chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHAKING A LOT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-MAY-2021 16:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-MAY-2021, the subject experienced shaking a lot. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The outcome of shaking a lot was not reported. This report was non-serious.
Student received #4 Polio, #5 Dtap, #2 MMR, #2 Varicella. 15 minutes later had redness and swelling of eyelids, cough and wheezing. 3/4 tsp. Benadryl was given. No outcome; Paramedics gave Albuterol breathing and Epinephrine treatment. Transported to E.R.
patient received an MMRII injection, but was unaware that she was not supposed to take the medication if she was taking immunosuppressant medications; The patient was concerned but reported no adverse events; This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history included renal transplant. Concomitant therapies included tacrolimus(PROGRAF) and mycophenolate sodium(MYFORTIC). Information about the patient's concurrent conditions and drug reactions or allergies was not provided.     On an unknown date, while the patient was on the above immunosuppressant medications, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). At the time of the report, the patient was concerned but reported no adverse events.
Dizziness, 10 hours.  Headache, >24 hours.  Elbow joint pain, >24 hours. Nausea, 10 hours. Dry heaves, 3 times in 8 hours.  Pressure in nasal cavity, 6 hours.  Tingly face, 8 hours.  Loss of appetite, 24 hours. Fatigue, >24 hours.  No treatment besides lots of rest.
After I received the shot, my arm was sore for a day or two, but then it was fine. However, about a week later, a red patch about the size of a half dollar appeared on my arm where I received the vaccine. Then, over the course of the next 4-5 days, my arm felt very sore, stiff, and tight in the shoulder/armpit area. The patch spread, became larger, and developed a ring around it. By day 5, it covered the majority of my shoulder/upper arm area, and had a dark outer ring similar to ring worm. It was itchy and red. This is still happening. I have photos of the progression of each day to share if needed.
24 hours after receiving imms, pt c/o headache, stomach ache, nausea, went to bathroom, became extremely pale and limp. No loss of consciousness, lasted 5-10 minutes. Given juice and crackers. Felt better, but less energetic for 1 hour. then acting fine. 2pm today c/o some nausea. Also had 2 stools - unusual for pt. mom now questioning poss virus. Pt coming in for visit later today.
Menstral cycle happening more frequently.  About every 17 to 21 days. Normal cycle is about every 28 to 32 days.
Awoke with fever 101.6 and chills in middle of the night, lasted into the morning, it was off and on for a week. Daughter was sick previously. 08/09/2021 went to urgent care, tested for FLU and COVID. 08/12/2021 PM, received return result of COVID Positive. 08/13/2021 for Regenerator Infusion. Still feeling poorly, 08/15/2021, went to hospital for dehydration and they discovered pneumonia. Gave Zithromax 250 mg  once daily for five days/Cefdinir 300 mg twice daily for 10 days.
Patient came to get their second Pfizer vaccine. Patient's administration date was supposed to be 10/27/2021. Patient received their vaccination 5 days early rather than 4. Patient exhibited no side effects due to early vaccination.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 52-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown). At an unknown time after completing the vaccination series with TWINRIX, the subject experienced not responding to therapy. The healthcare professional did not know if there was a specific blood test result, or if the subject did not respond to hepatitis A coverage, hepatitis B coverage or both. Follow-up was received on 9 December 2011 from a healthcare professional. The subject has a relevant medical history of primary biliary cirrhosis and autoimmune type I hepatitis. The subject received TWINRIX vaccinations on 6 February 2002, 6 March 2002 and July 2002. On 7 June 2011, lab work showed hepatitis A antibody total as positive and hepatitis B core antibody total as negative. The subject received a booster hepatitis B vaccine. A titre was to be rechecked after 4 weeks. The outcome was unknown. The healthcare professional indicated that the event was non-serious and unknown if related to vaccination with TWINRIX. The healthcare professional indicated that the event may have been associated with lack of efficacy (details not provided).
