chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Continuing hot flashes; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 24May2021 at 18:15 as a single dose for COVID-19 immunisation. The patients' medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took AMOX and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 26May2021, the patient experienced continuing hot flashes which occurred when the patient was physically active; example while cleaning, walking et cetera. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event continuing hot flashes was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Body aches, fever, chills, nausea, abdominal pain x 12hrs. Pain, redness and swelling at injection site x 7 days. Treated with Ibuprofen and Acetaminophen.
Fever 105 degree 2 days..pain all over ..in bed sick 7 days..lost 4 lbs  mouth became very red and extremely painful...headache...exhausted..had to go to my doctor 2 times
Patient hospitalized with shortness of breath and pneumonia (from 2/15/2021 to 2/21/2021) and patient died at another facility on 3/2/2021.
On 04 OCT 2009 we received from a health care professional the following information: A male patient, born on 26 May 1921, was vaccinated with 0.5 ml FLUVIRIN subcutaneously in SEP 2009. On 30 SEP 2009 the patient experienced fluid pooling at elbow and wrong route of vaccination (subcutaneously). He had not recovered at time of the report. No: NA09-005090. This case was previously reported as MA2009-2841. Follow up report received on 19 Jan 2010: It was reported that there might have been an issue with muscle mass and the reporter not sure of specifications of pooling. The reporter stated that the patient was fine. Follow up report received on 12 Apr 2010: It was reported that PRA tried to contact the reporter twice without any response so far. No further information was expected and case will be closed. Following internal review of the data on 14 Apr 2010, the case PHHY2009US61202 was identified as a duplicate of this case PHHY2009US60509. The case PHHY2009US61202 will be deactivated.
nausea &diarhea x week fever 102.  fatigue chills    pain & itching at injection site body aches headache
Pt presented to our office for redness, swelling and painful site where she had received the COVID vaccine from Moderna on 12/29/2020.  She presented today, 1/7/2021 with the adverse event.  The size of site was approximately 11cm, hard, and warm to touch.   She reports immediately after the vaccine, the injection site was slightly painful and sore but went away until 01/04/2021.
Seasonal influenza was administered on 9/30/22 and another dose was administered on 1/13/2023
Onset of crying approx 2hrs p/ DTP given. Loud unconsolable crying lasted for 24hrs. Inject site swollen & red, quarter size.
At 11:08 patient slumped down in chair and stated "oh no, here it goes." Patient lost consciousness at 11:09am.  I continued to speak to him and he was unable to hear initially.  He did cry out and gasp and tighten then started to have a few slow jerky movements bringing both arms and body up from the chair. It appeared as if he may vomit and I repositioned to ensure he would not slide off of the chair.  The movements lasted about a minute and then he started to come to.  He described feeling dizzy, disoriented, nauseous, and sweaty.  During the event his pupils were non responsive. At 11:17 he went pale and started feeling as if he was spinning and experiencing tingling.  He was still reclined in the chair and sitting up aided with the tingling.  He was given a cold pack to help regulate and given ice water at 11:18.  He stated he had not eaten yet today as he usually doesn't eat until 11. His temperature had dropped to 96.1 vs 97.5 prior to the vaccination.  BP was checked at 11:25 and was 120/72 which is lower than usual for him and to be expected with the LOC.  After drinking his water, I had him attempt to stand while grasping the wall/table for 2 minutes to assess his steadiness, then standing unassisted for 2 minutes.  After he felt steady enough we had him walk 10-15 feet and stand for another 2 minutes.  Patient was feeling tired and instructed not to drive home.  The situation was conveyed to his wife and they were instructed to seek ER/Urgent care if any of his symptoms reappeared. They stayed in the area to eat lunch and I checked in again at 12:12pm with the patient and he is feeling better after eating but still tired.  I also recommended following up with his primary as I will be sending her a copy of this report.
Headache, Myalgia, Arthralgia, fatigue, decreased appetite Narrative: Headache, fatigue, myalgia, arthralgia, decreased appetite; treating with tylenol.
Headache; Mild 102 degree temp; Achy; Achy joints; Tired; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 18Apr2021 at 11:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and benazepril (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 11:00, the patient experienced headache, mild 102 degree (units unspecified) temperature, felt achy, had achy joints and felt tired. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, mild 102 degree (units unspecified) temperature, felt achy, had achy joints and felt tired was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided: For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Date of refrigeration given as 5/7/2021. No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-156111 Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-156111.
Dtap, Ipv and MMR given approximately 3pm 09/10/2007. Child woke up at 5am 09/11/2007 itching. At 7am same day mother states she noticed red blotchy areas arms, small area on lower abd., redness on cheeks. Child went to school.  On 09/12/2007 am same s&s as above with eyelids "mildly swollen" as well. Mother states child given dose of Benadryl with some improvement.  States no apparent signs of difficulty breathing, not coughing or clearing throat. States is playing and seems uneffected except some ithing.  Also states some of the red areas also includes some welts. Mother also states area around injection on left leg is "a little red". This nurse advises she consult with her physician.  Will call this nurse after Dr. visit.  KGermain RN.
