chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme headache and high fever, numbness in face, tingling fingers, impaired vision and loss of balance, very confused.  Fever and worst of symptoms lasted approximately 6 hours.  After major symptoms subsided, nausea, confusion , and generally sick feeling lasted 24 hours additional.
Hot and sweaty within 3 minutes; Hot and sweaty within 3 minutes; SOB; nausea; tired; headache; muscle pain/weakness; muscle pain/weakness; dizziness; fever; high BP and HR; high BP and HR; throat swelled up; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Feb2021 at 12:30 PM as SINGLE DOSE for covid-19 immunisation. Medical history was reported as very healthy, no medical problems, MDD. The patient had no known allergies. The patient received other medication in two weeks. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 12:45 PM, patient experienced hot and sweaty within 3 minutes, SOB, nausea, tired, headache, muscle pain/weakness, dizziness, fever, high BP and HR, throat swelled up. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: high, heart rate: high. The patient received treatment due to the events with exam, muscle relaxers, pain meds, Zofran. The outcome of all events was recovered with sequel on an unspecified date in 2021.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Patient reports significant bruising around injection site with mild pain for first two days after injection. Bruising has decreased after one week, but still noticeable. One day after injection, patient also reports pain and tingling shooting up side of neck up to scalp on the same side as the injection site. Massaging scalp helps marginally, but does not completely relieve symptoms. Manufacturer was contacted regarding unusual adverse events. Pharmacist and manufacturer advised patient to visit primary care provider for possible underlying complications due to lack of clinical data and/or non-reported similar unusual adverse events.
feels really sick; couldn't get out of bed and eat; couldn't get out of bed and eat; dizzy; headache; because of her nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy), HEADACHE (headache) and NAUSEA (because of her nausea). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy), HEADACHE (headache) and NAUSEA (because of her nausea) outcome was unknown.      Concomitant medication included thyroid medication.
crying unconsolable for more than 3hrs;3cm x 3cm lump on thigh
Itching; This is a spontaneous report from a contactable consumer (patient). This 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: ER8730), via an unspecified route of administration administered in left arm on 25Mar2021 11:10 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No additional administered vaccines. No prior vaccinations within 4 weeks. No AE following prior vaccinations. No Family Medical History Relevant to AE. Patient stated on 15Mar2021 she received the first dose and probably 3 to 4 hours after the vaccine (25Mar2021) she started itching on her hands, feet, back just really itchy and happened for a couple of hours. Patient stated she took diphenhydramine hydrochloride (BENADRYL) and it settled down but she was due for her second shot and wants to know if she should take it. AE did not require a visit to emergency room and physician office. Outcome of the event was recovered on 25Mar2021. No investigation assessment.
(R) shoulder site of DTaP/IPV vaccine, became red, warm, and swollen. Pt. was seen 2 days later and I recommended BENADRYL, and MOTRIN or TYLENOL as needed. Asked to return to office for increased redness, increased pain, or fever.
This non-serious initial spontaneous case, was received from a Pharmacist on 26-Sep-2017, concerning a patient of unspecified gender with age less than 65 years (as reported). On 06-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number (as reported 178502), anatomical location, expiry date: not reported). It was reported that FLUAD was indicated for patients 65 years and older (explicitly coded to inappropriate age at vaccine administration). No issues were reported since administration. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Swollen, red reaction at injection site. Did not occur until 6 days following injection.
within 24hrs of injection was lethargic and tired. Pain at injection site.; within 24hrs of injection was lethargic and tired. Pain at injection site.; within 24hrs of injection was lethargic and tired. Pain at injection site.; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pregnancy induced nausea" (unspecified if ongoing). The patient was 1 trimester pregnant at the time of exposure to bnt162b2 omi xbb.1.5. The patient was 1 trimester pregnant at the event onset. The patient took concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 14Oct2023, outcome "unknown", described as "Maternal Exposure During Pregnancy, first trimester"; LETHARGY (non-serious), FATIGUE (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 15Oct2023, outcome "recovered" and all described as "within 24hrs of injection was lethargic and tired. Pain at injection site.". Therapeutic measures were not taken as a result of lethargy, fatigue, vaccination site pain.  Additional information: Delivery date was reported as May2024. Vaccine was administered at Pharmacy or Drug Store. Other medications reported in two weeks was antinausea. Patient reported no history of COVID disease before and after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My pain starts same day of these vaccines and is getting worse. My both arms are weak, can't even raised them for one minute because I feel heaviness and pain right where the shots was given. I feel nodules on shot site and my joints are painful.
