chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site. Redness, swelling, and bruising at injection site. Nausea. A hard knot formed in the muscle under the injection site. It took approximately 7 weeks for the swelling, bruising, and muscle not to self-resolve.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11 -JUN-2013), an unknown number of patients might have received dose of PNEUMOVAX 23 (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might have received improperly stored PNEUMOVAX 23 was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Severe headache next day lasting through the night and into day 3 (less severe right now), which is today.
3/16/2021 I had my first dose of Pfizer Covid-19 Vaccine.  3/19/2021 everything I ate or drank tasted horrible, I was running a slight fever and I was extremely tired. 3/20/2021, the tiredness and fever are gone, but still having issues with taste. 3/22/2021, still having issues with taste. Things I loved before the vaccine I can no longer tolerate because they taste so bad. I am eating ice so I don't dehydrate.  This is the worst experience I have ever had and I doubt that I will get the second dose.
felt a stinging sensation inside the node; the injection site after receiving both the first and second dose of the Shingrix vaccine was sore; Chills; Fever of 101.4; lymph node under her left arm, in the arm pit, was swollen; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, fever, axillary lymph nodes enlarged, lymph node pain and injection site pain. On an unknown date, the outcome of the chills, fever and axillary lymph nodes enlarged were recovered/resolved and the outcome of the lymph node pain and injection site pain were unknown.   It was unknown if the reporter considered the chills, fever, axillary lymph nodes enlarged, lymph node pain and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed chills, a fever of 101.4, and the lymph node under her left arm, in the arm pit, was swollen.  She described that she felt a stinging sensation inside the node. She had to prop her arm up most of the night because of the lymph node.  The lymph node swelling lasted for 2 to 3 days.  The fever resolved within 8 hours and the chills were gone after 36 hours. She indicated that the injection site after receiving Shingrix vaccine was sore. The reporter consented to follow up. The reporter gave permission for her physician to be contact. For tolerance to 2nd dose, refer case US2020AMR003032.
Which resulted to an appearance of dimple where injection  site was. It was a white mark and faint white ring; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose of the Pfizer covid 19 vaccine last 11Apr2021, in the vaccination site she stated that they placed a band aid like round adhesive that had clear center and they injected needle through that. Which resulted to an appearance of dimple where injection site was. It was a white mark and faint white ring. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt. came to clinic with c/o of him left arm having adema and erythema from upper arm to wrist. Area was red with some adema noted. Pt stated that area was better today than on yesterday. Seen by NP and was advised to take Benadryl 25mg QAH for the next 2 days. Pt. was advised to go to local ER if he developed shortness of breath or wheezing. 01/25/2008 ADENDUM STATUS- COMPLETED; pt. received a pneumonia vaccine in this arm on 1-23-2008.
after the 8th day of receiving vaccine, arm had a 2 1/2" very red mark and was hot and pain going down my arm.  Pain dissipated after 24 hours but the red hot spot continued for almost two weeks.  Not painful to the touch.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 30-MAR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient reported rash/itchiness on the chest area post vaccine shot. does not report any other symptoms and no swelling of the mouth areas (face, lips, tongue). no trouble breathing. patient had also picked up allergy medications earlier in the day for an unrelated allergy symptoms of the body. Counseled patient on benadryl and will follow up next day as well. Patient reported okay to drive home and will take benadryl when he arrives at home safely.
No adverse effects were reported; patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information was reported regarding the patient's concomitant medications, concurrent conditions or medical history.  On 04-APR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # M037245 with expiration date on 21-FEB-2019 (route of administration was not reported) for prophylaxis. However, no adverse effects were reported.  Lot number M037245 is not a valid lot for hepatitis a vaccine, inactivated(VAQTA).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002785:
Initial and follow up information has been received from a registered medical assistant concerning a 67 year old white retired male who on 8/11/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647028/0564N). It was reported that the patient "...developed swelling in arm from elbow up to neck and chest area. Red rash also in the same areas warm to the touch". On 8/13/04 the patient was seen in the office and was afebrile. He was placed on methylprednisolone and cetirizine hydrochloride  for allergic reaction, and was instructed to go to the emergency room if his symptoms got worse. As of 10/5/04 the patient recovered from the events, and did not need to follow up for any additional treatment in the emergency room. Additional follow up information received on 10/20/04 indicated that the patient was given pneumococcal 23v polysaccharide vaccine on 8/11/04, and returned to clinic on 8/13/04 with "...left arm swollen and red extending through shoulder and left upper chest". The medical assistant indicated that the patient had had pneumococcal 23v polysaccharide vaccine in 1997 and that there had been no reaction at that time. Left arm swollen and red extending through shoulder and left upper chest was considered immediately life threatening. No further information is available. The medical assistant also reported at least 2 other patients maybe even 3 other patients with the same reaction when vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0410USA00285).