Information has been received from a registered nurse concerning a 48 year old male with no drug reactions/allergies who on 05-SEP-2008 was intramuscularly vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (lot number 660685/0619X). Concomitant therapy included (ADACEL) given in the other arm. On 6-SEP-2008 the patient developed "shakes and chills" and a 3 x 6 inch, red area at the injection site. The red area is sore to touch. The patient is being treated with antibiotics. Medical attention was sought at the office visit. At the time of reporting the patient was recovering. No other information is available. Additional information has been requested.
Patient started calling out for help within minutes of receiving vaccine and she reported sweating and momentary dizziness. She was given water and was asked to sit down for a total of 30 minutes. She said that she had just eaten before coming to the pharmacy but was fasting previous prior to that. She claimed that she felt better but we did not feel that it was safe for her to drive home.  Her emergency contact was called and he came and picked patient up.
woke up in middle of night with extreme pain on right lower rib cage (front and back), no rash
Patient reported a rash/swollen red portion on right upper arm that extended down to elbow region. Patient stated it was itchy, warm and swollen that subsided however rash left.
This subject was a 5 month old male, who experienced seizure-like activity, while enrolled in a study. The subject received three doses of study vaccines (Daptacel, IPOL and ActHIB); last doses prior to the event were administered on 11May06. The subject also received his third doses of Prevnar and Recombivax, the same day. The subject experienced seizure-like activity, 2 days post immunization, described as shaking episode upon waking up, which lasted up to a minute, was not accompanied by fever and was followed by fatigue. There were 3 or 4 such episodes. Per the mother, the subject was evaluated by a pediatrician and reportedly there were no concerns. No further details were provided about diagnostics and treatment. A neurological appointment was scheduled to take place approx 1.5 months after the event. A follow up conversation with the parent revealed that the subject had not had such instances for a week prior to the contact. The event was ongoing. The event of seizure-like activity was reported by the investigator as related to the study vaccine (Daptacel) and unrelated to ActHIB, IPOL, Prevnar and Recombivax. (OMIC)
loose stools, feeling flushed, fever upto 101, headache, dizziness
left upper arm large area of erythema and warmth. no fluctuance. measures about 7cm x 4 cm
Expired Moderna vaccine administered to patient; expired vaccine is stored and then administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that they received the Moderna vaccine vials with a manufacturing date of 1-Dec-2021 and an expiration date of 1-Apr-2022 Lot-026L21B. They also received Moderna vaccine vials with a manufacturing date of10-Dec-2021 with an expiration date of Jul-2022 Lot-001M21A. It was reported that vaccine was administered to patients from  06-APR-2022 to 09-Apr-2022. The vial was initially stored in refrigerator on 05-Apr-2022. It was reported that vial did not undergo temperature excursion and patient reported no adverse events at that time. No treatment medications were reported.   This case was linked to MOD-2022-539070 (Patient Link).
client returned to clinic 2/9/09 stating she noted small lump left tricep region appr. 10 days prior.  reports area getting progressively larger. area appr. 25cm. slightly reddened, warm, sensitive to touch, hard.  denies fever, other systemic signs/symptoms.  referred to primary care provider.  placed on antibiotics for 7 days with follow up visit scheduled 12/16/09.
No reactions 1st day. Next day 2-22-23 in mid afternoon, I had to recline on couch as knees swollen (esp. L knee w/ water on top), constant, dull, aching joint pain in knees, bilateral hip groins, and bilateral, greater trochanters. Elevated them with no change. At nite, as pain continued, took 1/2 Vicodin twice thru nite to get some sleep but not good. Very stiff upon standing and still ongoing . Stiffness and soreness though less on Sept. 28.
STOMACH CRAMPS    LOWER BACK AROUND KIDNEY AREA ( NO KIDNEY MALFUNCTION)     DIFFICULT TAKING A FULL BREATH FEELS LIKE A  BALL BAT TO MY CHEST   PAIN STARTED ON 02-05-2021.    TODAYS DATE IS 02-08-2021. BLOOD PRESSURE IS 124/68  HEART RATE IS 51.   OXEG IS 99.1    RIDE MY ROAD BIKE 30 MILES EVERY OTHER DAY.
Varicella vaccine breakthrough. Developed rash on torso 6/8/06. No fever. Diagnosed in our office on 6/10/06 with vaccine modified varicella by another MD. Had over 150 lesions.
Varicella like rash at injection site on right upper arm. Does have spots on abdomin also.
