chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; swollen lymph node glands; the swelling also was on side of my face all down to the jaw line; swelling above my ears and I can tell that the ear was swollen on the inside; I was had very sharp pain every so often in my ears; sharp pain in my throat; I wasn't able to do too much drinking or eating; under my jaw line was swollen and this was very uncomfortable it hurts; under my jaw line was swollen and this was very uncomfortable it hurts; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206 and Expiry Date of covid 19 vaccine: Unknown), dose 1 via an unspecified route of administration on 07Mar2021 (at the age of 69-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Back problems (she had injection in my back probably 6 weeks ago), Aneurysm that she kept a watch on, High blood pressure, Cholesterol and Thyroid. The patient concomitant medications included a lot of other unspecified medicine. On 11Mar2021, the patient experienced allergic reaction, swollen lymph node glands, the swelling also was on side of her face all down to the jaw line, swelling above her ears and she can tell that the ear was swollen on the inside, very sharp pain every so often in her ears, sharp pain in her throat, she was not able to do too much drinking or eating, under her jaw line was swollen and this was very uncomfortable it hurts. The clinical details of the events as follows: consumer stated, she did not want to use the portal to report this but she wanted to talk about the side effects that she had only received the very first shot of the COVID vaccine and she felt like she had allergic reaction, so she also wondering should she even get the second shot, but her side effects was definitely the swollen lymph node glands, the swelling also was on side of her face all down to the jaw line and also swelling above her ears and she could tell that the ear was swollen on the inside and she was had very sharp pain every so often in her ears and she was not really able to do too much drinking or eating because every time she would swallow she would have sharp pain in her throat, yeah and her swelling lymph node gland was also from her ear down, neck and under her jaw line was swollen that did not take place until 4 days later after she took the shot, the first shot and this was very uncomfortable it hurts. Consumer stated, so she would like someone to basically call me and let her know is it safe for her to take second shot and she worried about it. There was no investigation Assessment provided. No treatment was received for the events. The patient outcome of the events was resolved on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 13SEP96 & p/vax devel two red spots, one on the back of leg & one on forehead & was feverish;
sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 08-Dec-2020.  This case involves a patient of unknown demographics who got sick (illness), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient had shot three times and got sick four days later and stayed sick for three or more weeks. The patient did not have one in twenty years and had not been sick since then. The patient did not care what the doctor said and reported not going to take another one.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Ringing Ear; Headache; Chills; Nausea; Left sore arm; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing Ear), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Left sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic and Prediabetes. Concomitant products included METFORMIN for an unknown indication.    On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing Ear), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Left sore arm). At the time of the report, TINNITUS (Ringing Ear) had not resolved and HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Left sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Information has been received from a physician concerning a 70 year old male who "about three weeks ago" on approximately 12-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. The patient presented to the clinic on 05-MAR-2007 (about three weeks after vaccination which was also reported to be as soon as he could since he just got back from a cruise), complaining of a "very painful rash on his trunk." The physician reported that the patient started to develop shingles about two days into his cruise (specific date not specified). There was no product quality complaint involved. No further information was provided. Additional information has been requested.  Information has been received from a physician and a registered nurse concerning a 71 year old male with no known allergies who on 02-JAN-2007 at 14:00 was vaccinated SC in the left arm with 0.65 ml first dose of ZOSTAVAX (Oka/Merck) (lot # 654603/1405F). Mid February the patient developed a spide-like bite on his left lower neck, two days later this progressed into lbister lesions which were painful and severely sensitive. The pain was noted to be in the left shoulder into the chest. The patient presented to the clinic on 05-MAR-2007, complaining of a "very painful rash on his trunk". The physician reported that the patient started to develop shingles about two days into his cruise. There were no labs performed. On an unspecified date the patient recovered. It was reported that the patient had no recent exposure to chicken pox or herpes zoster. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Breakthrough case admission after 2 admissions Pfizer 3/8/21 Lot# EN6206;  Pfizer 3/29/21 lot# ER8732;  Pfizer 11/28/21 Lot# FG3527
Was the sickest I ever felt. Much worse than the two prior doses.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Was the sickest I ever felt. Much worse than the two prior doses.".  Additional information: The patient was not diagnosed with covid prior to vaccination. The patient was not test for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101288014 similar report from same reporter
Injection site pain and swelling, also fatigue, headache, joint pain ,chills,  nausea, and fever.
