chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness and soreness at site of injection; itching site of injection; soreness at site of injection; site of injection feels warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness and soreness at site of injection), VACCINATION SITE PRURITUS (itching site of injection), VACCINATION SITE PAIN (soreness at site of injection) and VACCINATION SITE WARMTH (site of injection feels warm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy since an unknown date. Concurrent medical conditions included Hypertension.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (tenderness and soreness at site of injection). In February 2021, the patient experienced VACCINATION SITE PRURITUS (itching site of injection), VACCINATION SITE PAIN (soreness at site of injection) and VACCINATION SITE WARMTH (site of injection feels warm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Tenderness, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (tenderness and soreness at site of injection), VACCINATION SITE PRURITUS (itching site of injection), VACCINATION SITE PAIN (soreness at site of injection) and VACCINATION SITE WARMTH (site of injection feels warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided
Vomiting/vomiting from almost a month now; can't stand up/not even stand up; Diarrhea; Weakness, not even stand up; don't need to be feeling like this; Pain; Lost my sense smell; This is a spontaneous report from a non-contactable consumer (patient).  A 77-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 12Mar2021 (Lot Number: EN6148; Expiration Date: Dec2021) as single dose, dose 2 via an unspecified route of administration on 02Apr2021 (Lot Number: EP7534; Expiration Date: Jul2021) as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  When probed for the concern, consumer stated, "I got sick after the shot, I am reporting side effects.". When paraphrased the concern with Covid vaccine, consumer stated, "Yes on both of them, I got two (shots), first one on (12Mar2021) and second one (02Apr2021) and I got sick from both of them.". In response, consumer stated, "I got problem from both of them, vomiting, diarrhea, weakness not even stand up. I am 77 years old, I don't need to be feeling like this from these shot, I was fine before I got." When probed for vaccine expiration date, consumer stated, "The first one EN6148 was "Dec21" (not clarified) and the second one just got the expiration date "7/21" (not clarified the date), but I am going to ask a question when they gave me the shot, the shot was lying on the table and an hour after a gap they gave us the shot, was that still good at that time, an hour after out of the ice?" When probed for height and weight, consumer stated, "It has nothing to do with my height and nothing do with my weight. This shot has almost killed (intent: general) me." Consumer stated, "I got sick after this, I have been vomiting from almost a month now, I can't stand up, paining, with time I lost my "pace" (not clarified), I lost my sense smell every time, it's started with me like COVID, based the symptoms I am having it seems like that I am having COVID." The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error).    No concomitant medications was reported. It was reported that product was unknown. No treatment drug details was reported.   Reporter did not allow further contact
Patient received KINRIX, supposed to have been Hep A. Dr has been notified of error and will be contacting parents.
Around 6 p.m. Pt. developed 105 fever that lasted all night despite Tylenol. The following day still warm. Still in bed with moaning and headache. Refuse to get out of bed. Could not stand. No appetite. Possible loss of conscious. Eyes rolled back in head.
Flu like symptions: headache, body ache, ache in the joints, tiredness.
shots given friday 5/10/02-mom reported fussiness Satu and when awoke sunday 5/12/02 both arms had red area, warm to touch, very slight swelling. Treated w/ Augmentin 600 Stat and 300 BID X 10 days, Zyrtec 5 mg qd. F/U 5/13/02 redness almost resolved. Child acting fine
Patient's right arm has hurt since having the injection. Stated it hurt when she sleeps on it up to her neck.
pt recvd flu vax @ 10AM; pt denied egg allergy & neuro problems; 1030AM pt exp swelling on lt deltoid sl above & to lt of inject site; @ 1050 wheal & redness were noted on pt's chest & upper back & swelling on deltoid had inc; MD was notifi
feel horrible, shots knocked me on my can; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site discomfort (received first dose on an unknown date also experienced Injection site discomfort and feeling unwell, refer case US2021AMR190683).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had both shingles shots and felt horrible. The shots knocked him/ her on the can. The patient advised others to get the shots.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190683:same reporter/patient (1st dose)
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot# L001312 with expiration date of 24-FEB-2017) (strength, dose and route unknown). No adverse effects reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
6 days post vaccine administration, raised erythematous progressive rash associated with urticaria and itch developing on bilateral breasts and lower back but progressing over 5 days
Patient experienced a baseball sized edema. The area was erythematic and hot to the touch. As of 12/03/2001, the swelling had decreased to the size of a ping pong ball. The lymph nodes in the right axilla were enlarged. Patient feels ok, but has concerns about the reaction. Treatment consisted of ice or heat applied to right deltoid for 10-15 minutes 2-3 X day, 10 mg of Claritin once a day and RTC if site increased in size, redness or drainage.
