chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling under my left arm; nausea; soreness at injection site; fever; chills; body ache; swollen neck gland; stomach cramp; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 10:45 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood triglycerides increased from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM; GLUCOSAMINE]) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. Patient was allergic to penicillin, aspirin, sulfa, biaxin. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:45 AM (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, patient experienced nausea, soreness at injection site, fever, chills, body ache, swollen neck gland, stomach cramp. On 18Mar2021, patient experienced swelling under my left arm. Therapeutic measures were taken as a result of fever included Tylenol. No treatment was taken as a result of events included nausea, soreness at injection site, chills, body ache, swollen neck gland, stomach cramp. The events was reported as non serious. The outcome of the event swelling under my left arm was unknown and all other events was not recovered.    No follow-up attempts are needed. No further information is expected.
Vaccine (dose 1) received on 02/08/2012 On 02/16/2021 I noticed a dime-sized knot  at the injection site which itched.  This went away on its own on 02/18/2021. On 02/19/2021 at 6am, I noticed a large, circular, red rash (9cm by 7cm) at the injection site. It is not painful or itchy, but is warm to the touch. No treatment used.
15 yo old boy c/o difficultly sore throat approximately twenty minutes after receiving the second dose of the Pfizer vaccine. He appears well and has a normal voice. Auscultation of his larynx did not reveal stridor. No rash, wheezing, or other associated signs or symptoms. He was treated with 25 mg of oral diphenhydramine with a resolution of symptoms after an extended monitoring period.   Per MD    Clinical Lead
pt recvd vax 23DEC94 & 6 hrs later devel head jerking, eye blinking & staring; pt became unresponsive was taken to ER & had t102;
Person complained of "thick tongue" approximately 5 minutes after receiving the H1N1 injection. B/P 168/72
Injection-site reaction increasing in size and pain.  Currently, about the size of a lemon, raised, burning, and painful to touch.
Patient passed out fell to ground and started with jerking motions.  Pateinet was taking by ambulance to the emergency room. Pateints blood pressure and pulse where low when checked by paramedics.
Vaccines were given on 7/23/13 to this 24 lb, 8 oz male.  Mom called our office nurse phone line on 7/24/13 at 12:29 pm  documented phone call by nurse: " pt's mother who stated pt was seen for office visit yesterday and received 3 vaccinations. Mom stated pt had nosebleed in middle of night (1:00 am). Mom stated she contacted after-hours nurse and was given nosebleed instructions and was instructed to report nosebleed to provider today. Mother states pt has not had any further nosebleeds, has no other symptoms and no signs of any reaction to vaccines other mild discomfort at injection site. Mother inquires if nosebleed could have been caused as reaction to vaccines received yesterday? Provider's response at 2:57 pm: Please let mom know that nosebleeds are very unlikely to be related to his vaccines. More likely his nose was just dry and it was coincidental. Mom can use nasal saline drops to keep his nose moist or apply Vaseline to his nasal passages.  Call if nosebleeds persist. Mom informed at 3:05 pm and had no further questions or concerns.
Woke up with pain across the back of my neck and severe lethargy. Dizziness, nausea, chills and severe lethargy throughout the day caused me to stay in bed until about 4pm - a very rare event. Began to feel better at about 7pm. Felt much better the next day.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. In 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-DEC-2015, the patient was treated at a physicians office for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
Pt experienced numbness of the right arm, warmth and swelling at injection site. He took ADVIL at 4am and experienced extreme vomiting till noon the next day.
Three days post vax, pt experienced 12 x 18 cm erythematous area on left triceps area.
Patient states that her arm has been hurting for 4 months - can't raise arm to lift things out of cupboards. Has taken TYLENOL and applied BIOFREEZE without relief. She seems to think also got flu shot same day - did not.
11:30am began to feel like had needles in her tongue. Head down while sitting in waiting room. Took to exam table to lay down. B/P 190/96, 180/100. 11:48am sitting on edge of exam table. Reports feeling better-generally and with hot tongue. Face and neck flushed. 11:50am c/o 200/110. Pt to ER via WIC 12:15pm. In ER ex nurse B/P 200/96.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just finished the 2nd set of Shingrix. The patient experienced sore arm for couple of days. The follow-up could not be possible as no contact details were available.
