chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased joint pain and stiffness; Increased joint pain and stiffness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Increased joint pain and stiffness) and ARTHRALGIA (Increased joint pain and stiffness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 26-Nov-2021, the patient experienced JOINT STIFFNESS (Increased joint pain and stiffness) and ARTHRALGIA (Increased joint pain and stiffness). At the time of the report, JOINT STIFFNESS (Increased joint pain and stiffness) and ARTHRALGIA (Increased joint pain and stiffness) was resolving.            No concomitant medication provided. No treatment information mentioned.  Patient had increased joint pain and stiffness ever since taking Moderna booster.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-569498 (Patient Link).
This spontaneous case, initially received from other health professional, concerns a 32-year-old, adult pregnant female patient. The patient had four previous pregnancies, out of which miscarriage occurred in two pregnancies. The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptive method. The patient had no history of birth defects and congenital anomalies in the previous pregnancies. The patient did not use any medications prior to pregnancy. The patient's husband did not use any medications prior to conception. The patient's concomitant medications included prenatal vitamins and folic acid for unknown indications. On 26-Sep-2018, the pregnant patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252659, expiry date: 31-May-2019 and anatomical location: not reported). It was reported that, after vaccine administration, the patient did not experience any adverse event. There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. The patient's estimated delivery date (EDD) was reported as 06-Feb-2019. The reporter assessed this case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (IRD: 27-Sep-2018): The sentence in the narrative was changed from 'the patient had no birth defects and congenital anomalies were occurred in previous pregnancies" to "the patient had no history of birth defects and congenital anomalies in the previous pregnancies".
35 y/o and 25 weeks pregnant at the time of vaccination, first time pregnancy, EDD 7/22/201. Received vaccine on Thus 4/8/21 during 9am appointment and felt arm/muscle pain immediately after, slight throat tightness. Waited for 30 minutes due to previous history of allergies and cleared to leave. After first 12 hours, had initial onset of feverish, chills, moderate headache, and fatigue that lasted through 48 hours after vaccine. Friday 4/9/21 evening ~7pm, almost 36 hours after vaccine, woke up from brief nap with profuse sweating, chills, and severe, constant abdominal pain. Symptom was new and never felt previously throughout entire pregnancy. Consulted with L&D who advised to test, hydrate, and monitor symptoms. Severe abdominal pain lasted over 4 hours, only began to subside around midnight. Next morning, pain was not as severe, but was still persisted through Sunday, and began to slowly subside with each day. Telemedicine consult with doctor on Tues 4/13/21 to review symptoms, follow up tests ordered.
I have suffered with Endometriosis and PCOS for nearly my entire reproductive life. Two weeks after my first Pfizer vaccine, I had doubling over intense pain that made me pass out. I have had a hx of this due to Endometriosis but have not experienced these symptoms in years. The following day I began an out of cycle period which was full of major clots. I am typically on a 28 day cycle so for it to be off is unusual. The most telling is the  amount of bleeding and clots I have never experienced in my entire life. Clots have been continuing for 3 days now and the size of a small orange or plum. I have not been sexually active in over a year so there is no risk of pregnancy or anything that would warrant clots of this nature.
armpit pain; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (armpit pain) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced AXILLARY PAIN (armpit pain). At the time of the report, AXILLARY PAIN (armpit pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
On 3/19/01, pt was seen for an injection site reaction. It was reported that no medication was ordered. Unspecified medical attention was sought. Another pt (WAES 01032345) who recvd same vax with same lot # had a similar experience. Addtl info has been requested.
Dizzy disoriented. Evening had itching in scalp base progressing to entire scalp. Next day had hives on chest.
Small number of hives two hours after shot that faded within an hour; small number of hives 24 hours after shot that faded within an hour.
Patient states that approximately 30 minutes after shot he had stomache discomfort. Denies nausea, emesis, diarrhea, fever, difficulty breathing, chest pain, chills. Denies itching, redness, warmth or harden, hives, coughing, sleepy, wheezing or abdominal cramping. Stomache discomfort lasted approximately 9 hours. Denies seeking medical treatment or taking any medication for this.