Within 30 seconds-1 minute after completing shots, client developed 1-2 mm hives - few on top of each hand, few on left neck under jaw, and a few on upper left forehead. Also had generalized red blotchiness on face and all four limbs. All symptoms disappeared about 2 minutes after first appearance. Per mom, no further appearance since.
Approximately 1 month after my second dose of Moderna I noted a noticeable indentation in the skin and fatty tissue on my left deltoid area at the site of dose 1 and dose 2 of my Moderna vaccines. No pain or redness at the site.  I received by booster dose in my right deltoid. No indentation noted in the right deltoid area to date.  I discussed with my PCP at my annual PE on 9/3/21 and she believed it could be lipolysis related to the Moderna vaccine. This indentation remains to this day (11/23/21). Just reporting for information purposes only. Thank you!
Pt recvd vax & 10 days later exp a rash; event resolved 2 wks; no further details are available;
HCP believed that the vaccine caused ALS.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000112.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "unknown", described as "HCP believed that the vaccine caused ALS.". Therapeutic measures were taken as a result of amyotrophic lateral sclerosis. Additional information included: On 25Jan2023, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 Vaccine as unspecified dose for Covid-19 vaccination. It was reported that the individual's healthcare professional believed that the vaccine caused ALS (amyotrophic lateral sclerosis). The disease was still ongoing and the individual was getting treated. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SHINGLES; Information has been received from a lawyer and an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 19-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, in or about January 2016, the patient was treated by a provider for the following injures resulting from zoster vaccine live (ZOSTAVAX): shingles(onset date unknown). The outcome of the event shingles was unknown.
16OCT97 sharp head pains, weakness, sweats & joint aches, gone next day;premeditated w/DPH & Ibuprofen for #2 & #3-no problems;
Swelling from injection site in Left deltoid to Left hand. Pain with ROM. Reaction to influenza vaccine.
approx 7 1/2hr p/vax pt devel t>103, n/v,lethargy;fever came down 2hr p/tepid bath given;slept well through remainder of noc 17SEP96;c/o h/a, fatigue;18SEP96 c/o discomfort in inj site;
20" after injection patient self-reported feeling lightheaded, dizziness,  "foggy", generalized tingling in her hands and feet and felt like her  tongue was a bit swollen. Stated she felt "funny".  Also stated that she had a similar reaction after her first dose but states this reaction was more severe.
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 28-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Fever; arm pain - unable to lift arm that was injected; Chills; Very bad headache; Body Aches; Extreme exhaustion - slept all day; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in unspecified arm, on 06Feb2021, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that Sunday on 07Feb2021, the patient had chills, very bad headache, body aches, extreme exhaustion - slept all day, fever sunday night around 8:30 PM- 100 / 101 F - broke around at 3 AM, and arm pain - unable to lift arm that was injected. The patient woke up this morning Monday 08Feb2021 and feeling much better than the patient did. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Patient experienced shaking, anxiety, SOB, and fever of 102 degrees F. She went to the emergency dept where they did an EKG, urine screen, and chest x-ray. All came back normal so doctor did not do any blood work. They gave her IV fluids and she was released 5 hours later.
Severe ear pain in the side of the shot, lasted for three days.  Sharp shooting pains from ear up my head and down my neck only on the side of the booster shot. Every now and then I get bad ear pains only on my left side. I have not had problems with my ears before, never got ear infections as a kid.
I haven't felt better, I still have the reaction of the vaccine; Body ache; Sore throat; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 20Mar2021 (at the age of 53-year-old) as dose 1, single for covid-19 immunization. The patient medical history reported as none. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) Once a day, oral and Vitamins. The patient reported that I had vaccine, Saturday on 20Mar2021 and till today I haven't felt better, I still have the reaction of the vaccine. I had body ache, sore throat, headache, fever 102.1, I took Tylenol to control the fever and the symptoms I had, I took Tylenol (later clarified as treatment) every 4 hours, because I can't take these symptoms, I wasn't getting concerned but now since it has got two days from the vaccine, all I hear is the first dose, it should be very mild, it's the second dose that is difficult. Patient stated I called to make sure if the symptoms that I am feeling are safe or not, is it usual to feel this or not. Patient stated since I got the vaccine, symptoms mostly I started that night, but I truly felt that on 21Mar2021, and still experiencing the symptoms. The patient also stated that he was due to receive second shot, after 21 days, which was scheduled in April. The patient underwent lab tests and procedures which included body temperature: 102.1 on an unspecified date. Therapeutic measures were taken as a result of the events with Tylenol every 4 hours. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Admitted after being exposed to patient with COVID-19 and developing cough, fatigue, fever; found to be in Atrial Fib with rapid ventricular response.  COVID Testing (+)
Extreme fatigue and body aches for 28 hours Very warm feeling throughout body for 16 hours but never had a fever Swelling and pain at the injection site for 3 days A half circle rash for 7 days that was itchy on Days 3-5