chrisvoncsefalvay/vaers-outcomes huggingface dataset:
leg is still swollen; Blood Clot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6202), in left arm and on 16Mar2021 as dose 2, single (Lot number: EN6206) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "her sinus gets backed up" (unspecified if ongoing), notes: Allergies: She has no specific allergy, her sinus gets backed up but there's nothing specific that she is allergic to. There were no concomitant medications. The following information was reported: THROMBOSIS (medically significant) with onset Nov2021, outcome "not recovered", described as "Blood Clot"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "leg is still swollen". The events "blood clot" and "leg is still swollen" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound testes: (Nov2021) Blood Clot, notes: Result: Blood Clot;  Unit: Not Provided.  Clinical information: When probed for what product she was calling about, the caller states that she had got her card with the vaccination on it, it's a vaccination record card, she got 2 doses. Caller clarified that it was the vaccine for covid. Caller states that she was calling because she had a side effect after the vaccine, she had a Blood clot, she had a blood clot in her leg and she didn't have that before the vaccine. Email: Decline. The Blood Clot was detect in Nov2021, it was right before the holiday, she didn't have one before the vaccine. HCP: Caller states that she had a doctor that she was now seeing. She didn't think about the blood clot, she having this blood clot for 6-7 months now, the blood clot was just not going away, that was why she called to find out if this is a side effect of covid, she didn't think about this till just this month. Caller did not want the doctor to be contacted. The Blood Clot was in the left leg groin area, when probed for the outcome she responds that her Leg was still swollen, it had been swollen since, it had not gone down at all. It was still the same. She got the vaccines in the Left arm, for both vaccine. Investigation: Yes, it started before the holiday, she had an Ultrasound of the Left leg Before the holiday. She did not know the specific date. She had no specific allergy, her sinus gets backed up but there's nothing specific that she was allergic to. Caller declined being transferred to the other department at the moment, stating that she would like to think about this. first.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 08-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016,orally (incorrect product storage). The vaccine was administered at public  health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt returned to pharmacy 3-5 min. after vaccine H1N1, tachycardic, diaphoretic and complaining of difficulty breathing. Epipen was prepared but never admin. Pt was fine 30-45 min. later and had rash at injection site.
Localized allergic reaction at injection site with angioedema 2 days after injection.  Prescribed: antihistamine/prednisone course.
Patient administered monovalent dose as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered monovalent dose as booster) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered monovalent dose as booster).    No concomitant medications were provided. The HCP stated that they could not give the Moderna as a booster starting 31-Aug-2022, but they administered 15 monovalent doses as boosters. The HCP also stated some patients already had 3 boosters. No treatment medications were reported.
Information has been received from a physician concerning an approximately 14 year old female who on 31-AUG-2009 was vaccinated intramuscularly with her first 0.5mL dose of GARDASIL (lot number not reported) . On 31-AUG-2009, after getting the vaccine, the patient "had a syncope and then tonic seizure movements". The patient recovered from syncope and tonic seizure movement on 31-AUG-2009. The patient sought unspecified medical attention. Upon internal review, tonic seizure movement was determined to be an other important medical event. Additional information has been requested.
3 hours after shot the patient got a headache and the patient's arm started to swell and become tender and red. 2 days post shot her arm started to swell even more despite icing it. she developed a red streak down her arm they continued to widen and lengthen and she developed little bug bite like bumps on her vaccinated arm the burned  and itched. She was advised to take ibuprofen, continue to ice and take Zyrtec since she can't tolerate Benadryl and she will go to her PCP tomorrow.
13NOV92 swollen, painful area from shoulder to elbow; 17NOV92 rash, hives, itching; 19NOV92 to MD started meds;
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant Human albumin (rHA) (M-M-R II) vaccines experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger. On 26-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event reported.   This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232: US-009507513-2102USA003923:
Pt developed flu like respiratory symptoms nine days /p receiving Flu vax(1990-91 formula).Pt was admitted to acute care facility /w a respiratory infection, sepsis, & T. F/U info,recvd 25Jan91 resulted in reclassification as a 15 day rept
Patient received Moderna booster vaccine and high dose flu vaccine on the same day. The day after she felt very nauseous and had to vomit. The patient had passed out after vomiting and had a lot of fluid in their mouth when they woke up. She claims it appeared she was foaming at the mouth.
By the afternoon patient had swelling and redness on her arm of injection site. The next day it was extremely painful and she had red welts at the injection site and down her arm as well. The pain has started to resolve but she still has the welts. Denies any trouble breathing.