10/27/21, 5:30am- Chills, Body Aches, Headache, Fatigue 10/27/21, 7:30am- Took Tynenol 10/27/21, 11:00am- Chills, Body Aches, Headache, Fatigue 10/27/21, 3:00pm- Symptoms subsided for the most part, mild headache remained
pt recvd vax & pt went limp mom's arms & stared w/eyes opened & arms crossed over chest; episode lasted 30 seconds; pt was then alert & crying; pt's pupils equal & reactive pt followed past midline; pt became playful;
Narrative: COVID infection following COVID vaccine series 05/24 Janssen, dose#1 08/14 pt cc: cough, rhinorrhea exposure: unknown 08/16 COVID swab, result: detected 08/16 SARS-COV-2 LINEAGE AY.25 08/16 SARS-COV-2 CLADE 21A DELTA
DTaP #5 given Left DT red, swollen, hot to touch. Started Sat. Tylenol and ice to area by pt's mother.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 77-year-old female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed fatigue (first and second dose, felt tiredness), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This is a report referring to a 29 year old male who, on 6/6/99, received his 1st dose of Lymerix. Four hours later, the pt experienced chills, shakes and body aches. These symptoms lasted for 2 hours and then resolved. No treatment was given. The most recent information, received on 7/8/99, reports the condition of the pt is resolved.
numb right side of my face; body had a bunch of like pins and needle in it; Headache; This is a spontaneous report from a contactable consumer. This 38-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3302), via unspecified route of administration, on 03Mar2021 (at the age of 38-year-old), as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 03Mar2021 probably 5 minutes after vaccination, the patient experienced like right side of her body had a bunch of like pins and needle in it and was like numb and she didn't know, she tried looking it up, but she didn't see anything about that happening. Consumer further stated, when she was saying that she got it in her left arm but the right side of her face, arm, leg all of it felt bad. She wasn't sure if it was a normal reaction or not. She doesn't know whether or not she should be getting the second shot or not. The patient asked regarding the events if other people had the same experience or not. The patient stated that she did not took any medication for treatment of other events but took ibuprofen as a treatment for headache. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Patient complained of Flushing/sweating, Nausea, and dizziness.  BP 143/97, HR 76, RR 18 -- > 137/91, 75, 18.  Pt A&O x4, VSS, no Resp distress.  Water/juice given.  Pt states symptoms resolved and released from vaccination site.
her left arm started getting red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (her left arm started getting red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma and High cholesterol.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (her left arm started getting red). At the time of the report, VACCINATION SITE ERYTHEMA (her left arm started getting red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Patient was vaccinated with Moderna vaccine not approved for age group due to miscommunication.  Patient is 17 years  old.  Pt was observed for 15 mins and there weren't any adverse events reported.
Extended Spike in blood pressure and heart rate.   Went from home by ambulance to the ER.  Sent home after six hours.  No crisis event but went to my dr.    Saw cardiologist 3/12 and wearing a two-week Zio patch to rule out other issues.
On 4/7/11 pt. returned for #2 TWINRIX vaccine. After receiving inj. pt. reported that on 3/3/11 after receiving Polio, #1 TWINRIX, TYPHIM VI & Yellow Fever vaccines his (R) knee became edematous & which painful. Cough lasted 3-4 days. He denies fever, rash or joint warmness.
Same day: Sore arm at site. Next day: Tired, not able to accomplish much. Some aches and pains, but not bad. After that:  Felt good/normal. Two weeks later:  Noticed a low-grade headache in the front of my head, assumed it was allergies as usual for this time of year, and started taking Zyrtec, but this has made no difference compared to past years. This has continued more or less daily, with onset in the afternoon (around 3:00 or so) and evening (around 9:00 or so). Headache is not too bad, but very noticeable (about 4 on a scale of 1 to 10). I take two Advil in the afternoon and that helps, but maybe only until evening when I have another headache.
Per patient reports, a few days after vaccine administration patient developed rapid heart rate, broke out into cold sweat, went into A-Fib, was put on ELIQUIS, patient was later put in the hospital for rapid heartrate in the 160's, was given IV meds and had cardioversion, A-fib now under control but on medication. Patient has seen Dr.
PARTIAL ADMINISTRATION OF VACCINE; This spontaneous report received from a pharmacist 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: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced partial administration of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial administration of vaccine was not reported. This report was non-serious.
Site: Pain at Injection Site-Medium, Systemic: Diarrhea-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
I received the vaccine on 3/10/21 and felt fine until 3/16/21 in the AM.  When I turned from my left side to my right side I became extremely dizzy and disoriented.  The room was spinning and I became nausea.    It happened a few  more times throughout the day on Tuesday.  Same thing happened on Wednesday 3/17/21 while still lying in bed.  I feel exhausted and neaseaus on an off during today and when I turn my head I become dizzy.