persisitent pain in elbow and shoulder, with periods of higher intensity pain, occasional numbness
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEGA 3 FISH OIL [FISH OIL] as pills. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies, Other medication in 2 weeks product Statins stop date 28Aug2023. Patient received Paxlovid from 29Aug2023 to 02Sep2023 as Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case number PHEH2013US016637 is an initial spontaneous report received from a nurse on 02 Aug 2013 with a follow up information received from a nurse on 29 Oct 2013. This report refers to a 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with an initial dose of MENVEO (batch number: A11042) intramuscularly in the right deltoid on 18 Jul 2012. She inadvertently received another dose of MENVEO (batch number: A12006) intramuscularly in the left deltoid on 30 Jul 2013. No adverse event was reported following medication error (inappropriate schedule of vaccine administered). Follow up infromation received from a nurse on 29 Oct 2013: Patient demographics 9gender, weight and height), vaccination date of first dose, vaccination sites of both doses updated.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pneumonia (hospitalized for pneumonia for 12 days). Previously administered products included Influenza vaccine with an associated reaction of injection site pain (Received Influenza vaccine and experienced injection site pain (refer case US2018GSK144776)). Concurrent medical conditions included chronic obstructive pulmonary disease and emphysema. On 30th July 2018, the patient received the 1st dose of SHINGRIX. On 30th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the headache, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the headache, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The patient experienced pain and swelling at injection site, and also experienced headache, she could feel the pain and swelling immediately as she received the injection. The caller described the pain as worse than a typical flu shot but not bad enough to prevent her from getting the second dose. This case has been linked with case US2018GSK144776 reported by the same reporter for the same patient.
On 10/9/20: Patient is a 5-year-old received a flu shot at school yesterday. Reaction started about 8 hours after the flu shot.  There is slight area of redness.  Today the redness is increased and has some swelling.  Is no pain but there is itching.  No fevers no chills.  Patient never had a similar reaction to any immunizations in the past.  Patient allergic to amoxicillin.  There is no sore throat no difficulty breathing or swallowing. Saw in ED and given Keflex for possible cellulitis. 10/12/20:  Suspected local skin reaction secondary to influenza vaccine  Unlikely a cellulitis as reaction occurred <12 hours after injection, but given no assessment by employee at time of swelling will continue as ordered by other physician (will only complete 7 days)  continue supportive care- PRN benadryl, cool compresses  Mom to call if not improving, worsening, or any other concerns  Follow up: PRN
Developed pain in left armpit approx 36 hrs after vaccinations given. Also some redness at injection site of L arm. Pain resolved by following am (2/22/06). Later that evening of 2/22/06 L arm pain returned and noticed a lump in L axilla. Advised cold pack and ibuprofen every 4-6hrs on MD consult.
Tinnitus in left ear starting 3 days after first injection. Tinnitus in right ear starting 3 days after second injection.  Sustained tinnitus  in both ears still
Starting on July 2nd my feet started tingling and going numb. On July 3rd my feet and lower legs were tingling and going numb in the evening. On the 3rd, I also got the worst headache I have ever experienced in my life. On the 4th I woke up with a lingering headache and the back of my neck was kind of stiff.  My feet and legs were tingling/feeling numb on and off during the day and my left arm started to go tingly/numb as well. At about 2:30 a.m. on July 5th, I woke up with difficulty breathing and all 4 legs and arms were numb and tingly, and I was very weak. I was taken to the E.R. by my family. At the E.R. they did a lumbar puncture and  blood work and sent me by ambulance to larger hospital. While there, I went through further testing including an MRI and additional blood work. The conclusion was that I was experiencing paresthesia possibly caused by a strong autoimmune reaction.
Pfizer-BioNTech COVID-19 Vaccine EUA The most troubling of the side effects, if it is a side effect, is that I had an "eye flasher" for the first time on 4/12/2021. I went to the doctor on 4/13/2021, and the doctor confirmed that this is what it was. I do not know if it is related, but coming so soon after the vaccination, I thought it is possible and wanted to report it.  (I also had more common symptoms the day after the shot (the day after being 4/8/2021), with those symptoms being tiredness and fever of 101.2. Those symptoms lasted about a day.)
Same day post vax, the pt developed a fever and an injection site reaction characterized by a 5 cm by 6 cm area of redness and warmth. The pt recovered within 36 hours.
Redness at site shortly post vax, complaint of itching, swelling and pain at site. Redness extended down to antecubital.  Benadryl given and ice.
administration past beyond use date/Exp 10/03/21 (03Oct2021); administration past beyond use date/Exp 10/03/21 (03Oct2021); This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (administration past beyond use date/Exp 10/03/21 (03Oct2021)) and EXPIRED PRODUCT ADMINISTERED (administration past beyond use date/Exp 10/03/21 (03Oct2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administration past beyond use date/Exp 10/03/21 (03Oct2021)) and EXPIRED PRODUCT ADMINISTERED (administration past beyond use date/Exp 10/03/21 (03Oct2021)). At the time of the report, PRODUCT STORAGE ERROR (administration past beyond use date/Exp 10/03/21 (03Oct2021)) and EXPIRED PRODUCT ADMINISTERED (administration past beyond use date/Exp 10/03/21 (03Oct2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
shaking muscle; abdominal burning; Headache; Nausea; joint pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (joint pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 12-Aug-2021, the patient experienced TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills). At the time of the report, TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) had not resolved.            No concomitant medications reported.   Treatment information not reported.   Reporter did not allow further contact
Patient was under 50 years old and not immunocompromised but received second Pfizer booster
Rapid HR, chest tightness, sob, for about 2 minutes. Has happened 4 times over an 48 hr period.
