chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; This is a spontaneous report from a contactable nurse (patient). A 50-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 28Jan2021 (age at the vaccination 50-year-old) as second dose single for covid-19 immunisation. Medical history included breast cancer survivor, extreme burning and ongoing swelling (I am a 16-year breast cancer survivor and had extreme burning and swelling at my tumor field). Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (Lot number: EH9899) via an unspecified route of administration, administered in left arm on 07Jan2021 12:00 PM for Covid-19 immunisation. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. if other vaccine in four weeks reported as no. On 28Jan2021 04:45 PM it was reported that patient 16-year breast cancer survivor and had extreme burning and swelling at my tumor field. Even today patient have pain and swelling in my left breast and left arm. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available currently available the reported events can be considered as an aggravation of the underlying medical condition, nevertheless the contributory role of the vaccine BNT162B2 to this aggravation cannot be excluded because of strong temporal relationship. The case will be reassessed if there is any new information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Breakthrough COVID infection. Patient fully vaccinated Feb 9, 2021. Patient tested positive for COVID on Sept 20. 2021.
Patient report that his arm is very sore unable to move arm up... injection site red and warm to touch... also experiencing severe headache and sift neck...108 degree fever and feel nauseous....
Patient reports feeling 'light-headed' at 1903. Patient assisted to exam table, head lowered and feet elevated. Patient offered water. Vital signs taken. 1905 HR 41, BP 80/66. Patient awake and oriented to person, place and time. 1915 patient states he is feeling better HR 51, BP 89/65. 1930 patient assisted to sitting and then standing.  Patient states 'I feel better.' I asked if he felt he was 'ok' to leave and the patient states 'Yes, thank you.'
Passed out; Felt very sick for 12 hrs; Body was shaking; Chills so bad; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ILLNESS (Felt very sick for 12 hrs), TREMOR (Body was shaking) and CHILLS (Chills so bad). On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On 25-Feb-2021, ILLNESS (Felt very sick for 12 hrs), TREMOR (Body was shaking) and CHILLS (Chills so bad) had resolved. On 26-Feb-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved.            Concomitant medication and treatment information were not reported. Patient did not experienced any side effects after the first dose of vaccination.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Atrial Fibrilation recorded several times on holter monitor, chest pain, unusual palpitations, irregular pulse. First afib recorded on 5/18/2021.  Post menopausal vaginal bleeding for 5 days several weeks after vaccine. These signs and symptoms were not recognized as adverse events to the vaccine until today because I had been having chest pain since having Covid 19 in November 2020. However, I had not had irregular rhythm until after the vaccine. After reading a Moderna Vaccine fact sheet describing myocarditis with irregular rhythm as a reaction to the vaccine, and reading an article about women of all ages reporting female reproductive abnormalities including post menopausal vaginal bleeding, I made the connection.
Patient woke up at 5:30 a.m. with a knot in his arm and throbbing pain at his finger tips as well as a tingling sensation from the elbow down to the fingers.  Patient was instructed to massage the injection site area as well as ice it on and off for several hours. He was also told to take Ibuprofen or Tylenol which he chose Ibuprofen. He felt improvement after 4 hours but still showed signs of tingling in the fingers and hand by 5:20 p.m. Patient will continue these measures to improve this.
15-30 min p/shot lethargy, was given APAP, then began jerking, then 930PM had a 3 min sz, t101 AX, was up to 103 AX;
Prolonged crying for 3-4 hrs x 24 hrs; t105 for over 24 hrs;
The pulmonary hypertension diagnosis came about when I had my echocardiogram with the cardiologist. It was in December. The second diagnosis I was given on March 27th, that's when I found out that I have the mild coronary artery calcification in the LAD distribution. I was given a script to get lab work done a CMP panel, lipid panel, and a CPK. I got them on the 28th of March. I was then prescribed rosuvastatin 10 mg. I am due to get a CT angiogram on May 11th to find out the extent of the calcification. These symptoms are ongoing we just need to find out the extent of it.
On day of vaccination pt had minor itch/irritation but no fever, pain etc. Approximately 1 week after noticed twitches in left arm, mainly affecting shoulder/bicep area. Seemed to affect joint/muscle tendon. Described as dull pain, especially when he would stretch or pull arm back. Joint mobility is main effect has been that way for 3 weeks now with times of relief but still affecting him.