I started to have a flare up of my ulcerative colitis; This is a spontaneous report from a contactable pharmacist (Patient). A 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Jan2021 13:00 as dose 1, single for COVID-19 immunization.  Medical history included colitis ulcerative from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that on 02Feb2021 06:00, two days after the first dose he started to have a flare up of his ulcerative colitis which he had not had a flare up for over 4 years. This flare lasted almost 3 weeks. It went away by the time he had to do the second dose. Patient had to take mesalamine, high two prednisone, dicyclomine and patient had a very bad time. Patient had to visit emergency room and physician office due to event. Since the vaccination, patient tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction: negative   on 01Mar2021 Nasal Swab. The outcome of the event was recovered with sequelae.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on close temporal relationship the causal association of the events ulcerative colitis flare up and blood in my feces with the usage of the vaccine BNT162B2 cannot be excluded. 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.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, hard of hearing, nerve damage, multiple allergies and sinusitis. On an unknown date, the outcome of the shingles, hard of hearing, nerve damage and multiple allergies were not recovered/not resolved and the outcome of the sinusitis was unknown. It was unknown if the reporter considered the shingles, hard of hearing, nerve damage, multiple allergies and sinusitis to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm down below the shoulder. After vaccination, the patient had shingles in the middle of his spine and he experienced trouble with the nerves in both legs. The patient also experienced damaged hearing which also started from last year and it was getting worse and varies from day to day. The patient also getting allergies including sinus in his head, which started later a receiving the SHINGRIX dose. The patient failed to get the 2nd dose of SHINGRIX in August or September 2018. The patient had an appointment with surgical on 6th March 2019 to did a hearing test. The reporter consented to follow up.
I20.0 UNSTABLE ANGINA 4/25/2023 ANEMIA UNSTABLE ANGINA I21.4 ACUTE NON ST ELEVATION MI 4/25/2023 ANEMIA UNSTABLE ANGINA
right under her jawline, on the side where she got her shot, like her lymph node or whatever it is, is swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 12Jul2021 as DOSE 1, SINGLE for covid-19 immun-isation. Medical history included heart issues from an unknown date and unknown if ongoing I have heart issues. The patient's concomitant medications were not reported. On Jul2021 caller reports I am not doing too good stating that she received her first covid vaccine dose on 12Jul2021, she reports that I was kind of not feeling good before that because I have heart issues and she say her doctor. Caller reports that she started feeling better but now, starting about 1 hour ago, on the right side (the same side as my shot) in front her right ear, my lymph node under her jaw line she started noticing a swollen area that is big. Caller reports that she called her HCP, but they didn't want to address it, but they said she could come in, but she reports that her car is broken down and she isn't able to get to the office. Caller now asking should I be worried about this, should I go to the ER. Caller reports that she didn't know if her symptom is from the vaccine or if it is related to the heart monitor she has been wearing since Tuesday that she just took off today at 3:00 reporting that she may be having a reaction to the stickers that come with the heart monitor. Also asking It's not going to cut off my breathing right, it's been like an hour now if something bad was going to happen it would have already happened right. Caller reports I just wish this hadn't have happened because now I don't want the second dose. The caller is calling regarding COVID-19 vaccine. The caller states she had the vaccine on 12Jul2021, and her second dose is not until 02Aug2021. She mentions she is a heart patient. She wasn't feeling so good, but she explains that kind of happened before the shot. She is calling regarding what happened in the past 30 minutes. Right under her jawline, on the side where she got her shot, like her lymph node or whatever it is, is swollen. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many joints, tremendous fatigue, inability to concentrate, dizziness.  Swelling, pain, redness left arm shoulder to elbow.Took Tylenol, spent most of the day in bed.  Not hungry. By Tues I felt much better, but fatigued (still needed 2 naps), little appetite.  Wed continued recovery, but weak, arm continued red, swollen, painful to the touch.  Today, Sunday and a week after injection, I feel normal.
Information has been received from the physician concerning a 6-year-old male with no pre-existing allergies, birth defects, or medical conditions who on 22-NOV-2004 was vaccinated subcutaneously in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot# reported as "0649F"). There was no illness at the time of vaccination. On 03-NOV-2006 the patient experienced a rash on his trunk, arms and legs for 5 days. Subsequently, the patient recovered on 08-NOV-2006. Additional information has been requested.
patient was admitted overnight to ER, found 2 embolism and was diagnosed with pulmonary embolism. being treated with blood thinners. discharged 6/19/21
Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides; Palpitation; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides), PALPITATIONS (Palpitation), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle pain). On 23-Feb-2021, the patient experienced CHEST DISCOMFORT (Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides) and PALPITATIONS (Palpitation). On 19-Feb-2021, HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved. At the time of the report, CHEST DISCOMFORT (Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides) and PALPITATIONS (Palpitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No corrective treatment was provided.