5cm by 4cm swollen right upper arm and 2 by 2 cm lower right arm lateral aspect.
sore arm; headache; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 37-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on left arm on 23Mar2021 at 15:00 PM (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history includes hypothyroidism. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 10:00 AM, the patient had experienced sore arm, headache and fatigue. The patient had not received any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events for headache, fatigue, sore arm was recovered on an unknown date at the time of this report.    No follow-up attempts are possible. No further information is expected.
The mother of an 18 month old female reported that her daughter, inadvertently, received a subcutaneous injection of Prevnar on 7/15/00. The child also received a subcutaneous injection of TriHIBit (Aventis Pasteur Inc) "right next to" the Prevnar injection site. Fifteen days, post vax, the child developed nausea and vomiting.
That evening at dinner time felt fatigue, Arm ache, muscle ache, headache  Next day I was nausea and extreme fatigue. Glands was sore. I spent about 2 days in bed. I felt awful. The morning of the 15th I felt normal.
Fatigue; currently burning nose, sneezing, nasal drainage; discovery of nodule on Thyroid; elevated neutrophils and white blood count
Parents reported child's DOB, actual DOB   Child rec'd a Pfizer adult (.3cc, purple top) when he was 11 years old.
Swollen injection site in left upper tricep area which expanded over time to encompass the whole bicep and tricep.  Could not be covered by clothing.  This lasted more than 10 days.
** Began coughing in mid March after spending extended time in hot Florida sun. Coughing continued for approximately five weeks. Along with onset of coughing also developed a urinary-track infection.  Visited Dr., my PCP, April 23. I would have seen him earlier, but he was on vacation. I did do a Tele visit with Dr., in late March, who prescribed medicine for the urinary infection. By this time the coughing had subsided, so I did not seek her help with that issue. Subsequently, coughing started again. When I visited Dr. in April, he felt that the coughing was triggered by an allergic reaction and possibly by acid reflux. He prescribed medication to treat the allergies. I also took an OTC drug for acid reflux. The coughing stopped a short time later.
25 mins p/vax mom returned w/reddness in face & swelling lower eye lids; no resp distress; seen by MD;
This spontaneous report as received from a 62 year old female consumer reporting on herself, with a drug allergy/reaction to morphine. The patient's medical history was not reported. On 17-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml (reported as standard dose) (route, lot and expiration dates were not reported). Concomitant therapies included an unspecified flu vaccine (manufacturer unknown) 3 months before and regular regimen of unspecified medications. Approximately on 24-DEC-2013, reported as 1 to 2.5 weeks after vaccination, the patient stated that after receiving ZOSTAVAX she noticed that she began having very small eruptions of tiny bumps along her abdomen and left side. The patient stated that the bumps are very small. Around the size of the head of a pin and are itchy. Also explained that the bumps are intermittent and often appear one at a time before drying up. The patient stated that at this time she notices about six of these bumps that are currently dried up and may indicate the end of the occurrences all together. At the time of the report the patient was recovering from the events. The patient did not sought for medical attention or received any treatment. No lab diagnostics were performed. This is one of the two reports from the same source. Additional information has been requested.
Patient said she woke up in middle of night and had chills and shook for about 30 minutes. She also had a very sore arm on 12/5/2018.
body aches; chills; Low grade fever/low grade temp; Headache; she had like a little bubble in that shot area/a little swollen area; This is a spontaneous report from a contactable consumer (patient's husband).  A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9267), via an unknown route, on 23Feb2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided) administered on unknown date for COVID-19 immunisation. The patient did not have a relevant medical history and concomitant medications.  On 23Feb2021, the patient had body aches, chills, and low grade fever/low grade temp. Then, the patient developed headache. When she got the shot, she had like a little bubble in that shot area, he was not sure if that is common or not. He confirmed like a little swollen area. The patient took paracetamol (TYLENOL) that didn't work so she asked if could take acetylsalicylic acid (ASPIRIN). The patient was recovering from chills and had not recovered from headache. The outcome of the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
unknown vaccine site.  Patient reports losing vision 15 minutes after receiving her second dose of Pfizer-Biontech Covid-19 vaccine.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included elevated blood pressure.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue/tiredeness. On 13-MAR-2021, the subject experienced fast heart beats.consumer got the vaccine week ago, suffering from fatigue and tiredeness that did not go away and fast heart beats The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart beats, and had not recovered from fatigue/tiredeness. The reporter did not report causality between covid-19 vaccine ad26.cov2.s and  fast heart beats and fatigue/tiredness..Company causality between covid-19 vaccine ad26.cov2.s and fast heart beats, fatigue/ tiredeness was possible. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
very itchy; vaccination site redness; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (vaccination site redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (vaccination site redness). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (vaccination site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.