pt recv vax;3 wk later,devel low grade fever followed by 6 lesions located on lower abd&thigh;lesions were macular&papular in nature;
L upper thigh- 15 x 10 cm area of redness, warmth, and tightness
Entire left arm swollen to twice its normal size from shoulder to wrist. Hot to touch and red. Sometimes itchy and  painful. Redness spreading across chest. Low grade fever.
Fever; Sweating; Felt cold; Tired; it has been more than 6 months since the first Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, sweating, feeling cold, tiredness and incomplete course of vaccination. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the sweating, feeling cold, tiredness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fever, sweating, feeling cold and tiredness to be related to Shingrix.  Additional information was provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received Shingrix vaccine 32 weeks before the time of reporting. The patient's wife could not recall if it was 24 or 48 hours after the injection, patient felt tired and developed a fever. The fever kept getting higher and reached 103 degrees Fahrenheit. The patient felt cold and then felt normal and then felt cold again during the time he had the fever. The patient had periods of profuse sweating during the fever and he sweat right through the mattress pad on their bed. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was not sure, if he is going to get the injection again. The reporter did not wish to provide patient information nor her mailing address.  The reporter did not consent to follow up.      Lab Comments: On an unknown date, the lab test was performed.
Saturday Morning 2/6/21: I Began experiencing Itching on the "Left Stomach Area" - Upon Examination I noticed A Rash In The Area. The Rash Has Spread To Both Legs - The Left Leg Seems To Have The Heavier Rash.
pt recvd vax & exp h/a, diarrhea, flushing, indigestion, gen aching, (redness, heat & swelling, tenderness @ inj site); pt exp rxn w/1st vax
Leg swelling entire Ant thigh, Erythematous and indurated with central unroofed papules.
Patient reported that skin around vaccination site became red and hot. About 2 inches in diameter. It also swelled a little. Cleared up in a few days. Approximately 3 days per patient.
Patients received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant medication was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received. Narrative was updated.
Admitted from nursing home,  with Sepsis due to Covid19.1. Tx with solumedrol and remdesivir
Grandmother states left arm became very edematous, red and warm to touch-When they came to health department on 03/14/2011, had about one inch in width and 2 inch long reddened warm area on left arm
Patient developed shortness of breath the day after receiving his first Moderna vaccine. Symptoms increased over the next five days. Patient presented to the ED on 3/12/21 after being found hypoxic at their Primary Care doctor's office with O2 sats in the 60s. Patient was admitted to Hospital for pneumonia. Patient continued to require increasing amounts of high flow nasal canula O2 to maintain O2 sats and was diagnosed with multiple segmental pulmonary emboli on 3/16/21. On 3/17/21, patient was also diagnosed with a DVT on the right lower extremity.
This spontaneous report was received from a medical assistant and refers to unspecified amount of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. From 31-AUG-2017 until 21-SEP-2017, the patients were vaccinated with improperly storage doses of PROQUAD lot number N010866 with expiration date 01-OCT-2018, for prophylaxis (strength, dosage schedule, route of administration and anatomical location were not reported). No adverse events were reported. The vaccine doses were exposed to a temperature of 15 degree Fahrenheit (°F) to 46 °F (22.5 °F) for 4 hours and 1 minute. Previous temperature excursion was of -15 °F to 46 °F for 12 hours and 7 minutes. The data logger was involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA011291.