HEART ATTACK; KNOT ON LEG(SORE); This spontaneous report received from a patient and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack, and had a knot on leg which was sore for over 3 weeks.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, knot on leg(sore) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine ad26.cov2.s-heart attack. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
4 days post 2nd vaccine I started vaginal bleeding.  Lasted 2 weeks.  Bleeding stopped for a few days then I started my regular period on my regular schedule
Pain on the arm where he got the vaccine. Pain lasted for two days.; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old (current age/ age unit: 37 years, as reported) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN5318, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 03Feb2021 at 11:45 (at the age of 38 years old) as dose 1, single for COVID-19 immunisation. No medical history was reported. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not have other vaccine in four weeks and no other medications in two weeks. On 03Feb2021 at 11:45, the patient experienced pain on the arm where he got the vaccine. The pain lasted for two days. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Burning rash behind the knee on both of her legs; Burning rash behind the knee on both of her legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning rash behind the knee on both of her legs) and RASH (Burning rash behind the knee on both of her legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced RASH (Burning rash behind the knee on both of her legs). On an unknown date, the patient experienced BURNING SENSATION (Burning rash behind the knee on both of her legs). At the time of the report, BURNING SENSATION (Burning rash behind the knee on both of her legs) and RASH (Burning rash behind the knee on both of her legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137607 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137607:Same reporter
Blood pressure was severely low; Patient blacked out after rising from bed and taking a few steps; Information has been received on request by the Company from FDA under the act on 22-OCT-2020.  This spontaneous report was received from a physician concerning a 37-year-old non-pregnant patient. The patient was allergic to cottonseed, brewer's yeast, nickel and "sulfa". Concurrent conditions included hypothyroidism. Concomitant medications included tranylcypromine sulfate (PARNATE), liothyronine, thyroid (ARMOUR THYROID), vitamin C, vitamin D3, omega-3 and magnesium (unspecified). There was no information regarding her medical history.  On 07-NOV-2019 at 09:00, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm (dose, regimen, lot number and expiration date were not reported) administered as prophylaxis.    On 08-NOV-2019 at 09:00, 24 hours after vaccination, the patient's blood pressure was severely low (hypotension) at the time of awakening with a value of 64/42 (units not reported). After rising from her bed and taking a few steps, the patient blacked out (loss of consciousness). Her mother found her after hearing her fall to the floor. The patient came to a few seconds after blacking out. The patient notified the occurred to the Doctor's office, but no treatment was necessary as her blood pressure slowly returned to normal values as the day progressed.  The causality assessment between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information has been received from the physician office on 03-NOV-2020. The reporter reported receiving a vaccine adverse experience form and stated that they were not able to identify this patient, so she would not be able to fill out that form.  The date of vaccination was provided, but the reporter stated she still could not find the patient.
back and neck pain/ back was hurting and went up into his neck; back and neck pain/ back was hurting and went up into his neck; feeling "woozy/dizzy"/ lightheaded; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that her father received his 1st dose of vaccine on 25Jan2021. Yesterday on 01Feb2021, patient started experiencing back and neck pain and feeling "woozy/dizzy". She also reported that patient's back was hurting and went up into his neck.  Reporter said that he is really dizzy, that's what he's concerned about. And today on 02Feb2021, he was feeling lightheaded and dizzy. Reporter asking if these could be side effects from the vaccine since its a week later. She also would like to know if he should get the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient presented to ED with shortness of breath. Symptoms started on 9/1/21 with diagnosis of COVID-19. PCP prescribed doxycycline for PNA. Patient took 1 dose and came to the ER because it did not make her feel any better.
The patient reports constant bilateral shoulder pain that is worse when he runs or has gate duty which involves saluting repeatedly.  The onset of shoulder pain was approximately 2 weeks after the receipt of anthrax vaccine #5.  He does not take any medication for this pain and has not seen a medical provider
Patient was given a dose of MENACTRA Vaccine on X.XX.12 in a Clinic. Upon entering the information into the VFC website - the lot number had an expiration date of 2.9.12. Reported the incident in house. Memo has been sent out to check expiration dates before giving vaccine.
Headache; have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days; have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: EW0167) 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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 01May2021, outcome "unknown" and all described as "have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Caller mentioned that he may have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days. Upon Follow-up Transferring agent stated, "He received the first dose of the vaccine (Further clarification was unknown hence captured by Unspecified vaccine). The vaccine he received may had been in refrigerator for six days instead of five days, but he is not sure. He wants to know what it is means for him?" Consumer stated, "One of my friends is wondered and I spoke to him about getting a vaccine and they told me that they have extra doses that are lying around, and they may have given before it expires. I went to get the dose of the vaccine and my friend reached out to me after I got the dose and they said they are not sure but the dose they have given to me is in refrigerator for six days and I want to know if that's okay? "When asked for any side effect with the first dose, Consumer stated, " Just have Headache. "When Probed for the date of the first COVID-19 Shot, Consumer Stated, "May 1st."When Probed for the date of the second COVID-19 Shot, Consumer Stated, "23rd or 24th May. "Consumer stated, "My concern was the dose that I have received, my first vaccine dose. I was told that it may have been refrigerator for 6 days. I know that it is for 5 days. "When asked for any side effect with the first dose, Consumer stated, " Just have Headache. "Further information could not be done as consumer hung up the call abruptly. Hence limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Started feeling fatigue, body aches, chills, and low grade fever.  Symptoms have persisted on and off during the days since onset.