Reaction at vaccination site, red; Reaction at vaccination site...red, sore; Reaction at vaccination site...red, sore, hard; Lethargy; Loss of appetite; Loose bowel movement; Red in area distal to injection; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2020, the patient received Bexsero. In August 2020, less than a week after receiving Bexsero, the patient experienced injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel and erythema to be related to Bexsero.  Additional information was provided as follows: The patient was almost 19 years old. The patient received Bexsero one week prior to the date of reporting and had reaction at vaccination site which included red, sore, hard. Then lethargy, loss of appetite and loose bowel movement. After 3 days, The adverse events started to improve and at the time of reporting, now the patient had redness in area distal to injection. The follow up was not possible.
stomach ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine ) was not applicable No concomitant medications were reported by the reporter. No treatment drugs were reported by the reporter.   Reporter did not allow further contact
Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 13 month old female patient. On 11-APR-2017, she was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922.
Information has been received from a physician concerning a 5 year old female who was vaccinated with PROQUAD (Merck) (lot # not reported). The physician reported that the patient developed a breakthrough chicken pox rash more than one year after receiving PROQUAD (Merck) (dates unspecified). The patient, now 6 years old, was seen in the office on 28-MAY-2008 with 15 to 25 maculopapular lesions on the torso, without fever. The patient was not treated. On 05-JUN-2008, a representative from the physician's called and indicated that she did not think this case was for one of their patients, since their office does not administer PROQUAD. The representative looked in the physician's database for patients seen on 28-MAY-2008 and confirmed that no 6 year old females were on the schedule that day. Additional information is not expected.
After receiving the pfizer vaccine pt c/o dizziness , then slow to respond to questions pt later was unable to state her name and where she was, rapid response called; Pt taken to the ED.
Dose 1 given Dec 2020. Dose 2 Jan 2021. I was taking no medications. Never hospitalized. No child birth. Only surgery was laparoscopic gall bladder removed. Suddenly started experiencing abdominal worsening pain. Went to medical facility. Sent to get a CT scan. Results showed portal vein thrombosis. Never had a blood clot before. Was sent to hematology. Placed or xarelto. Tested and came back negative for clotting factors or bleeding disorders. As of today and on my most recent MRI from 12/6/21 the clot is now chronic and persistent. Clot has not responded to 6 months of anti coagulation. Newly diagnosed I now have a cystic renal lesion and a adrenal lesion. It was not there 6 months ago. I?ve had a total of 5 scans to date. I also have been diagnosed with moderate hip arthritis in both hips, tendinitis, edema. I was also sent to a GI doctor and as of today have to get a colonoscopy.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 24-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J011385, expiry date: 10-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984,  1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Developed facial swelling, sneezing, throat irritation possibly throat closing, itchy eyes; reaction started 3hrs later.  Took non-drowsy claritin.  Reaction resolved after 3 days decreased incrementally.  Had idiopathic anaphylactic reaction in the past 6-7 yrs ago.
Henoch Schonlein purpura developed 48 hours after vaccine. 1/28 ankle swelling & pain -> bruising on 1/29.
1pm - headache; 5:30 - nausea, hoarseness, throat swelling; 6:00 - sensitivity to light; 6:45 - vomiting.
Aches and pains; Slept a lot; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches and pains), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Aches and pains), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) had resolved.        No concomitant medications were provided. No treatment medications were reported.
Employee was experiencing itchiness and noticed a rash to injection site leading up right arm back and chest.  no other treatment given as employee reported even the next day and rash had subsided.
Fever of 101-102F, loss of appetite, bumps on abdomen worsening, difficulty sleeping.
