area red-hot to touch 4 1/2 inches long 6 1/2 inches wide. Rx for Benadryl 12.5mg/5ml tsp q 6 prn. Prelone 15mg/5ml 2 tsp bid day 1 tsp bid x 2 days-1/2 tsp bid x 2 days-Prenergan 12.5mg/5ml tsp q 4-6 prn.
32-year-old otherwise healthy woman presents to the emergency department with increasing fatigue and palpitations with tachycardia.  She received her Covid vaccine on March 8, had 3 days of subsequent myalgias with fevers, T-max 101.9 seemed to improve but she began having urticaria symptoms and was seen in this emergency department yesterday, 4/12 progressive recurrent urticaria symptoms unresponsive to antihistamines they were ultimately treated and improved with epinephrine.  Today (4/13/21) the patient had fatigue and progressive weakness with palpitations with exertion walking up the stairs.  She presented with tachycardia, her heart rate of 130, BP 140/79, she is afebrile with 100% pulse ox on room air.  She has no evidence of exudative pharyngitis or oropharyngeal allergic reaction.  No signs of meningitis.  She has no evidence of pneumonia.  No abdominal tenderness.  She does have some nausea.  She denies any urinary frequency urgency.  No abnormal vaginal discharge.  No other rashes.  COVID test negative. Patient admitted for observation
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination). At the time of the report, vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. Patient continued to have side effects six months later. No concomitant products or treatment information reported.
GARDASIL vaccine administered on 3/3/315. Site became red and warm to touch on day of injection and increased in size and redness on day 2. No fever. Treated with KEFLEX TID and CLARITIN daily for 1 week.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I took both vaccination with very few side effect) in a 47-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I took both vaccination with very few side effect). At the time of the report, VACCINATION COMPLICATION (I took both vaccination with very few side effect) outcome was unknown. No concomitant drug reported. No treatment information was provided by the reporter. Patient want to take legal action, as patient reported suffered alot after booster dose. This case was linked to MOD-2022-508838, MOD-2022-508853 (Patient Link).
15APR92 pt lethargic, nausea, loss of appetite, elevated temp suspected; 16APR92  flushed feeling; 17APR92 same sx including body aches & pain, edema glands behind ears; 18APR92 to ER for throat culture;rash;tendinitis, pharyngitis;
Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache
pediatric dose of RECOMVIBAX HB was administered to an adult patient; pediatric dose of RECOMVIBAX HB was administered to an adult patient; This spontaneous report was received from a nurse referring to a 63-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-JUL-2021, the patient was accidentally vaccinated with a pediatric dose of thimerosal free hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # S022584, expiration date 31-OCT-2021) 0.5 mL, intramuscularly (IM) (frequency and anatomical location not reported) for prophylaxis (incorrect dose administered, product administered to patient of inappropriate age). combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Vaccine administered at approx 1300.  EE reports having itching and swelling to left arm and site at approx 1630.  EE took oral benadryl at home.  Swelling and itching has ceased.  Redness noted to site, approx 2.5 inches in diameter.
started hurting last noc could not lie on last PM; c/o soreness, itching (rt arm); reddness starting on deltoid goes down arm to biceps-blistery-swollen-warm to touch
Approx 24 hours post vaccine injection, pt noticed area of redness about 3" under injection site. Upon arrival here, finding an area of redness, tissue has a fluid filled texture and is warm to the touch. She also reports having a severe headache for several hours today.
Information has been received from a licensed practical nurse for the Pregnancy Registry for GARDASIL, concerning a 26 year old female patient with a history of papilloma viral infection, who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (Lot number 659964/1978U) 0.5 mL IM. On 11-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (660393/0067X) 0.5 mL IM and on 08-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot number 660557/0072X) 0.5 mL IM. There was no concomitant medication. The nurse reported that the patient who received all three doses of GARDASIL was pregnant. A urine pregnancy test done on 08-OCT-2008 at the office was negative. The last menstrual period was on 14-OCT-2008 and the estimated delivery date will be on 21-JUL-2009. Follow up information was received from the LPN who reported that the patient with asthma (status post), had a 3 previous pregnancies (2 full term deliveries (39 weeks both) and 1 elective termination at 4 weeks). The patient did not had any birth defects or infant complications in any previous pregnancy. On 29-DEC-2008, the patient was placed on prenatal vitamins. On 13-0CT-2008 a PAP was performed, positive result for ASCUS and HRHPV. On 12-DEC-2008, a colposcopy was performed (results not provided). Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.