They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.  The vial was initially stored in the refrigerator on 04-Nov-2021 and the booster dose of the vaccine was administered to the patient on either 05-Nov-2021 or on 12-Nov-2021. The vial had not undergone any temperature excursions.
Vasovagal Syncope  occurred mmediately after leaving exam room once I reached the nurses station on the other side of hallway. First injection was MMR and I started feeling strange immediately afterwards as the second and third were being given. I did not recognize the signs of fainting, though, and tried to "shake it off" as I left the exam room and reached the nurses station to await paperwork.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the medical history, concurrent conditions and drug allergies of the patient was not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck)VARIVAX lot # L025208, expiry date 07-JUN-2017, 0.5 ml, subcutaneously (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the administered vaccine was stored was -0.15 degree Centigrade for 5 hours. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K007973, expiration date 03-JUN-2016) (lot # L003775, expiration date 04-FEB-2017) (dates of vaccination, dose, strength and route of administration were not provided). There was no concomitant medication reported. No product quality complaint was involved. Additional information has been requested.
Pain in joint involving hand; joints are swelling; my husband has to rub my hands because they are so sore; my husband has to rub my hands because they are so stiff; This non-serious case was reported by a consumer and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced joint pain (Verbatim: Pain in joint involving hand), swollen joints (Verbatim: joints are swelling), pain in hand (Verbatim: my husband has to rub my hands because they are so sore) and limbs stiffness (Verbatim: my husband has to rub my hands because they are so stiff). The outcome of the joint pain and swollen joints were not resolved and the outcome of the pain in hand and limbs stiffness were not reported.   It was unknown if the reporter considered the joint pain, swollen joints, pain in hand and limbs stiffness to be related to Shingles vaccine.     It was unknown if the company considered the joint pain, swollen joints, pain in hand and limbs stiffness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-NOV-2023 The reporter reported that she received the Shingles vaccine, and she had severe pain in all of the joints of both of her hands. At the reporting time the patient's joints were swelling and her physician told her it must be related to her receiving the vaccine. Patient woke up in the morning and her husband had to rub her hands because they were so sore and stiff. Reporter asked question what was going on, she was very concerned, and she requested to call her.
pt recvd vax; short of breath & wheezing 10 days p/ 2nd dose of vax;no oth sxs;no hx of asthma; allergy to house dust; taking care of a large number of cats at the time of sxs;
This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. The registered nurse reported that on an unknown date, the patient may had received one of improperly stored lots. It was reported that she was not sure which of the vaccines the unspecified patient received. This was the possible vaccines involved: PEDVAXHIB lot # M001814, expiration date: 15-OCT-2018 (dose, frequency, route and anatomical location were not reported), GARDASIL 9, M036059, expiration date: 03-JUN-2019 (dose, frequency, route and anatomical location were not reported), ROTATEQ, M006111, expiration date: 18-NOV-2017 (dose, frequency, route and anatomical location were not reported) and M-M-R II, M000768, expiration date: 05-JAN-2018 (dose, frequency, route and anatomical location were not reported)  for prophylaxis. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1hour/ 30minutes. There was no product quality complaint (PQC) involved.
Resting heart rate from 60-120bpm, chest pain, trouble breathing.  Lasts 30-60 seconds then heart rate returns to 60?s.  Happened 3x on 2/1 and 4x on 2/2.
Later in the afternoon had fever, bad headache and loss of appetite. On 10/9 similar issues which continued through 10/10. Was eating although not hungry on 10/10 when eating reached for glass of water and passed out with no notice/warning. Did not feel dizzy ar all before passing out. Woke up on floor and realized was on the floor and passed out again. The next time that woke up got up and went to get his oxygen. Realized had hurt hand and elbow on the blood. Daughter took him to ER since he was bleeding. The admitted him and did CAT and heart test. Left hospital on 10/11 because he did not like care. The doctors wanted him to stay. On the week of October 12th - 16th went to Primary Care doctor who gave him orders for an ultrasound on 10/21 and 10/22 an MRI. Went back to doctor for results and everything was clear. No other aes so far. Decided to report because saw story on TV about hospitalization associated with pneumonia vaccine.
Feet and legs Tingly like falling asleep. Pins needles also occasionally all over.  Head feels pressure like sinus but not sinus.  Hands feel slight vibration like small amount of electricity going through my body.  No symptoms felt while laying in bed. Start in the morning when moving around.
On 10/16/2001, vaccine given, no reaction. On 10/17/2001 had a one and one-half inch red, slightly swollen and slightly warm reaction. Instructed to take Benadryl and put warm compresses. Did not do. On 10/18/2001 red area increased to about 2.5 inches of redness and slightly warm to touch. Instructed again to take Benadryl.