Patient received COVID-19 vaccine at 9:22am ( LA). Patient was then seated in lobby for 15 minutes for monitoring. At 9:50am patient states she is tired and was given water and apple juice. At that point the patient was nauseated and had dry heaves. Patient was placed in room with her feet elevated and continuous monitoring. At 10:20 patient reports feeling dizzy and tired  BP 128/78 P: 68. Patient was laid down and given cold compress for neck. Patient complains of lip tingling but no other symptoms at this time.  BP 130/74 P:75, PO: 97% at 10:40am. Spoke with nurse manager and physician who instructed to administer 12.5mg of Benadryl IM (RA) at 10:44am. Patient continued to be monitored. At 11:00am patient states upper lip is no longer tingling but bottom lip still tingling along with still dizzy. 11:12am second dose of Benadryl 12.5mg IM (RA) given. BP120/80, P: 68, PO: 97%. At 12:22 patients reports symptoms resolved. BP: 118/87, P: 67, PO: 98%. Patient released to care of son and daughter with instructions to call in afternoon with update  as well as signs and symptoms to watch for. 2:30 patient called with update that no other symptoms but requesting to take OTC pain for pain in arm at injection site.
The day after receiving the vaccine on 9/11/21 I developed a headache, then the following day on 9/12, my joints started aching, and I was having abdominal cramps much like menstrual cramps, only more painful.   The joint pain lasted until around 10/22, the headache is low grade and ongoing, and the sharp abdominal pain comes and goes.
Hives. I had a few itchy spots on the inside "pits" of my elbows, then a few in my groin and inner thigh, and by Thursday they had spread sparsely from my ankles to my scalp (not on my face or chest). They were highly concentrated in areas where my skin touched itself (thigh, groin, under breast, armpit, etc). I was able to control it with Benadryl and cortisone cream, but its been a week and I'm still dealing with it.
Muscle twitching in the area of the injection; This case was reported by a consumer and described the occurrence of injection site muscle reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site muscle reaction. On an unknown date, the outcome of the injection site muscle reaction was unknown.   It was unknown if the reporter considered the injection site muscle reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked if the muscle twitching a normal side effect of the vaccine. The patient experienced muscle twitching in the area of the injection.
18 year old was given a full dose ( 1 mL); the 18 year old  patient was given a full dose ( 1 mL) of ENGERIX; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On 31st August 2022, the patient received Engerix B (intramuscular) 1 ml. On 31st August 2022, unknown after receiving Engerix B, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 6-SEP-2022 Reporter's Comments: The pharmacist reporting an adverse event .  The reporter stated that states the 18 year old  patient was given a full dose ( 1 mL) of ENGERIX in Left deltoid on 31-August 2022. The patient was not sure what number dose it was.  The reporter did not give consent to follow-up. Additional Supportive Information: The patient received full dose 1ml which lead to overdose.
Left arm red, hot and swollen from left deltoid to elbow. Using cold compress and Benadryl.
11-05-2008 11AM. Child had "convulsion" and was on way to ED when he "stopped breathing"-family stopped at fire dept and child was transported to ER supportive care given. Child was given supportive care and discharged home cond. good at 2PM.
Cellulitis to upper right arm noted that evening . Continued to spread and covered entire upper arm.  Tx- cool cloths, tylenol for discomfort. At present is resolving
Sinus infection; sore throat; ears that felt full; mucus drainage; pressure headache around the eyes and forehead; generally not feeling good; This is a spontaneous report from a contactable consumer (patient) via from a Pfizer sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Mar2021, patient began to have sinus infection, manifested by having a sore throat, ears that felt full, mucus drainage, pressure headache around the eyes and forehead, and generally not feeling good. Patient took antibiotics called Cefdinir 300mg twice a day for these symptoms. She reported that, 2nd vaccination was scheduled for tomorrow 01Apr2021. Patient wanted to know whether it is alright to push through her 2nd vaccination because she took antibiotics for her sinus infection. Therapeutic measures were taken as a result of events. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.