Immediately following IM injection patient experienced swelling & hardness around injection site. Skin was slightly bruised. Patient called from home approx. 2 hrs. following injection to report swelling decreased.
tenderness; Cold sore; Little cluster of blisters on the side of his face; Was exhausted all day; Temperature of 102; Violent shaking; Full blown flu; Feeling of nausea that was really bad; Felt pain  immediately after receiving the second dose / Achy feeling; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 20th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, immediately after receiving Shingrix, the patient experienced pain in arm. On 21st September 2019, the patient experienced fever, tremor, influenza-like symptoms and nausea. On 22nd September 2019, the patient experienced exhaustion. On 24th September 2019, the patient experienced cold sores, blister and tenderness. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the cold sores, blister, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the cold sores, blister, pain in arm, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient broke out with a cold sore which he described as a little cluster of blisters on the side of his face which he was treating with valacyclovir. The patient reported that he felt pain immediately after receiving the second dose of Shingrix on his left arm IM. The pain got worse and then he had a very sore arm. The soreness had resolved with a little tenderness. The patient got a temperature of 102, he almost went to the ER with violent shaking. The patient reported an achy feeling and full blown flu with a feeling of nausea that was really bad and exhausted all day. The patient consented to follow up.
Information has been received from a physician concerning a female who on approximately 15-JAN-2007 was vaccinated with Gardasil. On 28-MAR-2007, the patient was vaccinated with a second dose of Gardasil. On 02-APR-2007 the patient experienced itchiness and red spots on whole body. After seven days of itchiness, the patient received an injection to reduce the allergic response on the whole body. On approximately 28-APR-2007 the patient still experienced itchy palms and feet. Additionally the patient experienced aching and numbness in both hands and feet. She complained that it was hard to complete the housework due to aching and numbness. On approximately 01-MAY-2007 the patient experienced red spots and itchiness on face. Subsequently, the patient recovered from itchiness and red spots on whole body. However, the patient's itchy palms and feet as well as aching and numbness persisted. The red spots and itchiness on face also persisted. The reporter felt that itchiness and red spots on whole body, itchy palms and feet, aching, numbness, red spots and itchiness on face were related to therapy with Gardasil. Aching and numbness were considered to be disabling. No further information is available.
first vaccine given on 03/06/2021 lot number 030a21a second dose given on 04/03/2021 lot number 018b21a 5/25/2021 had a rapid c19 done in the ED, asymptomatic for covid Sent PCR on 5/26/2021, resulted positive on 5/27/2021 Patient presented to ED for vascular insufficiency on 5/25/2021, R/O DVT.  admitted to hospital.
Fever accompanied by painful paresthesia most prevalent in extremities. Pain level is about a 6. Frontal lobe migraine, throbbing and pressure. Pain level 4. Extreme fatigue.
know get very sick from the flu shot; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced know get very sick from the flu shot (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious know get very sick from the flu shot (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
t103 day of shot, swelling, erythema @ shot site, screaming, & crying for up to 18 hours after shot;
Information has been received on 23-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 22-SEP-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 05-JAN-2016, the patient was treated and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Presented 02/21/2021 - left arm w/ isolated rash approx. 4" below injection site, warm to touch. Rash approx 2" x 4" area. Treated w/topical OTC cortisone cream & ice. Rash still visible on 2/22/2021
50 mm redness, induration circle. Burning & itching feeling. Denies SOB, any other swelling or pain. Urgent care - Dx cellulitis & abscess - Rx. BACTRIM DS & BENADRYL.