Patient in office to meet with provider. Requested COVID-19 booster. Patient was administered Moderna COVID-19 vaccine, though he should have been recommended for Pfizer COVID-19 vaccine, as Moderna is not yet approved for use for this patient's age group. Internal incident report completed. Agent and Agent notified of error. Agency spoke with patient's mother with Agent Supervisor present to discuss this event and to discuss patient adverse reactions, if any. Mother reports patient is having body aches, sore arm, redness and firmness at the injection site, fever of 99.7, controlled with tylenol and ibuprofen, loss of appetite, and headaches starting 2/22/2022 evening. Patient is still currently experiencing these side effects. Agent recommended mother continue with supportive measures. Anticipates that patient will recover within the next few days. No additional booster repeat needed at this time. Mother provided with contact information should she have additional questions.
Mother reported daughter had a temp of 103 deg F Wednesday evening after getting the flu shot. Mom said injection site was sore but not red, swollen or hot. Mom mentioned that this has happened more than once when getting the shot.
This spontaneous prospective pregnancy report was received from a medical assistant refers to a 30 year old female patient. On 07-JUL-2014, the pregnant patient was inadvertently vaccinated with GARDASIL lot # J009788, 0.5 ml, intramuscular. The patient sought medical attention in the office. The patient became pregnant with LMP of 23-NOV-2013 and EDD of 30-AUG-2014. No adverse effects reported. No further information provided. Additional information has been requested.
Patient received dose and was in observation area for about 4 or 5 minutes when I noticed he looked very out of it and his head was wobbling. When I tried to speak with him he wasn't answering. I then ran to his side and by the time I was there he had passed out (eyes were open and rolling to the back of his head and he was not responsive). I told my technician to call 911 and went to grab the epinephrine and emergency kit while a customer stayed next to him. He came to within a minute and I did not need to administer epinephrine, etc. He said he was okay but we called EMS, who then took over and patient decided to go with them to ambulance/ER.
Mild headache and then went away; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Mild headache and then went away) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 24-Nov-2020. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015, Restless legs syndrome since 20-Jun-2021 and Insomnia since 23-Oct-2015. Concomitant products included LAMOTRIGINE (LAMICTAL) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Insomnia and Restless legs syndrome, ESTRADIOL (ESTROGEN), ESCITALOPRAM OXALATE (LEXAPRO), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Mild headache and then went away). At the time of the report, HEADACHE (Mild headache and then went away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive (Positive) Rapid Test Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided.   This case was linked to MOD-2021-348417, MOD-2021-348434 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received contains added patient demographic and details, medical history, concomitants medications.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were not reported and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered nurse via email. The age at the vaccination was not reported. The nurse had a question since this was the second time this had come to her attention in the clinic. The patient was given SHINGRIX vaccine and might had been given it not exactly in the deltoid muscle might be a few inches away from the site, which led to vaccine administered at inappropriate site. The reaction was massive which included erythema, swelling, site pain. The reporter was trying to figure out if this was just a side effect or was it because they were not getting it to the muscle exactly. The reporter had a question as would like to know was intramuscular had to absolutely go in the muscle all the way which was the right way but what if it was given a few inches away would that cause this side effect. The sales representative had not spoken with the reporter. Therefore, no additional details was provided other than what was on the email.
This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. On 9th September 2018, the patient received the 1st dose of Shingrix (intramuscular). In September 2018, 1 days after receiving Shingrix, the patient experienced fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling. In September 2018, the outcome of the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling were recovered/resolved. It was unknown if the reporter considered the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling to be related to Shingrix. Additional details were provided as follows: This case was reported by the physician who herself was the patient. The patient received Shingrix on left arm. The patient experienced shivering (chills) and periorbital bone pain and swelling under eyes after vaccination. The symptoms resolved after 2.5 days. The reporter had consented to follow up. For tolerance to next dose, refer case US2018GSK232142.
I received my 3rd dose on 12/22/2021. My COVID-19 infection symptoms started on 12/19/2022. I had fever, cough, and body aches. On 12/20/2022 I had chest congestions, body aches, cough, headaches, and fever. On 12/21/2022 I did a home test which was positive. I called my doctor's office on the same day and they returned my call around 01:00PM. I was also took TYLENOL to reduce fever and body aches. My doctor prescribed me with PAXLOVID for 5 days. I still have cough and chest congestions but I am recovering.
receive 3 doses, 1/8. 4/28 and 5/20
Significant cellulitis of lt arm in the vicinity of injection site of Tdap given 2/27/07. 3 large areas red and hot-tender to touch.