blood in urine; 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 BLOOD URINE PRESENT (blood in urine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (blood in urine). At the time of the report, BLOOD URINE PRESENT (blood in urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported via chat bot and asked if anyone reported having blood in urine after taking the vaccine. No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   Reporter did not allow further contact
-Large red blotch on neck immediately after injection; resolved within 20 minutes, no shortness of breath or other signs of allergic reaction - Extreme fatigue next day (slept 15 hours) - diarrhea (moderate, x4 day on Day 2 and Day 3 after injection ) - stomach/abdominal cramps - feeling unwell day of injection, and on Day 2 and Day 3 after injection - headache - feeling hot (but no fever) - severe arm pain (injection site) - no appetite Note: it is now the end of Day 3 after the vaccine, and my son feels well.
Received 1st Covid Vaccination  June 14th. Received 2nd Covid Vaccination July 10th. Woke July 11th covered in rash scalp, face, neck, chest, arms, hands, back. Received medical care at urgent care center. August 13. Rx prednisone and Hydroxyzine. As of today, still have rash on hands, neck, and face.
Rec'd call from reporting symptoms after receiving her Pfizer COVID-19 booster vaccine on 12/6/2021 in the right deltoid. Patient stated she developed swelling of the lymph node the size of a golf ball and pain 5 to 6/10 in the right arm. Patient stated the increases with movement. Patient stated the swelling and pain started this morning at 0300. Patient stated she has been alternating Tylenol and Ibuprofen for the pain and swelling. Patient stated she has also been applying warm compresses for the swelling. Patient stated the measures she has been taking is giving some relief. Patient stated the last time she took Ibuprofen was 0300 and Tylenol was 0830. Patient stated she does not feel like she needs to be seen by a provider at this time and wants to watch for a couple of days to see if symptoms resolve on their own. IF symptoms don't resolve Patient stated she will contact the Vaccine Support Line to be seen by a provider. Advised Patient to continue alternating the Tylenol and Ibuprofen per pack instructions as needed for pain and swelling and to apply cold compresses for 15 to 20 minutes at a time every 2 hours as needed. Patient voiced understanding and had no further questions at this time.
PSA numbers went up; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA numbers went up) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA numbers went up). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA numbers went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Prostatic specific antigen: increased (High) increased.         No concomitant drug details were reported. No treatment details were reported. On follow-up Patient said he has a MRI for his prostate cancer coming up Friday (30Jul2021).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Suspected drug start dates has been updated.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised that the expiration dates were  deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufacturer dates on the box and vials. Therefore, we contacted Pfizer to obtained expiration dates directly from them.  No adverse reaction were reported from the patient at the time of vaccination. No adverse reactions were reported since the administration of vaccination.
Tinnitus--ringing in ears--constant-- Increased bowel movements--multiple times a day--was normal prior to booster shot
Fever 103 and vomiting beginning a few hours after DTAP was given and lasting 12 hours. No treatment given. Per mom this has happened after each DTAP vaccine (done by another pediatrician).
Six weeks after vaccine,  started having menstrual cycles that are very heavy every 18-20 days. Have always been regular before
Kidney stones; Vaccine caused sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4475283-00.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162590), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEPHROLITHIASIS (medically significant), outcome "recovering", described as "Kidney stones"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Vaccine caused sore arm". The action taken for adalimumab was unknown.  Clinical Information: It was reported that, solicited report from the USA by a consumer of an adult male with events of gxcv non-serious kidney stones and vaccine caused sore arm with Humira (Adalimumab). On unknown dates, the patient experienced kidney stones and vaccine caused sore arm. On an unknown date, vaccine caused sore arm resolved. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "kidney stones" and "vaccine caused sore arm" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of kidney stones" and "vaccine caused sore arm. 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