pt exp hives on buttocks 2 days p/flu shot; on the 3rd day hives spread w/swelling of hands & feet;
26 y/o female with no PMH c/o mild dizziness and nausea 13 min post pfizer covid-19 vaccine 1st dose. Pt reports no similar prior experiences including syncope, seizures, dizziness, nausea and vomiting with needles, blood draws or vaccines. Pt was given oral fluids and laid down on a cot, she reported mild improvement after laying down ~5 min. Pt then reported a worsening of nausea and then began gagging and spitting up saliva into an emesis bag for ~15min. Pt did not vomit. Pt suddenly placed emesis bag on the cot and lost postural tone, losing consciousness laying backwards onto the cot. Patient did not hit her head. Pt VS remained stable throughout the entire encounter, she was not able to follow commands. Additional information for Item 18: EMS was called, pt was stretcher and attached to monitor. Pt was transferred to hospital via EMS because she was unable to follow commands and has no history of seizures or syncope.   Denies: history of similar prior experiences or syncope, HA, SOB, CP, itchiness, rash, respiratory distress, facial/extremity swelling, paresthesias, numbness  Vaccine administered @9:03am in left deltoid. Symptoms began @9:16am.   Pt ate bread and had coffee for breakfast.   PMH: none Meds: none Allergies: NKDA, NKFA, NKEA  @9:37am: BP: 112/65, HR: 105 bpm, SPO2: 100% @9:45am: BP: 116/70, HR: 97, SPO2: 99%  General: well appearing, obese female Eyes: unable to assess bc pt was closing her eyes and refused to open them Cardiac: normal S1S2, sinus tachycardia, normal rhythm  Lung: clear to auscultation b/l, no respiratory distress, no rales Neuro: unable to assess bc pt was not following commands
This spontaneous report was received from a physician refers to a 20-month-old patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 13-MAR-2017, the patient was vaccinated with a dose of VARIVAX lot # M039318 (expiration date, dose, route of vaccination were not reported) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014463: US-009507513-1704USA000004: US-009507513-1705USA013512: US-009507513-1705USA013527:
Mother reports child was febrile 7/22-7/23/16 with 101 degree-102 degree fever, then 7/24 fev. blister-type/hives of extremities which opened-numerous hives approximately 50 noted of all extremities, today-fever resolved.
On 6-13-2022, I began having head congestion, a cough and a sensation of fluid in right ear. These symptoms continued thru the next day. On 6-15, I started having a headache, body aches, feeling of fever (did not check) and chills. I took a home COVID19 test with positive results. I called my doctor the same day and he ordered PAXLOVID and to take OTC medications for symptoms. I began taking MUCINEX, at times ROBITUSSIN and TYLENOL. I started taking the PAXLOVID on 6-16. I am feeling better now. I am reporting a breakthrough case of COVID19.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling at site of injection. Patient was seated after receiving the vaccine and suddenly collasped. Patient maintained consciousness throughout the episode and her symptoms have improved.
Mild headache, increased heart rate, muscle aches, mild fatigue, moderate pain at injection site.
9:45am pt c/o a "little tingling on upper and lowers lips".  Pt speech and mental status at baseline.  Pt able to swallow water and mental status at baseline.  No noted redness or hives on patient body.  Pt refusing Benadryl x 2.  Pt reports at 10AM " I am feeling better or less tingling only a "tiny bit".  Pt at 10:10am "I am better now". Pt able to ambulate safely to checkout area.
Seven days after vaccine admin, hands and ankle became painful and noticeable swollen. They continue to day #13 following vaccine
Fever, diarrhea, ached all over, diaphoretic; pt stated was treated for bacterail infect in ER:
This spontaneous report was received from a physician via medical records through Pfizer (reference # 2017016276) and concerns a currently 57 year old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prophylaxis. On an unknown date, the patient experienced allergic reaction to PNEUMOVAX23. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX23. All available medical records will be provided upon request. Additional information has been requested.
I received the Tdap shot and just felt a little soreness for a few days. After 2 weeks, my arm was extremely painful at the site. I took ADVIL, but it didn't help. Then it went away for a few days. Now, 3 weeks later, I'm in extreme pain at my left arm where the shot was given and radiating down my arm to my elbow. It is very painful. After the 2 weeks, I got a pinched nerve, I think, but don't know if it was related to the shot or not. No redness. No swelling. No fever. The pain is about a 6/10.
Allergic - watery eyes, itching, coughing, wheezing. Treated with prednisone.