Gout attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious) with onset 21Apr2021, outcome "unknown", described as "Gout attack". Therapeutic measures were taken as a result of gout.  Additional information: The patient took Colcrys and Allopurinol as a treatment drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022).    No concomitant product use was reported. The patient received half dose. The vial did not undergo any temperature excursions. Date the vial was initially stored in the refrigerator was 04-Jun-2022.  No treatment information was provided.
This report was received from the manufacturer and assigned manufacturer report number 2015321532 for PREVNAR regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced severe swelling, redness (erythema) and pain after receiving a dose of PNEUMOVAX23. At the time of the report, the outcome of severe swelling, redness and pain was unknown. The relatedness between the events and therapy with PNEUMOVAX23 was not reported. Additional information has been requested.
Covid arm 7 days after injection at site. Circular swelling with redness and itching
Woke up with stomach cramping the morning after the vaccine.  Cramping was  fairly severe and lower back pain - cold sweats and feeling like was going to have diarrhea, but did not.  Was able to get up and go about the day for a few hours, but fatigued and tired.  When got home in the afternoon to lay down broke out with cold sweats and nausea and vomited once.  Was better by the next day.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 years, in left arm 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's relevant medical history included: "High BP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Negative; (04Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 21Feb2023 to 26Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt became disoriented and dizzy a few minutes after getting the shots. she sat down and was cleared a few minutes later by EMT's. She recovered quickly and left.
Person was lain down immediately following vaccination upon fainting.  Head was protected during fall by vaccinator. Laid to floor, feet elevated. Pale in appearance.  Woke quickly, was oriented.  Water was provided, within a couple of minutes was able to sit up and complete recovery in seated position.
Itching on back and chest, started 30 min after injection. Benadryl and Dexacort given.
inability to be able to walk due to severe pain, swelling on both legs,, inflamation in joins, tingilling on toes and fingers radiating to legs and arms  inability to stand due to instability ,  neck glands inflamation, it required to have epi-pen at my side for 3 days
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-JUL-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N000336, expiry date 03-JUL-2018 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 15 to 46 degrees Fahrenheit (F) for 1 hour and 30 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Numbness and tingling on right hand, all fingers two days after TDAP injection; numbness did not go away after one month.  After 3 weeks, there was increased numbness and symptoms of nerve pain started.  The nerve pain is in the palm of the right hand, there is continued numbness and tingling in all fingers on the right hand.
After 10 mins patient received Pfizer vaccine, he felt nauseated and got faint for about 5 seconds. After drinking water and apple juice he said  he felt better but still nauseous. When 911 arrived, they checked his vital and it was normal. Upon checking up he got better and chose not to go to hospital.
Pt recvd vax 12JUN92 & suddenly went limp, appeared pale & poss cyanotic; taken to hosp;
tested positive on 25Apr2022; tested positive on 25Apr2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing), notes: Mild asthma; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN 24 FE; ALLEGRA; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL].  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Apr2022, outcome "unknown" and all described as "tested positive on 25Apr2022". Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. Dose Number: 3 Batch/Lot No: Unknown. Unable to locate or read the details. the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient took Paxlovid for 5 days. I tested positive on 25Apr2022 and started Paxlovid on 27Apr2022. symptoms improved, and went back to work, but then symptoms returned on 06May2022. My congestion is worse now than it was before. Some of my other symptoms (sore throat, muscle aches, and chills) are more mild. Date of start of reaction/event was 06May2022 (08:00 AM). Outcome of reaction/event at the time of last observation was Not recovered/ not resolved. No Hospitalization Prolonged. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills/sweats/fever/aches for about 5-6 hours.  Then left with aches and mild headache. Occasional nausea throughout the day and fatigue.
Fever starting at 102.1    2:00am saturday thru Monday pm down to 99.1 Chills first. Bad headache 3 days Body aches-every joint still some..Tuesday PM extreme tiredness.     round red mark at shot site that was warm to the touch--- Tuesday PM almost gone.
After each shot...the next day and for several days after, I had a racing heartbeat while sedentary.  I also had high blood pressure.  This happened after both shots.  I know have a constant heavy feeling in my chest with tension in my back between my shoulder blades.  I am currently under a Dr.'s care for these symptoms.