16x11 cm warm, red, slightly edematous smooth patch at anterior (R) thigh -> A/IMP - cellulitis.
As reported by his mother today,  on the way home after leaving clinic yesterday where he received is influenza vaccine, he started coughing.  by suppertime increased work of breathing and wheezing.  Mom gave him Albuterol at 1800 and he improved.  No issues or recurrences and no other symptoms at the time.
This spontaneous report as received from a medical assistant refers to a 2 month old female patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA006807: US-009507513-1807USA006808: US-009507513-1807USA006809: US-009507513-1807USA006810.
anaphylactic reaction/anaphylaxis; This is a spontaneous report from a Pfizer Sponsored Program from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EK4176), via an unspecified route of administration on 09Jan2021 at 0.3 mL, single (standard like 0.3ml by injection once to deltoid, side unknown) to prevent from getting COVID. The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylactic reaction/anaphylaxis on 09Jan2021. Clinical course: The patient got the vaccine while waiting to go into the watch room, to be watched for a few minutes, and she experienced anaphylactic reaction/anaphylaxis, she went down, they gave her an Epinephrine, she didn't respond to the first dose, a second dose was given in the arm where the vaccine was given, then she was picked up by an ambulance. Agent stated the caller has been on hold for almost an hour. Caller clarifies dose was given in the arm, it occurred on Saturday with the same lot. Saturday and it went away on Saturday, the patient was worried about it coming back, thus why she asked about Epinephrine pen, the patient was taken to the hospital, and given Epinephrine a couple more times, and it resolved eventually, the patient was not admitted, she went to the Emergency Department. It could have required hospitalization but would most likely say life threatening had she not been treated. Reporter seriousness for anaphylaxis is life threatening. The outcome of event was recovered on 09Jan2021.  Relatedness of bnt162b2 to reaction anaphylaxis is related for primary source.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylactic reaction/anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
throwing up; slight headache; nausea or what feels like motion sickness; nausea or what feels like motion sickness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 06Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throwing up, slight headache, nausea or what feels like motion sickness on 06Feb2021. It was reported that, patient had side effects and different reaction since Saturday after she had the vaccine. The patient wanted to know what she could do with her feeling after having the vaccine. Patient was feeling better yesterday. She took the vaccine on Saturday morning and since Saturday night she had been throwing up, had a slight headache, and nausea or what feels like motion sickness. When she got up this morning she still felt a little nauseous and wanted to know what to do about this. Also enquired what should she do about the second dose, she was due to go back on the 22Feb2021. Patient was unable to reach the doctor and was going to try and get her doctor again. The outcome of the events throwing up, slight headache was recovering and nausea or what feels like motion sickness was not recovered.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
immed flushing & itching followed by sensation of confusion & chest discomfort;no objective findings;sx resolved w/in 2hr;
My face swelled up substantially and was very tight and burned a bit. My arms and legs swelled a little. I took a Benadryl and the swelling went down within an hour.
At 8 AM, Parents noted large red area about 50 cent size that is hard to the touch and warm.  On the upper Right thigh  and is 1/2 the size of a baseball. No elevated temp.
Breakthrough case admission after 2 vaccines Pfizer 3/27/21 lot# EN6202;  Pfizer 4/17/21 lot# ER8732
Began running fever around 10 pm on 12/13/2021 (day of vaccination). Fever escalated to 104.2 by 3 am. Felt heart pounding and took pulse via blood pressure cuff (cardiologist recommended). Resting heart rate recorded between 130 - 140 bpm; tachycardia range. Resting heart rate persisted between 115 - 125 on 12/14/2021 with a fever of 100 - 102. Called the doctor on 12/14/2021. Instructed to continue to monitor and call if the bpm escalated to 130-140 again or did not return to normal as fever subsided. Heart rate recovered to normal range (below 100 bpm) on 12/15/2021.
macular degeneration; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer report for self. This female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a procedure called "macular degeneration" before her 2nd dose vaccine schedule. She had 1st dose last 18Feb2021 and 2nd dose scheduled on 11Mar2021. The outcome of event was unknown.  Information about lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: to amend "Product Not Administered" to unchecked.