Per patient, she had a stomach ache, headache, felt weak and very tired. These symptoms improved, but did not resolve beginning on 10/13/17. All symptoms resolved by 10/16/17. Five pounds lost during this time when did not feel well. Also with 1 episode of chills. Also had a sore arm, for about 3-4 days, but thinks this was within what was to be expected.
nausea; headache; This is a spontaneous report from a contactable consumer.  A 65-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation .  Medical history included migraine.  The patient's concomitant medications were not reported.  The patient experienced nausea, headache on 19Jan2021. The outcome of events was unknown.    Information on Lot/Batch number has been requested.
Patient Mom called, states patient started having sore right arm, Saturday 07/09.  Right upper arm red, warm, hard.  Ice packs applied.  Still red and sore today.
This case was reported by a pharmacist via call center representative and described the occurrence of sciatica in a 75-year-old male patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. Concurrent medical conditions included sciatica (on right leg). On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced sciatica. On an unknown date, the outcome of the sciatica was unknown. It was unknown if the reporter considered the sciatica to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX vaccine in the left deltoid. The pharmacist had a patient who received the SHINGRIX vaccination a day before reporting and began to experience sciatica down his left leg.
About 40 minutes after administration she felt flushing of her neck, ears and face.  Felt very hot.  Afebrile. Took Benadryl almost immediately.  The burning feeling lasted a few hours but felt that the Benadryl helped.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown ages. On unknown dates, patients may have been administered VAQTA that was exposed to -0.6 C for 4860 minutes, or 81 hours on "10 or 11 occasions from 10/31 to 11/13" (year unspecified) (dose, route and lot number were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports received from the same source (MARRS#1311USA008513 and MARRS#1311USA009162). Additional information has been requested.
Patient received J&J vaccine on 8/18/2021 at approximately 5:42pm. Prior to getting vaccine, he stated that he had fear of needles but wanted to get vaccine anyway. He was given vaccine and counseled to stay by the pharmacy for at least 15 minutes. Patient got up after getting vaccine and was walking around near pharmacy when he felt his vision get blurry and he was dizzy. Pharmacy tech noticed patient was not feeling well and causght patient just before he fell toward pharmacy counter. Patient did not hit his head. He was sitting on the floor and felt nauseous, sweaty, and dizzy. He stated he hadn't eaten for hours. He was given a bottle of water and drank it. After nausea feeling passed after 5-10 minutes, patient took 1 glucose tablet. By this time, he was feeling better. He was able to get up from the floor and sit in a chair. Patient also stated he had "blacked out" for a few minutes and did not recall almost falling near the pharmacy counter. He also stated he was feeling very shaky prior to blacking out. These events all took place within about 15 minutes. Patient remained at pharmacy for a total of about 45 minutes before someone came and picked him up.
8-21-10 Pain, slight swelling and tenderness (L) thigh, T. 99.8. Started on Cephalexin 250/5 10 ml BID. 8-23-10 (L) proximal thigh swollen, no significant erythema or fluctuance. T. 99.6. TSF to hospital per car per mother.
I had body aches, runny nose, headache, felt achy all over, I felt miserable. I made an appointment to go in to see my doctor who did a test, that checked for RSV, COVID-19, Influenza A and B. pneumonia. All four test came back negative, she said I had a sinus infection, she told me to take SUDAFED and also prescribed a Z-PAK. I got sick from the Z-PAK, I cannot take this medication.
reported having a "severe reaction"; This spontaneous report was received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       In November 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) route of administration reported as "injection", for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported).         In November 2018, the patient experienced a severe reaction (vaccination complication). At the time of reporting, the outcome of the event was unknown.        The causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Redness/swelling at site, pruritus, difficulty breathing, warm to touch, patient "felt hot" all night, sweating.
upset stomach; her head was throbbing with a really bad headache; This is a spontaneous report received from a non-contactable consumer (Patient).  A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 (unsure of the date but about 3 weeks ago) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, with the first vaccine she developed upset stomach and her head was throbbing with a really bad headache. This developed about 12 hours later. She is still having stomach issues and head hurts. Patient was scheduled to receive her second dose of the vaccine. She inquired whether the vaccine work with the spike protein and also inquired whether she can take an antinausea medicine or a xanax before the vaccine to help with her stomach. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
a 1/5 th red line on my left arm going up my arm about 10 inches with a single red dot on the tip of my middle left finger. Both lasted for approx. 5 days
Pt had large bruise @ inject site; nurse reports that several pts have had a large bruise than usual @ 2 to 3 wks; recovered;