CHILLS; SORE ARM AND LEG PAIN; FEVER; COULD NOT WALK FOR 3 WEEKS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had some severe reactions and patient cannot take aspirin or ibuprofen. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced could not walk for 3 weeks. On 11-MAR-2021, the patient experienced chills. On 11-MAR-2021, the patient experienced sore arm and leg pain. On 11-MAR-2021, the patient experienced fever. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Positive. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk for 3 weeks, and chills, sore arm and leg pain, and fever on 11-MAR-2021. This report was non-serious.
This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: 1801USA002808: 1806USA010171: 1806USA010178: 1806USA010179: 1806USA010180: 1806USA010176: 1806USA010181: 1806USA010174: 1806USA010173: 1806USA010175.
On 12/20/2022, I was very suddenly lethargic and had a headache. I slept for three or four hours. I took a home antigen test on 12/21/2022 and got a positive result. That day, I had a lot of upper respiratory symptoms. I had headache, a fever of 101, congestion, and fatigue. I contacted a doctor through an online app, and he advised me to treat it as a cold. I slept a lot that day. On 12/22/2022, I began to feel better, since the symptoms were milder. I felt stir crazy, so I went out and drove for a bit. By 12/23/2022, I felt pretty much like my normal self. I treated my symptoms with DAYQUIL and NYQUIL, plus AFRIN for nasal congestion. On 12/23/2022 and 12/25/2022, I tested and got positive results. On 12/29/2022, I tested myself again and got a negative result. I developed depression in late January 2023. I was laid off from work around that time, so that likely contributed to it. I have chronic major depression, so it's not so unusual for me. In February 2023, I experienced a loss of interest in normal activities, negative thoughts, trouble sleeping, and lethargy. I didn't recognize my symptoms as ones of depression until late February 2023. At first, I didn't really do anything, because I had experienced it before and knew that it would come and go. On 3/7/2023, I had trouble getting out of bed and had negative thoughts. I also called my husband in tears at one point. This was my lowest point. I'm doing a little better now, since I'm able to do more, but I am still having negative thoughts and passing suicidal ideation. I am due to undergo ECT treatments at a hospital in the very near future. I will likely receive one to two weeks of treatments.
tennis ball sized swollen area on left side of the chest very close to the arm pit.  There is a general constant pain which increases with movement and/or palpation.  Tylenol PRN has reduced the pain but temporarily and not significantly.
rash around the injection site; body soreness; severe headache; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash around the injection site), PAIN (body soreness), HEADACHE (severe headache) and INJECTION SITE REACTION (COVID Arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE RASH (rash around the injection site), PAIN (body soreness), HEADACHE (severe headache) and INJECTION SITE REACTION (COVID Arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE RASH (rash around the injection site), PAIN (body soreness), HEADACHE (severe headache) and INJECTION SITE REACTION (COVID Arm) outcome was unknown.            No relevant concomitant medications were reported.    This case was linked to MOD-2021-030502 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to the company on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash around the injection site), PAIN (body soreness), HEADACHE (severe headache) and INJECTION SITE REACTION (COVID Arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE RASH (rash around the injection site), PAIN (body soreness), HEADACHE (severe headache) and INJECTION SITE REACTION (COVID Arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE RASH (rash around the injection site), PAIN (body soreness), HEADACHE (severe headache) and INJECTION SITE REACTION (COVID Arm) outcome was unknown.            No relevant concomitant medications were reported.    This case was linked to MOD-2021-030502 (Patient Link).
This spontaneous report as received from a physician refers to a 27 year old female patient. She had no pertinent medical history, and no drug reactions/allergies. The patient completed the 3 dose series of GARDASIL, administered intramuscularly on unspecified dates at another practice. The patient took no concomitant medications. On 17-MAR-2014 the patient had a positive HPV DNA Pap test result. The outcome of had positive HPV DNA Pap test result was reported as not recovered/not resolved and the patient received no treatment for the event. A causality assessment was not provided. This case is cross-referenced with case 1403USA010930, regarding the another patient (reported by the same physician), who also had a positive HPV DNA Pap test result after administration of GARDASIL. Additional information has been requested.
FLU-LIKE SYMPTOMS/HEADACHE/NAUSEA/VOMITING/FEVER/CHILLS; TINGLING SENSATION IN LEG; SWEATING; HOT FLASHES; EXTREME LEG SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no other medical condition and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tingling sensation in leg. On 09-APR-2021, the subject experienced flu-like symptoms/headache/nausea/vomiting/fever/chills. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced hot flashes. On 09-APR-2021, the subject experienced extreme leg soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in leg on APR-2021, had not recovered from extreme leg soreness, and flu-like symptoms/headache/nausea/vomiting/fever/chills, and the outcome of sweating and hot flashes was not reported. This report was non-serious.