Received 2 mo Immunes on 5/9/16. Woke from nap on 5/9/16 inconsolable crying, mottled lower extremities. Seen in ER. Afebrile, increased HR to 146. Tyl given after calmed down dischg home. Immune sites clear.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021. Based on the information learned, County Health took the following steps: Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information: The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
Woke up with body aches, headache, threw-up once around 9:30 AM
Chills that started 12 hours after shot but resolved within a few hours.   Bad headache that started the following day, but has persisted for 7 days straight with OTC medicine (advil and tylenol) not doing much to stop symptom
epigastric pain and discomfort; epigastric pain and discomfort; He said is felt like a hernia, with cramping and discomfort; He said is felt like a hernia, with cramping and discomfort; This is a spontaneous report from a contactable Physician. A 52-years-old male patient (physician) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Auto call back 26Apr2021 at 10:36am, caller was a physician who received his first dose of Pfizer-Biontech Covid19 vaccine this past Friday. On Saturday morning, around 10:30-11am, he started to experience increasing epigastric pain and discomfort. He said it was felt like a hernia, with cramping and discomfort. His symptoms have slowly resolved, and he stated that he was "back to normal" today. He reports that he had a "pretty high threshold" for pain, but these symptoms "stopped me" on Saturday. The outcome of the events was recovered.   No Follow-up attempts are needed. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit three days after vaccination patient reports fever one day after vaccination and two days after vaccination suddenly felt hot and fell to her knees holding onto a couch. Able to ambulate to bed afterwards. Patient also reports swollen lymph node in left axilla. Patient denies  chills, headache, blurry vision, nausea, vomiting, abdominal pain, myalgias, or respiratory symptoms. Does not report loss of consciousness, rash, or injury after fall but does report not eating or drinking prior to fall. Vital signs within normal ranges except blood pressure 135/70 mmHg. Advised to keep hydrated and eat well.
Nurse reported that the patient received an expired dose of MMRII.; No adverse effect reported.; Information has been received from a nurse, referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies was not reported. Concomitant therapies included sterile diluent.  On an unknown date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # N008366, expiration date: 13-MAR-2019, therapy type: rHA, strength and frequency were unknown) subcutaneously for prophylaxis (expired vaccine used). No adverse effect was reported.
Rotavirus given at 6 months where had not gotten previous doses (1st dose by accident) no reaction.
Facial, temporal, and scalp edema (which was not expected). Seems more prononunced on left side. Protruding veins on temples otherwise not noted in normal conditions. Milder, but still ongoing after additional 24 hours.  Fever, myalgia, tiredness (expected)
Early morning woke up with bad headache, diarrhea throughout the day,  vomited early evening all on Friday April 2nd.  Started to feel better in the evening and started to drink a bit of gatorade.  However Saturday morning April 3rd woke up between 6-7am and went to the bathroom and turned around to walk back out and blacked out - most likely dehydrated.   Fortunately did not fall down as my wife caught me slumped up against the wall and got me down to the floor.  After 5-10 minutes was able to get back to bed and after another hour or so was able to start drinking fluids and keep them down through the day.   By late afternoon/early evening had a small meal and was starting to feel better - never did have a fever (checked frequently on Friday and Saturday)
Received anthrax, typhoid vi, and smallpox vaccines on 29 May '11. Ten days later on 8 Jun '11 he awoke during the night with chest pain, "as if someone was sitting on me", fever and shaking chills, and heat and swelling of smallpox vaccination site. Transported to the ER and then to Hospital for admission. Serial ECGs monitored and revealed persistent, subtle, lateral ST-T wave lability. Elevated troponin I of 0.37 (normal 0.10), elevated sed rate of 22 and elevated CRP at 66.5. Blood cultures and urine negative. Echocardiogram normal and EF 55%. Troponin trended downward and repeat echo prior to discharge remained unchanged. Notes say he is asymptomatic now and has been refraded, deployment re-scheduled for Dec 2011.
Vaccine administered on 11/19/2021 expired on 11/18/2021.
My COVID-19 symptoms started on 12/04/2022 in the morning around 08:00AM. I had a sore throat and tiredness. I did a COVID-19 home test on 12/04/2022 which was positive. I did a telehealth with my doctor who prescribed me with PAXLOVID for 5 days 2 times a day. I had mild symptoms. As of today I feel better than before.
About 3 minutes after receiving her injection, the patient was standing and ready to walk to the waiting area.  She got dizzy and passed out. Within a minute, she became alert again.  She then remained seated for about a half hour (1st on the floor, then a chair). After about a half hour, she still felt fine and left with her family with instructions to continue to monitor her.
Initially extreme fatigue and sore arm Sunday and Monday. Tuesday swelling in Lymph nodes in next on left side. The following day nauseated, dizzy and diaphoretic. Advised to lay down and relax. Symptoms lasted 2 days.
On 27th started having vomiting & diarrhea, than that went away & then started running t100-101, then broke out in rash 4MAY95; took to ER on 3rd & 4th of MAY; rash was around hips, legs, ankles & around top of diaper; area around inj red;