Patient had a fever and low blood pressure a few days after the shots. He had to be hospitalized. The doctor from the hospital said it was because of getting both shots a once.
Patient felt extremely anxious with some chest tightness that resolved within 5 minutes after sitting down and drinking H20  Patietn declined EMS transport to ED stated she no chest tightness after resting x 5 mins. Held in clinic for 45 minutes.
Started with an itchy painful rash on leg and it has spread all over leg and on arms. Treated with hydrocortisone and then with an antifungal over the last year. Still spreading.  Her joint pain began with her knees, and now she has pain in all joints incl ankles, wrists, fingers, elbows and hip.  No treatment. She has been complaining of an occasional racing heartbeat and palpitations.  cant find how to list all dates of shots on here, they are 6/16/08 lot 1267U 8/18/08 0072X  12/23/08 lot 1061U. 12/29/09 pt continuity code with 374340.
Information has been received from a licensed practical nurse, concerning her 19 year old daughter with Crohn's disease, who on 26-FEB-2006 was vaccinated with the first dose of Gardasil. Concomitant therapy included PENTASA, FLAGYL, REMICADE and prednisone. Following the vaccination (duration of time not specified), her daughter experienced esophagitis, dysphagia, and weight loss. On unknown dates, her daughter was vaccinated with the second and third doses of Gardasil, and following each of these vaccinations, she experienced a return of the esophagitis, dysphagia and weight loss. Diagnostics studies included an endoscopy and a biopsy, both of which ruled out herpes esophagitis. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2016, the patient was vaccinated with a dose of PEDVAXHIB injection (dose, route and lot # not reported) that was expired "in June 2016". The reporter did not had lot # and complete expiration date of the expired vaccine administered. The reporter did not know if the patient had experienced any adverse events. No product quality complaint was involved. Additional information is not expected as the reporter did not provide consent to contact.
Flu shot at about 130pm later in the evening Lt arm felt a little sore & when she raised arm above head felt pain & had swelling in neck lt side. Soreness in arm gone still swelling neck & tenderness. On exam 2 pea size nodules supraclavicular are with soft tissue swelling tender to touch, nausea, upset stomach referred to clinic.
Patient presented w/ fever x 1d. S/p COVID #1. Tm 99.6F; defervesce w/ antipyretics. Assoc w/ chest pain w/ breathing; denied resp distress, shortness of breath, palpitations, LOC, MS change. or other neuro/cardio/pulm difficulties. Denied cough, rhinorrhea, vomit, diarrhea, rash, or lethargy. Normal PO and UOP. Provider referred patient  to visit ER on 07/12/21.   On 07/13/21, nurse reached patient to follow ER visit. Patient stated that symptoms resolved after 07/12/21 visit.  Patient did not went to ER.
I was playing golf and I got a runny nose, I didn't test right away. On July 2nd I test positive. On the first day i had a fever not a high fever. And then I developed congestion in my chest and a cough and that was it for the whole time. I started taking the Pizer drug on July 3rd and took that for 5 days. I feel good now but still have congestion.
Myocarditis with Covid Severe burning of lungs and fatigue along with all delta symptoms
at least one case where the child was given the Hep B series early; This spontaneous report was received from a nurse prescriber referring to a child of unknown age (reported as at least one case). There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On unknown dates, the patient was early given the hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, dose, route, frequency, lot number and expiration date were not reported) series for prophylaxis (inappropriate schedule of product administration).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA002297:
a high and low temperature excursion for PNEUMOVAX23 syringes; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 02-DEC-2020, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot number T032003 with expiration date 08-MAY-2022; route was not reported) for prophylaxis (incorrect product storage).   The storage temperature of the vaccine was above 47 degrees Fahrenheit (60 degrees Fahrenheit) for a time frame of 85 hours. There was no previous temperature excursion. The call was because of a data logger involved. No product quality complaint was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T032003; expirationdate: 08-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Severe headache,  Numbness,  and migraine,  nausea  for 9 days
Client had seizure activity approx. 10 mins after receiving vaccine. He was sitting on chair in observation area then fell to the left, hitting his head on the ground. He then proceeded to have what looked to be seizure activity, jerking movements of arms and legs. 911 was called by lead RN. Client regained consciousness approx. 10-15 seconds later.  V/S taken @ 12:07pm: BP 133/72, HR 118, O2: 88, RR 22, AOx3   Client appeared diaphoretic, pallor to face, slurred speech. Denied hx of seizures. V/S taken @ 12:18pm: BP 133/71, HR 118, O2 88, RR 22, AOx3. Reported hx of asthma and uses an inhaler. Reported smoking marijuana prior to receiving vaccine. At 12:20 EMS arrived and assumed care of client. Was transported to hospital